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Sample records for hiv pre-exposure prophylaxis

  1. Pre-exposure prophylaxis of HIV

    Science.gov (United States)

    Naswa, Smriti; Marfatia, Y. S.

    2011-01-01

    Pre-exposure prophylaxis (PrEP) is an experimental approach to HIV prevention and consists of antiretroviral drugs to be taken before potential HIV exposure in order to reduce the risk of HIV infection and continued during periods of risk. An effective PrEP could provide an additional safety net to sexually active persons at risk, when combined with other prevention strategies. Women represent nearly 60% of adults infected with HIV and PrEP can be a female-controlled prevention method for women who are unable to negotiate condom use. Two antiretroviral nucleoside analog HIV-1 reverse transcriptase inhibitor drugs are currently under trial as PrEP drugs, namely tenofovirdisoproxilfumarate (TDF) alone and TDF in combination with emricitabine (FTC), to be taken as daily single dose oral drugs. There are 11 ongoing trials of ARV-based prevention in different at risk populations across the world. The iPrex trial showed that daily use of oral TDF/FTC by MSM resulted in 44% reduction in the incidence of HIV. This led to publication of interim guidance by CDC to use of PrEP by health providers for MSM. Few other trials are Bangkok Tenofovir Study, Partners PrEP Study, FEM-PrEP study, and VOICE (MTN-003) study. Future trials are being formulated for intermittent PrEP (iPrEP) where drugs are taken before and after sex, “stand-in dose” iPrEP, vaginal or rectal PrEP, etc. There are various issues/concerns with PrEP such as ADRs and resistance to TDF/FTC, adherence to drugs, acceptability, sexual disinhibition, use of PrEP as first line of defense for HIV without other prevention strategies, and cost. The PrEP has a potential to address unmet need in public health if delivered as a part of comprehensive toolkit of prevention services, including risk-reduction, correct and consistent use of condoms, and diagnosis and treatment of sexually transmitted infections. PMID:21799568

  2. Pre-Exposure Prophylaxis for HIV Prevention : Safety Concerns

    NARCIS (Netherlands)

    Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

    Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present

  3. HIV Pre-exposure Prophylaxis Program Implementation Using Intervention Mapping.

    Science.gov (United States)

    Flash, Charlene A; Frost, Elizabeth L T; Giordano, Thomas P; Amico, K Rivet; Cully, Jeffrey A; Markham, Christine M

    2018-04-01

    HIV pre-exposure prophylaxis has been proven to be an effective tool in HIV prevention. However, numerous barriers still exist in pre-exposure prophylaxis implementation. The framework of Intervention Mapping was used from August 2016 to October 2017 to describe the process of adoption, implementation, and maintenance of an HIV prevention program from 2012 through 2017 in Houston, Texas, that is nested within a county health system HIV clinic. Using the tasks outlined in the Intervention Mapping framework, potential program implementers were identified, outcomes and performance objectives established, matrices of change objectives created, and methods and practical applications formed. Results include the formation of three matrices that document program outcomes, change agents involved in the process, and the determinants needed to facilitate program adoption, implementation, and maintenance. Key features that facilitated successful program adoption and implementation were obtaining leadership buy-in, leveraging existing resources, systematic evaluation of operations, ongoing education for both clinical and nonclinical staff, and attention to emergent issues during launch. The utilization of Intervention Mapping to delineate the program planning steps can provide a model for pre-exposure prophylaxis implementation in other settings. Copyright © 2018. Published by Elsevier Inc.

  4. Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns.

    Science.gov (United States)

    Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

    2017-04-01

    Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www.clinicaltrials.gov " and scholar.google, using combination search terms 'pre-exposure prophylaxis', 'safety concerns in the use of pre-exposure prophylaxis', 'truvada use as PrEP', 'guidelines for PrEP use', 'HIV pre-exposure prophylaxis' and 'tenofovir' to identify clinical trials and literature on PrEP. We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was tenofovir disoproxil fumarate/emtricitabine in a combined form as Truvada ® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits

  5. Recent advances in pre-exposure prophylaxis for HIV.

    Science.gov (United States)

    Desai, Monica; Field, Nigel; Grant, Robert; McCormack, Sheena

    2017-12-11

    Although pre-exposure prophylaxis (PrEP)-the use of antiretroviral drugs by non-infected people to prevent the acquisition of HIV-is a promising preventive option, important public health questions remain. Daily oral emtricitabine (FTC)-tenofovir disoproxil fumarate (TDF) is highly efficacious in preventing the acquisition of HIV in people at risk as a result of a range of different types of sexual exposure. There is good evidence of efficacy in women and men, and when men who have sex with men use event based dosing. Studies have been conducted in several countries and epidemics. Because adherence to this treatment varies greatly there are questions about its public health benefit. Oral FTC-TDF is extremely safe, with minimal impact on kidney, bone, or pregnancy outcomes, and there is no evidence that its effectiveness has been reduced by risk compensation during open label and programmatic follow-up. It is too early to assess the impact of this treatment on the incidence of sexually transmitted infections (STIs) at a population level. Many challenges remain. Access to pre-exposure prophylaxis is limited and disparities exist, including those governed by race and sex. Different pricing and access models need to be explored to avoid further widening inequalities. The optimal combination prevention program needs to be defined, and this will depend on local epidemiology, service provision, and cost effectiveness. This review updates the evidence base for pre-exposure prophylaxis regarding its effectiveness, safety, and risk compensation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. Adolescent pre-exposure prophylaxis for HIV prevention: current perspectives

    Directory of Open Access Journals (Sweden)

    Machado DM

    2017-11-01

    Full Text Available Daisy Maria Machado,1 Alexandre Machado de Sant’Anna Carvalho,2 Rachel Riera3 1Disciplina de Infectologia Pediátrica, Departamento de Pediatria, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, 2Universidade Federal do Rio de Janeiro, Rio de Janeiro, 3Disciplina de Medicina Baseada em Evidências, Departamento de Medicina, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil Abstract: Adolescents are a critical population that is disproportionately impacted by the HIV epidemic. More than 2 million adolescents between the age group of 10 and 19 years are living with HIV, and millions are at risk of infection. HIV risks are considerably higher among girls, especially in high-prevalence settings such as eastern and southern Africa. In addition to girls, there are other vulnerable adolescent subgroups, such as teenagers, who use intravenous (IV drugs, gay and bisexual boys, transgender youth, male sex workers, and people who fall into more than one of these categories. Pre-exposure prophylaxis (PrEP is a new intervention for people at high risk for acquiring HIV, with an estimated HIV incidence of >3%. Recent data from trials show evidence of the efficacy of PrEP as a powerful HIV prevention tool in high-risk populations, including men who have sex with men, HIV-1-serodiscordant heterosexual couples, and IV drug users. The reported efficacy in those trials of the daily use of oral tenofovir, alone or in combination with emtricitabine, to prevent HIV infection ranged from 44% to 75% and was heavily dependent on adherence. Despite the proven efficacy of PrEP in adult trials, concerns remain about its feasibility in real-life scenarios due to stigma, cost, and limited clinician experience with PrEP delivery. Recent studies are attempting to expand the inquiry into the efficacy of such HIV prophylaxis approaches in adolescent populations, but there are still many gaps in knowledge, and no

  7. Adolescent pre-exposure prophylaxis for HIV prevention: current perspectives

    Science.gov (United States)

    Machado, Daisy Maria; de Sant’Anna Carvalho, Alexandre Machado; Riera, Rachel

    2017-01-01

    Adolescents are a critical population that is disproportionately impacted by the HIV epidemic. More than 2 million adolescents between the age group of 10 and 19 years are living with HIV, and millions are at risk of infection. HIV risks are considerably higher among girls, especially in high-prevalence settings such as eastern and southern Africa. In addition to girls, there are other vulnerable adolescent subgroups, such as teenagers, who use intravenous (IV) drugs, gay and bisexual boys, transgender youth, male sex workers, and people who fall into more than one of these categories. Pre-exposure prophylaxis (PrEP) is a new intervention for people at high risk for acquiring HIV, with an estimated HIV incidence of >3%. Recent data from trials show evidence of the efficacy of PrEP as a powerful HIV prevention tool in high-risk populations, including men who have sex with men, HIV-1-serodiscordant heterosexual couples, and IV drug users. The reported efficacy in those trials of the daily use of oral tenofovir, alone or in combination with emtricitabine, to prevent HIV infection ranged from 44% to 75% and was heavily dependent on adherence. Despite the proven efficacy of PrEP in adult trials, concerns remain about its feasibility in real-life scenarios due to stigma, cost, and limited clinician experience with PrEP delivery. Recent studies are attempting to expand the inquiry into the efficacy of such HIV prophylaxis approaches in adolescent populations, but there are still many gaps in knowledge, and no country has yet approved it for use with adolescents. The aim of this review was to identify and summarize the evidence from studies on PrEP for adolescents. We have compiled and reviewed published studies focusing on safety, feasibility, adherence to therapeutics, self-perception, and legal issues related to PrEP in people aged between 10 and 24 years. PMID:29238237

  8. PRE-EXPOSURE PROPHYLAXIS FOR PREVENTION OF HIV INFECTION

    Directory of Open Access Journals (Sweden)

    Ana Rita Diniz

    2015-04-01

    Full Text Available Objectives: To review existing data on Pre-Exposure Prophylaxis (PrEP for prevention of HIV infection, including the role of medical male circumcision, oral administration of antiretroviral drugs and topical microbicides. Data Sources: PubMed and www.clinicaltrials.gov. Review Methods: Comprehensive review. Results: Medical male circumcision has been shown to prevent 48-60% of new HIV-1 infections. The efficacy rate of antiretroviral drugs given per os to prevent HIV infection varies in direct association with the adherence rate (62.2% in TDF2 study with 84% adherence; 44% in iPrEx study with <50% adherence; 48% in Bangkok study with 67% adherence; 67-75% in Partners PrEP study with 82% adherence; and 6% in FEM-PrEP study with 40% adherence. As for the use of topic microbicides, the CAPRISA 004 study showed 39% reduction in HIV infection using a 1% tenofovir gel. On the other hand, PRO2000 gel showed a modest reduction of 30% which was not statistically significant. Conclusions: The studies suggest that medical male circumcision is highly cost-effective at preventing HIV infection but requires careful communication strategies to be successful. PrEP using antiretroviral drugs is also very effective but it is highly dependent on the adherence rate. As for topical microbicides, 1% tenofovir gel is currently the only promising option.

  9. To whom is HIV pre-exposure prophylaxis proposed?

    Science.gov (United States)

    Ayerdi-Aguirrebengoa, Oskar; Vera-García, Mar; Puerta-López, Teresa; Raposo-Utrilla, Montserrat; Rodríguez-Martín, Carmen; Del Romero-Guerrero, Jorge

    2017-05-01

    HIV Pre-Exposure Prophylaxis (PrEP) consists of administering antiretroviral drugs to seronegative individuals with high risk practices. The aim of the study was to describe the characteristics of recent seroconverted HIV patients in order to determine the profile of the appropriate candidates for PrEP. A descriptive study of all patients diagnosed with HIV infection in 2014, and who had achieved a documented negative serology over the previous 12 months. A specific form was completed to determine the sociodemographic, behavioural, and clinical features, with complementary tests being performed for other sexually transmitted infections. Almost all (98.4%) of the 61 recent seroconverted were men who have sex with men, and aged between 20 to 39 years (88.5%). They also had a background of sexually transmitted infections (80.3%), performed multiple and unprotected sexual practices (82.7%), and under the effect of recreational drugs (87%). The evaluation of the risk factors for HIV infection in seronegative patients should enable the appropriate candidates for PrEP to be identified. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  10. What is the place of pre-exposure prophylaxis in HIV prevention?

    Science.gov (United States)

    De Man, Jeroen; Colebunders, Robert; Florence, Eric; Laga, Marie; Kenyon, Christopher

    2013-01-01

    New tools are needed to bring down ongoing high HIV incidence. This review aims to evaluate the place of one of these new tools (pre-exposure prophylaxis) in a comprehensive prevention strategy. Several trials have demonstrated the safety and the efficacy of pre-exposure prophylaxis in HIV prevention. Two large trials have, however, failed to show such efficacy. This was likely due to poor adherence in these trials. New forms of long-acting pre-exposure prophylaxis currently in trials may deal with these problems of low adherence. Pre-exposure prophylaxis has been demonstrated to be cost-effective within certain settings. The introduction of pre-exposure prophylaxis into prevention programs needs to be carefully thought through. For example, pre-exposure prophylaxis-induced risk compensation, at both an individual and population level, could undermine other aspects of a comprehensive HIV prevention program. In conclusion, pre-exposure prophylaxis could be a useful additional tool for the prevention of HIV in specific high-risk groups. It should be implemented in a way that deals with issues such as ensuring high adherence and ensuring that pre-exposure prophylaxis does not detract from, but complements, other more fundamental elements of HIV prevention programs.

  11. Young Transgender Women's Attitudes Toward HIV Pre-exposure Prophylaxis.

    Science.gov (United States)

    Wood, Sarah M; Lee, Susan; Barg, Frances K; Castillo, Marne; Dowshen, Nadia

    2017-05-01

    Our primary aim was to explore themes regarding attitudes toward HIV pre-exposure prophylaxis (PrEP) among young transgender women (YTW), in order to develop a theoretical model of PrEP uptake in this population disproportionally affected by HIV. Qualitative study nested within a mixed-method study characterizing barriers and facilitators to health services for YTW. Participants completed an in-depth interview exploring awareness of and attitudes toward PrEP. Key themes were identified using a grounded theory approach. Participants (n = 25) had a mean age of 21.2 years (standard deviation 2.2, range 17-24) and were predominately multiracial (36%) and of HIV-negative or unknown status (68%). Most participants (64%) reported prior knowledge of PrEP, and 28% reported current use or intent to use PrEP. Three major content themes that emerged were variability of PrEP awareness, barriers and facilitators to PrEP uptake, and emotional benefits of PrEP. Among participants without prior PrEP knowledge, participants reported frustration that PrEP information has not been widely disseminated to YTW, particularly by health care providers. Attitudes toward PrEP were overwhelmingly positive; however, concerns were raised regarding barriers including cost, stigma, and adherence challenges. Both HIV-positive and negative participants discussed emotional and relationship benefits of PrEP, which were felt to extend beyond HIV prevention alone. A high proportion of YTW in this study had prior knowledge of PrEP, and attitudes toward PrEP were positive among participants. Our findings suggest several domains to be further explored in PrEP implementation research, including methods of facilitating PrEP dissemination and emotional motivation for PrEP uptake. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  12. Non-daily pre-exposure prophylaxis for HIV prevention

    Science.gov (United States)

    Anderson, Peter L.; García-Lerma, J. Gerardo; Heneine, Walid

    2015-01-01

    Purpose of review To discuss non-daily pre-exposure prophylaxis (PrEP) modalities that may provide advantages compared with daily PrEP in cost and cumulative toxicity, but may have lower adherence forgiveness. Recent Findings Animal models have informed our understanding of early viral transmission events, which help guide event-driven PrEP dosing strategies. These models indicate early establishment of viral replication in rectal or cervicovaginal tissues, so event-driven PrEP should rapidly deliver high mucosal drug concentrations within hours of the potential exposure event. Macaque models have demonstrated the high biological efficacy for event-driven dosing of oral tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) against both vaginal and rectal virus transmission. In humans, the IPERGAY study demonstrated 86% efficacy for event-driven oral TDF/FTC dosing among men who have sex with men (MSM), while no similar efficacy data are available on women or heterosexual men. The HPTN 067 study showed that certain MSM populations adhere well to non-daily PrEP while other populations of women adhere more poorly to non-daily versus daily regimens. Pharmacokinetic studies following oral TDF/FTC dosing in humans, indicate that TFV-diphosphate (the active form of TFV) accumulates to higher concentrations in rectal versus cervicovaginal tissue but non-adherence in trials complicates the interpretation of differential mucosal drug concentrations. Summary Event-driven dosing for TFV-based PrEP has promise for HIV prevention in MSM. Future research of event-driven PrEP in women and heterosexual men should be guided by a better understanding of the importance of mucosal drug concentrations for PrEP efficacy and its sensitivity to adherence. PMID:26633641

  13. HIV pre-exposure prophylaxis trials: socio-economic and ethical ...

    African Journals Online (AJOL)

    The advent of HIV pre-exposure prophylaxis (PrEP) as a HIV-prevention strategy has received optimistic support among HIV researchers. However, discourse on PrEP trials has tended to be dominated by the disputes arising between some activist groups and researchers about the research methodologies. Instead, this ...

  14. Offering pre-exposure prophylaxis for HIV prevention to pregnant and postpartum women: a clinical approach.

    Science.gov (United States)

    Seidman, Dominika L; Weber, Shannon; Cohan, Deborah

    2017-03-08

    HIV prevention during pregnancy and lactation is critical for both maternal and child health. Pregnancy provides a critical opportunity for clinicians to elicit women's vulnerabilities to HIV and offer HIV testing, treatment and referral and/or comprehensive HIV prevention options for the current pregnancy, the postpartum period and safer conception options for future pregnancies. In this commentary, we review the safety of oral pre-exposure prophylaxis with tenofovir/emtricitabine in pregnant and lactating women and suggest opportunities to identify pregnant and postpartum women at substantial risk of HIV. We then describe a clinical approach to caring for women who both choose and decline pre-exposure prophylaxis during pregnancy and postpartum, highlighting areas for future research. Evidence suggests that pre-exposure prophylaxis with tenofovir/emtricitabine is safe in pregnancy and lactation. Identifying women vulnerable to HIV and eligible for pre-exposure prophylaxis is challenging in light of the myriad of individual, community, and structural forces impacting HIV acquisition. Validated risk calculators exist for specific populations but have not been used to screen and offer HIV prevention methods. Partner testing and engagement of men living with HIV are additional means of reaching at-risk women. However, women's vulnerabilities to HIV change over time. Combining screening for HIV vulnerability with HIV and/or STI testing at standard intervals during pregnancy is a practical way to prompt providers to incorporate HIV screening and prevention counselling. We suggest using shared decision-making to offer women pre-exposure prophylaxis as one of multiple HIV prevention strategies during pregnancy and postpartum, facilitating open conversations about HIV vulnerabilities, preferences about HIV prevention strategies, and choosing a method that best meets the needs of each woman. Growing evidence suggests that pre-exposure prophylaxis with tenofovir

  15. [From Evidence to Health Policy Making: Pre-Exposure Prophylaxis for HIV Prevention].

    Science.gov (United States)

    Ko, Nai-Ying

    2016-12-01

    Pre-exposure prophylaxis (PrEP), in combination with traditional prevention strategies (such as condom use, voluntary HIV counseling and testing, and treatment for sexually transmitted infections), has been shown to effectively prevent HIV infection. As of September 2015, the World Health Organization recommends that people at substantial risk of HIV infection should be offered PrEP as an additional prevention choice, as part of comprehensive prevention. This article introduces how to apply a systematic review using the methodology of Grading of Recommendations Assessment, Development and Evaluation (GRADE) to write clinical guidelines. With support from the Taiwan Centers for Disease Control, the Taiwan AIDS Society published clinical guidelines for oral pre-exposure prophylaxis in Taiwan. Nurses are responsible to apply evidence-based knowledge and to use their professional influence to shape health policies related to HIV prevention.

  16. Polarised press reporting about HIV prevention: Social representations of pre-exposure prophylaxis in the UK press.

    Science.gov (United States)

    Jaspal, Rusi; Nerlich, Brigitte

    2017-09-01

    Pre-exposure prophylaxis is a novel biomedical HIV prevention option for individuals at high risk of HIV acquisition. Although pre-exposure prophylaxis has yielded encouraging results in various clinical trials, opponents argue that pre-exposure prophylaxis poses a number of risks to human health and to sexually transmitted infection prevention efforts. Using qualitative thematic analysis and social representation theory, this article explores coverage of pre-exposure prophylaxis in the UK print media between 2008 and 2015 in order to chart the emerging social representations of this novel HIV prevention strategy. The analysis revealed two competing social representations of pre-exposure prophylaxis: (1) as a positive development in the 'battle' against HIV (the hope representation) and (2) as a medical, social and psychological setback in this battle, particularly for gay/bisexual men (the risk representation). These social representations map onto the themes of pre-exposure prophylaxis as a superlatively positive development; pre-exposure prophylaxis as a weapon in the battle against HIV/AIDS; and risk, uncertainty and fear in relation to pre-exposure prophylaxis. The hope representation focuses on taking (individual and collective) responsibility, while the risk representation focuses on attributing (individual and collective) blame. The implications for policy and practice are discussed.

  17. Safety of oral tenofovir disoproxil fumarate-based pre-exposure prophylaxis for HIV prevention.

    Science.gov (United States)

    Mugwanya, Kenneth K; Baeten, Jared M

    2016-01-01

    Tenofovir disoproxil fumarate (TDF)-based pre-exposure prophylaxis is a novel HIV prevention strategy for individuals at increased sexual risk for HIV infection. For any biomedical prevention intervention, the bar for tolerating adverse effects in healthy persons is high compared to therapeutic interventions. We provide a concise summary of the clinical safety of TDF-based pre-exposure prophylaxis with focus on TDF-related effects on tolerability, kidney function, bone density, HIV resistance, sexual and reproductive health. The evidence base for this review is derived from a literature search of both randomized and observational studies evaluating efficacy and safety of TDF-based PrEP, TDF alone or in combination with emtricitabine, identified from PUBMED and EMBASE electronic databases, clinicaltrials.gov and major HIV conferences. TDF-based pre-exposure prophylaxis is a potent intervention against HIV acquisition when taken which is generally safe and well tolerated. The risk of the small, non-progressive, and reversible decline in glomerular filtration rate and bone mineral density as well as the potential selection for drug resistance associated with PrEP are outweighed, at the population level and broadly for individuals, by PrEP's substantial reduction in the risk of HIV infection.

  18. Antiretroviral pre-exposure prophylaxis prevents vaginal transmission of HIV-1 in humanized BLT mice.

    Directory of Open Access Journals (Sweden)

    Paul W Denton

    2008-01-01

    Full Text Available Worldwide, vaginal transmission now accounts for more than half of newly acquired HIV-1 infections. Despite the urgency to develop and implement novel approaches capable of preventing HIV transmission, this process has been hindered by the lack of adequate small animal models for preclinical efficacy and safety testing. Given the importance of this route of transmission, we investigated the susceptibility of humanized mice to intravaginal HIV-1 infection.We show that the female reproductive tract of humanized bone marrow-liver-thymus (BLT mice is reconstituted with human CD4+ T and other relevant human cells, rendering these humanized mice susceptible to intravaginal infection by HIV-1. Effects of HIV-1 infection include CD4+ T cell depletion in gut-associated lymphoid tissue (GALT that closely mimics what is observed in HIV-1-infected humans. We also show that pre-exposure prophylaxis with antiretroviral drugs is a highly effective method for preventing vaginal HIV-1 transmission. Whereas 88% (7/8 of BLT mice inoculated vaginally with HIV-1 became infected, none of the animals (0/5 given pre-exposure prophylaxis of emtricitabine (FTC/tenofovir disoproxil fumarate (TDF showed evidence of infection (Chi square = 7.5, df = 1, p = 0.006.The fact that humanized BLT mice are susceptible to intravaginal infection makes this system an excellent candidate for preclinical evaluation of both microbicides and pre-exposure prophylactic regimens. The utility of humanized mice to study intravaginal HIV-1 transmission is particularly highlighted by the demonstration that pre-exposure prophylaxis can prevent intravaginal HIV-1 transmission in the BLT mouse model.

  19. Combining biomedical preventions for HIV: Vaccines with pre-exposure prophylaxis, microbicides or other HIV preventions.

    Science.gov (United States)

    McNicholl, Janet M

    2016-12-01

    Biomedical preventions for HIV, such as vaccines, microbicides or pre-exposure prophylaxis (PrEP) with antiretroviral drugs, can each only partially prevent HIV-1 infection in most human trials. Oral PrEP is now FDA approved for HIV-prevention in high risk groups, but partial adherence reduces efficacy. If combined as biomedical preventions (CBP) an HIV vaccine could provide protection when PrEP adherence is low and PrEP could prevent vaccine breakthroughs. Other types of PrEP or microbicides may also be partially protective. When licensed, first generation HIV vaccines are likely to be partially effective. Individuals at risk for HIV may receive an HIV vaccine combined with other biomedical preventions, in series or in parallel, in clinical trials or as part of standard of care, with the goal of maximally increasing HIV prevention. In human studies, it is challenging to determine which preventions are best combined, how they interact and how effective they are. Animal models can determine CBP efficacy, whether additive or synergistic, the efficacy of different products and combinations, dose, timing and mechanisms. CBP studies in macaques have shown that partially or minimally effective candidate HIV vaccines combined with partially effective oral PrEP, vaginal PrEP or microbicide generally provided greater protection than either prevention alone against SIV or SHIV challenges. Since human CBP trials will be complex, animal models can guide their design, sample size, endpoints, correlates and surrogates of protection. This review focuses on animal studies and human models of CBP and discusses implications for HIV prevention.

  20. The future of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection.

    Science.gov (United States)

    Özdener, Ayşe Elif; Park, Tae Eun; Kalabalik, Julie; Gupta, Rachna

    2017-05-01

    People at high risk for HIV acquisition should be offered pre-exposure prophylaxis (PrEP). Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) is currently the only medication recommended for pre-exposure prophylaxis (PrEP) by the Centers for Disease Control and Prevention (CDC) in people at high risk for HIV acquisition. This article will review medications currently under investigation and the future landscape of PrEP therapy. Areas covered: This article will review clinical trials that have investigated nontraditional regimens of TDF/FTC, antiretroviral agents from different drug classes such as integrase strand transfer inhibitors (INSTI), nucleoside reverse transcriptase inhibitors (NRTI), and non-nucleoside reverse transcriptase inhibitors (NNRTI) as potential PrEP therapies. Expert commentary: Currently, there are several investigational drugs in the pipeline for PrEP against HIV infection. Increased utilization of PrEP therapy depends on provider identification of people at high risk for HIV transmission. Advances in PrEP development will expand options and access for people and reduce the risk of HIV acquisition.

  1. Pre-Exposure Prophylaxis and Antiretroviral Resistance: HIV Prevention at a Cost?

    OpenAIRE

    Hurt, Christopher B.; Eron, Joseph J.; Cohen, Myron S.

    2011-01-01

    Prompted by 3 cases of resistance noted in the Pre-Exposure Prophylaxis Initiative and TDF2 trials, we examined literature on mutations elicited by antiretrovirals used for pre-exposure prophylaxis. We discuss signature mutations, how rapidly these emerge, and individual-level and public health consequences of antiretroviral resistance.

  2. Planning for pre-exposure prophylaxis to prevent HIV transmission: challenges and opportunities

    Science.gov (United States)

    2010-01-01

    There are currently several ongoing or planned trials evaluating the efficacy of pre-exposure prophylaxis (PrEP) as a preventative approach to reducing the transmission of HIV. PrEP may prove ineffective, demonstrate partial efficacy, or show high efficacy and have the potential to reduce HIV infection in a significant way. However, in addition to the trial results, it is important that issues related to delivery, implementation and further research are also discussed. As a part of the ongoing discussion, in June 2009, the Bill & Melinda Gates Foundation sponsored a Planning for PrEP conference with stakeholders to review expected trial results, outline responsible educational approaches, and develop potential delivery and implementation strategies. The conference reinforced the need for continued and sustained dialogue to identify where PrEP implementation may fit best within an integrated HIV prevention package. This paper identifies the key action points that emerged from the Planning for PrEP meeting. PMID:20624303

  3. Pre-exposure prophylaxis and antiretroviral resistance: HIV prevention at a cost?

    Science.gov (United States)

    Hurt, Christopher B; Eron, Joseph J; Cohen, Myron S

    2011-12-01

    Pre-exposure prophylaxis (PrEP), the use of antiretrovirals (ARVs) by human immunodeficiency virus (HIV)-uninfected individuals to prevent acquisition of the virus during high-risk sexual encounters, enjoyed its first 2 major successes with the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 and the Pre-Exposure Prophylaxis Initiative (iPrEx). These successes were buoyed by additional positive results from the TDF2 and Partners PrEP trials. Although no seroconverters in either arm of CAPRISA developed resistance to tenofovir, 2 participants in iPrEx with undetected, seronegative acute HIV infection were randomized to receive daily oral tenofovir-emtricitabine and resistance to emtricitabine was later discovered in both men. A similar case in the TDF2 study resulted in resistance to both ARVs. These cases prompted us to examine existing literature on the nature of resistance mutations elicited by ARVs used for PrEP. Here, we discuss the impact of signature mutations selected by PrEP, how rapidly these emerge with daily ARV exposure, and the individual-level and public health consequences of ARV resistance.

  4. The impact of pre-exposure prophylaxis (PrEP) on HIV epidemics in Africa and India: A simulation study

    NARCIS (Netherlands)

    D.C.J. Vissers (Debby); H.A.C.M. Voeten (Hélène); N.J.D. Nagelkerke (Nico); J.D.F. Habbema (Dik); S.J. de Vlas (Sake)

    2008-01-01

    textabstractBackground: Pre-exposure prophylaxis (PrEP) is a promising new HIV prevention method, especially for women. An urgent demand for implementation of PrEP is expected at the moment efficacy has been demonstrated in clinical trials. We explored the long-term impact of PrEP on HIV

  5. Untangling the cost-effectiveness knot: who is oral antiretroviral HIV pre-exposure prophylaxis really for?

    NARCIS (Netherlands)

    Hankins, Catherine A.

    2014-01-01

    Clinical trials of HIV pre-exposure prophylaxis (PrEP) antiretroviral drugs have shown excellent protection against HIV acquisition when plasma drug levels are detectable, indicating good adherence. Cost-effectiveness depends on epidemic context, adherence, drug cost, and other factors. For

  6. Condom migration after introduction of pre-exposure prophylaxis among HIV-uninfected adolescents in South Africa: A cohort analysis

    NARCIS (Netherlands)

    Maljaars, Lennart P.; Gill, Katherine; Smith, Philip J.; Gray, Glenda E.; Dietrich, Janan J.; Gomez, Gabriela B.; Bekker, Linda-Gail

    2017-01-01

    Background: Approximately 3 million adolescents and young adults (AYA), between the ages of 15 years and 24 years, are living with HIV in sub-Saharan Africa. The use of pre-exposure prophylaxis (PrEP) may be a promising HIV prevention tool to bridge the high-risk years of AYA between sexual debut

  7. Pre-exposure prophylaxis (PrEP) in HIV-uninfected individuals with high-risk behaviour

    NARCIS (Netherlands)

    Nadery, S.; Geerlings, S. E.

    2013-01-01

    The global incidence of human immunodeficiency virus (HIV) infection has decreased by 15% over the past years, but is still too high. Despite current programs to reduce the incidence of HIV infection, further approaches are needed to limit this epidemic. Oral antiretroviral pre-exposure prophylaxis

  8. Changes in renal function associated with oral emtricitabine/tenofovir disoproxil fumarate use for HIV pre-exposure prophylaxis

    OpenAIRE

    Glidden, David; Grant, Robert; Mulligan, Kathleen; Solomon, MM; Lama, JR; Glidden, DV; McMahan, V; Liu, AY; Vicente, J; Veloso, VG; Mayer, KH; Chariyalertsak, S

    2014-01-01

    Objective: Tenofovir disoproxil fumarate (TDF) pre-exposure prophylaxis decreases sexual acquisition of HIV infection. We sought to evaluate the renal safety of TDF in HIV-uninfected persons. Design and methods: The Iniciativa Profilaxis Pre-Exposición (iP

  9. Long acting systemic HIV pre-exposure prophylaxis: an examination of the field.

    Science.gov (United States)

    Lykins, William R; Luecke, Ellen; Johengen, Daniel; van der Straten, Ariane; Desai, Tejal A

    2017-12-01

    Oral pre-exposure prophylaxis for the prevention of HIV-1 transmission (HIV PrEP) has been widely successful as demonstrated by a number of clinical trials. However, studies have also demonstrated the need for patients to tightly adhere to oral dosing regimens in order to maintain protective plasma and tissue concentrations. This is especially true for women, who experience less forgiveness from dose skipping than men in clinical trials of HIV PrEP. There is increasing interest in long-acting (LA), user-independent forms of HIV PrEP that could overcome this adherence challenge. These technologies have taken multiple forms including LA injectables and implantables. Phase III efficacy trials are ongoing for a LA injectable candidate for HIV PrEP. This review will focus on the design considerations for both LA injectable and implantable platforms for HIV PrEP. Additionally, we have summarized the existing LA technologies currently in clinical and pre-clinical studies for HIV PrEP as well as other technologies that have been applied to HIV PrEP and contraceptives. Our discussion will focus on the potential application of these technologies in low resource areas, and their use in global women's health.

  10. Preparing for pre-exposure prophylaxis: perceptions and readiness of Canadian pharmacists for the implementation of HIV pre-exposure prophylaxis.

    Science.gov (United States)

    Yoong, Deborah; Naccarato, Mark; Sharma, Malika; Wilton, James; Senn, Heather; Tan, Darrell Hs

    2016-07-01

    Pre-exposure prophylaxis (PrEP) has been shown to reduce the risk of HIV transmission but has the potential to cause harm if not used properly. Pharmacists are well-positioned to foster PrEP's efficacy but little is known whether they would endorse it as an HIV prevention tool. The objective of the study was to determine Canadian HIV pharmacists' support for PrEP and to identify current barriers to promoting PrEP. Canadian pharmacists with experience in HIV care were invited to complete an online survey about their experiences, opinions, and learning needs regarding PrEP from December 2012 to January 2013. Among the 59 surveys received, 48 met criteria for final analysis. Overall, 33 (69%) respondents would provide education positively supporting the use of PrEP and 26 (54%) believed Health Canada should approve PrEP for use in Canada. Familiarity with the concept of PrEP and practice characteristics examined did not appear to be significantly associated with support for PrEP in univariable analyses. The principal barriers to promoting PrEP included inadequate drug coverage and insufficient knowledge to educate others. Many Canadian HIV pharmacists would endorse PrEP for high-risk patients; however, wider dissemination of information and lower drug costs may be needed to make PrEP more widely promoted. © The Author(s) 2015.

  11. Defining success with HIV pre-exposure prophylaxis: A prevention-effective adherence paradigm

    Science.gov (United States)

    Haberer, Jessica E.; Bangsberg, David R.; Baeten, Jared M.; Curran, Kathryn; Koechlin, Florence; Amico, K. Rivet; Anderson, Peter; Mugo, Nelly; Venter, Francois; Goicochea, Pedro; Caceres, Carlos; O’Reilly, Kevin

    2015-01-01

    Clinical trial data have shown that oral pre-exposure prophylaxis (PrEP) is efficacious when taken as prescribed; however, PrEP adherence is complex and must be understood within the context of variable risk for HIV infection and use of other HIV prevention methods. Different levels of adherence may be needed in different populations to achieve HIV prevention, and the optimal methods for achieving the necessary adherence for both individual and public health benefits are unknown. Guidance for PrEP use must consider these questions to determine the success of PrEP-based HIV prevention programs. In this article, we propose a new paradigm for understanding and measuring PrEP adherence, termed prevention-effective adherence, which incorporates dynamic HIV acquisition risk behaviors and the use of HIV alternative prevention strategies. We discuss the need for daily PrEP use only during periods of risk for HIV exposure, describe key issues for measuring and understanding relevant behaviors, review lessons from another health prevention field (i.e., family planning), and provide guidance for prevention-effective PrEP use. Moreover, we challenge emerging calls for sustained, near perfect PrEP adherence regardless of risk exposure and offer a more practical and public health-focused vision for this prevention intervention. PMID:26103095

  12. Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment.

    Science.gov (United States)

    Nelson, Antoinette G; Zhang, Xiaoping; Ganapathi, Usha; Szekely, Zoltan; Flexner, Charles W; Owen, Andrew; Sinko, Patrick J

    2015-12-10

    The year 2016 will mark an important milestone - the 35th anniversary of the first reported cases of HIV/AIDS. Antiretroviral Therapy (ART) including Highly Active Antiretroviral Therapy (HAART) drug regimens is widely considered to be one of the greatest achievements in therapeutic drug research having transformed HIV infection into a chronically managed disease. Unfortunately, the lack of widespread preventive measures and the inability to eradicate HIV from infected cells highlight the significant challenges remaining today. Moving forward there are at least three high priority goals for anti-HIV drug delivery (DD) research: (1) to prevent new HIV infections from occurring, (2) to facilitate a functional cure, i.e., when HIV is present but the body controls it without drugs and (3) to eradicate established infection. Pre-exposure Prophylaxis (PrEP) represents a significant step forward in preventing the establishment of chronic HIV infection. However, the ultimate success of PrEP will depend on achieving sustained antiretroviral (ARV) tissue concentrations and will require strict patient adherence to the regimen. While first generation long acting/extended release (LA/ER) DD Systems (DDS) currently in development show considerable promise, significant DD treatment and prevention challenges persist. First, there is a critical need to improve cell specificity through targeting in order to selectively achieve efficacious drug concentrations in HIV reservoir sites to control/eradicate HIV as well as mitigate systemic side effects. In addition, approaches for reducing cellular efflux and metabolism of ARV drugs to prolong effective concentrations in target cells need to be developed. Finally, given the current understanding of HIV pathogenesis, next generation anti-HIV DDS need to address selective DD to the gut mucosa and lymph nodes. The current review focuses on the DDS technologies, critical challenges, opportunities, strategies, and approaches by which novel

  13. Pre-exposure prophylaxis (PrEP against HIV: efficacy, safety and uncertainties

    Directory of Open Access Journals (Sweden)

    Santiago Moreno Guillen

    2017-09-01

    Full Text Available Despite the global stabilization of the number of new HIV infections in recent years, there has been an increase in new infections among men who have sex with men. This fact indicates the lack of effectiveness of the measures and prevention campaigns established so far for this group. It is therefore necessary to implement alternative preventive measures for them. Pre-exposure pharmacological prophylaxis (PrEP is one of the best evaluated options and has had high protection rates in both clinical and real-life trials. The strategy has also shown an adequate profile in terms of safety, tolerance, adverse effects and cost-effectiveness in the studies carried out to assess this important topic.

  14. HIV Prevention After Discontinuing Pre-Exposure Prophylaxis: Conclusions From a Case Study

    Directory of Open Access Journals (Sweden)

    Kai J. Jonas

    2018-05-01

    Full Text Available Pre-exposure prophylaxis (PrEP with tenofovir disoproxil fumarate in combination with emtricitabine (FTC is a highly effective form of HIV prevention. Endeavors of health-care providers and activists in many countries over the world are directed at making access to PrEP possible, or increasing PrEP use among men-who-have-sex-with-men (MSM. We argue while this effort is necessary, we also need to consider modes of HIV prevention after a period of PrEP use. PrEP uptake is not a one-way street, meaning that individuals may discontinue PrEP use, either voluntarily and involuntarily. Voluntary discontinued PrEP use in conjunction with decreased or no HIV risk exposure is unproblematic, but involuntary discontinuations with continuous high level of HIV risk exposure calls for tailored post-PrEP use HIV prevention. We present a case study of an MSM individual who discontinued PrEP for medical reasons (renal function and seroconverted soon afterward, to illustrate the need for tailored HIV prevention post-PrEP. Furthermore, we provide additional contexts of PrEP discontinuation leading to populations that are in need for post-PrEP types of HIV prevention. Subsequently, we present suggestions for modes of post-PrEP HIV prevention based on knowledge–communication–choice model. Community organization and health-care providers should consider and prepare their HIV prevention consulting protocols for such types of clients and add post-PrEP HIV prevention measures to their consulting offer.

  15. Primary Care Physicians' Willingness to Prescribe HIV Pre-exposure Prophylaxis for People who Inject Drugs.

    Science.gov (United States)

    Edelman, E Jennifer; Moore, Brent A; Calabrese, Sarah K; Berkenblit, Gail; Cunningham, Chinazo; Patel, Viraj; Phillips, Karran; Tetrault, Jeanette M; Shah, Minesh; Fiellin, David A; Blackstock, Oni

    2017-04-01

    Pre-exposure prophylaxis for HIV (PrEP) is recommended for people who inject drugs (PWID). Despite their central role in disease prevention, willingness to prescribe PrEP to PWID among primary care physicians (PCPs) is largely understudied. We conducted an online survey (April-May 2015) of members of a society for academic general internists regarding PrEP. Among 250 respondents, 74% (n = 185) of PCPs reported high willingness to prescribe PrEP to PWID. PCPs were more likely to report high willingness to prescribe PrEP to all other HIV risk groups (p's < 0.03 for all pair comparisons). Compared with PCPs delivering care to more HIV-infected clinic patients, PCPs delivering care to fewer HIV-infected patients were more likely to report low willingness to prescribe PrEP to PWID (Odds Ratio [95% CI] = 6.38 [1.48-27.47]). PCP and practice characteristics were not otherwise associated with low willingness to prescribe PrEP to PWID. Interventions to improve PCPs' willingness to prescribe PrEP to PWID are needed.

  16. PrEP Whores and HIV Prevention: The Queer Communication of HIV Pre-Exposure Prophylaxis (PrEP).

    Science.gov (United States)

    Spieldenner, Andrew

    2016-12-01

    HIV pre-exposure prophylaxis (PrEP) has been introduced as another biomedical tool in HIV prevention. Whereas other such tools-including post-exposure prophylaxis (PEP) and interruption of perinatal transmission-have been embraced by those impacted by HIV, PrEP has been met with more conflict, especially within the gay community and HIV organizations. The "PrEP whore" has come to designate the social value and personal practices of those taking PrEP. This study examines the "PrEP whore" discourse by using queer theory and quare theory. Within these theoretical vantage points, the study explicates four discursive areas: slut shaming, dirty/clean binaries, mourning the loss of condoms, and reclaiming the inner whore. The study illuminates possible discursive strategies that lie outside of the domains of public health and within the individual and community.

  17. Sexual behaviour of heterosexual men and women receiving antiretroviral pre-exposure prophylaxis for HIV prevention: a longitudinal analysis.

    Science.gov (United States)

    Mugwanya, Kenneth K; Donnell, Deborah; Celum, Connie; Thomas, Katherine K; Ndase, Patrick; Mugo, Nelly; Katabira, Elly; Ngure, Kenneth; Baeten, Jared M

    2013-12-01

    Scarce data are available to assess sexual behaviour of individuals using antiretroviral pre-exposure prophylaxis for HIV prevention. Increased sexual risk taking by individuals using effective HIV prevention strategies, like pre-exposure prophylaxis, could offset the benefits of HIV prevention. We studied whether the use of pre-exposure prophylaxis in HIV-uninfected men and women in HIV-serodiscordant couples was associated with increased sexual risk behaviour. We undertook a longitudinal analysis of data from the Partners PrEP Study, a double-blind, randomised, placebo-controlled trial of daily oral pre-exposure prophylaxis among HIV-uninfected partners of heterosexual HIV-serodiscordant couples (n=3163, ≥18 years of age). Efficacy for HIV prevention was publicly reported in July 2011, and participants continued monthly follow-up thereafter. We used regression analyses to compare the frequency of sex-unprotected by a condom-during the 12 months after compared with the 12 months before July 2011, to assess whether knowledge of pre-exposure prophylaxis efficacy for HIV prevention caused increased sexual risk behaviour. We analysed 56 132 person-months from 3024 HIV-uninfected individuals (64% male). The average frequency of unprotected sex with the HIV-infected study partner was 59 per 100 person-months before unmasking versus 53 after unmasking; we recorded no immediate change (p=0·66) or change over time (p=0·25) after July, 2011. We identified a significant increase in unprotected sex with outside partners after July, 2011, but the effect was small (average of 6·8 unprotected sex acts per year vs 6·2 acts in a predicted counterfactual scenario had patients remained masked, p=0·04). Compared with before July, 2011, we noted no significant increase in incident sexually transmitted infections or pregnancy after July, 2011. Pre-exposure prophylaxis, provided as part of a comprehensive prevention package, might not result in substantial changes in risk

  18. Knowledge, attitudes, and beliefs about HIV pre-exposure prophylaxis among US Air Force Health Care Providers

    OpenAIRE

    Hakre, Shilpa; Blaylock, Jason M; Dawson, Peter; Beckett, Charmagne; Garges, Eric C; Michael, Nelson L; Danaher, Patrick J; Scott, Paul T; Okulicz, Jason F

    2016-01-01

    Abstract Providers are central to effective implementation of HIV pre-exposure prophylaxis (PrEP). Primary care providers (PCP) and infectious disease physicians (ID) in the US Air Force (USAF) participated in a cross-sectional survey regarding knowledge, attitudes, and beliefs toward HIV PrEP. Characteristics associated with PrEP knowledge were assessed in univariate and multivariate analyses. Among 403 (40% of 1015 providers) participants, 9% (PCP 383, ID 20) ever prescribed PrEP. In univar...

  19. The promise of pre-exposure prophylaxis with antiretroviral drugs to prevent HIV transmission: a review

    NARCIS (Netherlands)

    Hankins, Catherine A.; Dybul, Mark R.

    2013-01-01

    Public health experts are wrestling with how to translate recent scientific findings from pre-exposure prophylaxis (PrEP) effectiveness trials into real-world programmes. This review summarizes clinical trial findings on oral and topical PrEP, discusses how decision-makers can evaluate the place of

  20. Impact of insurance coverage on utilization of pre-exposure prophylaxis for HIV prevention.

    Science.gov (United States)

    Patel, Rupa R; Mena, Leandro; Nunn, Amy; McBride, Timothy; Harrison, Laura C; Oldenburg, Catherine E; Liu, Jingxia; Mayer, Kenneth H; Chan, Philip A

    2017-01-01

    Pre-exposure prophylaxis (PrEP) can reduce U.S. HIV incidence. We assessed insurance coverage and its association with PrEP utilization. We reviewed patient data at three PrEP clinics (Jackson, Mississippi; St. Louis, Missouri; Providence, Rhode Island) from 2014-2015. The outcome, PrEP utilization, was defined as patient PrEP use at three months. Multivariable logistic regression was performed to determine the association between insurance coverage and PrEP utilization. Of 201 patients (Jackson: 34%; St. Louis: 28%; Providence: 28%), 91% were male, 51% were White, median age was 29 years, and 21% were uninsured; 82% of patients reported taking PrEP at three months. Insurance coverage was significantly associated with PrEP utilization. After adjusting for Medicaid-expansion and individual socio-demographics, insured patients were four times as likely to use PrEP services compared to the uninsured (OR: 4.49, 95% CI: 1.68-12.01; p = 0.003). Disparities in insurance coverage are important considerations in implementation programs and may impede PrEP utilization.

  1. Impact of insurance coverage on utilization of pre-exposure prophylaxis for HIV prevention.

    Directory of Open Access Journals (Sweden)

    Rupa R Patel

    Full Text Available Pre-exposure prophylaxis (PrEP can reduce U.S. HIV incidence. We assessed insurance coverage and its association with PrEP utilization. We reviewed patient data at three PrEP clinics (Jackson, Mississippi; St. Louis, Missouri; Providence, Rhode Island from 2014-2015. The outcome, PrEP utilization, was defined as patient PrEP use at three months. Multivariable logistic regression was performed to determine the association between insurance coverage and PrEP utilization. Of 201 patients (Jackson: 34%; St. Louis: 28%; Providence: 28%, 91% were male, 51% were White, median age was 29 years, and 21% were uninsured; 82% of patients reported taking PrEP at three months. Insurance coverage was significantly associated with PrEP utilization. After adjusting for Medicaid-expansion and individual socio-demographics, insured patients were four times as likely to use PrEP services compared to the uninsured (OR: 4.49, 95% CI: 1.68-12.01; p = 0.003. Disparities in insurance coverage are important considerations in implementation programs and may impede PrEP utilization.

  2. HIV Pre-Exposure Prophylaxis and Postexposure Prophylaxis in Japan: Context of Use and Directions for Future Research and Action.

    Science.gov (United States)

    DiStefano, Anthony S; Takeda, Makiko

    2017-02-01

    Biomedical HIV prevention strategies are playing an increasingly prominent role in addressing HIV epidemics globally, but little is known about their use in Japan, where persistent HIV disparities and a recently stable, but not declining, national epidemic indicate the need for evolving approaches. We conducted an ethnographic study to determine the context of pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) use and to identify directions for future research and action in Japan. We used data from observational fieldwork in the Kansai region and Tokyo Metropolitan Area (n = 178 persons observed), qualitative interviews (n = 32), documents and web-based data sources (n = 321), and email correspondences (n = 9) in the period 2013-2016. Drug approvals by Japan's regulatory agencies, insurance coverage for medications, and policies by healthcare institutions and government agencies were the main factors affecting PrEP and PEP legality, use, and awareness. Awareness and the observable presence of PrEP and PEP were very limited, particularly at the community level. PrEP and PEP held appeal for Japanese scientists and activists, and for study participants who represented various other stakeholder groups; however, significant concerns prevented open endorsements. Japanese health officials should prioritize a national discussion, weigh empirical evidence, and strongly consider formal approval of antiretroviral (ARV) medications for use in PrEP and both occupational and nonoccupational PEP. Once approved, social marketing campaigns can be used to advertise widely and increase awareness. Future research would benefit from theoretical grounding in a diffusion of innovations framework. These findings can inform current and future ARV-based prevention strategies at a critical time in the international conversation.

  3. Optimal costs of HIV pre-exposure prophylaxis for men who have sex with men.

    Directory of Open Access Journals (Sweden)

    Jennie McKenney

    Full Text Available Men who have sex with men (MSM are disproportionately affected by HIV due to their increased risk of infection. Oral pre-exposure prophylaxis (PrEP is a highly effictive HIV-prevention strategy for MSM. Despite evidence of its effectiveness, PrEP uptake in the United States has been slow, in part due to its cost. As jurisdictions and health organizations begin to think about PrEP scale-up, the high cost to society needs to be understood.We modified a previously-described decision-analysis model to estimate the cost per quality-adjusted life-year (QALY gained, over a 1-year duration of PrEP intervention and lifetime time horizon. Using updated parameter estimates, we calculated: 1 the cost per QALY gained, stratified over 4 strata of PrEP cost (a function of both drug cost and provider costs; and 2 PrEP drug cost per year required to fall at or under 4 cost per QALY gained thresholds.When PrEP drug costs were reduced by 60% (with no sexual disinhibition to 80% (assuming 25% sexual disinhibition, PrEP was cost-effective (at <$100,000 per QALY averted in all scenarios of base-case or better adherence, as long as the background HIV prevalence was greater than 10%. For PrEP to be cost saving at base-case adherence/efficacy levels and at a background prevalence of 20%, drug cost would need to be reduced to $8,021 per year with no disinhibition, and to $2,548 with disinhibition.Results from our analysis suggest that PrEP drug costs need to be reduced in order to be cost-effective across a range of background HIV prevalence. Moreover, our results provide guidance on the pricing of generic emtricitabine/tenofovir disoproxil fumarate, in order to provide those at high risk for HIV an affordable prevention option without financial burden on individuals or jurisdictions scaling-up coverage.

  4. Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand.

    Directory of Open Access Journals (Sweden)

    Pravan Suntharasamai

    Full Text Available Rapid easy-to-use HIV tests offer opportunities to increase HIV testing among populations at risk of infection. We used the OraQuick Rapid HIV-1/2 antibody test (OraQuick in the Bangkok Tenofovir Study, an HIV pre-exposure prophylaxis trial among people who inject drugs.The Bangkok Tenofovir Study was a randomized, double-blind, placebo-controlled trial. We tested participants' oral fluid for HIV using OraQuick monthly and blood using a nucleic-acid amplification test (NAAT every 3 months. We used Kaplan-Meier methods to estimate the duration from a positive HIV NAAT until the mid-point between the last non-reactive and first reactive oral fluid test and proportional hazards to examine factors associated with the time until the test was reactive.We screened 3678 people for HIV using OraQuick. Among 447 with reactive results, 436 (97.5% were confirmed HIV-infected, 10 (2.2% HIV-uninfected, and one (0.2% had indeterminate results. Two participants with non-reactive OraQuick results were, in fact, HIV-infected at screening yielding 99.5% sensitivity, 99.7% specificity, a 97.8% positive predictive value, and a 99.9% negative predictive value. Participants receiving tenofovir took longer to develop a reactive OraQuick (191.8 days than participants receiving placebo (16.8 days (p = 0.02 and participants infected with HIV CRF01_AE developed a reactive OraQuick earlier than participants infected with other subtypes (p = 0.04.The oral fluid HIV test performed well at screening, suggesting it can be used when rapid results and non-invasive tools are preferred. However, participants receiving tenofovir took longer to develop a reactive oral fluid test result than those receiving placebo. Thus, among people using pre-exposure prophylaxis, a blood-based HIV test may be an appropriate choice.ClinicalTrials.gov NCT00119106.

  5. HIV Pre-Exposure Prophylaxis Interest among Female Sex Workers in Guangxi, China

    Science.gov (United States)

    Zou, Yunfeng; Yang, Xiaobo; Abdullah, Abu S.; Zhong, Xiaoni; Ruan, Yuhua; Lin, Xinqin; Li, Mingqiang; Wu, Deren; Jiang, Junjun; Xie, Peiyan; Huang, Jiegang; Liang, Bingyu; Zhou, Bo; Su, Jinming; Liang, Hao; Huang, Ailong

    2014-01-01

    Objectives Acceptability of pre-exposure prophylaxis (PrEP) and willingness to participate in a clinical trial for both safety and efficacy of PrEP were investigated among female sex workers (FSWs) in Guangxi, China. Methods A cross-sectional study was performed in three cities in Guangxi. Structured, self-administered questionnaires were used to assess the acceptability of PrEP and the willingness to participate in a clinical trial. Multivariable logistic regression models were fitted to identify predictors. Results Among 405 participants, 15.1% had heard of PrEP. If PrEP was deemed to be effective, safe and provided for free, 85.9% reported that they would accept it, and 54.3% of those who accepted PrEP said that they would participate in a clinical trial. The increased acceptability of PrEP was associated with working in male dominated venues, higher income, a poor family relationship, better HIV/AIDS knowledge, not realizing HIV risk from unfamiliar clients, not being forced to use condoms by the gatekeepers, consistent use of condoms, and use of drugs to prevent STD infection. The increased willingness to participate in a clinical trial was associated with a poor family relationship, better HIV/AIDS knowledge, not realizing HIV risk from unfamiliar clients, a willingness to adhere to daily PreP use, and not being concerned about discrimination by others. The main reason for rejecting PrEP or participating in a clinical trial was the concern about the side effects of PrEP. Conclusions Acceptability of PrEP among Guangxi FSWs is relatively high, indicating that PrEP intervention programs may be feasible for Chinese FSWs. Given the fact that most of the participants had never heard of PrEP before, and that family, gatekeepers, and social discrimination could significantly affect its acceptability, a comprehensive mix of multiple interventions is necessary for the successful implementation of a PrEP program among this population in Guangxi. PMID:24465956

  6. Safety of oral tenofovir disoproxil fumarate-based HIV pre-exposure prophylaxis use in lactating HIV-uninfected women.

    Science.gov (United States)

    Mugwanya, Kenneth K; John-Stewart, Grace; Baeten, Jared

    2017-07-01

    In settings where HIV is prevalent in heterosexual populations, pregnancy and postpartum breastfeeding periods can be associated with substantial HIV acquisition risk. Pre-exposure prophylaxis (PrEP) with daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine is an attractive HIV prevention option for women who are lactating but data are limited on its safety during the lactation period. Areas covered: We provide a concise synthesis and summary of current evidence on the safety of TDF-based PrEP during breastfeeding. We conducted a review, searching Pubmed database and major PrEP conferences for primary studies with TDF-based PrEP exposure during postpartum breastfeeding. Expert opinion: TDF-based oral PrEP is an effective female-controlled HIV prevention option. There is evidence supporting the safety of TDF use for infant outcomes during breastfeeding in antiretroviral treatment regimens for HIV and hepatitis B virus, and more limited, but consistently safe, data from use of TDF as PrEP. The potential for risk is arguably outweighed for at-risk individuals by HIV prevention benefits, including indirect protection to the infant as a result of preventing HIV in the breastfeeding mother. As PrEP delivery is scaled up in heterosexual populations in high HIV prevalence settings and for at-risk persons in other settings, implementation science studies can provide a framework to increase the accrual of safety, acceptability, and use data related to PrEP during lactation.

  7. Willingness to Accept HIV Pre-Exposure Prophylaxis among Chinese Men Who Have Sex with Men

    Science.gov (United States)

    Li, Shuming; Li, Dongliang; Zhang, Lifen; Fan, Wensheng; Yang, Xueying; Yu, Mingrun; Xiao, Dong; Yan, Li; Zhang, Zheng; Shi, Wei; Luo, Fengji; Ruan, Yuhua; Jin, Qi

    2012-01-01

    Objective We investigated the awareness and acceptability of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) and potential predicting factors. Methods This study was conducted among MSM in Beijing, China. Study participants, randomly selected from an MSM cohort, completed a structured questionnaire, and provided their blood samples to test for HIV infection and syphilis. Univariate logistic regression analyses were performed to evaluate the factors associated with willingness to accept (WTA) PrEP. Factors independently associated with willingness to accept were identified by entering variables into stepwise logistic regression analysis. Results A total of 152 MSM completed the survey; 11.2% had ever heard of PrEP and 67.8% were willing to accept it. Univariate analysis showed that age, years of education, consistent condom use in the past 6 months, heterosexual behavior in the past 6 months, having ever heard of PrEP and the side effects of antiretroviral drugs, and worry about antiretroviral drugs cost were significantly associated with willingness to accept PrEP. In the multivariate logistic regression model, only consistent condom use in the past 6 months (odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.13–0.70) and having ever heard of the side effects of antiretroviral drugs (OR: 0.30; 95% CI: 0.14–0.67) were independently associated with willingness to accept PrEP. Conclusions The awareness of PrEP in the MSM population was low. Sexual behavioral characteristics and knowledge about ART drugs may have effects on willingness to accept PrEP. Comprehensive prevention strategies should be recommended in the MSM community. PMID:22479320

  8. Willingness to accept HIV pre-exposure prophylaxis among Chinese men who have sex with men.

    Directory of Open Access Journals (Sweden)

    Feng Zhou

    Full Text Available OBJECTIVE: We investigated the awareness and acceptability of pre-exposure prophylaxis (PrEP among men who have sex with men (MSM and potential predicting factors. METHODS: This study was conducted among MSM in Beijing, China. Study participants, randomly selected from an MSM cohort, completed a structured questionnaire, and provided their blood samples to test for HIV infection and syphilis. Univariate logistic regression analyses were performed to evaluate the factors associated with willingness to accept (WTA PrEP. Factors independently associated with willingness to accept were identified by entering variables into stepwise logistic regression analysis. RESULTS: A total of 152 MSM completed the survey; 11.2% had ever heard of PrEP and 67.8% were willing to accept it. Univariate analysis showed that age, years of education, consistent condom use in the past 6 months, heterosexual behavior in the past 6 months, having ever heard of PrEP and the side effects of antiretroviral drugs, and worry about antiretroviral drugs cost were significantly associated with willingness to accept PrEP. In the multivariate logistic regression model, only consistent condom use in the past 6 months (odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.13-0.70 and having ever heard of the side effects of antiretroviral drugs (OR: 0.30; 95% CI: 0.14-0.67 were independently associated with willingness to accept PrEP. CONCLUSIONS: The awareness of PrEP in the MSM population was low. Sexual behavioral characteristics and knowledge about ART drugs may have effects on willingness to accept PrEP. Comprehensive prevention strategies should be recommended in the MSM community.

  9. Role of oral pre-exposure prophylaxis (PrEP) in current and future HIV prevention strategies.

    Science.gov (United States)

    Burns, David N; Grossman, Cynthia; Turpin, Jim; Elharrar, Vanessa; Veronese, Fulvia

    2014-12-01

    Treatment as prevention is expected to have a major role in reducing HIV incidence, but other prevention interventions will also be required to bring the epidemic under control, particularly among key populations. One or more forms of pre-exposure prophylaxis (PrEP) will likely play a critical role. Oral PrEP with emtricitabine-tenofovir (Truvada®) is currently available in the US and some other countries, but uptake has been slow. We review the concerns that have contributed to this slow uptake and discuss current and future research in this critical area of HIV prevention research.

  10. Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting.

    Directory of Open Access Journals (Sweden)

    Madeline C Montgomery

    Full Text Available The HIV epidemic in the United States (US disproportionately affects gay, bisexual, and other men who have sex with men (MSM. Pre-exposure prophylaxis (PrEP using co-formulated tenofovir disoproxil fumarate (TDF and emtricitabine (FTC has demonstrated high efficacy in reducing HIV incidence among MSM. However, low adherence was reported in major efficacy trials and may present a substantial barrier to successful PrEP implementation. Rates of adherence to PrEP in "real-world" clinical settings in the US remain largely unknown.We reviewed demographic and clinical data for the first 50 patients to enroll in a clinical PrEP program in Providence, Rhode Island. We analyzed self-reported drug adherence as well as drug concentrations in dried blood spots (DBS from patients who attended either a three- or six-month follow-up appointment. We further assessed drug concentrations and the resistance profile of a single patient who seroconverted while taking PrEP.Of the first 50 patients to be prescribed PrEP, 62% attended a follow-up appointment at three months and 38% at six months. Of those who attended an appointment at either time point (70%, n = 35, 92% and 95% reported taking ±4 doses/week at three and six months, respectively. Drug concentrations were performed on a random sample of 20 of the 35 patients who attended a follow-up appointment. TDF levels consistent with ±4 doses/week were found in 90% of these patients. There was a significant correlation between self-reported adherence and drug concentrations (r = 0.49, p = 0.02. One patient who had been prescribed PrEP seroconverted at his three-month follow-up visit. The patient's drug concentrations were consistent with daily dosing. Population sequencing and ultrasensitive allele-specific PCR detected the M184V mutation, but no other TDF- or FTC-associated mutations, including those present as minor variants.In this clinical PrEP program, adherence was high, and self-reported drug adherence

  11. Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting.

    Science.gov (United States)

    Montgomery, Madeline C; Oldenburg, Catherine E; Nunn, Amy S; Mena, Leandro; Anderson, Peter; Liegler, Teri; Mayer, Kenneth H; Patel, Rupa; Almonte, Alexi; Chan, Philip A

    2016-01-01

    The HIV epidemic in the United States (US) disproportionately affects gay, bisexual, and other men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) using co-formulated tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) has demonstrated high efficacy in reducing HIV incidence among MSM. However, low adherence was reported in major efficacy trials and may present a substantial barrier to successful PrEP implementation. Rates of adherence to PrEP in "real-world" clinical settings in the US remain largely unknown. We reviewed demographic and clinical data for the first 50 patients to enroll in a clinical PrEP program in Providence, Rhode Island. We analyzed self-reported drug adherence as well as drug concentrations in dried blood spots (DBS) from patients who attended either a three- or six-month follow-up appointment. We further assessed drug concentrations and the resistance profile of a single patient who seroconverted while taking PrEP. Of the first 50 patients to be prescribed PrEP, 62% attended a follow-up appointment at three months and 38% at six months. Of those who attended an appointment at either time point (70%, n = 35), 92% and 95% reported taking ±4 doses/week at three and six months, respectively. Drug concentrations were performed on a random sample of 20 of the 35 patients who attended a follow-up appointment. TDF levels consistent with ±4 doses/week were found in 90% of these patients. There was a significant correlation between self-reported adherence and drug concentrations (r = 0.49, p = 0.02). One patient who had been prescribed PrEP seroconverted at his three-month follow-up visit. The patient's drug concentrations were consistent with daily dosing. Population sequencing and ultrasensitive allele-specific PCR detected the M184V mutation, but no other TDF- or FTC-associated mutations, including those present as minor variants. In this clinical PrEP program, adherence was high, and self-reported drug adherence accurately

  12. Mathematical modeling of HIV prevention measures including pre-exposure prophylaxis on HIV incidence in South Korea.

    Science.gov (United States)

    Kim, Sun Bean; Yoon, Myoungho; Ku, Nam Su; Kim, Min Hyung; Song, Je Eun; Ahn, Jin Young; Jeong, Su Jin; Kim, Changsoo; Kwon, Hee-Dae; Lee, Jeehyun; Smith, Davey M; Choi, Jun Yong

    2014-01-01

    Multiple prevention measures have the possibility of impacting HIV incidence in South Korea, including early diagnosis, early treatment, and pre-exposure prophylaxis (PrEP). We investigated how each of these interventions could impact the local HIV epidemic, especially among men who have sex with men (MSM), who have become the major risk group in South Korea. A mathematical model was used to estimate the effects of each these interventions on the HIV epidemic in South Korea over the next 40 years, as compared to the current situation. We constructed a mathematical model of HIV infection among MSM in South Korea, dividing the MSM population into seven groups, and simulated the effects of early antiretroviral therapy (ART), early diagnosis, PrEP, and combination interventions on the incidence and prevalence of HIV infection, as compared to the current situation that would be expected without any new prevention measures. Overall, the model suggested that the most effective prevention measure would be PrEP. Even though PrEP effectiveness could be lessened by increased unsafe sex behavior, PrEP use was still more beneficial than the current situation. In the model, early diagnosis of HIV infection was also effectively decreased HIV incidence. However, early ART did not show considerable effectiveness. As expected, it would be most effective if all interventions (PrEP, early diagnosis and early treatment) were implemented together. This model suggests that PrEP and early diagnosis could be a very effective way to reduce HIV incidence in South Korea among MSM.

  13. Dissimilarities in the metabolism of antiretroviral drugs used in HIV pre-exposure prophylaxis in colon and vagina tissues.

    Science.gov (United States)

    To, Elaine E; Hendrix, Craig W; Bumpus, Namandjé N

    2013-10-01

    Attempts to prevent HIV infection through pre-exposure prophylaxis (PrEP) include topical application of anti-HIV drugs to the mucosal sites of infection; however, a potential role for local drug metabolizing enzymes in modulating the exposure of the mucosal tissues to these drugs has yet to be explored. Here we present the first report that enzymes belonging to the cytochrome P450 (CYP) and UDP-glucuronosyltransferase (UGT) families of drug metabolizing enzymes are expressed and active in vaginal and colorectal tissue using biopsies collected from healthy volunteers. In doing so, we discovered that dapivirine and maraviroc, a non-nucleoside reverse transcriptase inhibitor and an entry inhibitor currently in development as microbicides for HIV PrEP, are differentially metabolized in colorectal tissue and vaginal tissue. Taken together, these data should help to guide the optimization of small molecules being developed for HIV PrEP. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. Social Justice and HIV Vaccine Research in the Age of Pre-Exposure Prophylaxis and Treatment as Prevention

    Science.gov (United States)

    Bailey, Theodore C.; Sugarman, Jeremy

    2014-01-01

    The advent of pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP) as means of HIV prevention raises issues of justice concerning how most fairly and equitably to apportion resources in support of the burgeoning variety of established HIV treatment and prevention measures and further HIV research, including HIV vaccine research. We apply contemporary approaches to social justice to assess the ethical justification for allocating resources in support of HIV vaccine research given competing priorities to support broad implementation of HIV treatment and prevention measures, including TasP and PrEP. We argue that there is prima facie reason to believe that a safe and effective preventive HIV vaccine would offer a distinct set of ethically significant benefits not provided by current HIV treatment or prevention methods. It is thereby possible to justify continued support for HIV vaccine research despite tension with priorities for treatment, prevention, and other research. We then consider a counter-argument to such a justification based on the uncertainty of successfully developing a safe and effective preventive HIV vaccine. Finally, we discuss how HIV vaccine research might now be ethically designed and conducted given the new preventive options of TasP and PrEP, focusing on the ethically appropriate standard of prevention for HIV vaccine trials. PMID:24033297

  15. Configuring the users of new HIV-prevention technologies: the case of HIV pre-exposure prophylaxis.

    Science.gov (United States)

    Holt, Martin

    2015-01-01

    HIV pre-exposure prophylaxis (PrEP) is a prevention technology that involves prescribing antiretroviral drugs to HIV-negative people to protect them from infection. This paper considers how the development of the technology has necessitated the parallel configuration of its users, and how this process has affected the perception and uptake of the technology. In designing a technology, potential users are typically defined, enabled and constrained, partly to create a target population (or market) for the technology, but also to reassure people that it can be used safely and effectively. This process may or may not be helpful for the uptake and use of the technology. Published research on PrEP indicates that while the technology was under trial, the primary focus was on the 'at-risk' subject in need of PrEP, with little or no consideration of the other qualities necessary for successful use. Post-trial accounts of PrEP have begun to outline desirable qualities of successful PrEP use, such as caution, compliance and being organised. It appears that the PrEP user was only partially configured during the technology's development, and the initial focus on risk has done little to counter fears of the technology, which may partially account for its slow uptake.

  16. The potential impact of pre-exposure prophylaxis for HIV prevention among men who have sex with men and transwomen in Lima, Peru: a mathematical modelling study

    NARCIS (Netherlands)

    Gomez, Gabriela B.; Borquez, Annick; Caceres, Carlos F.; Segura, Eddy R.; Grant, Robert M.; Garnett, Geoff P.; Hallett, Timothy B.

    2012-01-01

    HIV pre-exposure prophylaxis (PrEP), the use of antiretroviral drugs by uninfected individuals to prevent HIV infection, has demonstrated effectiveness in preventing acquisition in a high-risk population of men who have sex with men (MSM). Consequently, there is a need to understand if and how PrEP

  17. Cost Effectiveness of ‘On Demand’ Hiv Pre-Exposure Prophylaxis for Non-Injection Drug-Using Men Who Have Sex with Men in Canada

    Directory of Open Access Journals (Sweden)

    Estelle Ouellet

    2015-01-01

    Full Text Available BACKGROUND: Recent trials report the efficacy of continuous tenofovir-based pre-exposure prophylaxis (PrEP for prevention of HIV infection. The cost effectiveness of ‘on demand’ PrEP for non-injection drug-using men who have sex with men at high risk of HIV acquisition has not been evaluated.

  18. Ethical Implications of Social Stigma Associated with the Promotion and Use of Pre-Exposure Prophylaxis for HIV Prevention.

    Science.gov (United States)

    Herron, Patrick D

    2016-04-01

    Identifying sources of and eliminating social stigma associated with the promotion and use of pre-exposure prophylaxis (PrEP) for the prevention of sexually acquired HIV infection among men who have sex with men (MSM) is both a moral imperative and necessary requirement to ensure that public health objectives of HIV prevention can be met. This article will examine and address ethical concerns and criticisms regarding the use of PrEP, barriers to its promotion, and use among MSM and examine the types of social stigma associated with PrEP. An ethical justification for both healthcare and LGBT communities to address and overcome social stigma regarding the use of PrEP among MSM is offered.

  19. Changes in renal function associated with oral emtricitabine/tenofovir disoproxil fumarate use for HIV pre-exposure prophylaxis.

    Science.gov (United States)

    Solomon, Marc M; Lama, Javier R; Glidden, David V; Mulligan, Kathleen; McMahan, Vanessa; Liu, Albert Y; Guanira, Juan Vicente; Veloso, Valdilea G; Mayer, Kenneth H; Chariyalertsak, Suwat; Schechter, Mauro; Bekker, Linda-Gail; Kallás, Esper Georges; Burns, David N; Grant, Robert M

    2014-03-27

    Tenofovir disoproxil fumarate (TDF) pre-exposure prophylaxis decreases sexual acquisition of HIV infection. We sought to evaluate the renal safety of TDF in HIV-uninfected persons. The Iniciativa Profilaxis Pre-Exposición (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily TDF coformulated with emtricitabine (FTC/TDF) or placebo. Serum creatinine and phosphorus during randomized treatment and after discontinuation were measured, and creatinine clearance (CrCl) was estimated by the Cockcroft-Gault equation. Indicators of proximal renal tubulopathy (fractional excretion of phosphorus and uric acid, urine protein, and glucose) were measured in a substudy. There was a small but statistically significant decrease in CrCl from baseline in the active arm, compared to placebo, which was first observed at week 4 (mean change: -2.4 vs. -1.1 ml/min; P=0.02), persisted through the last on-treatment visit (mean change: +0.3 vs. +1.8 ml/min; P=0.02), and resolved after stopping pre-exposure prophylaxis (mean change: -0.1 vs. 0.0 ml/min; P=0.83). The effect was confirmed when stratifying by drug detection. The effect of FTC/TDF on CrCl did not vary by race, age, or history of hypertension. There was no difference in serum phosphate trends between the treatment arms. In the substudy, two participants receiving placebo had indicators of tubulopathy. In HIV-seronegative MSM, randomization to FTC/TDF was associated with a very mild nonprogressive decrease in CrCl that was reversible and managed with routine serum creatinine monitoring.

  20. Exposure ethics: does HIV pre-exposure prophylaxis raise ethical problems for the health care provider and policy maker?

    Science.gov (United States)

    Venter, Francois; Allais, Lucy; Richter, Marlise

    2014-07-01

    The last few years have seen dramatic progress in the development of HIV pre-exposure prophylaxis (PrEP). These developments have been met by ethical concerns. HIV interventions are often thought to be ethically difficult. In a context which includes disagreements over human rights, controversies over testing policies, and questions about sexual morality and individual responsibility, PrEP has been seen as an ethically complex intervention. We argue that this is mistaken, and that in fact, PrEP does not raise new ethical concerns. Some of the questions posed by PrEP are not specific to HIV prophylaxis, but simply standard public health considerations about resource allocation and striking a balance between individual benefit and public good. We consider sexual disinhibition in the context of private prescriptions, and conclude that only unjustified AIDS-exceptionalism or inappropriate moralism about sex supports thinking that PrEP raises new ethical problems. This negative conclusion is significant in a context where supposed ethical concerns about PrEP have been raised, and in the context of HIV exceptionalism. © 2013 John Wiley & Sons Ltd.

  1. Perceptions of pre-exposure prophylaxis (PrEP) among HIV-negative and HIV-positive men who have sex with men.

    OpenAIRE

    Jaspal, Rusi; Daramilas, C.

    2016-01-01

    open access article Pre-exposure prophylaxis (PrEP) is a novel bio-medical HIV prevention op- tion for individuals at high risk of HIV exposure. This qualitative interview study ex- plores perceptions and understandings of PrEP among a sample of 20 HIV-negative and HIV-positive men who have sex with men (MSM) in the UK, where there is a debate about the feasibility of o ering PrEP on the NHS. Data were analysed using qualitative thematic analysis and social representations theory from soci...

  2. Negotiating sexual safety in the era of biomedical HIV prevention: relationship dynamics among male couples using pre-exposure prophylaxis.

    Science.gov (United States)

    Malone, Jowanna; Syvertsen, Jennifer L; Johnson, Blake E; Mimiaga, Matthew J; Mayer, Kenneth H; Bazzi, Angela R

    2018-06-01

    Up to two-thirds of new cases of HIV transmission between gay, bisexual and other men who have sex with men in the USA are attributed to primary relationships. Understanding the relationship dynamics and sexual agreements of male-male couples can provide insight into HIV transmission patterns and prevention needs in this population. The daily use of antiretroviral pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV, but its negotiation and use within social and intimate relationship contexts remain understudied. We conducted semi-structured qualitative interviews with 20 male couples (n = 40 men) in which at least one partner was either using or in the process of initiating PrEP. Congruent with a theoretical focus on social theories of relationships and negotiated risk, couples were interviewed about relationship dynamics, trust, communication and sexual health practices, including their perception and use of PrEP. Overall, we found that couples showed heightened trust and communication when establishing open, sexual agreements and demonstrated high awareness of sexual risks and health practices in the context of PrEP use. This study demonstrates how understanding relationship dynamics can better inform HIV prevention and sexual health promotion efforts for male couples at risk of HIV.

  3. Perceptions about HIV pre-exposure prophylaxis among healthcare professionals in Spain (PERPPRES Study

    Directory of Open Access Journals (Sweden)

    Javier Sánchez-Rubio Ferrández

    2016-07-01

    Full Text Available Objective: To determine the level of support, knowledge and perceptions of pre-exposure prophylaxis (PrEP by Infectious Disease Specialists and Hospital Pharmacists in Spain. Methods: Cross-sectional study through an on-line 31-item survey (sociodemographical data, employment status/experience, knowledge of PrEP, use, identified barriers and economic issues. A univariate analysis was performed to evaluate the variables associated with support for PrEP, and compare the assessments by Specialists and Pharmacists. The questions about support for PrEP and agreement with the indication approval were repeated after showing data from published studies. The significance of the change in the answers was analyzed using the McNemar Test. Results: 211 questionnaires were received (80.1% from Pharmacists. 40.3% had low/no familiarity with PrEP (46.2% Pharmacists vs. 16.7% Physicians; p < 0.01. A 53.6% of them would support the use of PrEP (49.7% Pharmacists vs. 69% Physicians; p = 0.038. The minimum acceptable efficacy in order to support PrEP was 85.0 ± 15.5% (82.6 ± 12.1% by Physicians vs. 85.6 ± 15.0% by Pharmacists; p = 0.02. The variables associated with support were: medical profession (OR = 2.26; 95%CI 1.1-4.6; p = 0.038 and lower demand for efficacy (difference = 10.5%; 95%CI 6.9 to 14.1; p < 0.001. After receiving the information, there was an increase in their support for use and indication approval. Most participants (81.5% did not support its reimbursement. The main barriers identified were: an increase in risk behaviour (24.1%, increase in sexually transmitted diseases (19.0%, resistance (16.6% and cost (16.0%. Conclusions: More than half of participants were familiar with PrEP. The majority of them would support its use and the approval of the indication, but would not reimburse it. The use of PrEP in real practice is currently low.

  4. Willingness to use pre-exposure prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM) in Malaysia: findings from a qualitative study

    OpenAIRE

    Adam Bourne; Matteo Cassolato; Clayton Koh Thuan Wei; Bangyuan Wang; Joselyn Pang; Sin How Lim; Iskandar Azwa; Ilias Yee; Gitau Mburu

    2017-01-01

    Abstract Background: Men who have sex with men (MSM) continue to be disproportionately affected by HIV in Malaysia. Recent success has been observed within demonstration projects examining the efficacy of HIV pre-exposure prophylaxis (PrEP), an antiretroviral -based medication taken by HIV-negative men to prevent sero-conversion. In order for such promising findings to be translated in real-world settings, it is important to understand the acceptability of PrEP, including perceived barriers t...

  5. The Acceptability of Pre-Exposure Prophylaxis: Beliefs of Health-Care Professionals Working in Sexually Transmitted Infections Clinics and HIV Treatment Centers.

    NARCIS (Netherlands)

    Bil, Janneke P; Hoornenborg, Elske; Prins, Maria; Hogewoning, Arjan; Dias Goncalves Lima, Fernando; de Vries, Henry J C; Davidovich, Udi

    2018-01-01

    Pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV infections, but is not yet implemented in the Netherlands. As the attitudes of health-care professionals toward PrEP can influence future PrEP implementation, we studied PrEP knowledge and beliefs and their association with PrEP

  6. Acquisition of wild-type HIV-1 infection in a patient on pre-exposure prophylaxis with high intracellular concentrations of tenofovir diphosphate: a case report.

    NARCIS (Netherlands)

    Hoornenborg, Elske; Prins, Maria; Achterbergh, Roel C A; Woittiez, Lycke R; Cornelissen, Marion; Jurriaans, Suzanne; Kootstra, Neeltje A; Anderson, Peter L; Reiss, Peter; de Vries, Henry J C; Prins, Jan M; de Bree, Godelieve J

    2017-01-01

    Pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate is highly effective against acquisition of HIV infection, and only two cases of infection with a multidrug-resistant virus have been reported under adequate long-term adherence, as evidenced by tenofovir diphosphate

  7. Cost-effectiveness of Pre-Exposure Prophylaxis (PrEP) in preventing HIV-1 infections in rural Zambia: a modeling study

    NARCIS (Netherlands)

    Nichols, B.E.; Boucher, C.A.B.; van Dijk, J.H.; Thuma, P.E.; Nouwen, J.L.; Baltussen, R.; van de Wijgert, J.; Sloot, P.M.A.; van de Vijver, D.A.M.C.

    2013-01-01

    Background: Pre-exposure prophylaxis (PrEP) with tenofovir and emtricitabine effectively prevents new HIV infections. The optimal scenario for implementing PrEP where most infections are averted at the lowest cost is unknown. We determined the impact of different PrEP strategies on averting new

  8. The Acceptability of Pre-Exposure Prophylaxis: Beliefs of Health-Care Professionals Working in Sexually Transmitted Infections Clinics and HIV Treatment Centers

    NARCIS (Netherlands)

    Bil, Janneke P.; Hoornenborg, Elske; Prins, Maria; Hogewoning, Arjan; Dias Goncalves Lima, Fernando; de Vries, Henry J. C.; Davidovich, Udi

    2018-01-01

    Pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV infections, but is not yet implemented in the Netherlands. As the attitudes of health-care professionals toward PrEP can influence future PrEP implementation, we studied PrEP knowledge and beliefs and their association with PrEP

  9. Experiences Using Pre-Exposure Prophylaxis for Safer Conception Among HIV Serodiscordant Heterosexual Couples in the United States.

    Science.gov (United States)

    Bazzi, Angela R; Leech, Ashley A; Biancarelli, Dea L; Sullivan, Meg; Drainoni, Mari-Lynn

    2017-08-01

    Antiretroviral pre-exposure prophylaxis (PrEP) is a promising HIV prevention strategy for HIV serodiscordant couples (HIV-infected male, uninfected female) seeking safer conception. However, most research on PrEP for safer conception has focused on couples in sub-Saharan Africa; little is known about the perspectives or experiences of heterosexual couples in the United States. We conducted qualitative interviews with six couples (six women and five of their male partners) receiving PrEP for conception services at an urban safety net hospital in the US Northeast. In-depth interview guides explored couple relationships and contextual factors and attitudes, perceptions, and decision-making processes surrounding PrEP for safer conception. Thematic analyses focused on identifying the following emergent themes. We found that couple relationships were situated within broader social and cultural contexts of immigration, family, and community that shaped their experiences with HIV and serodiscordant relationship status. Despite strong partner support within relationships, HIV stigma and disapproval of serodiscordant relationships contributed to couples' feelings of social isolation and subsequent aspirations to have "normal" families. By enabling "natural" conception through condomless sex, PrEP for safer conception provided a sense of enhanced relationship intimacy. Couples called for increasing public awareness of PrEP through positive messaging as a way to combat HIV stigma. Findings suggest that relationship dynamics and broader social contexts appear to shape HIV serodiscordant couples' fertility desires and motivations to use PrEP. However, increased public awareness of PrEP for safer conception may be needed to combat HIV stigma at the community level.

  10. What Primary Care Providers Need to Know about Pre-Exposure Prophylaxis (PrEP) for HIV Prevention: Narrative Review

    Science.gov (United States)

    Krakower, Douglas; Mayer, Kenneth H.

    2013-01-01

    As HIV prevalence climbs globally, including more than 50,000 new infections per year in the United States, we need effective HIV prevention strategies. The use of antiretrovirals for pre-exposure prophylaxis (known as “PrEP”) among high-risk HIV-uninfected persons is emerging as one such strategy. Randomized controlled trials have demonstrated that once daily oral PrEP decreased HIV incidence among at-risk MSM and African heterosexuals, including HIV serodiscordant couples. An additional randomized control trial of a pericoital topical application of antiretroviral microbicide gel reduced HIV incidence among at-risk heterosexual South African women. Two other studies in African women did not demonstrate the efficacy of oral or topical PrEP, raising concerns about adherence patterns and efficacy in this population. The FDA Antiretroviral Advisory Panel reviewed these studies and additional data in May 2012 and recommended the approval of oral tenofovir-emtricitabine for PrEP in high-risk populations. Patients may seek PrEP from their primary care providers and those on PrEP require monitoring. Thus, primary care providers should become familiar with PrEP. This review outlines the current state of knowledge about PrEP as it pertains to primary care including identification of individuals likely to benefit from PrEP, counseling to maximize adherence and minimize potential increases in risky behavior, and monitoring for potential drug toxicities, HIV acquisition, and antiretroviral drug resistance. Issues related to cost and insurance coverage are also discussed. Recent data suggest that PrEP, in conjunction with other prevention strategies, holds promise in helping to curtail the HIV epidemic. PMID:22821365

  11. Economic evaluation of HIV pre-exposure prophylaxis among men-who-have-sex-with-men in England in 2016.

    Science.gov (United States)

    Ong, Koh Jun; Desai, Sarika; Field, Nigel; Desai, Monica; Nardone, Anthony; van Hoek, Albert Jan; Gill, Owen Noel

    2017-10-01

    Clinical effectiveness of pre-exposure prophylaxis (PrEP) for preventing HIV acquisition in men who have sex with men (MSM) at high HIV risk is established. A static decision analytical model was constructed to inform policy prioritisation in England around cost-effectiveness and budgetary impact of a PrEP programme covering 5,000 MSM during an initial high-risk period. National genitourinary medicine clinic surveillance data informed key HIV risk assumptions. Pragmatic large-scale implementation scenarios were explored. At 86% effectiveness, PrEP given to 5,000 MSM at 3.3 per 100 person-years annual HIV incidence, assuming risk compensation (20% HIV incidence increase), averted 118 HIV infections over remaining lifetimes and was cost saving. Lower effectiveness (64%) gave an incremental cost-effectiveness ratio of + GBP 23,500 (EUR 32,000) per quality-adjusted life year (QALY) gained. Investment of GBP 26.9 million (EUR 36.6 million) in year-1 breaks even anywhere from year-23 (86% effectiveness) to year-33 (64% effectiveness). PrEP cost-effectiveness was highly sensitive to year-1 HIV incidence, PrEP adherence/effectiveness, and antiretroviral drug costs. There is much uncertainty around HIV incidence in those given PrEP and adherence/effectiveness, especially under programme scale-up. Substantially reduced PrEP drug costs are needed to give the necessary assurance of cost-effectiveness, and for an affordable public health programme of sufficient size.

  12. HIV pre-exposure prophylaxis: Exploring the potential for expanding the role of pharmacists in public health.

    Science.gov (United States)

    Okoro, Olihe; Hillman, Lisa

    2018-05-19

    The study objectives were to a) assess knowledge and experience; b) describe perceptions and attitudes; and c) identify training needs of community-based pharmacists regarding HIV pre-exposure prophylaxis (PrEP). This was a cross-sectional survey study. The survey was administered online to pharmacists practicing in a community setting in the state of Minnesota. Measures included knowledge of and experience with HIV PrEP, perceptions and attitudes towards pharmacists' involvement, and HIV PrEP-specific training needs for pharmacists. With a survey response rate of approximately 13% (n = 347), most respondents (76.4%) agreed that HIV PrEP can be beneficial in high-risk populations. Forty-six percent of respondents were not aware of U.S. Food and Drug Administration approval of emtricitabine and tenofovir disoproxil fumarate for PrEP. Most respondents (71.1%) were "not at all familiar" with Centers for Disease Control and Prevention guidelines for PrEP. Twenty-one percent of respondents had sufficient knowledge to counsel patients on PrEP. Experience with counseling on PrEP (21.8%), having dispensed PrEP in the last 2 years (33.1%), fewer years in practice (≤10 years), location of practice site (urban or suburban), and having received HIV continuing education in the last 2 years (33.0%) were associated with more knowledge of HIV PrEP. Top concerns with counseling were knowledge about the medication and behavior modification. The most frequently indicated primary concerns with implementing PrEP initiatives were identifying appropriate candidates and patient adherence. As pharmacists' roles continue to expand, relevant content in pharmacy education and requisite training (including continuing education) are critical to addressing knowledge gaps and competencies that will enable pharmacists engage more effectively in public health efforts such as HIV prevention. Published by Elsevier Inc.

  13. HIV pre-exposure prophylaxis and health and community systems in the Global South: Thailand case study.

    Science.gov (United States)

    Colby, Donn; Srithanaviboonchai, Kriengkrai; Vanichseni, Suphak; Ongwandee, Sumet; Phanuphak, Nittaya; Martin, Michael; Choopanya, Kachit; Chariyalertsak, Suwat; van Griensven, Frits

    2015-01-01

    Pre-exposure prophylaxis (PrEP) is recommended by the World Health Organization as an effective method of HIV prevention for individuals at risk for infection. In this paper, we describe the unique role that Thailand has played in the global effort to combat the HIV epidemic, including its role in proving the efficacy of PrEP, and discuss the opportunities and challenges of implementing PrEP in a middle-income country. Thailand was one of the first countries in the world to successfully reverse a generalized HIV epidemic. Despite this early success, HIV prevalence has remained high among people who inject drugs and has surged among men who have sex with men (MSM) and transgender women (TGW). Two pivotal trials that showed that the use of oral antiretroviral medication as PrEP can reduce HIV transmission were conducted partially or entirely at Thai sites. Demonstration projects of PrEP, as well as clinical trials of alternative PrEP regimens, began or will begin in 2014-2015 in Thailand and will provide additional data and experience on how to best implement PrEP for high-risk individuals in the community. Financing of drug costs, the need for routine laboratory monitoring and lack of awareness about PrEP among at-risk groups all present challenges to the wider implementation of PrEP for HIV prevention in Thailand. Although significant challenges to wider use remain, PrEP holds promise as a safe and highly effective method to be used as part of a combined HIV prevention strategy for MSM and TGW in Thailand.

  14. Executive summary: Pre-exposure prophylaxis for prevention of HIV infection in adults in Spain: July 2016.

    Science.gov (United States)

    Moreno, Santiago; Antela, Antonio; García, Felipe; Del Amo, Julia; Boix, Vicente; Coll, Pep; Fortuny, Claudia; Sirvent, Juan L Gómez; Gutiérrez, Félix; Iribarren, José A; Llibre, Josep M; Quirós, Juan C López Bernaldo de; Losa, Juan Emilio; Lozano, Ana; Meulbroek, Michael; Olalla, Julián; Pujol, Ferran; Pulido, Federico; Crespo Casal, Manuel; García, Juan González; Aldeguer, José López; Molina, Jose A Pérez; Podzamczer Palter, Daniel; Román, Antonio Rivero

    Administration of antiretroviral drugs to individuals exposed to, but not infected by, HIV has been shown to reduce the risk of transmission. The efficacy of pre-exposure prophylaxis (PrEP) makes it obligatory to include it in an integral program of prevention of HIV transmission, together with other measures, such as use of the condom, training, counseling, and appropriate treatment of infected individuals. In this document, the AIDS Study Group (GeSIDA) of the Spanish Society of Infectious Diseases and Clinical Microbiology (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica [SEIMC]) provides its views on this important subject. The available evidence on the usefulness of PrEP in the prevention of transmission of HIV is presented, and the components that should make up a PrEP program and whose development and implementation are feasible in Spain are set out. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  15. Pre-exposure prophylaxis for HIV-1 prevention does not diminish the pregnancy prevention effectiveness of hormonal contraception.

    Science.gov (United States)

    Murnane, Pamela M; Heffron, Renee; Ronald, Allan; Bukusi, Elizabeth A; Donnell, Deborah; Mugo, Nelly R; Were, Edwin; Mujugira, Andrew; Kiarie, James; Celum, Connie; Baeten, Jared M

    2014-07-31

    For women at risk of HIV-1, effective contraception and effective HIV-1 prevention are global priorities. In a clinical trial of pre-exposure prophylaxis (PrEP) for HIV-1 prevention in HIV-1-serodiscordant couples, we estimated the effectiveness of hormonal contraceptives (oral contraceptive pills, injectable depot medroxyprogesterone acetate, and hormonal implants) for pregnancy prevention relative to no contraception among 1785 HIV-1-uninfected women followed up to 36 months. We compared the effectiveness of each method among women assigned PrEP versus placebo. Contraception was not required for participation, but was offered on-site and was recorded monthly; incident pregnancy was determined by monthly urine testing. For women using no contraception, overall pregnancy incidence was 15.4% per year. Women reporting oral contraceptive use had comparable pregnancy incidence to women using no contraception, and this lack of contraceptive effectiveness was similar for those assigned PrEP and placebo (17.7 and 10.0% incidence per year, respectively; P-value for difference in effect by PrEP use = 0.24). Women reporting injectable contraception had reduced pregnancy incidence compared to those reporting no contraception, which did not differ by arm (PrEP 5.1%, placebo 5.3% per year; P-value for difference = 0.47). Contraceptive effectiveness was highest among women using implants (pregnancy incidence <1% per year in both arms). PrEP had no adverse impact on hormonal contraceptive effectiveness for pregnancy prevention. As seen previously in similar populations, women reporting contraceptive pill use had little protection from pregnancy, possibly due to poor adherence. Injectable or implantable hormonal contraception and PrEP provide effective prevention for pregnancy and HIV-1.

  16. Cost-Effectiveness of Pre-exposure HIV Prophylaxis During Pregnancy and Breastfeeding in Sub-Saharan Africa

    Science.gov (United States)

    Wheeler, Stephanie B.; Stranix-Chibanda, Lynda; Hosek, Sybil G.; Watts, D. Heather; Siberry, George K.; Spiegel, Hans M. L.; Stringer, Jeffrey S.; Chi, Benjamin H.

    2016-01-01

    Introduction: Antiretroviral pre-exposure prophylaxis (PrEP) for the prevention of HIV acquisition is cost-effective when delivered to those at substantial risk. Despite a high incidence of HIV infection among pregnant and breastfeeding women in sub-Saharan Africa (SSA), a theoretical increased risk of preterm birth on PrEP could outweigh the HIV prevention benefit. Methods: We developed a decision analytic model to evaluate a strategy of daily oral PrEP during pregnancy and breastfeeding in SSA. We approached the analysis from a health care system perspective across a lifetime time horizon. Model inputs were derived from existing literature and local sources. The incremental cost-effectiveness ratio (ICER) of PrEP versus no PrEP was calculated in 2015 U.S. dollars per disability-adjusted life year (DALY) averted. We evaluated the effect of uncertainty in baseline estimates through one-way and probabilistic sensitivity analyses. Results: PrEP administered to pregnant and breastfeeding women in SSA was cost-effective. In a base case of 10,000 women, the administration of PrEP averted 381 HIV infections but resulted in 779 more preterm births. PrEP was more costly per person ($450 versus $117), but resulted in fewer disability-adjusted life years (DALYs) (3.15 versus 3.49). The incremental cost-effectiveness ratio of $965/DALY averted was below the recommended regional threshold for cost-effectiveness of $6462/DALY. Probabilistic sensitivity analyses demonstrated robustness of the model. Conclusions: Providing PrEP to pregnant and breastfeeding women in SSA is likely cost-effective, although more data are needed about adherence and safety. For populations at high risk of HIV acquisition, PrEP may be considered as part of a broader combination HIV prevention strategy. PMID:27355502

  17. Alcohol-antiretroviral interactive toxicity beliefs as a potential barrier to HIV pre-exposure prophylaxis among men who have sex with men

    OpenAIRE

    Seth C Kalichman; Lisa Eaton

    2017-01-01

    Abstract Introduction: Pre-exposure prophylaxis (PrEP) offers as much as 90% protection against HIV transmission. However, the effectiveness of PrEP depends on uptake and adherence to even intermittent dosing. Along with intoxication leading to unintentional non-adherence, believing that alcohol mixed with pharmaceuticals is harmful (i.e., interactive toxicity beliefs) may lead to poor uptake and intentional non-adherence. Methods: HIV-negative sexually active men who have sex with men (N?=?2...

  18. The promises and challenges of pre-exposure prophylaxis as part of the emerging paradigm of combination HIV prevention.

    Science.gov (United States)

    Cáceres, Carlos F; Koechlin, Florence; Goicochea, Pedro; Sow, Papa-Salif; O'Reilly, Kevin R; Mayer, Kenneth H; Godfrey-Faussett, Peter

    2015-01-01

    Towards the end of the twentieth century, significant success was achieved in reducing incidence in several global HIV epidemics through ongoing prevention strategies. However, further progress in risk reduction was uncertain. For one thing, it was clear that social vulnerability had to be addressed, through research on interventions addressing health systems and other structural barriers. As soon as antiretroviral treatment became available, researchers started to conceive that antiretrovirals might play a role in decreasing either susceptibility in uninfected people or infectiousness among people living with HIV. In this paper we focus on the origin, present status, and potential contribution of pre-exposure prophylaxis (PrEP) within the combination HIV prevention framework. After a phase of controversy, PrEP efficacy trials took off. By 2015, daily oral PrEP, using tenofovir alone or in combination with emtricitabine, has been proven efficacious, though efficacy seems heavily contingent upon adherence to pill uptake. Initial demonstration projects after release of efficacy results have shown that PrEP can be implemented in real settings and adherence can be high, leading to high effectiveness. Despite its substantial potential, beliefs persist about unfeasibility in real-life settings due to stigma, cost, adherence, and potential risk compensation barriers. The strategic synergy of behavioural change communication, biomedical strategies (including PrEP), and structural programmes is providing the basis for the combination HIV prevention framework. If PrEP is to ever become a key component of that framework, several negative beliefs must be confronted based on emerging evidence; moreover, research gaps regarding PrEP implementation must be filled, and appropriate prioritization strategies must be set up. Those challenges are significant, proportional to the impact that PrEP implementation may have in the global response to HIV.

  19. Pre-exposure prophylaxis of HIV: A right way to go or a long way to go?

    Science.gov (United States)

    Yu, Wenya; Wang, Lu; Han, Na; Zhang, Xiayan; Mahapatra, Tanmay; Mahapatra, Sanchita; Babu, Giridhara R.; Tang, Weiming; Detels, Roger; Zhao, Jinkou

    2014-01-01

    Antiretroviral drugs are being tried as candidates for the pre-exposure prophylaxis (PrEP) against HIV for a considerable period, due to their potential for immediate inhibition of viral replication. Discrepancies in the findings called for a critical review of the relevant efforts and their outcomes. A systematic literature search identified 143 eligible articles of which only 5 reported complete findings while another 11 were still on-going. Observed moderate efficacy and good safety profile seemed to identify PrEP as a promising step for minimizing the spread of HIV to relatively unaffected population and controlling the epidemic among high risk population groups. But the duration of this efficacy was found to depend heavily on the availability, adherence and other related issues like cost, political commitment, ethical consideration etc. To prevent potential cultural and behavioral modifications, proper pre-administration counseling also seemed critical for the success of PrEP as a cost-effective intervention with adequate coverage. PMID:25078629

  20. Views of policymakers, healthcare workers and NGOs on HIV pre-exposure prophylaxis (PrEP): a multinational qualitative study

    NARCIS (Netherlands)

    Wheelock, Ana; Eisingerich, Andreas B.; Gomez, Gabriela B.; Gray, Emily; Dybul, Mark R.; Piot, Peter

    2012-01-01

    To examine policymakers and providers' views on pre-exposure prophylaxis (PrEP) and their willingness to support its introduction, to inform policy and practice in this emerging field. Semistructured qualitative interview study. Peru, Ukraine, India, Kenya, Uganda, Botswana and South Africa. 35

  1. Economic evaluation of HIV pre-exposure prophylaxis strategies: protocol for a methodological systematic review and quantitative synthesis.

    Science.gov (United States)

    Thavorn, Kednapa; Kugathasan, Howsikan; Tan, Darrell H S; Moqueet, Nasheed; Baral, Stefan D; Skidmore, Becky; MacFadden, Derek; Simkin, Anna; Mishra, Sharmistha

    2018-03-15

    Pre-exposure prophylaxis (PrEP) with antiretrovirals is an efficacious and effective intervention to decrease the risk of HIV (human immunodeficiency virus) acquisition. Yet drug and delivery costs prohibit access in many jurisdictions. In the absence of guidelines for the synthesis of economic evaluations, we developed a protocol for a systematic review of economic evaluation studies for PrEP by drawing on best practices in systematic reviews and the conduct and reporting of economic evaluations. We aim to estimate the incremental cost per health outcome of PrEP compared with placebo, no PrEP, or other HIV prevention strategies; assess the methodological variability in, and quality of, economic evaluations of PrEP; estimate the incremental cost per health outcome of different PrEP implementation strategies; and quantify the potential sources of heterogeneity in outcomes. We will systematically search electronic databases (MEDLINE, Embase) and the gray literature. We will include economic evaluation studies that assess both costs and health outcomes of PrEP in HIV-uninfected individuals, without restricting language or year of publication. Two reviewers will independently screen studies using predefined inclusion criteria, extract data, and assess methodological quality using the Philips checklist, Second Panel on the Cost-effectiveness of Health and Medicines, and the International Society for Pharmacoeconomics and Outcomes Research recommendations. Outcomes of interest include incremental costs and outcomes in natural units or utilities, cost-effectiveness ratios, and net monetary benefit. We will perform descriptive and quantitative syntheses using sensitivity analyses of outcomes by population subgroups, HIV epidemic settings, study designs, baseline intervention contexts, key parameter inputs and assumptions, type of outcomes, economic perspectives, and willingness to pay values. Findings will guide future economic evaluation of PrEP strategies in terms of

  2. The Vaginal Microbiome and its Potential to Impact Efficacy of HIV Pre-exposure Prophylaxis for Women.

    Science.gov (United States)

    Velloza, Jennifer; Heffron, Renee

    2017-10-01

    This review describes existing evidence addressing the potential modulation of pre-exposure prophylaxis (PrEP) products, specifically 1% tenofovir (TFV) gel and oral tenofovir-based PrEP, by vaginal dysbiosis and discusses future considerations for delivering novel, long-acting PrEP products to women at high risk for vaginal dysbiosis and HIV. We describe results from analyses investigating the modification of PrEP efficacy by vaginal dysbiosis and studies of biological mechanisms that could render PrEP ineffective in the presence of specific microbiota. A secondary analysis from the CAPRISA-004 cohort demonstrated that there is no effect of the 1% TFV gel in the presence of non-Lactobacillus dominant microbiota. Another recent analysis comparing oral tenofovir-based PrEP efficacy among women with and without bacterial vaginosis in the Partners PrEP Study found that oral PrEP efficacy is not modified by bacterial vaginosis. Gardnerella vaginalis, commonly present in women with vaginal dysbiosis, can rapidly metabolize TFV particularly when it is locally applied and thereby prevent TFV integration into cells. Given that vaginal dysbiosis appears to modulate efficacy for 1% TFV gel but not for oral tenofovir-based PrEP, vaginal dysbiosis is potentially less consequential to HIV protection from TFV in the context of systemic drug delivery and high product adherence. Vaginal dysbiosis may undermine the efficacy of 1% TFV gel to protect women from HIV but not the efficacy of oral PrEP. Ongoing development of novel ring, injectable, and film-based PrEP products should investigate whether vaginal dysbiosis can reduce efficacy of these products, even in the presence of high adherence.

  3. Condom migration after introduction of pre-exposure prophylaxis among HIV-uninfected adolescents in South Africa: A cohort analysis

    Directory of Open Access Journals (Sweden)

    Lennart P. Maljaars

    2017-09-01

    Full Text Available Background: Approximately 3 million adolescents and young adults (AYA, between the ages of 15 years and 24 years, are living with HIV in sub-Saharan Africa. The use of pre-exposure prophylaxis (PrEP may be a promising HIV prevention tool to bridge the high-risk years of AYA between sexual debut and adulthood. Objectives: Concerns have been raised that the use of PrEP could lead to an increase in sexual risk behaviour and sexually transmitted infections in general and less condom use in particular among adolescents. Methods: This study assesses condom use among South African adolescents enrolled on a demonstration PrEP study, called Pluspills, being conducted in Cape Town and Soweto. A questionnaire on sexual risk behaviour was administered at baseline and after 4, 8 and 12 weeks. Three different questions on condom use were asked at each visit. Unless all answers indicated condom use at all times, a participant was scored ‘at risk’. McNemar’s tests and a Cochran’s Q test were used to investigate changes in condom use over time. Results: We interviewed 148 adolescents (66% female at baseline. Eighty-nine participants completed all visits. In this group, an increase in condom use was observed over the period of 12 weeks. Most participants who reported behavioural changes mentioned an increase in condom use. Conclusion: There was no sign of sexual risk compensation in the 12 weeks of the study. Observed increase in condom use can be explained by an increased awareness of personal HIV risk or by social desirability or recall biases. In future research, additional data including other biomarkers of unprotected sex and longer follow-up time would be useful to help understand the relationship between PrEP use, sexual risk perception and consequent behaviours, especially in adolescents.

  4. Exploring Patterns of Awareness and Use of HIV Pre-Exposure Prophylaxis Among Young Men Who Have Sex with Men.

    Science.gov (United States)

    Strauss, Benjamin B; Greene, George J; Phillips, Gregory; Bhatia, Ramona; Madkins, Krystal; Parsons, Jeffrey T; Mustanski, Brian

    2017-05-01

    Pre-exposure prophylaxis (PrEP) has shown promise as a safe and effective HIV prevention strategy, but there is limited research on awareness and use among young men who have sex with men (YMSM). Using baseline data from the "Keep It Up! 2.0" randomized control trial, we examined differences in PrEP awareness and use among racially diverse YMSM (N = 759; mean age = 24.2 years). Participants were recruited from study sites in Atlanta, Chicago, and New York City, as well as through national advertising on social media applications. While 67.5 % of participants reported awareness of PrEP, 8.7 % indicated using the medication. Awareness, but not use, varied by demographic variables. PrEP-users had twice as many condomless anal sex partners (ERR = 2.05) and more condomless anal sex acts (ERR = 1.60) than non-users. Future research should aim to improve PrEP awareness and uptake among YMSM and address condom use.

  5. [Compliancy of pre-exposure prophylaxis for HIV infection in men who have sex with men in Chengdu].

    Science.gov (United States)

    Xu, J Y; Mou, Y C; Ma, Y L; Zhang, J Y

    2017-05-10

    Objective: To evaluate the compliancy of HIV pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM) in Chengdu, Sichuan province, and explore the influencing factors. Methods: From 1 July 2013 to 30 September 2015, a random, open, multi-center and parallel control intervention study was conducted in 328 MSM enrolled by non-probability sampling in Chengdu. The MSM were divided into 3 groups randomly, i.e. daily group, intermittent group (before and after exposure) and control group. Clinical follow-up and questionnaire survey were carried out every 3 months. Their PrEP compliances were evaluated respectively and multivariate logistic regression analysis was conducted to identify the related factors. Results: A total of 141 MSM were surveyed, in whom 59(41.8 % ) had good PrEP compliancy. The PrEP compliancy rate was 69.0 % in daily group, higher than that in intermittent group (14.3 % ), the difference had significance ( χ (2)=45.29, P <0.001). Multivariate logistic analysis indicated that type of PrEP was the influencing factors of PrEP compliancy. Compared with daily group, the intermittent group had worse PrEP compliancy ( OR =0.07, 95 %CI : 0.03-0.16). Conclusion: The PrEP compliance of the MSM in this study was poor, the compliancy would be influenced by the type of PrEP.

  6. Knowledge, Attitudes, and Experiences of HIV Pre-Exposure Prophylaxis (PrEP) Trial Participants in Botswana.

    Science.gov (United States)

    Toledo, Lauren; McLellan-Lemal, Eleanor; Henderson, Faith L; Kebaabetswe, Poloko M

    2015-03-01

    Recent clinical trials have shown that a daily dose of oral TDF/FTC pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency (HIV) risk. Understanding trial participants' perspectives about retention and PrEP adherence is critical to inform future PrEP trials and the scale-up and implementation of PrEP programs. We analyzed 53 in-depth interviews conducted in April 2010 with participants in the TDF2 study, a Phase 3, randomized, double-blind, placebo-controlled clinical trial of daily oral TDF/FTC with heterosexual men and women in Francistown and Gaborone, Botswana. We examined participants' knowledge, attitudes, and experiences of the trial, identified facilitators and barriers to enrollment and retention, and compared participant responses by study site, sex, and study drug adherence. Our findings point to several factors to consider for participant retention and adherence in PrEP trials and programs, including conducting pre-enrollment education and myth reduction counseling, providing accurate estimates of participant obligations and side effect symptoms, ensuring participant understanding of the effects of non-adherence, gauging personal commitment and interest in study outcomes, and developing a strong external social support network for participants.

  7. HIV pre-exposure prophylaxis for women and infants prevents vaginal and oral HIV transmission in a preclinical model of HIV infection.

    Science.gov (United States)

    Kovarova, Martina; Shanmugasundaram, Uma; Baker, Caroline E; Spagnuolo, Rae Ann; De, Chandrav; Nixon, Christopher C; Wahl, Angela; Garcia, J Victor

    2016-11-01

    Approximately 1.5 million HIV-positive women become pregnant annually. Without treatment, up to 45% will transmit HIV to their infants, primarily through breastfeeding. These numbers highlight that HIV acquisition is a major health concern for women and children globally. They also emphasize the urgent need for novel approaches to prevent HIV acquisition that are safe, effective and convenient to use by women and children in places where they are most needed. 4'-Ethynyl-2-fluoro-2'-deoxyadenosine, a potent NRTI with low cytotoxicity, was administered orally to NOD/SCID/γc -/- mice and to bone marrow/liver/thymus (BLT) humanized mice, a preclinical model of HIV infection. HIV inhibitory activity in serum, cervicovaginal secretions and saliva was evaluated 4 h after administration. 4'-Ethynyl-2-fluoro-2'-deoxyadenosine's ability to prevent vaginal and oral HIV transmission was evaluated using highly relevant transmitted/founder viruses in BLT mice. Strong HIV inhibitory activity in serum, cervicovaginal secretions and saliva obtained from animals after a single oral dose of 4'-ethynyl-2-fluoro-2'-deoxyadenosine (10 mg/kg) demonstrated efficient drug penetration into relevant mucosal sites. A single daily oral dose of 4'-ethynyl-2-fluoro-2'-deoxyadenosine resulted in efficient prevention of vaginal and oral HIV transmission after multiple high-dose exposures to transmitted/founder viruses in BLT humanized mice. Our data demonstrated that 4'-ethynyl-2-fluoro-2'-deoxyadenosine efficiently prevents both vaginal and oral HIV transmission. Together with 4'-ethynyl-2-fluoro-2'-deoxyadenosine's relatively low toxicity and high potency against drug-resistant HIV strains, these data support further clinical development of 4'-ethynyl-2-fluoro-2'-deoxyadenosine as a potential pre-exposure prophylaxis agent to prevent HIV transmission in women and their infants. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial

  8. Understanding Adherence to Daily and Intermittent Regimens of Oral HIV Pre-exposure Prophylaxis Among Men Who Have Sex with Men in Kenya

    OpenAIRE

    Mugo, Peter Mwangi; Sanders, Eduard J.; Mutua, Gaudensia; van der Elst, Elisabeth; Anzala, Omu; Barin, Burc; Bangsberg, David R.; Priddy, Frances H.; Haberer, Jessica E.

    2014-01-01

    A qualitative assessment of Kenyan men who have sex with men taking daily and intermittent oral HIV pre-exposure prophylaxis (PrEP) found stigma, sex work, mobility, and alcohol impacted adherence. We analyzed quantitative data from the same cohort to explore different definitions of intermittent adherence. Volunteers were randomized to daily emtricitabine/tenofovir or placebo, or intermittent (prescription: Mondays/Fridays/after sex, maximum 1 dose/day) emtricitabine/tenofovir or placebo (2:...

  9. Pre-exposure Prophylaxis Against Human Immunodeficiency Virus

    Directory of Open Access Journals (Sweden)

    Güle ÇINAR

    2018-03-01

    Full Text Available According to the Center for Disease Control and Prevention (CDC, there were 2.1 million new human immunodeficiency virus (HIV cases reported worldwide in 2015, which shows that siginificant work needs to be done to prevent the transmission of HIV. Research to date has focused mainly on high-risk men who have sex with men, but many women around the world are also at a high risk for HIV transmissions. In studies conducted, the incidence of HIV infection in high-risk individuals decreases over 90% when high-risk individuals use pre-exposure prophylaxis (PreP HIV, tenofovir disoproxil fumarate-emtricitabine (TDF-FTC safely. Current data and studies on pre-exposure prophylaxis were discussed in this review.

  10. A Cross-Sectional Online Survey of HIV Pre-Exposure Prophylaxis Adoption Among Primary Care Physicians.

    Science.gov (United States)

    Blackstock, Oni J; Moore, Brent A; Berkenblit, Gail V; Calabrese, Sarah K; Cunningham, Chinazo O; Fiellin, David A; Patel, Viraj V; Phillips, Karran A; Tetrault, Jeanette M; Shah, Minesh; Edelman, E Jennifer

    2017-01-01

    Among health care providers, prescription of HIV pre-exposure prophylaxis (PrEP) has been low. Little is known specifically about primary care physicians (PCPs) with regard to PrEP awareness and adoption (i.e., prescription or referral), and factors associated with adoption. To assess PrEP awareness, PrEP adoption, and factors associated with adoption among PCPs. Cross-sectional online survey conducted in April and May 2015. Members of a national professional organization for academic primary care physicians (n = 266). PrEP awareness, PrEP adoption (ever prescribed or referred a patient for PrEP [yes/no]), provider and practice characteristics, and self-rated knowledge, attitudes, and beliefs associated with adoption. The survey response rate was 8.6 % (266/2093). Ninety-three percent of respondents reported prior awareness of PrEP. Of these, 34.9 % reported PrEP adoption. In multivariable analysis of provider and practice characteristics, compared with non-adopters, adopters were more likely to provide care to more than 50 HIV-positive patients (vs. 0, aOR = 6.82, 95 % CI 2.06-22.52). Compared with non-adopters, adopters were also more likely to report excellent, very good, or good self-rated PrEP knowledge (15.1 %, 33.7 %, 30.2 % vs. 2.5 %, 18.1 %, 23.8 %, respectively; p < 0.001) and to perceive PrEP as extremely safe (35.1 % vs. 10.7 %; p = 0.002). Compared with non-adopters, adopters were less likely to perceive PrEP as being moderately likely to increase risk behaviors ("risk compensation") (12.8 % vs. 28.8 %, p = 0.02). While most respondents were aware of PrEP, only one-third of PrEP-aware PCPs reported adoption. Adopters were more likely to have experience providing HIV care and to perceive PrEP as extremely safe, and were less likely to perceive PrEP use as leading to risk compensation. To enhance PCP adoption of PrEP, educational efforts targeting PCPs without HIV care experience should be considered, as well as training

  11. Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa.

    Science.gov (United States)

    Heffron, Renee; Ngure, Kenneth; Odoyo, Josephine; Bulya, Nulu; Tindimwebwa, Edna; Hong, Ting; Kidoguchi, Lara; Donnell, Deborah; Mugo, Nelly R; Bukusi, Elizabeth A; Katabira, Elly; Asiimwe, Stephen; Morton, Jennifer; Morrison, Susan; Haugen, Harald; Mujugira, Andrew; Haberer, Jessica E; Ware, Norma C; Wyatt, Monique A; Marzinke, Mark A; Frenkel, Lisa M; Celum, Connie; Baeten, Jared M

    2017-11-06

    Introduction : Pre-exposure prophylaxis (PrEP) can provide high protection against HIV infection and is a recommended intervention for HIV-negative persons with substantial HIV risk, such as individuals with a partner living with HIV.  Demonstration projects of PrEP have been conducted in diverse settings worldwide to illustrate practical examples of how PrEP can be delivered.  Methods : We evaluated delivery of PrEP for HIV-negative partners within heterosexual HIV serodiscordant couples in an open-label demonstration project in East Africa.  The delivery model integrated PrEP into HIV treatment services, prioritizing PrEP for HIV-negative partners within serodiscordant couples prior to and during the first 6 months after the partner living with HIV initiated antiretroviral therapy (ART).  We measured adherence to PrEP through medication event monitoring system (MEMS) bottle caps and quantification of tenofovir in plasma among a random sample of participants. We estimated HIV infections prevented using a counterfactual cohort simulated from the placebo arm of a previous PrEP clinical trial. Results : We enrolled 1,010 HIV serodiscordant couples that were naïve to ART and PrEP.  Ninety-seven percent (97%) of HIV-negative partners initiated PrEP, and when PrEP was dispensed, objective measures suggest high adherence: 71% of HIV-negative participants took ≥80% of expected doses, as recorded via MEMS, and 81% of plasma samples had tenofovir detected.  A total of 4 incident HIV infections were observed (incidence rate=0.24 per 100 person-years), a 95% reduction (95% CI 86-98%, pproject for African HIV-negative individuals whose partners were known to be living with HIV.  Delivery of PrEP to HIV-negative partners within HIV serodiscordant couples was feasible and should be prioritized for wide-scale implementation.

  12. Pre-exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Kidney Tubular Dysfunction in HIV-Uninfected Individuals.

    Science.gov (United States)

    Jotwani, Vasantha; Scherzer, Rebecca; Glidden, David V; Mehrotra, Megha; Defechereux, Patricia; Liu, Albert; Gandhi, Monica; Bennett, Michael; Coca, Steven G; Parikh, Chirag R; Grant, Robert M; Shlipak, Michael G

    2018-06-01

    Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is becoming increasingly adopted for HIV prevention. Tenofovir can cause proximal tubular damage and chronic kidney disease in HIV-infected persons, but little is known regarding its nephrotoxic potential among HIV-uninfected persons. In this study, we evaluated the effects of PrEP on urine levels of the following: α1-microglobulin (α1m), a marker of impaired tubular reabsorption; albuminuria, a measure of glomerular injury; and total proteinuria. The Iniciativa Profilaxis Pre-Exposicion (iPrEx) study randomized HIV-seronegative men and transgender women who have sex with men to oral TDF/FTC or placebo. The iPrEx open-label extension (iPrEx-OLE) study enrolled former PrEP trial participants to receive open-label TDF/FTC. A cross-sectional analysis compared urine biomarker levels by study arm in iPrEx (N = 100 treatment arm, N = 100 placebo arm). Then, urine biomarker levels were compared before and after PrEP initiation in 109 participants of iPrEx-OLE. In iPrEx, there were no significant differences in urine α1m, albuminuria, or proteinuria by treatment arm. In iPrEx-OLE, after 24 weeks on PrEP, urine α1m and proteinuria increased by 21% [95% confidence interval (CI): 10 to 33] and 18% (95% CI: 8 to 28), respectively. The prevalence of detectable α1m increased from 44% to 65% (P < 0.001) and estimated glomerular filtration rate declined by 4 mL/min/1.73 m (P < 0.001). There was no significant change in albuminuria (6%; 95% CI: -7% to 20%). PrEP with TDF/FTC was associated with a statistically significant rise in urine α1m and proteinuria after 6 months, suggesting that PrEP may result in subclinical tubule dysfunction.

  13. Design and evaluation of mucoadhesive vaginal tablets of tenofovir disoproxil fumarate for pre-exposure prophylaxis of HIV.

    Science.gov (United States)

    Khan, Arshad Bashir; Thakur, Ram Sharnagat

    2018-03-01

    To design and evaluate novel, feasible, safe, mucoadhesive intravaginal tablets of tenofovir disoproxil fumarate (TDF). It may provide pre-exposure prophylaxis for women against HIV. TDF intravaginal tablets were formulated employing poylvinylpyrrolidone (PVP) as the matrix forming polymer and various mucoadhesive polymers such as carbopol 934, 940, chitosan, and sodium carboxymethylcellulose (SCMC). Wet granulation was used. The evaluation involved testing drug-excipient compatibility, precompression parameters such as percentage yield, bulk density and tapped density of the granules, Carr's index, Hausner ratio, angle of repose, post compression parameters such as color, shape, physical dimensions, weight variation, hardness, friability, swelling index, assay, in vitro dissolution study and ex vivo mucoadhesion studies. Based on in vitro evaluation, C1 was selected as the best formulation and evaluated further for release kinetics, curve fitting analysis, absorption studies using liquid chromatography-mass spectrometry (LC-MS) technique and histopathological assessment in female Sprague-Dawley rats. C1 followed Higuchi model kinetics. Accelerated stability study was as per ICH guidelines by keeping C1 at 40 ± 2 °C and 75 ± 5% RH for six months. C1 was selected as the best formulation due to better swelling index (65.93% at 24 h), prolonged release of 100.62% cumulative drug release (CDR) at 24 h, superior mucoadhesion force (35.93 × 10 2 dynes/cm 2 ) and retention time (16 h). The study revealed that C1 remained stable for six months. C1 showed nil systemic absorption which is desirable and according to histopathological study, C1, exhibited minimal damage on the rat vaginal epithelium indicating safety.

  14. Knowledge, Practices, and Barriers to HIV Pre-Exposure Prophylaxis (PrEP) Prescribing Among Washington State Medical Providers.

    Science.gov (United States)

    Wood, Brian R; McMahan, Vanessa M; Naismith, Kelly; Stockton, Jonathan B; Delaney, Lori A; Stekler, Joanne D

    2018-01-04

    We aimed to assess HIV pre-exposure prophylaxis (PrEP) awareness and prescribing practices among Washington State medical providers from diverse professional disciplines and practice types. In May 2016, we administered an anonymous online survey to licensed medical practitioners who provide primary, longitudinal, walk-in, emergency, obstetric, gynecologic, sexually transmitted infection (STI), or family planning care. Of 735 eligible providers, 64.8% had heard of PrEP. Younger providers and providers with a Doctor of Medicine (MD) degree were more likely to be aware of PrEP compared to older providers (p=0.0001) and providers of other training backgrounds (Advanced Registered Nurse Practitioner [ARNP], Doctor of Osteopathic Medicine [DO], or Physician Assistant [PA]) (p=0.04). Among providers aware of PrEP, most frequent reported concerns about prescribing were adherence (46.0%) and costs (42.9%). Providers felt very (20.1%) or somewhat (33.8%) comfortable discussing PrEP overall, but very (26.8%) or somewhat (44.7%) uncomfortable discussing cost and insurance issues. The 124 PrEP prescribers reported a median of 2 (range 1-175, total 1,142) patients prescribed PrEP. Prior authorizations and insurance denials had prevented prescriptions for 28.7% and 12.1% of prescribers, respectively. Interventions to improve PrEP access should include education to inform medical providers about PrEP, with particular attention to provider types less likely to be aware. Continued efforts to eliminate cost and insurance barriers and educate providers regarding financial resources would help improve PrEP access.

  15. HIV risk and awareness and interest in pre-exposure and post-exposure prophylaxis among sheltered women in Miami.

    Science.gov (United States)

    Doblecki-Lewis, Susanne; Lester, Larissa; Schwartz, Bryanna; Collins, Constance; Johnson, Rai; Kobetz, Erin

    2016-09-01

    Pre- and non-occupational post-exposure prophylaxis for the prevention of HIV infection are recommended for adults at substantial risk of HIV. Women experiencing homelessness have increased risk of HIV infection compared with stably-housed women. We conducted a survey of 74 sheltered women at Lotus House Women's Shelter (Lotus House) in Miami to assess risk behaviour as well as knowledge and perception of pre- and non-occupational post-exposure prophylaxis in this population. Of surveyed women, 58.1% engaged in vaginal and/or anal sex while sheltered, and of sexually-active women 55.4% reported inconsistent condom use. 83.8% of women reported no concern regarding HIV acquisition due to their behaviour. Few women surveyed (20.8%) had previously heard of pre- or non-occupational post-exposure prophylaxis. The majority (58.3%) of respondents indicated receptiveness to these prevention methods when introduced. Those indicating that they would consider pre- or non-occupational post-exposure prophylaxis were significantly younger than those indicating that they would not consider these prevention strategies (p = 0.004). Education and referral for pre- and non-occupational post-exposure prophylaxis should be considered for sheltered women at risk of HIV infection. Additional research to optimise implementation of biomedical prevention strategies in this population is needed. © The Author(s) 2015.

  16. Sex, PrEP, and Stigma: Experiences with HIV Pre-exposure Prophylaxis Among New York City MSM Participating in the HPTN 067/ADAPT Study.

    Science.gov (United States)

    Franks, Julie; Hirsch-Moverman, Yael; Loquere, Avelino S; Amico, K Rivet; Grant, Robert M; Dye, Bonnie J; Rivera, Yan; Gamboa, Robert; Mannheimer, Sharon B

    2018-04-01

    The HPTN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT) study evaluated daily and non-daily dosing schedules for oral pre-exposure prophylaxis (PrEP) to prevent HIV. A qualitative sub-study including focus groups and in-depth interviews was conducted among men who have sex with men participating in New York City to understand their experience with PrEP and study dosing schedules. The 37 sub-study participants were 68% black, 11% white, and 8% Asian; 27% were of Hispanic/Latino ethnicity. Mean age was 34 years. Themes resulting from qualitative analysis include: PrEP is a significant advance for HIV prevention; non-daily dosing of PrEP is congruent with HIV risk; and pervasive stigma connected to HIV and risk behavior is a barrier to PrEP adherence, especially for non-daily dosing schedules. The findings underscore how PrEP intersects with other HIV prevention practices and highlight the need to understand and address multidimensional stigma related to PrEP use.

  17. Motivators, concerns, and barriers to adoption of pre-exposure prophylaxis for HIV prevention among gay and bisexual men in HIV serodiscordant male relationships

    Science.gov (United States)

    Brooks, Ronald A.; Kaplan, Rachel L.; Lieber, Eli; Landovitz, Raphael J.; Lee, Sung-Jae; Leibowitz, Arleen A.

    2011-01-01

    The purpose of this study was to identify factors that may facilitate or impede future adoption of pre-exposure prophylaxis (PrEP) for HIV prevention among gay and bisexual men in HIV-serodiscordant relationships. This qualitative study utilized semi-structured interviews conducted with a multi-racial/ethnic sample of 25 gay and bisexual HIV serodiscordant male couples (n=50 individuals) recruited from community settings in Los Angeles, California. A modified grounded theory approach was employed to identify major themes relating to future adoption of PrEP for HIV prevention. Motivators for adoption included protection against HIV infection, less concern and fear regarding HIV transmission, the opportunity to engage in unprotected sex, and endorsements of PrEP’s effectiveness. Concerns and barriers to adoption included the cost of PrEP, short- and long-term side effects, adverse effects of intermittent use or discontinuing PrEP, and accessibility of PrEP. The findings suggest the need for a carefully planned implementation program along with educational and counseling interventions in the dissemination of an effective PrEP agent. PMID:21476147

  18. Counseling Framework for HIV-Serodiscordant Couples on the Integrated Use of Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention.

    Science.gov (United States)

    Morton, Jennifer F; Celum, Connie; Njoroge, John; Nakyanzi, Agnes; Wakhungu, Imeldah; Tindimwebwa, Edna; Ongachi, Snaidah; Sedah, Eric; Okwero, Emmanuel; Ngure, Kenneth; Odoyo, Josephine; Bulya, Nulu; Haberer, Jessica E; Baeten, Jared M; Heffron, Renee

    2017-01-01

    For HIV-serodiscordant couples, integrated delivery of antiretroviral therapy (ART) for HIV-positive partners and time-limited pre-exposure prophylaxis (PrEP) for negative partners virtually eliminates HIV transmission. Standardized messaging, sensitive to the barriers and motivators to HIV treatment and prevention, is needed for widespread scale-up of this approach. Within the Partners Demonstration Project, a prospective interventional project among 1013 serodiscordant couples in Kenya and Uganda, we offered ART to eligible HIV-positive partners and PrEP to HIV-negative partners before ART initiation and through the HIV-positive partner's first 6 months of ART use. We conducted individual and group discussions with counseling staff to elicit the health communication framework and key messages about ART and PrEP that were delivered to couples. Counseling sessions for serodiscordant couples about PrEP and ART included discussions of HIV serodiscordance, PrEP and ART initiation and integrated use, and PrEP discontinuation. ART messages emphasized daily, lifelong use for treatment and prevention, adherence, viral suppression, resistance, side effects, and safety of ART during pregnancy. PrEP messages emphasized daily dosing, time-limited PrEP use until the HIV-positive partner sustained 6 months of high adherence to ART, adherence, safety during conception, side effects, and other risks for HIV. Counseling messages for HIV-serodiscordant couples are integral to the delivery of time-limited PrEP as a "bridge" to ART-driven viral suppression. Their incorporation into programmatic scale-up will maximize intervention impact on the global epidemic.

  19. Sexual risk behaviors and acceptability of HIV pre-exposure prophylaxis among HIV-negative gay and bisexual men in serodiscordant relationships: a mixed methods study.

    Science.gov (United States)

    Brooks, Ronald A; Landovitz, Raphael J; Kaplan, Rachel L; Lieber, Eli; Lee, Sung-Jae; Barkley, Thomas W

    2012-02-01

    The objective of this mixed methods study was to examine current sexual risk behaviors, acceptability and potential adoption of pre-exposure prophylaxis (PrEP) for HIV prevention, and sexual behavior intentions with PrEP adoption among HIV-negative gay and bisexual men (GBM) in HIV serodiscordant relationships. A multiracial/ethnic sample of 25 HIV-negative GBM in serodiscordant relationships completed a qualitative interview and a brief interviewer-administered survey. A modified grounded theory approach was used to identify key themes relating to acceptability and future adoption of PrEP. Participants reported engaging in sexual risk behaviors that place them at risk for HIV infection. Participants also reported a high level of acceptability for PrEP and willingness to adopt PrEP for HIV prevention. Qualitative themes explaining future PrEP adoption included: (1) the opportunity to engage in sex using a noncondom HIV prevention method, (2) protection from HIV infection, and (3) less anxiety when engaging in sex with an HIV-positive partner. Associated with the future adoption of PrEP, a majority (64%) of participants indicated the likelihood for an increase in sexual risk behaviors and a majority (60%) of participants also indicated the likelihood for a decrease or abandonment of condom use, both of which are in contrast to the findings from the large iPrEx study. These findings suggest that the use of PrEP by HIV-negative GBM in serodiscordant relationships carries with it the potential for risk compensation. The findings suggest that PrEP only be offered as part of a comprehensive HIV prevention strategy that includes ongoing risk reduction counseling in the delivery of PrEP to help moderate risk compensation.

  20. HIV providers' likelihood to prescribe pre-exposure prophylaxis (PrEP) for HIV prevention differs by patient type: a short report.

    Science.gov (United States)

    Adams, Leah M; Balderson, Benjamin H

    2016-09-01

    Pre-exposure prophylaxis (PrEP), the antiretroviral treatment regimen for HIV-negative people at high risk of acquiring HIV, has demonstrated efficacy across clinical trials in several patient populations. The Centers for Disease Control (CDC) have released detailed guidelines to aid providers in prescribing PrEP for their high-risk patients, including men who have sex with men (MSM), high-risk heterosexuals, and injection drug users (IDUs). Given that much attention in PrEP has focused on MSM patients, the present study used an online survey to assess factors involved in HIV care providers' (n = 363) decisions about prescribing PrEP, along with their willingness to prescribe PrEP to patients from various risk populations (e.g., MSM, heterosexuals, IDUs). The efficacy of PrEP was an important factor in providers' decisions about prescribing PrEP, as were considerations about patients' adherence to the regimen, regular follow-up for care, and medication costs. This survey's findings also suggest that providers' willingness to prescribe PrEP varies by patient group, with providers most willing to initiate the regimen with MSM who have an HIV-positive partner, and least willing to prescribe to high-risk heterosexuals or IDUs. In the context of the current CDC recommendations for PrEP that include MSM, heterosexuals, and IDUs, examining providers' rationales for and barriers against supporting this HIV prevention strategy across patient groups merits further attention.

  1. What qualities in a potential HIV pre-exposure prophylaxis service are valued by black men who have sex with men in London? A qualitative acceptability study.

    OpenAIRE

    Witzel, TC; Nutland, W; Bourne, A

    2018-01-01

    Black men who have sex with men (BMSM) have higher HIV incidence and prevalence when compared to other MSM, despite similar levels of condom use and testing. Pre-exposure prophylaxis (PrEP) could be a useful intervention to reduce these inequalities. This research therefore aims to understand the dimensions of acceptability of a potential PrEP service for BMSM aged 18-45 years in London. In-depth semi-structured interviews were conducted with 25 PrEP-eligible BMSM between April and August 201...

  2. Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention.

    Directory of Open Access Journals (Sweden)

    Andrew Mujugira

    Full Text Available Stable heterosexual HIV-1 serodiscordant couples in Africa have high HIV-1 transmission rates and are a critical population for evaluation of new HIV-1 prevention strategies. The Partners PrEP Study is a randomized, double-blind, placebo-controlled trial of tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis to decrease HIV-1 acquisition within heterosexual HIV-1 serodiscordant couples. We describe the trial design and characteristics of the study cohort.HIV-1 serodiscordant couples, in which the HIV-1 infected partner did not meet national guidelines for initiation of antiretroviral therapy, were enrolled at 9 research sites in Kenya and Uganda. The HIV-1 susceptible partner was randomized to daily oral tenofovir, emtricitabine-tenofovir, or matching placebo with monthly follow-up for 24-36 months.From July 2008 to November 2010, 7920 HIV-1 serodiscordant couples were screened and 4758 enrolled. For 62% (2966/4758 of enrolled couples, the HIV-1 susceptible partner was male. Median age was 33 years for HIV-1 susceptible and HIV-1 infected partners [IQR (28-40 and (26-39 respectively]. Most couples (98% were married, with a median duration of partnership of 7.0 years (IQR 3.0-14.0 and recent knowledge of their serodiscordant status [median 0.4 years (IQR 0.1-2.0]. During the month prior to enrollment, couples reported a median of 4 sex acts (IQR 2-8; 27% reported unprotected sex and 14% of male and 1% of female HIV-1 susceptible partners reported sex with outside partners. Among HIV-1 infected partners, the median plasma HIV-1 level was 3.94 log(10 copies/mL (IQR 3.31-4.53 and median CD4 count was 496 cells/µL (IQR 375-662; the majority (64% had WHO stage 1 HIV-1 disease.Couples at high risk of HIV-1 transmission were rapidly recruited into the Partners PrEP Study, the largest efficacy trial of oral PrEP. (ClinicalTrials.gov NCT00557245.

  3. Awareness and willingness to use HIV pre-exposure prophylaxis amongst gay and bisexual men in Scotland: implications for biomedical HIV prevention.

    Directory of Open Access Journals (Sweden)

    Ingrid Young

    Full Text Available To investigate the awareness of, and willingness to use, HIV Pre-Exposure Prophylaxis (PrEP, and willingness to take part in a PrEP study among gay and bisexual men in Scotland.Cross-sectional survey of 17 gay commercial venues in Glasgow and Edinburgh in May 2011 (N = 1515, 65.2% response rate; 1393 are included in the analyses.Just under one-third of participants had heard of PrEP (n = 434; 31.2%, with awareness associated with being aged older than 35 years, talking to UAI partners about HIV, and with having had an HIV or STI test in the previous 12 months. Around half were willing to take part in a PrEP study (n = 695; 49.9% or to take PrEP on a daily basis (n = 756; 54.3%. In multivariate analysis, willingness to take PrEP was associated with lower levels of education, regular gay scene attendance, 'high-risk' unprotected anal intercourse (UAI and testing for HIV or STI in the previous 12 months. Reasons for not wanting to participate in a PrEP study or take PrEP included perceptions of low personal risk of HIV and concerns with using medication as an HIV prevention method.There is a willingness to engage in new forms of HIV prevention and research amongst a significant number of gay and bisexual men in Scotland. Future biomedical HIV interventions need to consider the links between sexual risk behaviour, testing, and potential PrEP use.

  4. Oral Pre-Exposure Prophylaxis (PrEP) for Prevention of HIV in Serodiscordant Heterosexual Couples in the United States: Opportunities and Challenges

    Science.gov (United States)

    Myers, Julie E.; Kurth, Ann E.; Cohen, Stephanie E.; Mannheimer, Sharon B.; Simmons, Janie; Pouget, Enrique R.; Trabold, Nicole; Haberer, Jessica E.

    2014-01-01

    Abstract Oral HIV pre-exposure prophylaxis (PrEP) is a promising new biomedical prevention approach in which HIV-negative individuals are provided with daily oral antiretroviral medication for the primary prevention of HIV-1. Several clinical trials have demonstrated efficacy of oral PrEP for HIV prevention among groups at high risk for HIV, with adherence closely associated with level of risk reduction. In the United States (US), three groups have been prioritized for initial implementation of PrEP—injection drug users, men who have sex with men at substantial risk for HIV, and HIV-negative partners within serodiscordant heterosexual couples. Numerous demonstration projects involving PrEP implementation among MSM are underway, but relatively little research has been devoted to study PrEP implementation in HIV-serodiscordant heterosexual couples in the US. Such couples face a unique set of challenges to PrEP implementation at the individual, couple, and provider level with regard to PrEP uptake and maintenance, adherence, safety and toxicity, clinical monitoring, and sexual risk behavior. Oral PrEP also provides new opportunities for serodiscordant couples and healthcare providers for primary prevention and reproductive health. This article provides a review of the critical issues, challenges, and opportunities involved in the implementation of oral PrEP among HIV-serodiscordant heterosexual couples in the US. PMID:25045996

  5. Awareness of and willingness to use oral pre-exposure prophylaxis for HIV prevention among HIV-serodiscordant heterosexual couples: a cross-sectional survey in Xinjiang, China.

    Directory of Open Access Journals (Sweden)

    Peierdun Mijiti

    Full Text Available OBJECTIVES: We aimed to investigate the awareness of and willingness to use oral pre-exposure prophylaxis (PrEP for HIV prevention among HIV-negative partners in HIV-serodiscordant heterosexual couples in Xinjiang, China and determine factors that predict willingness to use oral PrEP. METHODS: Between November 2009 and December 2010, a cross-sectional survey was carried out among 351 HIV-negative partners in HIV-serodiscordant heterosexual couples from three cities in Xinjiang, China. Participants completed a self-administered questionnaire to assess their awareness of and willingness to use oral PrEP. Additionally, blood samples were collected to test for HIV infection. Univariate and multivariate logistic regression analyses were performed to identify predictors of willingness to use oral PrEP. RESULTS: Only 10 participants (2.8% reported having heard of PrEP, and only two reported ever using PrEP. However, 297 (84.6% reported that they were willing to use oral PrEP if it was proven to be both safe and effective. Results of multivariate analysis revealed the following independent predictors of willingness to use oral PrEP: monthly household income (adjusted odds ratio = 2.78, <1000 RMB vs. ≥ 1000 RMB, 95% confidence interval: 1.36-5.69, perceived likelihood of contracting HIV from HIV-positive partner (adjusted odds ratio = 2.63, likely vs. unlikely, 95% confidence interval: 1.12-6.19, and worrying about being discriminated against by others due to oral PrEP use (adjusted odds ratio = 9.43, No vs. Yes, 95% confidence interval: 3.78-23.50. CONCLUSIONS: Our results showed HIV-negative partners in HIV-serodiscordant heterosexual couples in China had low awareness of oral PrEP but high willingness to use oral PrEP for HIV prevention. Cost of oral PrEP should be taken into consideration in future PrEP prevention strategy. In addition, efforts should be made to reduce stigma attached to oral PrEP use, which may increase its acceptability among

  6. Perceptions among Dutch men who have sex with men and their willingness to use rectal microbicides and oral pre-exposure prophylaxis to reduce HIV risk--a preliminary study

    NARCIS (Netherlands)

    Marra, Elske; Hankins, Catherine A.

    2015-01-01

    Oral pre-exposure prophylaxis (PrEP) with antiretroviral (ARV) tablets and topical PrEP or microbicides containing ARV drugs could help to reduce HIV incidence. These methods hold promise for men who have sex with men (MSM) who are at higher risk of acquiring HIV. This mixed-methods study in the

  7. Southern African guidelines on the safe use of pre-exposure prophylaxis in persons at risk of acquiring HIV-1 infection

    Directory of Open Access Journals (Sweden)

    Linda-Gail Bekker

    2016-03-01

    Full Text Available The Southern African HIV Clinicians Society published its first set of oral pre-exposure prophylaxis (PrEP guidelines in June 2012 for men who have sex with men (MSM who are at risk of HIV infection. With the flurry of data that has been generated in PrEP clinical research since the first guideline, it became evident that there was a need to revise and expand the PrEP guidelines with new evidence of safety and efficacy of PrEP in several populations, including MSM, transgender persons, heterosexual men and women, HIV-serodiscordant couples and people who inject drugs. This need is particularly relevant following the World Health Organization (WHO Consolidated Treatment Guidelines released in September 2015. These guidelines advise that PrEP is a highly effective, safe, biomedical option for HIV prevention that can be incorporated with other combination prevention strategies in Southern Africa, given the high prevalence of HIV in the region. PrEP should be tailored to populations at highest risk of HIV acquisition, whilst further data from studies in the region accrue to guide optimal deployment to realise the greatest impact regionally. PrEP may be used intermittently during periods of perceived HIV acquisition risk, rather than continually and lifelong, as is the case with antiretroviral treatment. Recognition and accurate measurement of potential risk in individuals and populations also warrants discussion, but are not extensively covered in these guidelines.

  8. Southern African guidelines on the safe use of pre-exposure prophylaxis in persons at risk of acquiring HIV-1 infection

    Science.gov (United States)

    Rebe, Kevin; Venter, Francois; Maartens, Gary; Moorhouse, Michelle; Conradie, Francesca; Wallis, Carole; Black, Vivian; Harley, Beth; Eakles, Robyn

    2016-01-01

    The Southern African HIV Clinicians Society published its first set of oral pre-exposure prophylaxis (PrEP) guidelines in June 2012 for men who have sex with men (MSM) who are at risk of HIV infection. With the flurry of data that has been generated in PrEP clinical research since the first guideline, it became evident that there was a need to revise and expand the PrEP guidelines with new evidence of safety and efficacy of PrEP in several populations, including MSM, transgender persons, heterosexual men and women, HIV-serodiscordant couples and people who inject drugs. This need is particularly relevant following the World Health Organization (WHO) Consolidated Treatment Guidelines released in September 2015. These guidelines advise that PrEP is a highly effective, safe, biomedical option for HIV prevention that can be incorporated with other combination prevention strategies in Southern Africa, given the high prevalence of HIV in the region. PrEP should be tailored to populations at highest risk of HIV acquisition, whilst further data from studies in the region accrue to guide optimal deployment to realise the greatest impact regionally. PrEP may be used intermittently during periods of perceived HIV acquisition risk, rather than continually and lifelong, as is the case with antiretroviral treatment. Recognition and accurate measurement of potential risk in individuals and populations also warrants discussion, but are not extensively covered in these guidelines. PMID:29568613

  9. Comparing the impact of increasing condom use or HIV pre-exposure prophylaxis (PrEP use among female sex workers

    Directory of Open Access Journals (Sweden)

    Zindoga Mukandavire

    2016-03-01

    Full Text Available In many settings, interventions targeting female sex workers (FSWs could significantly reduce the overall transmission of HIV. To understand the role HIV pre-exposure prophylaxis (PrEP could play in controlling HIV transmission amongst FSWs, it is important to understand how its impact compares with scaling-up condom use—one of the proven HIV prevention strategies for FSWs. It is important to remember that condoms also have other benefits such as reducing the incidence of sexually transmitted infections and preventing pregnancy. A dynamic deterministic model of HIV transmission amongst FSWs, their clients and other male partners (termed ‘pimps’ was used to compare the protection provided by PrEP for HIV-negative FSWs with FSWs increasing their condom use with clients and/or pimps. For different HIV prevalence scenarios, levels of pimp interaction, and baseline condom use, we estimated the coverage of PrEP that gives the same reduction in endemic FSW HIV prevalence or HIV infections averted as different increases in condom use. To achieve the same impact on FSW HIV prevalence as increasing condom use by 1%, the coverage of PrEP has to increase by >2%. The relative impact of PrEP increases for scenarios where pimps contribute to HIV transmission, but not greatly, and decreases with higher baseline condom use. In terms of HIV infections averted over 10 years, the relative impact of PrEP compared to condoms was reduced, with a >3% increase in PrEP coverage achieving the same impact as a 1% increase in condom use. Condom promotion interventions should remain the mainstay HIV prevention strategy for FSWs, with PrEP only being implemented once condom interventions have been maximised or to fill prevention gaps where condoms cannot be used.

  10. Pre-exposure prophylaxis for the prevention of HIV infection in high risk populations: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Junjun Jiang

    Full Text Available Nearly ten randomized controlled trials (RCTs of pre-exposure prophylaxis (PrEP have been completed or are ongoing worldwide to evaluate the effectiveness of PrEP in HIV transmission among HIV-uninfected high risk populations. The purpose of this study was to evaluate the role of PrEP to prevent HIV transmission through a Mata-analysis.A comprehensive computerized literature search was carried out in PubMed, EMbase, Ovid, Web of Science, Science Direct, Wan Fang, CNKI and related websites to collect relevant articles (from their establishment date to August 30, 2013. The search terms were "pre-exposure prophylaxis", "high risk population", "HIV infection", "reduction", "relative risk" and "efficacy". We included any RCT assessing PrEP for the prevention of HIV infection in high risk populations. Interventions of the studies were continuously daily or intermittent doses of single or compound antiretrovirals (ARVs before HIV exposure or during HIV exposure. A meta-analysis was conducted using Stata 10.0. A random-effects method was used to calculate the pooled relative risk (RR and 95% confidence intervals (CI for all studies included.Seven RCTs involving 14,804 individuals in high risk populations were eligible for this study. The number of subjects in the experimental groups was 8,195, with HIV infection rate of 2.03%. The number of subjects in the control groups was 6,609, with HIV infection rate of 4.07%. The pooled RR was 0.53 (95% CI = 0.40 ∼ 0.71, P<0.001. The re-analyzed pooled RR were 0.61 (95% CI = 0.48 ∼ 0.77, P<0.001, 0.49 (95% CI = 0.38 ∼ 0.63, P<0.001, respectively, by excluding the largest study or two studies without statistical significance. Publication bias analysis revealed a symmetry funnel plot. The fail-safe number was 1,022.These results show that PrEP is an effective strategy for reducing new HIV infections in high risk populations.

  11. Acceptability and willingness to use HIV pre-exposure prophylaxis among HIV-negative men who have sex with men in Switzerland.

    Science.gov (United States)

    Gredig, Daniel; Uggowitzer, Franziska; Hassler, Benedikt; Weber, Patrick; Nideröst, Sibylle

    2016-01-01

    Pre-exposure prophylaxis (PrEP) is discussed as an additional HIV prevention method targeting men who have sex with men (MSM). So far, PrEP has not been approved in Switzerland and only little is known about the acceptability of PrEP among MSM living in Switzerland. Given the slow uptake of PrEP among MSM in the USA, the objectives of the study were to investigate the acceptability for PrEP and to identify factors influencing the acceptability for this prevention method and the willingness to adopt it. During a 4-month period we conducted five focus group discussions with 23 consecutively sampled HIV-negative MSM aged 22-60 years living in Switzerland. We analyzed the data according to qualitative content analysis. The acceptability of PrEP varied considerably among the participants. Some would use PrEP immediately after its introduction in Switzerland because it provides an alternative to condoms which they are unable or unwilling to use. Others were more ambivalent towards PrEP but still considered it (1) an additional or alternative protection to regular condom use, (2) an option to engage in sexual activities with less worries and anxieties or (3) a protection during receptive anal intercourse independently of the sexual partner's protective behaviour. Some participants would not consider using PrEP at all: they do not see any benefit in PrEP as they have adopted safer sex practices and did not mention any problems with condom use. Others are still undecided and could imagine using an improved form of PrEP. The results provide a valuable basis for a model explaining the acceptability of PrEP among MSM and suggest including the personal HIV protection strategy in the considerations adopted.

  12. Intimacy motivations and pre-exposure prophylaxis (PrEP) adoption intentions among HIV-negative men who have sex with men (MSM) in romantic relationships.

    Science.gov (United States)

    Gamarel, Kristi E; Golub, Sarit A

    2015-04-01

    In the USA, men who have sex with men (MSM) in primary partnerships are at elevated risk for human immunodeficiency virus (HIV) infection. Pre-exposure prophylaxis (PrEP), a new biomedical prevention strategy, has potential to reduce HIV transmission. This study examined predictors of PrEP adoption intentions among HIV-negative MSM in primary partnerships. The sample included HIV-negative MSM (n = 164) who participated in an ongoing cross-sectional study with an in-person interview examining PrEP adoption intentions. Higher HIV risk perception, intimacy motivations for condomless sex, recent condomless anal sex with outside partners, education, and age were each independently associated with PrEP adoption intentions. In a multivariate model, only age, education, and intimacy motivations for condomless sex were significantly associated with PrEP adoption intentions. Intimacy motivations may play a central role in PrEP adoption for MSM couples. Incorporating relationship dynamics into biomedical strategies is a promising avenue for research and intervention.

  13. Biomedical HIV Prevention Including Pre-exposure Prophylaxis and Opiate Agonist Therapy for Women Who Inject Drugs: State of Research and Future Directions.

    Science.gov (United States)

    Page, Kimberly; Tsui, Judith; Maher, Lisa; Choopanya, Kachit; Vanichseni, Suphak; Mock, Philip A; Celum, Connie; Martin, Michael

    2015-06-01

    Women who inject drugs (WWID) are at higher risk of HIV compared with their male counterparts as a result of multiple factors, including biological, behavioral, and sociostructural factors, yet comparatively little effort has been invested in testing and delivering prevention methods that directly target this group. In this article, we discuss the need for expanded prevention interventions for WWID, focusing on 2 safe, effective, and approved, yet underutilized biomedical prevention methods: opiate agonist therapy (OAT) and oral pre-exposure prophylaxis (PrEP). Although both interventions are well researched, they have not been well examined in the context of gender. We discuss the drivers of women injectors' higher HIV risk, review the effectiveness of OAT and PrEP interventions among women, and explain why these new HIV prevention tools should be prioritized for WWID. There is substantial potential for impact of OAT and PrEP programs for WWID in the context of broader gender-responsive HIV prevention initiatives. Although awaiting efficacy data on other biomedical approaches in the HIV prevention research "pipeline," we propose that the scale-up and implementation of these proven, safe, and effective interventions are needed now.

  14. The Potential Impact of Pre-Exposure Prophylaxis for HIV Prevention among Men Who Have Sex with Men and Transwomen in Lima, Peru: A Mathematical Modelling Study

    Science.gov (United States)

    Caceres, Carlos F.; Segura, Eddy R.; Grant, Robert M.; Garnett, Geoff P.; Hallett, Timothy B.

    2012-01-01

    Background HIV pre-exposure prophylaxis (PrEP), the use of antiretroviral drugs by uninfected individuals to prevent HIV infection, has demonstrated effectiveness in preventing acquisition in a high-risk population of men who have sex with men (MSM). Consequently, there is a need to understand if and how PrEP can be used cost-effectively to prevent HIV infection in such populations. Methods and Findings We developed a mathematical model representing the HIV epidemic among MSM and transwomen (male-to-female transgender individuals) in Lima, Peru, as a test case. PrEP effectiveness in the model is assumed to result from the combination of a “conditional efficacy” parameter and an adherence parameter. Annual operating costs from a health provider perspective were based on the US Centers for Disease Control and Prevention interim guidelines for PrEP use. The model was used to investigate the population-level impact, cost, and cost-effectiveness of PrEP under a range of implementation scenarios. The epidemiological impact of PrEP is largely driven by programme characteristics. For a modest PrEP coverage of 5%, over 8% of infections could be averted in a programme prioritising those at higher risk and attaining the adherence levels of the Pre-Exposure Prophylaxis Initiative study. Across all scenarios, the highest estimated cost per disability-adjusted life year averted (uniform strategy for a coverage level of 20%, US$1,036–US$4,254) is below the World Health Organization recommended threshold for cost-effective interventions, while only certain optimistic scenarios (low coverage of 5% and some or high prioritisation) are likely to be cost-effective using the World Bank threshold. The impact of PrEP is reduced if those on PrEP decrease condom use, but only extreme behaviour changes among non-adherers (over 80% reduction in condom use) and a low PrEP conditional efficacy (40%) would adversely impact the epidemic. However, PrEP will not arrest HIV transmission in

  15. The potential impact of pre-exposure prophylaxis for HIV prevention among men who have sex with men and transwomen in Lima, Peru: a mathematical modelling study.

    Directory of Open Access Journals (Sweden)

    Gabriela B Gomez

    Full Text Available HIV pre-exposure prophylaxis (PrEP, the use of antiretroviral drugs by uninfected individuals to prevent HIV infection, has demonstrated effectiveness in preventing acquisition in a high-risk population of men who have sex with men (MSM. Consequently, there is a need to understand if and how PrEP can be used cost-effectively to prevent HIV infection in such populations.We developed a mathematical model representing the HIV epidemic among MSM and transwomen (male-to-female transgender individuals in Lima, Peru, as a test case. PrEP effectiveness in the model is assumed to result from the combination of a "conditional efficacy" parameter and an adherence parameter. Annual operating costs from a health provider perspective were based on the US Centers for Disease Control and Prevention interim guidelines for PrEP use. The model was used to investigate the population-level impact, cost, and cost-effectiveness of PrEP under a range of implementation scenarios. The epidemiological impact of PrEP is largely driven by programme characteristics. For a modest PrEP coverage of 5%, over 8% of infections could be averted in a programme prioritising those at higher risk and attaining the adherence levels of the Pre-Exposure Prophylaxis Initiative study. Across all scenarios, the highest estimated cost per disability-adjusted life year averted (uniform strategy for a coverage level of 20%, US$1,036-US$4,254 is below the World Health Organization recommended threshold for cost-effective interventions, while only certain optimistic scenarios (low coverage of 5% and some or high prioritisation are likely to be cost-effective using the World Bank threshold. The impact of PrEP is reduced if those on PrEP decrease condom use, but only extreme behaviour changes among non-adherers (over 80% reduction in condom use and a low PrEP conditional efficacy (40% would adversely impact the epidemic. However, PrEP will not arrest HIV transmission in isolation because of its

  16. High HIV incidence in men who have sex with men following an early syphilis diagnosis: is there room for pre-exposure prophylaxis as a prevention strategy?

    Science.gov (United States)

    Girometti, Nicolò; Gutierrez, Angela; Nwokolo, Nneka; McOwan, Alan; Whitlock, Gary

    2017-08-01

    HIV pre-exposure prophylaxis (PrEP) is becoming a pivotal strategy for HIV prevention. Understanding the impact of risk factors for HIV transmission to identify those at highest risk would favour the implementation of PrEP, currently limited by costs. In this service evaluation, we estimated the incidence of bacterial STIs in men who have sex with men (MSM) diagnosed with early syphilis attending a London sexual health clinic according to their HIV status. In addition, we estimated the incidence of HIV infection in HIV-negative MSM, following a diagnosis of early syphilis. We undertook a retrospective case note review of all MSM patients diagnosed with early syphilis between January and June 2014. A number of sexual health screens and diagnoses of chlamydia, gonorrhoea and HIV were prospectively analysed following the syphilis diagnosis. 206 MSM were diagnosed with early syphilis. 110 (53%) were HIV-negative at baseline, 96 (47%) were HIV-positive. Only age (37 vs 32 years, p=0.0005) was significantly different according to HIV status of MSM at baseline. In HIV-negative versus HIV-positive MSM, incidence of rectal chlamydia infection at follow-up was 27 cases vs 50/100 person-years of follow-up (PYFU) (p=0.0039), 33 vs 66/100 PYFU (p=0.0044) for rectal gonorrhoea and 10 vs 26/100 PYFU (p=0.0044) for syphilis reinfection, respectively. Total follow-up for 110 HIV-negative MSM was 144 person-years. HIV incidence was 8.3/100 PYFU (CI 4.2 to 14). A diagnosis of early syphilis carries a high risk of consequent HIV seroconversion and should warrant prioritised access to prevention measures such as PrEP and regular STI screening to prevent HIV transmission. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  17. Complex and Conflicting Social Norms: Implications for Implementation of Future HIV Pre-Exposure Prophylaxis (PrEP Interventions in Vancouver, Canada.

    Directory of Open Access Journals (Sweden)

    Rod Knight

    Full Text Available HIV Pre-Exposure Prophylaxis (PrEP has been found to be efficacious in preventing HIV acquisition among seronegative individuals in a variety of risk groups, including men who have sex with men and people who inject drugs. To date, however, it remains unclear how socio-cultural norms (e.g., attitudes towards HIV; social understandings regarding HIV risk practices may influence the scalability of future PrEP interventions. The objective of this study is to assess how socio-cultural norms may influence the implementation and scalability of future HIV PrEP interventions in Vancouver, Canada.We conducted 50 interviews with young men (ages 18-24 with a variety of HIV risk behavioural profiles (e.g., young men who inject drugs; MSM. Interviews focused on participants' experiences and perceptions with various HIV interventions and policies, including PrEP.While awareness of PrEP was generally low, perceptions about the potential personal and public health gains associated with PrEP were interconnected with expressions of complex and sometimes conflicting social norms. Some accounts characterized PrEP as a convenient form of reliable protection against HIV, likening it to the female birth control pill. Other accounts cast PrEP as a means to facilitate 'socially unacceptable' behaviour (e.g., promiscuity. Stigmatizing rhetoric was used to position PrEP as a tool that could promote some groups' proclivities to take 'risks'.Stigma regarding 'risky' behaviour and PrEP should not be underestimated as a serious implementation challenge. Pre-implementation strategies that concomitantly aim to improve knowledge about PrEP, while addressing associated social prejudices, may be key to effective implementation and scale-up.

  18. A novel Online-to-Offline (O2O) model for pre-exposure prophylaxis and HIV testing scale up.

    Science.gov (United States)

    Anand, Tarandeep; Nitpolprasert, Chattiya; Trachunthong, Deondara; Kerr, Stephen J; Janyam, Surang; Linjongrat, Danai; Hightow-Weidman, Lisa B; Phanuphak, Praphan; Ananworanich, Jintanat; Phanuphak, Nittaya

    2017-03-13

    PrEP awareness and uptake among men who have sex with men (MSM) and transgender women (TG) in Thailand remains low. Finding ways to increase HIV testing and PrEP uptake among high-risk groups is a critical priority. This study evaluates the effect of a novel Adam's Love Online-to-Offline (O2O) model on PrEP and HIV testing uptake among Thai MSM and TG and identifies factors associated with PrEP uptake. The O2O model was piloted by Adam's Love (www.adamslove.org) HIV educational and counselling website. MSM and TG reached online by PrEP promotions and interested in free PrEP and/or HIV testing services contacted Adam's Love online staff, received real-time PrEP eCounseling, and completed online bookings for receiving services at one of the four sites in Bangkok based on their preference. Auto-generated site- and service-specific e-tickets and Quick Response (QR) codes were sent to their mobile devices enabling monitoring and check-in by offline site staff. Service uptake and participant's socio-demographic and risk behaviour characteristics were analyzed. Factors associated with PrEP uptake were assessed using multiple logistic regression. Between January 10th and April 11th, 2016, Adam's Love reached 272,568 people online via the PrEP O2O promotions. 425 MSM and TG received eCounseling and e-tickets. There were 325 (76.5%) MSM and TG who checked-in at clinics and received HIV testing. Nine (2.8%) were diagnosed with HIV infection. Median (IQR) time between receiving the e-ticket and checking-in was 3 (0-7) days. Of 316 HIV-negative MSM and TG, 168 (53.2%) started PrEP. In a multivariate model, higher education (OR 2.30, 95%CI 1.14-4.66; p  = 0.02), seeking sex partners online (OR 2.05, 95%CI 1.19-3.54; p  = 0.009), being aware of sexual partners' HIV status (OR 2.37, 95%CI 1.29-4.35; p  = 0.008), ever previously using post-exposure prophylaxis (PEP) (OR 2.46, 95%CI 1.19-5.09; p  = 0.01), and enrolment at Adam's Love clinic compared to the other three sites

  19. Acceptability of microbicidal vaginal rings and oral pre-exposure prophylaxis for HIV prevention among female sex workers in a high-prevalence US city.

    Science.gov (United States)

    Peitzmeier, Sarah M; Tomko, Catherine; Wingo, Erin; Sawyer, Anne; Sherman, Susan G; Glass, Nancy; Beyrer, Chris; Decker, Michele R

    2017-11-01

    Biomedical HIV prevention tools including oral pre-exposure prophylaxis (PrEP) and vaginal microbicidal rings hold unique value for high-risk women who may have limited capacity for condom negotiation, including the key populations of sex workers and drug users. Commercial sex is a PrEP indicator in CDC guidelines, yet little is known about female sex workers' (FSWs) knowledge of and attitudes toward PrEP or the recently developed monthly vaginal microbicide rings. We describe knowledge and attitudes toward PrEP and microbicide rings in a sample of 60 mostly drug-using FSWs in Baltimore, Maryland, a high HIV-prevalence US city. Just 33% had heard of PrEP, but 65% were interested in taking daily oral PrEP and 76% were interested in a microbicide vaginal ring; 87% were interested in at least one of the two methods. Results suggest method mix will be important as biomedical tools for HIV prophylaxis are implemented and scaled up in this population, as 12% were interested in PrEP but not vaginal rings, while 19% were interested in vaginal rings but not in PrEP. Self-efficacy for daily oral adherence was high (79%) and 78% were interested in using PrEP even if condoms were still necessary. Women who had experienced recent client-perpetrated violence were significantly more interested in PrEP (86% vs 53%, p = 0.009) and microbicidal rings (91% vs 65%, p = 0.028) than women who had not recently experienced violence. No differences were observed by demographics nor HIV risk behaviors, suggesting broad potential interest in daily PrEP and monthly-use vaginal microbicides in this high-risk population.

  20. Pre-exposure rabies prophylaxis: a systematic review

    Science.gov (United States)

    Recuenco, Sergio; Navarro-Vela, Ana Maria; Deray, Raffy; Vigilato, Marco; Ertl, Hildegund; Durrheim, David; Rees, Helen; Nel, Louis H; Abela-Ridder, Bernadette; Briggs, Deborah

    2017-01-01

    Abstract Objective To review the safety and immunogenicity of pre-exposure rabies prophylaxis (including accelerated schedules, co-administration with other vaccines and booster doses), its cost–effectiveness and recommendations for use, particularly in high-risk settings. Methods We searched the PubMed, Centre for Agriculture and Biosciences International, Cochrane Library and Web of Science databases for papers on pre-exposure rabies prophylaxis published between 2007 and 29 January 2016. We reviewed field data from pre-exposure prophylaxis campaigns in Peru and the Philippines. Findings Pre-exposure rabies prophylaxis was safe and immunogenic in children and adults, also when co-administered with routine childhood vaccinations and the Japanese encephalitis vaccine. The evidence available indicates that shorter regimens and regimens involving fewer doses are safe and immunogenic and that booster intervals could be extended up to 10 years. The few studies on cost suggest that, at current vaccine and delivery costs, pre-exposure prophylaxis campaigns would not be cost-effective in most situations. Although pre-exposure prophylaxis has been advocated for high-risk populations, only Peru and the Philippines have implemented appropriate national programmes. In the future, accelerated regimens and novel vaccines could simplify delivery and increase affordability. Conclusion Pre-exposure rabies prophylaxis is safe and immunogenic and should be considered: (i) where access to postexposure prophylaxis is limited or delayed; (ii) where the risk of exposure is high and may go unrecognized; and (iii) where controlling rabies in the animal reservoir is difficult. Pre-exposure prophylaxis should not distract from canine vaccination efforts, provision of postexposure prophylaxis or education to increase rabies awareness in local communities. PMID:28250534

  1. Low prevalence of transmitted K65R and other tenofovir resistance mutations across different HIV-1 subtypes: implications for pre-exposure prophylaxis.

    Science.gov (United States)

    Chan, Philip A; Huang, Austin; Kantor, Rami

    2012-10-15

    Tenofovir-containing regimens have demonstrated potential efficacy as pre-exposure prophylaxis (PrEP) in preventing HIV-1 infection. Transmitted drug resistance mutations associated with tenofovir, specifically the reverse transcriptase (RT) mutation K65R, may impact the effectiveness of PrEP. The worldwide prevalence of transmitted tenofovir resistance in different HIV-1 subtypes is unknown. Sequences from treatment-naïve studies and databases were aggregated and analyzed by Stanford Database tools and as per the International AIDS Society (IAS-USA) resistance criteria. RT sequences were collected from GenBank, the Stanford HIV Sequence Database and the Los Alamos HIV Sequence Database. Sequences underwent rigorous quality control measures. Tenofovir-associated resistance mutations included K65R, K70E, T69-insertion and ≥3 thymidine analogue mutations (TAMs), inclusive of M41L or L210W. A total of 19,823 sequences were evaluated across diverse HIV-1 subtypes (Subtype A: 1549 sequences, B: 9783, C: 3198, D: 483, F: 372, G: 594, H: 41, J: 69, K: 239, CRF01_AE: 1797 and CRF02_AG: 1698). Overall, tenofovir resistance prevalence was 0.4% (n=77/19,823, 95% confidence interval or CI: 0.3 to 0.5). K65R was found in 20 sequences (0.1%, 95% CI: 0.06 to 0.15). Differences in the prevalence of K65R between HIV-1 subtypes were not statistically significant. K70E and ≥3 TAMs were found in 0.015% (95% CI: 0.004 to 0.04) and 0.27% (95% CI: 0.2 to 0.4) of sequences, respectively. Prevalence of transmitted K65R and other tenofovir resistance mutations across diverse HIV-1 subtypes and recombinants is low, suggesting minimal effect on tenofovir-containing PrEP regimens.

  2. Transitioning to HIV Pre-Exposure Prophylaxis (PrEP) from Non-Occupational Post-Exposure Prophylaxis (nPEP) in a Comprehensive HIV Prevention Clinic: A Prospective Cohort Study.

    Science.gov (United States)

    Siemieniuk, Reed A C; Sivachandran, Nirojini; Murphy, Pauline; Sharp, Andrea; Walach, Christine; Placido, Tania; Bogoch, Isaac I

    2015-08-01

    The uptake of pre-exposure prophylaxis (PrEP) for HIV prevention remains low. We hypothesized that a high proportion of patients presenting for HIV non-occupational post-exposure prophylaxis (nPEP) would be candidates for PrEP based on current CDC guidelines. Outcomes from a comprehensive HIV Prevention Clinic are described. We evaluated all patients who attended the HIV Prevention Clinic for nPEP between January 1, 2013 and September 30, 2014. Each patient was evaluated for PrEP candidacy based on current CDC-guidelines and subjectively based on physician opinion. Patients were then evaluated for initiation of PrEP if they met guideline suggestions. Demographic, social, and behavioral factors were then analyzed with logistic regression for associations with PrEP candidacy and initiation. 99 individuals who attended the nPEP clinic were evaluated for PrEP. The average age was 32 years (range, 18-62), 83 (84%) were male, of whom 46 (55%) men who had have sex with men (MSM). 31 (31%) met CDC guidelines for PrEP initiation, which had very good agreement with physician recommendation (kappa=0.88, 0.78-0.98). Factors associated with PrEP candidacy included sexual exposure to HIV, prior nPEP use, and lack of drug insurance (p<0.05 for all comparisons). Combining nPEP and PrEP services in a dedicated clinic can lead to identification of PrEP candidates and may facilitate PrEP uptake. Strategies to ensure equitable access of PrEP should be explored such that those without drug coverage may also benefit from this effective HIV prevention modality.

  3. Diaryltriazine non-nucleoside reverse transcriptase inhibitors are potent candidates for pre-exposure prophylaxis in the prevention of sexual HIV transmission.

    Science.gov (United States)

    Ariën, Kevin K; Venkatraj, Muthusamy; Michiels, Johan; Joossens, Jurgen; Vereecken, Katleen; Van der Veken, Pieter; Abdellati, Saïd; Cuylaerts, Vicky; Crucitti, Tania; Heyndrickx, Leo; Heeres, Jan; Augustyns, Koen; Lewi, Paul J; Vanham, Guido

    2013-09-01

    Pre-exposure prophylaxis and topical microbicides are important strategies in the prevention of sexual HIV transmission, especially since partial protection has been shown in proof-of-concept studies. In search of new candidate drugs with an improved toxicity profile and with activity against common non-nucleoside reverse transcriptase inhibitor (NNRTI)-resistant HIV, we have synthesized and investigated a library of 60 new diaryltriazine analogues. From this library, 15 compounds were evaluated in depth using a broad armamentarium of in vitro assays that are part of a preclinical testing algorithm for microbicide development. Antiviral activity was assessed in a cell line, and in primary human cells, against both subtype B and subtype C HIV-1 and against viruses resistant to therapeutic NNRTIs and the candidate NNRTI microbicide dapivirine. Toxicity towards primary blood-derived cells, cell lines originating from the female reproductive tract and female genital microflora was also studied. We identified several compounds with highly potent antiviral activity and toxicity profiles that are superior to that of dapivirine. In particular, compound UAMC01398 is an interesting new candidate that warrants further investigation because of its superior toxicity profile and potent activity against dapivirine-resistant viruses.

  4. Perceptions of and intentions to adopt HIV pre-exposure prophylaxis among black men who have sex with men in Los Angeles.

    Science.gov (United States)

    Brooks, Ronald A; Landovitz, Raphael J; Regan, Rotrease; Lee, Sung-Jae; Allen, Vincent C

    2015-12-01

    This study assessed perceptions of pre-exposure prophylaxis (PrEP) and their association with PrEP adoption intention among a convenience sample of 224 low socioeconomic status black men who have sex with men (BMSM) residing in Los Angeles. Participants received educational information about PrEP and completed an in-person interview. More than half (60%) of the participants indicated a high intention to adopt PrEP. Younger BMSM (18-29 years) were twice as likely to report a high intention to adopt PrEP compared to older BMSM (30+ years). Only 33% of participants were aware of PrEP and no participant had ever used PrEP. Negative perceptions were associated with a lower PrEP adoption intention and included being uncomfortable taking an HIV medicine when HIV-negative and not knowing if there are long-term side effects of taking an HIV medication. These findings suggest that BMSM may adopt PrEP but that negative perceptions may limit its uptake among this population. In order to facilitate PrEP adoption among BMSM targeted educational and community awareness programmes are needed to provide accurate information on the benefits of PrEP and to address the negative perceptions of PrEP held by local BMSM populations. © The Author(s) 2015.

  5. Oral pre-exposure prophylaxis by anti-retrovirals raltegravir and maraviroc protects against HIV-1 vaginal transmission in a humanized mouse model.

    Directory of Open Access Journals (Sweden)

    C Preston Neff

    Full Text Available Sexual HIV-1 transmission by vaginal route is the most predominant mode of viral transmission, resulting in millions of new infections every year. In the absence of an effective vaccine, there is an urgent need to develop other alternative methods of pre-exposure prophylaxis (PrEP. Many novel drugs that are currently approved for clinical use also show great potential to prevent viral sexual transmission when administered systemically. A small animal model that permits rapid preclinical evaluation of potential candidates for their systemic PrEP efficacy will greatly enhance progress in this area of investigation. We have previously shown that RAG-hu humanized mouse model permits HIV-1 mucosal transmission via both vaginal and rectal routes and displays CD4 T cell loss typical to that seen in the human. Thus far systemic PrEP studies have been primarily limited to RT inhibitors exemplified by tenofovir and emtricitabine. In these proof-of-concept studies we evaluated two new classes of clinically approved drugs with different modes of action namely, an integrase inhibitor raltegravir and a CCR5 inhibitor maraviroc as potential systemically administered chemo-prophylactics. Our results showed that oral administration of either of these drugs fully protects against vaginal HIV-1 challenge in the RAG-hu mouse model. Based on these results both these drugs show great promise for further development as orally administered PrEPs.

  6. Knowledge of Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Men Who Have Sex with Men in Denver, Colorado

    Science.gov (United States)

    Al-Tayyib, Alia A.; Thrun, Mark W.; Haukoos, Jason S.; Walls, N. Eugene

    2014-01-01

    As part of the National HIV Behavioral Surveillance System among men who have sex with men (MSM) in Denver, Colorado, we assessed knowledge of pre-exposure prophylaxis (PrEP); willingness to use PrEP; and potential changes in risk behaviors among HIV-negative participants reporting sexual activity with a male partner in the preceding 12 months. We examined knowledge of PrEP before (2008) and after (2011) results of the iPrEx trial were available. Of the 425 participants in the 2008 sample, 91 (21 %) were aware of PrEP compared to 131 (28 %) of the 461 participants in the 2011 sample (adjusted prevalence ratio: 1.43, 95 % confidence interval: 1.18, 1.72). Despite the increase in 2011, few MSM in Denver were aware of PrEP. Educating high-risk MSM about the potential utility of PrEP as an adjunct to other effective prevention methods is needed when considering the addition of PrEP to the HIV prevention arsenal. PMID:23824227

  7. HIV Care Providers' Intentions to Prescribe and Actual Prescription of Pre-Exposure Prophylaxis to At-Risk Adolescents and Adults.

    Science.gov (United States)

    Mullins, Tanya L Kowalczyk; Zimet, Gregory; Lally, Michelle; Xu, Jiahong; Thornton, Sarah; Kahn, Jessica A

    2017-12-01

    Pre-exposure prophylaxis (PrEP) is indicated for use in US adults, and little is known about clinician intentions to prescribe and actual prescription of PrEP to adolescents younger than 18. Fifty-six clinicians who care for HIV-infected and at-risk youth completed an anonymous online survey in 2014. Primary outcomes were (1) intentions to prescribe PrEP to adolescents and adults in four risk categories [men who have sex with men (MSM), transgender women, heterosexuals with multiple partners of unknown HIV status, heterosexuals with HIV-infected partners]; and (2) actual prescription of PrEP to adolescents and adults in these risk groups. Independent variables included clinician characteristics, experience prescribing nonoccupational postexposure prophylaxis, familiarity with and knowledge of PrEP and PrEP guidance, attitudes toward PrEP, and facilitating factors for prescribing PrEP and incorporation of PrEP guidance into practice. Variables associated with intention to prescribe ("very likely to prescribe" vs. other responses) and actual prescription of PrEP stratified by age and risk category were identified in logistic regression models. Mean age was 45.9 years (standard deviation 10.7); 64% were physicians. More clinicians reported high intention to prescribe PrEP to adult versus adolescent MSM (p = 0.02) and transgender women (p = 0.001). Variables associated with intention to prescribe and prescription of PrEP differed by age and risk category. In adolescents, those variables included positive beliefs, higher number of facilitating factors, and fewer barriers to PrEP prescription. Designing strategies based on these findings that address both facilitating factors and barriers to PrEP prescription may improve PrEP uptake by at-risk youth.

  8. Are Centers for Disease Control and Prevention Guidelines for Preexposure Prophylaxis Specific Enough? Formulation of a Personalized HIV Risk Score for Pre-Exposure Prophylaxis Initiation.

    Science.gov (United States)

    Beymer, Matthew R; Weiss, Robert E; Sugar, Catherine A; Bourque, Linda B; Gee, Gilbert C; Morisky, Donald E; Shu, Suzanne B; Javanbakht, Marjan; Bolan, Robert K

    2017-01-01

    Preexposure prophylaxis (PrEP) has emerged as a human immunodeficiency virus (HIV) prevention tool for populations at highest risk for HIV infection. Current US Centers for Disease Control and Prevention (CDC) guidelines for identifying PrEP candidates may not be specific enough to identify gay, bisexual, and other men who have sex with men (MSM) at the highest risk for HIV infection. We created an HIV risk score for HIV-negative MSM based on Syndemics Theory to develop a more targeted criterion for assessing PrEP candidacy. Behavioral risk assessment and HIV testing data were analyzed for HIV-negative MSM attending the Los Angeles LGBT Center between January 2009 and June 2014 (n = 9481). Syndemics Theory informed the selection of variables for a multivariable Cox proportional hazards model. Estimated coefficients were summed to create an HIV risk score, and model fit was compared between our model and CDC guidelines using the Akaike Information Criterion and Bayesian Information Criterion. Approximately 51% of MSM were above a cutpoint that we chose as an illustrative risk score to qualify for PrEP, identifying 75% of all seroconverting MSM. Our model demonstrated a better overall fit when compared with the CDC guidelines (Akaike Information Criterion Difference = 68) in addition to identifying a greater proportion of HIV infections. Current CDC PrEP guidelines should be expanded to incorporate substance use, partner-level, and other Syndemic variables that have been shown to contribute to HIV acquisition. Deployment of such personalized algorithms may better hone PrEP criteria and allow providers and their patients to make a more informed decision prior to PrEP use.

  9. "Why should I take drugs for your infection?": outcomes of formative research on the use of HIV pre-exposure prophylaxis in Nigeria.

    Science.gov (United States)

    Idoko, John; Folayan, Morenike Oluwatoyin; Dadem, Nancin Yusufu; Kolawole, Grace Oluwatosin; Anenih, James; Alhassan, Emmanuel

    2015-04-10

    Nigeria has the second highest number of new HIV infections annually. Therefore, it is important to explore new strategies for preventing new infections. The introduction of pre-exposure prophylaxis (PrEP) for use by persons at high risk of HIV infection has new potential in preventing new HIV infections. The aim of this study is to explore the public opinion, community interest, and perceptions about the use and access to PrEP in Nigeria. This formative study used a mixed method approach to collect data on public opinions and perceptions on appropriate target groups for PrEP access, community interest, perceptions about the use of PrEP as an HIV-prevention tool, how best to communicate with participants about PrEP, concerns about PrEP use by serodiscordant couples, and suggestions for the design and implementation of a PrEP demonstration project. Telephone and in-depth interviews were conducted, and focus group discussions and consultative meetings were held with critical stakeholders engaged in HIV-prevention, treatment, care, and support programmes in Nigeria. An online survey was also conducted. HIV serodiscordant couples were identified as the appropriate target group for PrEP use. Most respondents felt that PrEP use by key affected populations would help reduce the HIV incidence. Stigma was identified as a major concern and a potential barrier for the acceptance and use of PrEP by HIV serodiscordant couples. Electronic and print media were identified as important means for massive public education to prevent stigma and create awareness about PrEP. In a male dominated society such as Nigeria, HIV-negative male partners in serodiscordant relationships may resist enrolment in PrEP programmes. This may be complicated by the fact that the identified index partner in most serodiscordant relationships in Nigeria is an HIV-positive woman, who is often diagnosed during pregnancy. PrEP uptake and use by HIV serodiscordant couples in Nigeria may face notable but

  10. Pre-Exposure Prophylaxis YouTube Videos: Content Evaluation.

    Science.gov (United States)

    Kecojevic, Aleksandar; Basch, Corey; Basch, Charles; Kernan, William

    2018-02-16

    Antiretroviral (ARV) medicines reduce the risk of transmitting the HIV virus and are recommended as daily pre-exposure prophylaxis (PrEP) in combination with safer sex practices for HIV-negative individuals at a high risk for infection, but are underused in HIV prevention. Previous literature suggests that YouTube is extensively used to share health information. While pre-exposure prophylaxis (PrEP) is a novel and promising approach to HIV prevention, there is limited understanding of YouTube videos as a source of information on PrEP. The objective of this study was to describe the sources, characteristics, and content of the most widely viewed PrEP YouTube videos published up to October 1, 2016. The keywords "pre-exposure prophylaxis" and "Truvada" were used to find 217 videos with a view count >100. Videos were coded for source, view count, length, number of comments, and selected aspects of content. Videos were also assessed for the most likely target audience. The total cumulative number of views was >2.3 million, however, a single Centers for Disease Control and Prevention video accounted for >1.2 million of the total cumulative views. A great majority (181/217, 83.4%) of the videos promoted the use of PrEP, whereas 60.8% (132/217) identified the specific target audience. In contrast, only 35.9% (78/217) of the videos mentioned how to obtain PrEP, whereas less than one third addressed the costs, side effects, and safety aspects relating to PrEP. Medical and academic institutions were the sources of the largest number of videos (66/217, 30.4%), followed by consumers (63/217, 29.0%), community-based organizations (CBO; 48/217, 22.1%), and media (40/217, 18.4%). Videos uploaded by the media sources were more likely to discuss the cost of PrEP (PYouTube videos can be used to share reliable PrEP information with individuals. Further research is needed to identify the best practices for using this medium to promote and increase PrEP uptake. ©Aleksandar Kecojevic

  11. Effect of pre-exposure prophylaxis and combination HIV prevention for men who have sex with men in the UK: a mathematical modelling study.

    Science.gov (United States)

    Punyacharoensin, Narat; Edmunds, William John; De Angelis, Daniela; Delpech, Valerie; Hart, Graham; Elford, Jonathan; Brown, Alison; Gill, O Noel; White, Richard Guy

    2016-02-01

    HIV transmission in men who have sex with men (MSM) in the UK has shown no sign of decreasing in the past decade. Additional prevention measures are needed. We aimed to estimate the effect of various potential interventions implemented individually and in combination on prevention of HIV infection. We extended a deterministic partnership-based mathematical model for HIV transmission, informed by detailed behavioural and surveillance data, to assess the effect of seven different HIV interventions implemented in MSM (aged 15-64 years) in the UK during 2014-20, including increasing rates of HIV testing, test-and-treat programmes, pre-exposure prophylaxis (PrEP), and sexual behavioural changes. We did sensitivity analyses on risk compensation. We predicted a baseline of 16 955 new infections (IQR 13 156-21 669) in MSM in the UK during 2014-20. At a coverage of ≤50%, testing twice a year outperformed all other interventions. Of all intervention combinations, only the combined effect of test and treat and annual HIV testing (61·8%, IQR 47·2-81·8, of total incidence) was greater than the sum of effects of the two interventions individually (32·6%, 23·7-46·0, and 23·9%, 16·5-33·3, respectively). Simultaneous PrEP, expansion of HIV testing, and initiation of test-and-treat programme in 25% of high-activity MSM could save 7399 (IQR 5587-9813) UK MSM from HIV infection (43·6%, IQR 32·9-57·9, of total incidence). An increase in unsafe sex or sexual partners to 50% or more could substantially reduce the effect of interventions, but is unlikely to negate the prevention benefit completely. PrEP could prevent a large number of new HIV infections if other key strategies including HIV testing and treatment are simultaneously expanded and improved. Without PrEP, HIV incidence in MSM in the UK is unlikely to decrease substantially by the end of this decade. Health Protection Agency (now Public Health England). Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Brief Report: Medication Sharing Is Rare Among African HIV-1 Serodiscordant Couples Enrolled in an Efficacy Trial of Oral Pre-exposure Prophylaxis (PrEP) for HIV-1 Prevention.

    Science.gov (United States)

    Thomson, Kerry A; Haberer, Jessica E; Marzinke, Mark A; Mujugira, Andrew; Hendrix, Craig W; Celum, Connie; Ndase, Patrick; Ronald, Allan; Bangsberg, David R; Baeten, Jared M

    2017-06-01

    Sharing of pre-exposure prophylaxis (PrEP) medications is a concern for PrEP implementation. For HIV-1 serodiscordant couples, sharing may undermine the HIV-1 prevention benefit and also cause antiretroviral resistance if taken by HIV-1 infected partners. Within a PrEP efficacy trial among HIV-1 serodiscordant couples, we assessed the occurrence of PrEP sharing by self-report and plasma tenofovir concentrations in HIV-1 infected partners. PrEP sharing was self-reported at <0.01% of visits, and 0%-1.6% of randomly selected and 0% of purposively selected specimens from HIV-1 infected participants had detectable tenofovir concentrations (median: 66.5 ng/mL, range: 1.3-292 ng/mL). PrEP sharing within HIV-1 serodiscordant couples was extremely rare.

  13. Clinical effectiveness and cost-effectiveness of HIV pre-exposure prophylaxis in men who have sex with men: risk calculators for real-world decision-making.

    Directory of Open Access Journals (Sweden)

    Anders Chen

    Full Text Available BACKGROUND: Oral pre-exposure prophylaxis (PrEP can be clinically effective and cost-effective for HIV prevention in high-risk men who have sex with men (MSM. However, individual patients have different risk profiles, real-world populations vary, and no practical tools exist to guide clinical decisions or public health strategies. We introduce a practical model of HIV acquisition, including both a personalized risk calculator for clinical management and a cost-effectiveness calculator for population-level decisions. METHODS: We developed a decision-analytic model of PrEP for MSM. The primary clinical effectiveness and cost-effectiveness outcomes were the number needed to treat (NNT to prevent one HIV infection, and the cost per quality-adjusted life-year (QALY gained. We characterized patients according to risk factors including PrEP adherence, condom use, sexual frequency, background HIV prevalence and antiretroviral therapy use. RESULTS: With standard PrEP adherence and national epidemiologic parameters, the estimated NNT was 64 (95% uncertainty range: 26, 176 at a cost of $160,000 (cost saving, $740,000 per QALY--comparable to other published models. With high (35% HIV prevalence, the NNT was 35 (21, 57, and cost per QALY was $27,000 (cost saving, $160,000, and with high PrEP adherence, the NNT was 30 (14, 69, and cost per QALY was $3,000 (cost saving, $200,000. In contrast, for monogamous, serodiscordant relationships with partner antiretroviral therapy use, the NNT was 90 (39, 157 and cost per QALY was $280,000 ($14,000, $670,000. CONCLUSIONS: PrEP results vary widely across individuals and populations. Risk calculators may aid in patient education, clinical decision-making, and cost-effectiveness evaluation.

  14. Motives of Dutch men who have sex with men for daily and intermittent HIV pre-exposure prophylaxis usage and preferences for implementation: A qualitative study

    NARCIS (Netherlands)

    Bil, Janneke P.; van der Veldt, Wendy M.; Prins, Maria; Stolte, Ineke G.; Davidovich, Udi

    2016-01-01

    Although PrEP is not yet registered in Europe, including the Netherlands, its approval and implementation are expected in the near future. To inform future pre-exposure prophylaxis (PrEP) implementation, this study aimed to gain insight into motives and preferences for daily or intermittent PrEP use

  15. Awareness and attitudes of pre-exposure prophylaxis for HIV prevention among physicians in Guatemala: Implications for country-wide implementation.

    Science.gov (United States)

    Ross, Ian; Mejia, Carlos; Melendez, Johanna; Chan, Philip A; Nunn, Amy C; Powderly, William; Goodenberger, Katherine; Liu, Jingxia; Mayer, Kenneth H; Patel, Rupa R

    2017-01-01

    HIV continues to be a major health concern with approximately 2.1 million new infections occurring worldwide in 2015. In Central America, Guatemala had the highest incident number of HIV infections (3,700) in 2015. Antiretroviral pre-exposure prophylaxis (PrEP) was recently recommended by the World Health Organization (WHO) as an efficacious intervention to prevent HIV transmission. PrEP implementation efforts are underway in Guatemala and success will require providers that are knowledgeable and willing to prescribe PrEP. We sought to explore current PrEP awareness and prescribing attitudes among Guatemalan physicians in order to inform future PrEP implementation efforts. We conducted a cross-sectional survey of adult internal medicine physicians at the main teaching hospital in Guatemala City in March 2015. The survey included demographics, medical specialty, years of HIV patient care, PrEP awareness, willingness to prescribe PrEP, previous experience with post-exposure prophylaxis, and concerns about PrEP. The primary outcome was willingness to prescribe PrEP, which was assessed using a 5-point Likert scale for different at-risk population scenarios. Univariate and multivariate logistic regression was performed to identify predictors for willingness to prescribe PrEP. Eighty-seven physicians completed the survey; 66% were male, 64% were internal medicine residency trainees, and 10% were infectious disease (ID) specialists. Sixty-nine percent of physicians were PrEP aware, of which 9% had previously prescribed PrEP. Most (87%) of respondents were willing to prescribe PrEP to men who have sex with men (MSM), sex workers, injection drug users, or HIV-uninfected persons having known HIV-positive sexual partners. Concerns regarding PrEP included development of resistance (92%), risk compensation (90%), and cost (64%). Univariate logistic regression showed that younger age, being a resident trainee, and being a non-ID specialist were significant predictors for

  16. Values and Preferences on the Use of Oral Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Multiple Populations: A Systematic Review of the Literature.

    Science.gov (United States)

    Koechlin, Florence M; Fonner, Virginia A; Dalglish, Sarah L; O'Reilly, Kevin R; Baggaley, Rachel; Grant, Robert M; Rodolph, Michelle; Hodges-Mameletzis, Ioannis; Kennedy, Caitlin E

    2017-05-01

    Daily oral pre-exposure prophylaxis (PrEP) is the use of antiretroviral drugs by HIV-negative people to prevent HIV infection. WHO released new guidelines in 2015 recommending PrEP for all populations at substantial risk of HIV infection. To prepare these guidelines, we conducted a systematic review of values and preferences among populations that might benefit from PrEP, women, heterosexual men, young women and adolescent girls, female sex workers, serodiscordant couples, transgender people and people who inject drugs, and among healthcare providers who may prescribe PrEP. A comprehensive search strategy reviewed three electronic databases of articles and HIV-related conference abstracts (January 1990-April 2015). Data abstraction used standardised forms to categorise by population groups and relevant themes. Of 3068 citations screened, 76 peer-reviewed articles and 28 conference abstracts were included. Geographic coverage was global. Most studies (N = 78) evaluated hypothetical use of PrEP, while 26 studies included individuals who actually took PrEP or placebo. Awareness of PrEP was low, but once participants were presented with information about PrEP, the majority said they would consider using it. Concerns about safety, side effects, cost and effectiveness were the most frequently cited barriers to use. There was little indication of risk compensation. Healthcare providers would consider prescribing PrEP, but need more information before doing so. Findings from a rapidly expanding evidence base suggest that the majority of populations most likely to benefit from PrEP feel positively towards it. These same populations would benefit from overcoming current implementation challenges with the shortest possible delay.

  17. Community member perspectives from transgender women and men who have sex with men on pre-exposure prophylaxis as an HIV prevention strategy: implications for implementation

    Directory of Open Access Journals (Sweden)

    Galindo Gabriel R

    2012-11-01

    Full Text Available Abstract Background An international randomized clinical trial (RCT on pre-exposure prophylaxis (PrEP as an human immunodeficiency virus (HIV-prevention intervention found that taken on a daily basis, PrEP was safe and effective among men who have sex with men (MSM and male-to-female transgender women. Within the context of the HIV epidemic in the United States (US, MSM and transgender women are the most appropriate groups to target for PrEP implementation at the population level; however, their perspectives on evidenced-based biomedical research and the results of this large trial remain virtually unknown. In this study, we examined the acceptability of individual daily use of PrEP and assessed potential barriers to community uptake. Methods We conducted semi-structured interviews with an ethnoracially diverse sample of thirty HIV-negative and unknown status MSM (n = 24 and transgender women (n = 6 in three California metropolitan areas. Given the burden of disease among ethnoracial minorities in the US, we purposefully oversampled for these groups. Thematic coding and analysis of data was conducted utilizing an approach rooted in grounded theory. Results While participants expressed general interest in PrEP availability, results demonstrate: a lack of community awareness and confusion about PrEP; reservations about PrEP utilization, even when informed of efficacious RCT results; and concerns regarding equity and the manner in which a PrEP intervention could be packaged and marketed in their communities. Conclusions In order to effectively reduce HIV health disparities at the population level, PrEP implementation must take into account the uptake concerns of those groups who would actually access and use this biomedical intervention as a prevention strategy. Recommendations addressing these concerns are provided.

  18. Awareness of pre-exposure prophylaxis (PrEP) among women who inject drugs in NYC: the importance of networks and syringe exchange programs for HIV prevention.

    Science.gov (United States)

    Walters, Suzan M; Reilly, Kathleen H; Neaigus, Alan; Braunstein, Sarah

    2017-06-29

    Women who inject drugs (WWID) are at heightened risk for HIV due to biological, behavioral, and structural factors. Pre-exposure prophylaxis (PrEP) could aid in HIV prevention for WWID. However, little is known about WWID awareness of PrEP, which is a necessary step that must occur before PrEP uptake. We report factors associated with greater awareness among WWID to identify efficient means of awareness dissemination. Data from the 2015 National HIV Behavioral Surveillance (NHBS) system cycle on injection drug use collected in New York City (NYC) were used. Bivariable analyses, using chi-squared statistics, were conducted to examine correlates of awareness of PrEP with socio-demographic, behavioral, and health care variables. Multivariable logistic regression was used to estimate adjusted associations and determine differences in awareness of PrEP. The analysis consisted of 118 WWID. Awareness of PrEP was relatively low (31%), and risk factors were high. In the last 12 months, almost two thirds (65%) reported condomless sex, approximately one third (31%) reported transactional sex, and one third (32%) reported sharing injection equipment. In multivariable logistic regression, increased PrEP awareness was associated with reported transactional sex (AOR 3.32, 95% CI 1.22-9.00) and having a conversation about HIV prevention at a syringe exchange program (SEP) (AOR 7.61, 95% CI 2.65-21.84). We did not find race, education, household income, age, binge drinking, or sexual identity to be significantly associated with PrEP awareness. Large proportions of WWID were unaware of PrEP. These findings suggest that social networks (specifically sex work and SEP networks) are an efficient means for disseminating messaging about prevention materials such as PrEP. We recommend that SEP access increase, SEP processes be adopted in other health care settings, and WWID networks be utilized to increase PrEP awareness.

  19. Community member perspectives from transgender women and men who have sex with men on pre-exposure prophylaxis as an HIV prevention strategy: implications for implementation

    Science.gov (United States)

    2012-01-01

    Background An international randomized clinical trial (RCT) on pre-exposure prophylaxis (PrEP) as an human immunodeficiency virus (HIV)-prevention intervention found that taken on a daily basis, PrEP was safe and effective among men who have sex with men (MSM) and male-to-female transgender women. Within the context of the HIV epidemic in the United States (US), MSM and transgender women are the most appropriate groups to target for PrEP implementation at the population level; however, their perspectives on evidenced-based biomedical research and the results of this large trial remain virtually unknown. In this study, we examined the acceptability of individual daily use of PrEP and assessed potential barriers to community uptake. Methods We conducted semi-structured interviews with an ethnoracially diverse sample of thirty HIV-negative and unknown status MSM (n = 24) and transgender women (n = 6) in three California metropolitan areas. Given the burden of disease among ethnoracial minorities in the US, we purposefully oversampled for these groups. Thematic coding and analysis of data was conducted utilizing an approach rooted in grounded theory. Results While participants expressed general interest in PrEP availability, results demonstrate: a lack of community awareness and confusion about PrEP; reservations about PrEP utilization, even when informed of efficacious RCT results; and concerns regarding equity and the manner in which a PrEP intervention could be packaged and marketed in their communities. Conclusions In order to effectively reduce HIV health disparities at the population level, PrEP implementation must take into account the uptake concerns of those groups who would actually access and use this biomedical intervention as a prevention strategy. Recommendations addressing these concerns are provided. PMID:23181780

  20. Effectiveness and cost effectiveness of oral pre-exposure prophylaxis in a portfolio of prevention programs for injection drug users in mixed HIV epidemics.

    Directory of Open Access Journals (Sweden)

    Sabina S Alistar

    Full Text Available BACKGROUND: Pre-exposure prophylaxis with oral antiretroviral treatment (oral PrEP for HIV-uninfected injection drug users (IDUs is potentially useful in controlling HIV epidemics with a significant injection drug use component. We estimated the effectiveness and cost effectiveness of strategies for using oral PrEP in various combinations with methadone maintenance treatment (MMT and antiretroviral treatment (ART in Ukraine, a representative case for mixed HIV epidemics. METHODS AND FINDINGS: We developed a dynamic compartmental model of the HIV epidemic in a population of non-IDUs, IDUs who inject opiates, and IDUs in MMT, adding an oral PrEP program (tenofovir/emtricitabine, 49% susceptibility reduction for uninfected IDUs. We analyzed intervention portfolios consisting of oral PrEP (25% or 50% of uninfected IDUs, MMT (25% of IDUs, and ART (80% of all eligible patients. We measured health care costs, quality-adjusted life years (QALYs, HIV prevalence, HIV infections averted, and incremental cost effectiveness. A combination of PrEP for 50% of IDUs and MMT lowered HIV prevalence the most in both IDUs and the general population. ART combined with MMT and PrEP (50% access averted the most infections (14,267. For a PrEP cost of $950, the most cost-effective strategy was MMT, at $520/QALY gained versus no intervention. The next most cost-effective strategy consisted of MMT and ART, costing $1,000/QALY gained compared to MMT alone. Further adding PrEP (25% access was also cost effective by World Health Organization standards, at $1,700/QALY gained. PrEP alone became as cost effective as MMT at a cost of $650, and cost saving at $370 or less. CONCLUSIONS: Oral PrEP for IDUs can be part of an effective and cost-effective strategy to control HIV in regions where injection drug use is a significant driver of the epidemic. Where budgets are limited, focusing on MMT and ART access should be the priority, unless PrEP has low cost.

  1. HIV-negative male couples' attitudes about pre-exposure prophylaxis (PrEP) and using PrEP with a sexual agreement.

    Science.gov (United States)

    Mitchell, Jason W; Lee, Ji-Young; Woodyatt, Cory; Bauermeister, José; Sullivan, Patrick; Stephenson, Rob

    2016-08-01

    One efficacious strategy to help prevent HIV is oral pre-exposure prophylaxis (PrEP), a daily regimen of antiretroviral treatment taken by HIV-negative individuals. Two of the recommendations of Centers for Disease Control and Prevention (CDC) guidelines for PrEP pertain to being in a relationship (i.e., male couples). Despite the recognition of how primary partners in male couples' relationships shape HIV risk and CDC's PrEP guidelines, there is a paucity of data that examine HIV-negative male couples' attitudes toward PrEP use and using PrEP with a sexual agreement. A sexual agreement is an explicit agreement made between two individuals about what sex and other related behaviors may occur within and outside of their relationship. In this qualitative study, we examine HIV-negative male couples' attitudes toward PrEP use and whether they thought PrEP could be integrated into a sexual agreement. Data for this study are drawn from couple-level interviews conducted in 2014 with 29 HIV-negative male couples who had a sexual agreement and were from Atlanta or Detroit. Both passive (e.g., flyers) and active (e.g., targeted Facebook advertisements) recruitment methods were used; the sample was stratified by agreement type. Thematic analysis was applied to identify the following themes regarding HIV-negative male couples' attitudes toward PrEP use: (1) PrEP and condom use; (2) concerns about PrEP (e.g., effectiveness, side effects, and promoting sexually risky behavior); and (3) accessibility of PrEP. Some thought PrEP could be a part of couples' agreement because it could help reduce sexual anxiety and sexual risk, and would help keep the couple safe. Others described PrEP use with an agreement as something for "others". Some were also concerned that incorporating PrEP could usurp the need for a sexual agreement in a couples' relationship. These themes highlight the need to improve informational messaging and promotion efforts about PrEP among HIV-negative male couples

  2. Willingness of community-recruited men who have sex with men in Washington, DC to use long-acting injectable HIV pre-exposure prophylaxis.

    Directory of Open Access Journals (Sweden)

    Matthew E Levy

    Full Text Available Clinical trials are currently investigating the safety and efficacy of long-acting injectable (LAI agents as HIV pre-exposure prophylaxis (PrEP. Using National HIV Behavioral Surveillance data, we assessed the self-reported willingness of men who have sex with men (MSM to use LAI PrEP and their preference for LAI versus daily oral PrEP.In 2014, venue-based sampling was used to recruit MSM aged ≥18 years in Washington, DC. Participants completed an interviewer-administered survey followed by voluntary HIV testing. This analysis included MSM who self-reported negative/unknown HIV status at study entry. Correlates of being "very likely" to use LAI PrEP and preferring it to daily oral PrEP were identified using multivariable logistic regression.Of 314 participants who self-reported negative/unknown HIV status, 50% were <30 years old, 41% were non-Hispanic Black, 37% were non-Hispanic White, and 14% were Hispanic. If LAI PrEP were offered for free or covered by health insurance, 62% were very likely, 25% were somewhat likely, and 12% were unlikely to use it. Regarding preferred PrEP modality, 67% chose LAI PrEP, 24% chose oral PrEP, and 9% chose neither. Correlates of being very likely versus somewhat likely/unlikely to use LAI PrEP included age <30 years (aOR 1.64; 95% CI 1.00-2.68, reporting ≥6 (vs. 1 sex partners in the last year (aOR 2.60; 95% CI 1.22-5.53, previous oral PrEP use (aOR 3.67; 95% CI 1.20-11.24, and being newly identified as HIV-infected during study testing (aOR 4.83; 95% CI 1.03-22.67. Black (vs. White men (aOR 0.48; 95% CI 0.24-0.96 and men with an income of <$20,000 (vs. ≥$75,000; aOR 0.37; 95% CI 0.15-0.93 were less likely to prefer LAI to oral PrEP.If LAI PrEP were found to be efficacious, its addition to the HIV prevention toolkit could facilitate more complete PrEP coverage among MSM at risk for HIV.

  3. Effectiveness and Cost Effectiveness of Oral Pre-Exposure Prophylaxis in a Portfolio of Prevention Programs for Injection Drug Users in Mixed HIV Epidemics

    Science.gov (United States)

    Alistar, Sabina S.; Owens, Douglas K.; Brandeau, Margaret L.

    2014-01-01

    Background Pre-exposure prophylaxis with oral antiretroviral treatment (oral PrEP) for HIV-uninfected injection drug users (IDUs) is potentially useful in controlling HIV epidemics with a significant injection drug use component. We estimated the effectiveness and cost effectiveness of strategies for using oral PrEP in various combinations with methadone maintenance treatment (MMT) and antiretroviral treatment (ART) in Ukraine, a representative case for mixed HIV epidemics. Methods and Findings We developed a dynamic compartmental model of the HIV epidemic in a population of non-IDUs, IDUs who inject opiates, and IDUs in MMT, adding an oral PrEP program (tenofovir/emtricitabine, 49% susceptibility reduction) for uninfected IDUs. We analyzed intervention portfolios consisting of oral PrEP (25% or 50% of uninfected IDUs), MMT (25% of IDUs), and ART (80% of all eligible patients). We measured health care costs, quality-adjusted life years (QALYs), HIV prevalence, HIV infections averted, and incremental cost effectiveness. A combination of PrEP for 50% of IDUs and MMT lowered HIV prevalence the most in both IDUs and the general population. ART combined with MMT and PrEP (50% access) averted the most infections (14,267). For a PrEP cost of $950, the most cost-effective strategy was MMT, at $520/QALY gained versus no intervention. The next most cost-effective strategy consisted of MMT and ART, costing $1,000/QALY gained compared to MMT alone. Further adding PrEP (25% access) was also cost effective by World Health Organization standards, at $1,700/QALY gained. PrEP alone became as cost effective as MMT at a cost of $650, and cost saving at $370 or less. Conclusions Oral PrEP for IDUs can be part of an effective and cost-effective strategy to control HIV in regions where injection drug use is a significant driver of the epidemic. Where budgets are limited, focusing on MMT and ART access should be the priority, unless PrEP has low cost. PMID:24489747

  4. The Safety of Tenofovir-Emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP) in Individuals With Active Hepatitis B.

    Science.gov (United States)

    Solomon, Marc M; Schechter, Mauro; Liu, Albert Y; McMahan, Vanessa M; Guanira, Juan V; Hance, Robert J; Chariyalertsak, Suwat; Mayer, Kenneth H; Grant, Robert M

    2016-03-01

    Pre-exposure prophylaxis (PrEP) with daily oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) prevents HIV infection. The safety and feasibility of HIV PrEP in the setting of hepatitis B virus (HBV) infection were evaluated. The Iniciativa Profilaxis Pre-Exposición study randomized 2499 HIV-negative men and transgender women who have sex with men to once-daily oral FTC/TDF versus placebo. Hepatitis serologies and transaminases were obtained at screening and at the time PrEP was discontinued. HBV DNA was assessed by polymerase chain reaction, and drug resistance was assessed by population sequencing. Vaccination was offered to individuals susceptible to HBV infection. Of the 2499 participants, 12 (0.5%; including 6 randomized to FTC/TDF) had chronic HBV infection. After stopping FTC/TDF, 5 of the 6 participants in the active arm had liver function tests performed at follow-up. Liver function tests remained within normal limits at post-stop visits except for a grade 1 elevation in 1 participant at post-stop week 12 (alanine aminotransferase = 90, aspartate aminotransferase = 61). There was no evidence of hepatic flares. Polymerase chain reaction of stored samples showed that 2 participants in the active arm had evidence of acute HBV infection at enrollment. Both had evidence of grade 4 transaminase elevations with subsequent resolution. Overall, there was no evidence of TDF or FTC resistance among tested genotypes. Of 1633 eligible for vaccination, 1587 (97.2%) received at least 1 vaccine; 1383 (84.7%) completed the series. PrEP can be safely provided to individuals with HBV infection if there is no evidence of cirrhosis or substantial transaminase elevation. HBV vaccination rates at screening were low globally, despite recommendations for its use, yet uptake and efficacy were high when offered.

  5. The Safety of Tenofovir–Emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP) in Individuals With Active Hepatitis B

    Science.gov (United States)

    Schechter, Mauro; Liu, Albert Y.; McManhan, Vanessa M.; Guanira, Juan V.; Hance, Robert J.; Chariyalertsak, Suwat; Mayer, Kenneth H.; Grant, Robert M.

    2016-01-01

    Background: Pre-exposure prophylaxis (PrEP) with daily oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) prevents HIV infection. The safety and feasibility of HIV PrEP in the setting of hepatitis B virus (HBV) infection were evaluated. Methods: The Iniciativa Profilaxis Pre-Exposición study randomized 2499 HIV-negative men and transgender women who have sex with men to once-daily oral FTC/TDF versus placebo. Hepatitis serologies and transaminases were obtained at screening and at the time PrEP was discontinued. HBV DNA was assessed by polymerase chain reaction, and drug resistance was assessed by population sequencing. Vaccination was offered to individuals susceptible to HBV infection. Results: Of the 2499 participants, 12 (0.5%; including 6 randomized to FTC/TDF) had chronic HBV infection. After stopping FTC/TDF, 5 of the 6 participants in the active arm had liver function tests performed at follow-up. Liver function tests remained within normal limits at post-stop visits except for a grade 1 elevation in 1 participant at post-stop week 12 (alanine aminotransferase = 90, aspartate aminotransferase = 61). There was no evidence of hepatic flares. Polymerase chain reaction of stored samples showed that 2 participants in the active arm had evidence of acute HBV infection at enrollment. Both had evidence of grade 4 transaminase elevations with subsequent resolution. Overall, there was no evidence of TDF or FTC resistance among tested genotypes. Of 1633 eligible for vaccination, 1587 (97.2%) received at least 1 vaccine; 1383 (84.7%) completed the series. Conclusions: PrEP can be safely provided to individuals with HBV infection if there is no evidence of cirrhosis or substantial transaminase elevation. HBV vaccination rates at screening were low globally, despite recommendations for its use, yet uptake and efficacy were high when offered. PMID:26413853

  6. Alcohol-antiretroviral interactive toxicity beliefs as a potential barrier to HIV pre-exposure prophylaxis among men who have sex with men.

    Science.gov (United States)

    Kalichman, Seth C; Eaton, Lisa

    2017-07-17

    Pre-exposure prophylaxis (PrEP) offers as much as 90% protection against HIV transmission. However, the effectiveness of PrEP depends on uptake and adherence to even intermittent dosing. Along with intoxication leading to unintentional non-adherence, believing that alcohol mixed with pharmaceuticals is harmful (i.e., interactive toxicity beliefs) may lead to poor uptake and intentional non-adherence. HIV-negative sexually active men who have sex with men ( N  = 272) at a large Gay Pride event in Atlanta, GA, completed anonymous surveys of demographic characteristics, sexual behaviour, alcohol use and PrEP-related alcohol interactive toxicity beliefs. A total of 118 (43%) men surveyed had two or more male sex partners and condomless anal sex in the previous six months. Alcohol use was reported by over 90% of men and it was common for participants to believe that mixing alcohol and antiretrovirals is toxic; 75% endorsed at least one interactive toxicity belief. Among the 118 men who had engaged in condomless anal sex and had multiple sex partners, one in three stated that they were not interested in PrEP and men not interested in PrEP were significantly more likely to binge drink and hold interactive toxicity beliefs. These results mirror studies that find interactive toxicity beliefs are a potent predictor of intentional antiretroviral non-adherence among people living with HIV and suggest interactive toxicity beliefs may impede PrEP uptake and adherence. Messages to increase PrEP awareness and adherence may also take steps to counter erroneous beliefs about mixing alcohol with antiretrovirals in the context of PrEP.

  7. Framing HIV Pre-Exposure Prophylaxis (PrEP) for the General Public: How Inclusive Messaging May Prevent Prejudice from Diminishing Public Support.

    Science.gov (United States)

    Calabrese, Sarah K; Underhill, Kristen; Earnshaw, Valerie A; Hansen, Nathan B; Kershaw, Trace S; Magnus, Manya; Krakower, Douglas S; Mayer, Kenneth H; Betancourt, Joseph R; Dovidio, John F

    2016-07-01

    Strategic framing of public messages about HIV pre-exposure prophylaxis (PrEP) may influence public support for policies and programs affecting access. This survey study examined how public attitudes toward PrEP differed based on the social group PrEP was described as benefiting ("beneficiary") and the moderating effect of prejudice. Members of the general public (n = 154) recruited online were randomly assigned to three beneficiary conditions: general population, gay men, or Black gay men. All participants received identical PrEP background information before completing measures of PrEP attitudes (specifying beneficiary), racism, and heterosexism. Despite anticipating greater PrEP adherence among gay men and Black gay men and perceiving PrEP as especially beneficial to the latter, participants expressed lower support for policies/programs making PrEP affordable for these groups vs. the general population. This disparity in support was stronger among participants reporting greater prejudice. Inclusive framing of PrEP in public discourse may prevent prejudice from undermining implementation efforts.

  8. Barriers to Access and Adoption of Pre-Exposure Prophylaxis for the Prevention of HIV Among Men Who Have Sex With Men (MSM) in a Relatively Rural State.

    Science.gov (United States)

    Hubach, Randolph D; Currin, Joseph M; Sanders, Carissa A; Durham, André R; Kavanaugh, Katherine E; Wheeler, Denna L; Croff, Julie M

    2017-08-01

    Biomedical intervention approaches, including antiretroviral pre-exposure prophylaxis (PrEP), have been demonstrated to reduce HIV incidence among several at-risk populations and to be cost effective. However, there is limited understanding of PrEP access and uptake among men who have sex with men (MSM) residing in relatively rural states. Twenty semistructured interviews were conducted (August-November 2016) to assess opinions of and perceived barriers to accessing and adopting PrEP among MSM residing in Oklahoma. Participants perceived substantial barriers to accessing PrEP including a stigmatizing environment and less access to quality, LGBT-sensitive medical care. Overall, geographic isolation limits access to health providers and resources that support sexual health for Oklahoma MSM. Addressing stigma situated across ecological levels in an effort to increase adoption of PrEP by MSM residing in rural states remains necessary. Without this, social determinants may continue to negatively influence PrEP adoption and sexual health outcomes.

  9. What qualities in a potential HIV pre-exposure prophylaxis service are valued by black men who have sex with men in London? A qualitative acceptability study.

    Science.gov (United States)

    Witzel, T Charles; Nutland, Will; Bourne, Adam

    2018-07-01

    Black men who have sex with men (BMSM) have higher HIV incidence and prevalence when compared to other MSM, despite similar levels of condom use and testing. Pre-exposure prophylaxis (PrEP) could be a useful intervention to reduce these inequalities. This research therefore aims to understand the dimensions of acceptability of a potential PrEP service for BMSM aged 18-45 years in London. In-depth semi-structured interviews were conducted with 25 PrEP-eligible BMSM between April and August 2016. Interviews were recorded and transcribed verbatim, then subject to a thematic framework analysis, informed by intersectionality theory. BMSM had distinct preferences for sexual health services, which have implications for PrEP service development. Three primary domains emerged in our analysis: proximity and anonymity; quality, efficiency and reassurance; and understanding, empathy and identity. These relate, respectively, to preferences regarding clinic location and divisions from community, features of service delivery and staff characteristics. Due to concerns about confidentiality, community-based services may not be useful for this group. Careful consideration in regards to components used in service development will facilitate ongoing engagement. Interpersonal skills of staff are central to service acceptability, particularly when staff are perceived to be from similar cultural backgrounds as their patients.

  10. Understanding Adherence to Daily and Intermittent Regimens of Oral HIV Pre-exposure Prophylaxis Among Men Who Have Sex with Men in Kenya.

    Science.gov (United States)

    Mugo, Peter Mwangi; Sanders, Eduard J; Mutua, Gaudensia; van der Elst, Elisabeth; Anzala, Omu; Barin, Burc; Bangsberg, David R; Priddy, Frances H; Haberer, Jessica E

    2015-05-01

    A qualitative assessment of Kenyan men who have sex with men taking daily and intermittent oral HIV pre-exposure prophylaxis (PrEP) found stigma, sex work, mobility, and alcohol impacted adherence. We analyzed quantitative data from the same cohort to explore different definitions of intermittent adherence. Volunteers were randomized to daily emtricitabine/tenofovir or placebo, or intermittent (prescription: Mondays/Fridays/after sex, maximum 1 dose/day) emtricitabine/tenofovir or placebo (2:1:2:1), and followed for 4 months. By electronic monitoring, median adherence for daily dosing was 80 %. Median adherence for intermittent dosing was 71 % per a "relaxed" definition (accounting for off-prescription dosing) and 40 % per a "strict" definition (limited to the prescription). Factors associated with lower adherence included travel, transactional sex, and longer follow-up; higher adherence was associated with daily dosing and an income. The definition of intermittent dosing strongly affects interpretation of adherence. These findings suggest interventions should address challenges of mobility, sex work, and long-term PrEP.

  11. Cost-effectiveness of pre-exposure prophylaxis for HIV prevention in men who have sex with men in the UK: a modelling study and health economic evaluation.

    Science.gov (United States)

    Cambiano, Valentina; Miners, Alec; Dunn, David; McCormack, Sheena; Ong, Koh Jun; Gill, O Noel; Nardone, Anthony; Desai, Monica; Field, Nigel; Hart, Graham; Delpech, Valerie; Cairns, Gus; Rodger, Alison; Phillips, Andrew N

    2018-01-01

    In the UK, HIV incidence among men who have sex with men (MSM) has remained high for several years, despite widespread use of antiretroviral therapy and high rates of virological suppression. Pre-exposure prophylaxis (PrEP) has been shown to be highly effective in preventing further infections in MSM, but its cost-effectiveness is uncertain. In this modelling study and economic evaluation, we calibrated a dynamic, individual-based stochastic model, the HIV Synthesis Model, to multiple data sources (surveillance data provided by Public Health England and data from a large, nationally representative survey, Natsal-3) on HIV among MSM in the UK. We did a probabilistic sensitivity analysis (sampling 22 key parameters) along with a range of univariate sensitivity analyses to evaluate the introduction of a PrEP programme with sexual event-based use of emtricitabine and tenofovir for MSM who had condomless anal sexual intercourse in the previous 3 months, a negative HIV test at baseline, and a negative HIV test in the preceding year. The main model outcomes were the number of HIV infections, quality-adjusted life-years (QALYs), and costs. Introduction of such a PrEP programme, with around 4000 MSM initiated on PrEP by the end of the first year and almost 40 000 by the end of the 15th year, would result in a total cost saving (£1·0 billion discounted), avert 25% of HIV infections (42% of which would be directly because of PrEP), and lead to a gain of 40 000 discounted QALYs over an 80-year time horizon. This result was particularly sensitive to the time horizon chosen, the cost of antiretroviral drugs (for treatment and PrEP), and the underlying trend in condomless sex. This analysis suggests that the introduction of a PrEP programme for MSM in the UK is cost-effective and possibly cost-saving in the long term. A reduction in the cost of antiretroviral drugs (including the drugs used for PrEP) would substantially shorten the time for cost savings to be realised

  12. Willingness to use pre-exposure prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM) in Malaysia: findings from a qualitative study.

    Science.gov (United States)

    Bourne, Adam; Cassolato, Matteo; Thuan Wei, Clayton Koh; Wang, Bangyuan; Pang, Joselyn; Lim, Sin How; Azwa, Iskandar; Yee, Ilias; Mburu, Gitau

    2017-08-02

    Men who have sex with men (MSM) continue to be disproportionately affected by HIV in Malaysia. Recent success has been observed within demonstration projects examining the efficacy of HIV pre-exposure prophylaxis (PrEP), an antiretroviral -based medication taken by HIV-negative men to prevent sero-conversion. In order for such promising findings to be translated in real-world settings, it is important to understand the acceptability of PrEP, including perceived barriers to access or uptake. As part of a larger mixed-methods study exploring acceptability and willingness to use PrEP among MSM in Malaysia, 19 men took part in audio-recorded focus group discussions hosted by a community-based HIV organization and facilitated by a trained researcher. Discussions focussed on awareness and potential information management, general perceptions of PrEP and potential motivations or barriers to the use of PrEP, including those at the personal, social, health system or structural level. Data were transcribed verbatim and underwent a detailed thematic analysis. Rather than perceiving PrEP as a replacement for condoms in terms of having safer sex, many participants viewed it as an additional layer protection, serving as a crucial barrier to infection on occasions where condom use was intended, but did not occur. It was also perceived as more valuable to "at-risk" men, such as those in HIV sero-discordant relationships or those with a higher number of sexual partners. Elements of discussion tended to suggest that some men taking PrEP may be subject to stigma from others, on the assumption they may be promiscuous or engage in high-risk sexual behaviours. This qualitative study indicates that, broadly speaking, PrEP may be acceptable to MSM in Malaysia. However, in order for its potential to be realized, and uptake achieved, educative interventions are required to inform the target population as to the efficacy and potential, positive impact of PrEP. Given concerns for how those

  13. Passing the Baton: Community-based ethnography to design a randomized clinical trial on the effectiveness of oral pre-exposure prophylaxis for HIV prevention among Black men who have sex with men

    OpenAIRE

    Garcia, Jonathan; Colson, Paul W.; Parker, Caroline; Hirsch, Jennifer S.

    2015-01-01

    Although HIV interventions and clinical trials increasingly report the use of mixed methods, studies have not reported on the process through which ethnographic or qualitative findings are incorporated into RCT designs. We conducted a community-based ethnography on social and structural factors that may affect the acceptance of and adherence to oral pre-exposure prophylaxis (PrEP) among Black men who have sex with men (BMSM). We then devised the treatment arm of an adherence clinical trial dr...

  14. Low willingness and actual uptake of pre-exposure prophylaxis for HIV-1 prevention among men who have sex with men in Shanghai, China.

    Science.gov (United States)

    Ding, Yingying; Yan, Huamei; Ning, Zhen; Cai, Xiaofeng; Yang, Yin; Pan, Rong; Zhou, Yanqiu; Zheng, Huang; Gao, Meiyang; Rou, Keming; Wu, Zunyou; He, Na

    2016-05-23

    Little is known about the acceptance and actual uptake of pre-exposure prophylaxis (PrEP) and associated factors in men who have sex with men (MSM) in China. This study is the baseline survey of an intervention study designed to evaluate the effectiveness of tenofovirdisoproxil fumarate (TDF) on a daily use for human immunodeficiency virus (HIV) prevention among MSM in Shanghai, China. From October 2012 to December 2013, a total of 1,033 MSM in Shanghai were recruited by local district Centers for Disease Control and Prevention (CDC) and a MSM community-based non-governmental organization (NGO). Among them, 197 (19.1%) participants expressed willingness to use the TDF group at baseline survey, but only 26 (2.5%) participated in the TDF group and took TDF one tablet a day. Higher willingness to use PrEP was associated with being 45 years or older, non-local residents, having more male sex partners in the past 6 months and not using condom at last anal sex with man. Acutal uptake of PrEP was associated with having ≥ 11 male sex partners in lifetime and reporting no female sex partners in lifetime. Reasons for not participating in TDF group among those who expressed willingness to use PrEP at baseline survey included loss of contact, ineligiblity because of abnormal results for liver or renal function tests, change of mind, and HIV seroconversion before uptake of PrEP. Our findings suggest that promotion of PrEP in MSM remains challenging at current circumstancein China. Future research is needed to solicit effective education and intervention programs to promote acceptance of PrEP among Chinese MSM.

  15. Primary care clinicians' experiences prescribing HIV pre-exposure prophylaxis at a specialized community health centre in Boston: lessons from early adopters.

    Science.gov (United States)

    Krakower, Douglas S; Maloney, Kevin M; Grasso, Chris; Melbourne, Katherine; Mayer, Kenneth H

    2016-01-01

    An estimated 1.2 million Americans have indications for using antiretroviral pre-exposure prophylaxis (PrEP) to prevent HIV acquisition. For many of these at-risk individuals, the best opportunity to learn about and receive PrEP will be during routine visits to their generalist primary care clinicians. However, few generalist clinicians have prescribed PrEP, primarily because of practical concerns about providing PrEP in primary care settings. The experiences of specialized primary care clinicians who have prescribed PrEP can inform the feasibility of PrEP provision by generalists. During January to February 2015, 35 primary care clinicians at a community health centre in Boston that specializes in the care of sexual and gender minorities completed anonymous surveys about their experiences and practices with PrEP provision. Responses were analyzed with descriptive statistics. Thirty-two clinicians (response rate=91%) completed the surveys. Nearly all clinicians (97%) had prescribed PrEP (median 20 patients, interquartile range 11-33). Most clinicians reported testing and risk-reduction counselling practices concordant with U.S. Centers for Disease Control and Prevention guidelines for PrEP. Clinicians indicated that patients using PrEP experienced medication toxicities infrequently and generally reported high adherence. However, some clinicians' practices differed from guideline recommendations, and some clinicians observed patients with increased risk behaviours. Most clinicians (79%) rated PrEP provision as easy to accomplish, and 97% considered themselves likely to prescribe PrEP in the future. In a primary care clinic with specialized expertise in HIV prevention, clinicians perceived that PrEP provision to large numbers of patients was safe, feasible and potentially effective. Efforts to engage generalist primary care clinicians in PrEP provision could facilitate scale-up of this efficacious intervention.

  16. Acceptability of HIV Pre-Exposure Prophylaxis (PrEP) and Implementation Challenges Among Men Who Have Sex with Men in India: A Qualitative Investigation.

    Science.gov (United States)

    Chakrapani, Venkatesan; Newman, Peter A; Shunmugam, Murali; Mengle, Shruta; Varghese, Jarvis; Nelson, Ruban; Bharat, Shalini

    2015-10-01

    This qualitative study explored the acceptability of HIV pre-exposure prophylaxis (PrEP) among MSM in India, and identified facilitators and barriers to future PrEP uptake. In 2014, we conducted 10 focus groups (n=61) among a purposive sample of diverse MSM recruited through community-based organizations in Chennai and Mumbai, and 10 key informant interviews with community leaders and health care providers. Participants' mean age was 26.1 years (SD 4.8); 62% completed secondary education, and 42% engaged in sex work. No focus group participants had heard of PrEP, but once explained, most reported they would likely use it. PrEP was alternately perceived as a 'back-up plan', a condom substitute, or a burden with concurrent condom use. Facilitators were potential for covert use, sex without condoms, and anxiety-less sex. Potential barriers emerged around stigma associated with PrEP use, fear of disclosures to one's family, wife, or male steady partner, and being labeled as HIV-positive or promiscuous by peers. Preferences emerged for intermittent rather than daily PrEP use, injectable PrEP, and free or subsidized access through community organizations or government hospitals. Key informants expressed additional concerns about risk compensation, non-adherence, and impact on ART availability for treatment. Demonstration projects are needed in India to support PrEP implementation tailored for at-risk MSM. Educational interventions for MSM should address concerns about PrEP effectiveness, side effects, and mitigate risk compensation. Community engagement may facilitate broad acceptability and challenge stigma around PrEP use. Importantly, provision of free or subsidized PrEP is necessary to making implementation feasible among low socioeconomic status MSM in India.

  17. Does Pre-exposure prophylaxis (PrEP) for HIV prevention in men who have sex with men (MSM) change risk behavior? A systematic review.

    Science.gov (United States)

    Freeborn, Kellie; Portillo, Carmen J

    2017-08-03

    Pre-exposure prophylaxis (PrEP) for HIV has been available since 2012. Even so, PrEP has not been widely accepted among healthcare providers and MSM some of whom are convinced that PrEP decreases condom use, and increases sexually transmitted infections (STIs). A systematic review of the state of the evidence regarding the association of PrEP with condom use, STI incidence and change in sexual risk behaviors in MSM. A structured search of databases resulted in 142 potential citations, but only ten publications met inclusion criteria and underwent data abstraction and critical appraisal. An adapted Cochrane Collaboration domain based assessment tool was used to critically appraise the methodological components of each quantitative study, and the Mixed Methods Appraisal Tool (MMAT) was used to critically appraise qualitative and mixed-methods studies. Condom use in MSM utilizing PrEP is influenced by multiple factors. Studies indicate rates of STIs in treatment and placebo groups were high. PrEP did not significantly change STI rates between baseline and follow-up. Reporting of sexual risk improved when questionnaires were completed in private by clients. Our review found that PrEP may provide an opportunity for MSM to access sexual health care, testing, treatment and counselling services. We did not find any conclusive evidence that PrEP users increase sexual risk behaviors. The perception among healthcare providers that PrEP leads to increased sexual risk behaviors has yet to be confirmed. In order to provide effective sexual health services, clinicians need to be knowledgeable about PrEP as an HIV prevention tool. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  18. 'PrEP is not ready for our community, and our community is not ready for PrEP': pre-exposure prophylaxis for HIV for people who inject drugs and limits to the HIV prevention response.

    Science.gov (United States)

    Guise, Andy; Albers, Eliot Ross; Strathdee, Steffanie A

    2017-04-01

    Pre-exposure prophylaxis for HIV, or 'PrEP', is the use of antiretroviral medicines by people who are HIV-negative to protect themselves against acquiring HIV. PrEP has shown efficacy for preventing HIV acquisition. Despite the potential, many concerns have been voiced by people who inject drugs (PWID) and their organizations. There is a need to engage with these views and ensure their integration in to policy and strategy. This paper presents PWID views on PrEP to foster the uptake of these opinions into scientific and policy debate around PrEP METHODS: Critical analysis of a report of a community consultation led by the International Network of People who Use Drugs (INPUD). The INPUD report highlights enthusiasm from PWID for PrEP, but also three main concerns: the feasibility and ethics of PrEP, its potential use as a substitute for other harm reduction strategies and how a focus on PrEP heralds a re-medicalization of HIV. Each concern relates to evidenced gaps in essential services or opposition to harm reduction and PWID human rights. People who use drugs have fundamental concerns about the potential impacts of pre-exposure prophylaxis for HIV which reflect a 'fault line' in HIV prevention: a predominance of biomedical approaches over community perspectives. Greater community engagement in HIV prevention strategy is needed, or we risk continuing to ignore the need for action on the underlying structural drivers and social context of the HIV epidemic. © 2016 Society for the Study of Addiction.

  19. Southern African guidelines for the safe use of pre-exposure prophylaxis in men who have sex with men who are at risk for HIV infection

    Directory of Open Access Journals (Sweden)

    Southern African HIV Clinicians Society Consensus Committee

    2012-06-01

    Full Text Available Background. The use of oral antiretrovirals to prevent HIV infection among HIV-negative men who have sex with men (MSM has been shown to be safe and efficacious. A large, randomised, placebo-controlled trial showed a 44% reduction in the incidence of HIV infection among MSM receiving a daily oral fixed-dose combination of tenofovir disoproxil fumarate and emtricitabine (Truvada in combination with an HIV prevention package. Improved protection was seen with higher levels of adherence. Aim. The purpose of this guideline is to: (i explain what pre-exposure prophylaxis (PrEP is; (ii outline current indications for its use; (iii outline steps for appropriate client selection; and (iv provide guidance for monitoring and maintaining clients on PrEP. Method. PrEP is indicated for HIV-negative MSM who are assessed to be at high risk for HIV acquisition and who are willing and motivated to use PrEP as part of a package of HIV prevention services (including condoms, lubrication, sexually transmitted infection (STI management and risk reduction counselling. Recommendations. HIV testing, estimation of creatinine clearance and STI and hepatitis B screening are recommended as baseline investigations. Daily oral Truvada, along with adherence support, can then be prescribed for eligible MSM. PrEP should not be given to MSM with abnormal renal function, nor to clients who are unmotivated to use PrEP as part of an HIV prevention package; nor should it be commenced during an acute viral illness. Three-monthly follow-up visits to assess tolerance, renal function, adherence and ongoing eligibility is recommended. Six-monthly STI screens and annual creatinine levels to estimate creatinine clearance are recommended. Hepatitis B vaccination should be provided to susceptible clients. Gastro-intestinal symptoms and weight loss are common side-effects, mostly experienced for the first 4 - 8 weeks after initiating PrEP. There is a risk of the development of antiretroviral

  20. A novel Online-to-Offline (O2O) model for pre-exposure prophylaxis and HIV testing scale up

    NARCIS (Netherlands)

    Anand, Tarandeep; Nitpolprasert, Chattiya; Trachunthong, Deondara; Kerr, Stephen J.; Janyam, Surang; Linjongrat, Danai; Hightow-Weidman, Lisa B.; Phanuphak, Praphan; Ananworanich, Jintanat; Phanuphak, Nittaya

    2017-01-01

    PrEP awareness and uptake among men who have sex with men (MSM) and transgender women (TG) in Thailand remains low. Finding ways to increase HIV testing and PrEP uptake among high-risk groups is a critical priority. This study evaluates the effect of a novel Adam's Love Online-to-Offline (O2O) model

  1. Letter to the editor: Pre-exposure prophylaxis for HIV in Europe: The need for resistance surveillance

    NARCIS (Netherlands)

    C. Van Tienen (Carla); D.A.M.C. van de Vijver (David); T. Noori (Teymur); A. Sonnerborg (Anders); C.A.B. Boucher (Charles)

    2017-01-01

    markdownabstract__To the editor:__ In a recent paper by Hauser et al. in this journal, a prevalence of 10.8% of transmitted drugresistant viruses was reported among newly diagnosed HIV cases in Germany in 2013 and 2014. The authors conclude that genotypic resistance testing remains important for

  2. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

    Science.gov (United States)

    McCormack, Sheena; Dunn, David T; Desai, Monica; Dolling, David I; Gafos, Mitzy; Gilson, Richard; Sullivan, Ann K; Clarke, Amanda; Reeves, Iain; Schembri, Gabriel; Mackie, Nicola; Bowman, Christine; Lacey, Charles J; Apea, Vanessa; Brady, Michael; Fox, Julie; Taylor, Stephen; Antonucci, Simone; Khoo, Saye H; Rooney, James; Nardone, Anthony; Fisher, Martin; McOwan, Alan; Phillips, Andrew N; Johnson, Anne M; Gazzard, Brian; Gill, Owen N

    2016-01-01

    Summary Background Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir–emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect. Methods PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986). Findings We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64–96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3–11·3). 13 men (90% CI 9–23

  3. The promises and challenges of pre-exposure prophylaxis as part of the emerging paradigm of combination HIV prevention

    OpenAIRE

    C?ceres, Carlos F; Koechlin, Florence; Goicochea, Pedro; Sow, Papa-Salif; O'Reilly, Kevin R; Mayer, Kenneth H; Godfrey-Faussett, Peter

    2015-01-01

    Introduction: Towards the end of the twentieth century, significant success was achieved in reducing incidence in several global HIV epidemics through ongoing prevention strategies. However, further progress in risk reduction was uncertain. For one thing, it was clear that social vulnerability had to be addressed, through research on interventions addressing health systems and other structural barriers. As soon as antiretroviral treatment became available, researchers started to conceive that...

  4. HIV Pre-Exposure Prophylaxis Stigma as a Multidimensional Barrier to Uptake Among Women Who Attend Planned Parenthood.

    Science.gov (United States)

    Calabrese, Sarah K; Dovidio, John F; Tekeste, Mehrit; Taggart, Tamara; Galvao, Rachel W; Safon, Cara B; Willie, Tiara C; Caldwell, Abigail; Kaplan, Clair; Kershaw, Trace S

    2018-05-22

    PrEP uptake has lagged among US women. PrEP stigma is a recognized barrier to uptake among MSM but remains largely unexplored among women. This study examined the pervasiveness of PrEP stigma among US women and its implications for uptake. Setting/Methods: In a 2017 online survey of Planned Parenthood patients drawn from the three cities with the highest numbers of new HIV infections in Connecticut, 597 heterosexually-active, HIV-negative, PrEP-inexperienced women reported background characteristics, two dimensions of anticipated PrEP stigma (PrEP-user stereotypes and PrEP disapproval by others), and three indicators of potential PrEP uptake (interest in learning more about PrEP, intention to use PrEP, and comfort discussing PrEP with a provider). Participants commonly perceived PrEP-user stereotypes, with many believing that others would regard them as promiscuous (37%), HIV-positive (32%), bad (14%), or gay (11%) if they used PrEP. Thirty percent would feel ashamed to disclose PrEP use. Many participants expected disapproval by family (36%), sex partners (34%), and friends (25%). In adjusted analyses, perception of PrEP-user stereotypes was uniquely associated with lower comfort discussing PrEP with a provider. Expected PrEP disapproval by others was uniquely associated with less PrEP interest, less intention to use PrEP, and less comfort discussing PrEP with a provider. Exploratory moderation analyses suggested intention to use PrEP was greatest when participants anticipated low levels of both PrEP-user stereotypes and PrEP disapproval by others. Findings highlight the need for positive messaging targeting potential PrEP users and their social networks to increase PrEP acceptance and uptake.

  5. Motives of Dutch men who have sex with men for daily and intermittent HIV pre-exposure prophylaxis usage and preferences for implementation: A qualitative study.

    Science.gov (United States)

    Bil, Janneke P; van der Veldt, Wendy M; Prins, Maria; Stolte, Ineke G; Davidovich, Udi

    2016-09-01

    Although PrEP is not yet registered in Europe, including the Netherlands, its approval and implementation are expected in the near future. To inform future pre-exposure prophylaxis (PrEP) implementation, this study aimed to gain insight into motives and preferences for daily or intermittent PrEP use among Dutch HIV-negative men having sex with men (MSM).Between February and December 2013, semistructured interviews were conducted until data saturation was reached (N = 20). Interviews were analyzed using the Grounded Theory approach.Motives for (not) using daily PrEP were based on beliefs about PrEP efficacy and side effects, preferences for other prevention strategies, self-perceived HIV risk, self-perceived efficacy of PrEP adherence, beliefs about possible benefits (e.g., anxiety reduction, sex life improvement), and barriers of PrEP use (e.g., costs, monitoring procedures). The perceived benefits of intermittent versus daily PrEP use were the lower costs and side effects and the lower threshold to decision to start using intermittent PrEP. Barriers of intermittent PrEP versus daily PrEP use were the perceived need to plan their sex life and adhere to multiple prevention strategies. Although some perceived PrEP as a condom substitute, others were likely to combine PrEP and condoms for sexually transmitted infections (STI) prevention and increased HIV protection. Participants preferred PrEP service locations to have specialized knowledge of HIV, antiretroviral therapy, sexual behavior, STIs, patients' medical background, be easily approachable, be able to perform PrEP follow-up monitoring, and provide support.To maximize the public health impact of PrEP, ensuring high uptake among MSM at highest risk is important. Therefore, targeted information about PrEP efficacy and side effects need to be developed, barriers for accessing PrEP services should be minimized, and perceived self-efficacy to use PrEP should be addressed and improved. To prevent increases in STIs

  6. Motives of Dutch men who have sex with men for daily and intermittent HIV pre-exposure prophylaxis usage and preferences for implementation

    Science.gov (United States)

    Bil, Janneke P.; van der Veldt, Wendy M.; Prins, Maria; Stolte, Ineke G.; Davidovich, Udi

    2016-01-01

    Abstract Although PrEP is not yet registered in Europe, including the Netherlands, its approval and implementation are expected in the near future. To inform future pre-exposure prophylaxis (PrEP) implementation, this study aimed to gain insight into motives and preferences for daily or intermittent PrEP use among Dutch HIV-negative men having sex with men (MSM). Between February and December 2013, semistructured interviews were conducted until data saturation was reached (N = 20). Interviews were analyzed using the Grounded Theory approach. Motives for (not) using daily PrEP were based on beliefs about PrEP efficacy and side effects, preferences for other prevention strategies, self-perceived HIV risk, self-perceived efficacy of PrEP adherence, beliefs about possible benefits (e.g., anxiety reduction, sex life improvement), and barriers of PrEP use (e.g., costs, monitoring procedures). The perceived benefits of intermittent versus daily PrEP use were the lower costs and side effects and the lower threshold to decision to start using intermittent PrEP. Barriers of intermittent PrEP versus daily PrEP use were the perceived need to plan their sex life and adhere to multiple prevention strategies. Although some perceived PrEP as a condom substitute, others were likely to combine PrEP and condoms for sexually transmitted infections (STI) prevention and increased HIV protection. Participants preferred PrEP service locations to have specialized knowledge of HIV, antiretroviral therapy, sexual behavior, STIs, patients’ medical background, be easily approachable, be able to perform PrEP follow-up monitoring, and provide support. To maximize the public health impact of PrEP, ensuring high uptake among MSM at highest risk is important. Therefore, targeted information about PrEP efficacy and side effects need to be developed, barriers for accessing PrEP services should be minimized, and perceived self-efficacy to use PrEP should be addressed and improved. To prevent

  7. HIV pre-exposure prophylaxis and early antiretroviral treatment among female sex workers in South Africa: Results from a prospective observational demonstration project.

    Directory of Open Access Journals (Sweden)

    Robyn Eakle

    2017-11-01

    Full Text Available Operational research is required to design delivery of pre-exposure prophylaxis (PrEP and early antiretroviral treatment (ART. This paper presents the primary analysis of programmatic data, as well as demographic, behavioural, and clinical data, from the TAPS Demonstration Project, which offered both interventions to female sex workers (FSWs at 2 urban clinic sites in South Africa.The TAPS study was conducted between 30 March 2015 and 30 June 2017, with the enrolment period ending on 31 July 2016. TAPS was a prospective observational cohort study with 2 groups receiving interventions delivered in existing service settings: (1 PrEP as part of combination prevention for HIV-negative FSWs and (2 early ART for HIV-positive FSWs. The main outcome was programme retention at 12 months of follow-up. Of the 947 FSWs initially seen in clinic, 692 were HIV tested. HIV prevalence was 49%. Among those returning to clinic after HIV testing and clinical screening, 93% of the women who were HIV-negative were confirmed as clinically eligible for PrEP (n = 224/241, and 41% (n = 110/270 of the women who were HIV-positive had CD4 counts within National Department of Health ART initiation guidelines at assessment. Of the remaining women who were HIV-positive, 93% were eligible for early ART (n = 148/160. From those eligible, 98% (n = 219/224 and 94% (n = 139/148 took up PrEP and early ART, respectively. At baseline, a substantial fraction of women had a steady partner, worked in brothels, and were born in Zimbabwe. Of those enrolled, 22% on PrEP (n = 49/219 and 60% on early ART (n = 83/139 were seen at 12 months; we observed high rates of loss to follow-up: 71% (n = 156/219 and 30% (n = 42/139 in the PrEP and early ART groups, respectively. Little change over time was reported in consistent condom use or the number of sexual partners in the last 7 days, with high levels of consistent condom use with clients and low use with steady partners in both study groups

  8. Baseline Preferences for Daily, Event-Driven, or Periodic HIV Pre-Exposure Prophylaxis among Gay and Bisexual Men in the PRELUDE Demonstration Project

    Directory of Open Access Journals (Sweden)

    Stefanie J. Vaccher

    2017-12-01

    Full Text Available IntroductionThe effectiveness of daily pre-exposure prophylaxis (PrEP is well established. However, there has been increasing interest in non-daily dosing schedules among gay and bisexual men (GBM. This paper explores preferences for PrEP dosing schedules among GBM at baseline in the PRELUDE demonstration project.Materials and methodsIndividuals at high-risk of HIV were enrolled in a free PrEP demonstration project in New South Wales, Australia, between November 2014 and April 2016. At baseline, they completed an online survey containing detailed behavioural, demographic, and attitudinal questions, including their ideal way to take PrEP: daily (one pill taken every day, event-driven (pills taken only around specific risk events, or periodic (daily dosing during periods of increased risk.ResultsOverall, 315 GBM (98% of study sample provided a preferred PrEP dosing schedule at baseline. One-third of GBM expressed a preference for non-daily PrEP dosing: 20% for event-driven PrEP, and 14% for periodic PrEP. Individuals with a trade/vocational qualification were more likely to prefer periodic to daily PrEP [adjusted odds ratio (aOR = 4.58, 95% confidence intervals (95% CI: (1.68, 12.49], compared to individuals whose highest level of education was high school. Having an HIV-positive main regular partner was associated with strong preference for daily, compared to event-driven PrEP [aOR = 0.20, 95% CI: (0.04, 0.87]. Participants who rated themselves better at taking medications were more likely to prefer daily over periodic PrEP [aOR = 0.39, 95% CI: (0.20, 0.76].DiscussionIndividuals’ preferences for PrEP schedules are associated with demographic and behavioural factors that may impact on their ability to access health services and information about PrEP and patterns of HIV risk. At the time of data collection, there were limited data available about the efficacy of non-daily PrEP schedules, and clinicians only recommended daily PrEP to

  9. Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana.

    Directory of Open Access Journals (Sweden)

    Michael Kasonde

    Full Text Available Tenofovir-emtricitabine (TDF-FTC pre-exposure prophylaxis (PrEP has been found to be effective for prevention of HIV infection in several clinical trials. Two studies of TDF PrEP among men who have sex with men showed slight bone mineral density (BMD loss. We investigated the effect of TDF and the interaction of TDF and hormonal contraception on BMD among HIV-uninfected African men and women.We evaluated the effects on BMD of using daily oral TDF-FTC compared to placebo among heterosexual men and women aged 18-29 years enrolled in the Botswana TDF2 PrEP study. Participants had BMD measurements at baseline and thereafter at 6-month intervals with dual-energy X-ray absorptiometry (DXA scans at the hip, spine, and forearm.A total of 220 participants (108 TDF-FTC, 112 placebo had baseline DXA BMD measurements at three anatomic sites. Fifteen (6.8% participants had low baseline BMD (z-score of 3.0% at any anatomic site at any time after baseline were significantly greater for the TDF-FTC treatment group [34/68 (50.0% TDF-FTC vs. 26/79 (32.9% placebo; p = 0.04]. There was a small but significant difference in the mean percent change in BMD from baseline for TDF-FTC versus placebo at all three sites at month 30 [forearm -0.84% (p = 0.01, spine -1.62% (p = 0.0002, hip -1.51% (p = 0.003].Use of TDF-FTC was associated with a small but statistically significant decrease in BMD at the forearm, hip and lumbar spine. A high percentage (6.8% of healthy Batswana young adults had abnormal baseline BMD Further evaluation is needed of the longer-term use of TDF in HIV-uninfected persons.ClinicalTrials.gov NCT00448669.

  10. The cost and impact of scaling up pre-exposure prophylaxis for HIV prevention: a systematic review of cost-effectiveness modelling studies.

    Directory of Open Access Journals (Sweden)

    Gabriela B Gomez

    Full Text Available Cost-effectiveness studies inform resource allocation, strategy, and policy development. However, due to their complexity, dependence on assumptions made, and inherent uncertainty, synthesising, and generalising the results can be difficult. We assess cost-effectiveness models evaluating expected health gains and costs of HIV pre-exposure prophylaxis (PrEP interventions.We conducted a systematic review comparing epidemiological and economic assumptions of cost-effectiveness studies using various modelling approaches. The following databases were searched (until January 2013: PubMed/Medline, ISI Web of Knowledge, Centre for Reviews and Dissemination databases, EconLIT, and region-specific databases. We included modelling studies reporting both cost and expected impact of a PrEP roll-out. We explored five issues: prioritisation strategies, adherence, behaviour change, toxicity, and resistance. Of 961 studies retrieved, 13 were included. Studies modelled populations (heterosexual couples, men who have sex with men, people who inject drugs in generalised and concentrated epidemics from Southern Africa (including South Africa, Ukraine, USA, and Peru. PrEP was found to have the potential to be a cost-effective addition to HIV prevention programmes in specific settings. The extent of the impact of PrEP depended upon assumptions made concerning cost, epidemic context, programme coverage, prioritisation strategies, and individual-level adherence. Delivery of PrEP to key populations at highest risk of HIV exposure appears the most cost-effective strategy. Limitations of this review include the partial geographical coverage, our inability to perform a meta-analysis, and the paucity of information available exploring trade-offs between early treatment and PrEP.Our review identifies the main considerations to address in assessing cost-effectiveness analyses of a PrEP intervention--cost, epidemic context, individual adherence level, PrEP programme coverage

  11. Pre-exposure prophylaxis for MSM and transgender persons in early adopting countries

    NARCIS (Netherlands)

    Hoornenborg, Elske; Krakower, Douglas S.; Prins, Maria; Mayer, Kenneth H.

    2017-01-01

    : Pre-exposure prophylaxis (PrEP) is a potent and underutilized HIV prevention tool. In this paper we review the state of knowledge regarding PrEP implementation for men who have sex with men and transgender persons in early adopting countries. We focus on implementation of PrEP in demonstration

  12. Willingness to use HIV pre-exposure prophylaxis among gay men, other men who have sex with men and transgender women in Myanmar.

    Science.gov (United States)

    Draper, Bridget L; Fowkes, Freya J I; Oo, Zaw Min; Thein, Zaw Win; Aung, Poe Poe; Veronese, Vanessa; Ryan, Claire; Thant, Myo; Hughes, Chad; Stoové, Mark

    2017-07-26

    HIV pre-exposure prophylaxis (PrEP) has emerged as a key component of contemporary HIV combination prevention strategies. To explore the local suitability of PrEP, country-specific acceptability studies are needed to inform potential PrEP implementation. In the context of Myanmar, in addition to resource constraints, HIV service access by gay men, other men who have sex with men, and transgender women (GMT) continues to be constrained by legislative and community stigma and marginalization. We aimed to determine PrEP acceptability among GMT in Myanmar and explore the factors associated with willingness to use PrEP. GMT were recruited in Yangon and Mandalay through local HIV prevention outreach programmes in November and December 2014. Quantitative surveys were administered by trained peer educators and collected data on demographics, sexual risk, testing history and PrEP acceptability. A modified six-item PrEP acceptability scale classified self-reported HIV undiagnosed GMT as willing to use PrEP. Multivariable logistic regression identified factors associated with willingness to use PrEP. Among 434 HIV undiagnosed GMT, PrEP awareness was low (5%). PrEP acceptability was high, with 270 (62%) GMT classified as willing to use PrEP. GMT recruited in Mandalay (adjusted odds ratio (aOR) = 1.79; 95%CI = 1.05-3.03), who perceived themselves as likely to become HIV positive (aOR = 1.82; 95%CI = 1.10-3.02), who had more than one recent regular partner (aOR = 2.94; 95%CI = 1.41-6.14), no regular partners (aOR = 2.05; 95%CI = 1.10-3.67), more than five casual partners (aOR = 2.05; 95%CI = 1.06-3.99) or no casual partners (aOR = 2.25; 95%CI = 1.23-4.11) were more likely to be willing to use PrEP. The association between never or only occasionally using condoms with casual partners and willingness to use PrEP was marginally significant (aOR = 2.02; 95%CI = 1.00-4.10). GMT who reported concern about side effects and long-term use of PrEP were less

  13. Using data from a behavioural survey of men who have sex with men (MSM) to estimate the number likely to present for HIV pre-exposure prophylaxis (PrEP) in Ireland, 2017.

    Science.gov (United States)

    Nic Lochlainn, Laura; O'Donnell, Kate; Hurley, Caroline; Lyons, Fiona; Igoe, Derval

    2017-11-01

    In Ireland, men who have sex with men (MSM) have increased HIV risk. Pre-exposure prophylaxis (PrEP), combined with safe sex practices, can reduce HIV acquisition. We estimated MSM numbers likely to present for PrEP by applying French PrEP criteria to Irish MSM behavioural survey data. We adjusted for survey bias, calculated proportions accessing testing services and those likely to take PrEP. We estimated 1-3% of MSM in Ireland were likely to present for PrEP.

  14. Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study.

    Science.gov (United States)

    Luecke, Ellen H; Cheng, Helen; Woeber, Kubashni; Nakyanzi, Teopista; Mudekunye-Mahaka, Imelda C; van der Straten, Ariane

    2016-01-01

    The effectiveness of HIV pre-exposure prophylaxis (PrEP) requires consistent and correct product use, thus a deeper understanding of women's stated product formulation preferences, and the correlates of those preferences, can help guide future research. VOICE-D (MTN-003D), a qualitative ancillary study conducted after the VOICE trial, retrospectively explored participants' tablet and gel use, as well as their preferences for other potential PrEP product formulations. We conducted an analysis of quantitative and qualitative data from VOICE-D participants. During in-depth interviews, women were presented with pictures and descriptions of eight potential PrEP product formulations, including the oral tablet and vaginal gel tested in VOICE, and asked to discuss which product formulations they would prefer to use and why. Seven of the original product formulations displayed were combined into preferred product formulation categories based on exploratory factor and latent class analyses. We examined demographic and behavioural correlates of these preferred product formulation categories. In-depth interviews with participants were conducted, coded, and analysed for themes related to product preference. Of the 68 female participants who completed in-depth interviews (22 South Africa, 24 Zimbabwe, 22 Uganda), median age was 28 (range 21-41), 81% were HIV negative, and 49% were married or living with a partner. Four preferred product formulation categories were identified via exploratory factor analysis: 1) oral tablets; 2) vaginal gel; 3) injectable, implant, or vaginal ring; and 4) vaginal film or suppository. A majority of women (81%) expressed a preference for product formulations included in category 3. Characteristics significantly associated with each preferred product category differed. Attributes described by participants as being important in a preferred product formulation included duration of activity, ease of use, route of administration, clinic- versus self

  15. Willingness to use pre-exposure prophylaxis for HIV prevention among men who have sex with men in Malaysia: Findings from an online survey

    Science.gov (United States)

    Pang, Joselyn; Wei, Clayton Koh Thuan; Yee, Ilias Adam; Wang, Bangyuan; Cassolato, Matteo

    2017-01-01

    Objective We examined willingness to use pre-exposure prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM) in Malaysia. Methods An online survey of 990 MSM was conducted between March and April 2016. Eligibility criteria included being biological male, Malaysian citizen, 18 years of age or above, identifying as MSM, and being HIV negative or unknown status. Participants’ demographics, sexual and drug use behaviors, attitudes towards PrEP, and preferences regarding future access to PrEP were collected. Bivariate analysis and logistic regression were performed to determine factors associated with willingness to use PrEP. Results Fewer than half of participants (44%) knew about PrEP before completing the survey. Overall, 39% of the sample were willing to take PrEP. Multivariate logistic regression indicated that Malay men (AOR: 1.73, 95% CI:1.12, 2.70), having 2 or more male anal sex partners in the past 6 months (AOR: 1.98, 95% CI: 1.29, 3.05), previous knowledge of PrEP (AOR: 1.40, 95%CI: 1.06, 1.86), lack of confidence in practising safer sex (AOR: 1.36, 95% CI: 1.02, 1.81), and having ever paid for sex with a male partner (AOR: 1.39, 95% CI: 1.01, 1.91) were independently associated with greater willingness to use PrEP, while men who identified as heterosexual were less willing to use PrEP (AOR, 0.36, 95% CI: 0.13, 0.97). Majority of participants preferred to access PrEP at affordable cost below 100 Malaysian Ringgit (USD25) per month from community based organisations followed by private or government hospitals. Conclusions Overall, MSM in Malaysia reported a relatively low level of willingness to use PrEP, although willingness was higher among those previously aware of PrEP. There is a need to provide PrEP at affordable cost, increase demand and awareness of PrEP, and to provide access to this preventative medication via diverse, integrated and tailored sexual health services. PMID:28902857

  16. Willingness to use pre-exposure prophylaxis for HIV prevention among men who have sex with men in Malaysia: Findings from an online survey.

    Science.gov (United States)

    Lim, Sin How; Mburu, Gitau; Bourne, Adam; Pang, Joselyn; Wickersham, Jeffrey A; Wei, Clayton Koh Thuan; Yee, Ilias Adam; Wang, Bangyuan; Cassolato, Matteo; Azwa, Iskandar

    2017-01-01

    We examined willingness to use pre-exposure prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM) in Malaysia. An online survey of 990 MSM was conducted between March and April 2016. Eligibility criteria included being biological male, Malaysian citizen, 18 years of age or above, identifying as MSM, and being HIV negative or unknown status. Participants' demographics, sexual and drug use behaviors, attitudes towards PrEP, and preferences regarding future access to PrEP were collected. Bivariate analysis and logistic regression were performed to determine factors associated with willingness to use PrEP. Fewer than half of participants (44%) knew about PrEP before completing the survey. Overall, 39% of the sample were willing to take PrEP. Multivariate logistic regression indicated that Malay men (AOR: 1.73, 95% CI:1.12, 2.70), having 2 or more male anal sex partners in the past 6 months (AOR: 1.98, 95% CI: 1.29, 3.05), previous knowledge of PrEP (AOR: 1.40, 95%CI: 1.06, 1.86), lack of confidence in practising safer sex (AOR: 1.36, 95% CI: 1.02, 1.81), and having ever paid for sex with a male partner (AOR: 1.39, 95% CI: 1.01, 1.91) were independently associated with greater willingness to use PrEP, while men who identified as heterosexual were less willing to use PrEP (AOR, 0.36, 95% CI: 0.13, 0.97). Majority of participants preferred to access PrEP at affordable cost below 100 Malaysian Ringgit (USD25) per month from community based organisations followed by private or government hospitals. Overall, MSM in Malaysia reported a relatively low level of willingness to use PrEP, although willingness was higher among those previously aware of PrEP. There is a need to provide PrEP at affordable cost, increase demand and awareness of PrEP, and to provide access to this preventative medication via diverse, integrated and tailored sexual health services.

  17. Anti-retroviral Therapy Based HIV Prevention Among a Sample of Men Who Have Sex with Men in Cape Town, South Africa: Use of Post-exposure Prophylaxis and Knowledge on Pre-exposure Prophylaxis.

    Science.gov (United States)

    Hugo, J M; Stall, R D; Rebe, K; Egan, J E; De Swardt, G; Struthers, H; McIntyre, J A

    2016-12-01

    Men who have Sex with Men (MSM) have been affected disproportionately by the global HIV pandemic. Rates of consistent condom-use are low and there is a need for further biomedical prevention interventions to prevent new HIV infections. Post exposure prophylaxis (PEP) can reduce the risk of HIV, but uptake among MSM is low. Pre-exposure prophylaxis (PrEP), an innovative anti-retroviral-based HIV prevention tool might be an appropriate intervention for MSM who have recently accessed PEP that involves HIV negative individuals taking daily tenofovir+emtricitabine for HIV prevention. 44 MSM, attending a primary health-care level MSM-focused sexual health clinic in Cape Town, South Africa, who had initiated PEP were enrolled in this study. Participants were followed up after 2, 4 and 12 weeks. Self-administered electronic surveys were completed at the initial, 4 and 12 week visit. Barriers and facilitators to accessing PEP and remaining adherent were examined, as was knowledge about PrEP. Thirty-two participants (80 %) were <40 years of age (range 20-65 years). 35 % of the participants reported their reason for requiring PEP as condomless receptive anal intercourse. A further 20 % required PEP following condomless penetrative anal intercourse; 27.5 % required PEP due to a broken condom during receptive anal sex and 2 participants during insertive anal sex. Three participants did not complete 28 days of PEP or were lost to follow up. Over half (58.5 %) of the participants reported being completely adherent to their regime; under a third (31.7 %) reported missing one PEP dose; and 9.8 % reported missing more than one dose. 36/40 (90 %) had heard of PrEP and 30/40 (75 %) indicated that they would use PrEP if it were accessible to them. That we enrolled 44 MSM who accessed PEP from a Department of Health affiliated clinic over 12 months, speaks to the low uptake by MSM of PEP services in South Africa. Adherence was high and demonstrates that adherence

  18. Use of HIV pre-exposure prophylaxis during the preconception, antepartum and postpartum periods at two United States medical centers.

    Science.gov (United States)

    Seidman, Dominika L; Weber, Shannon; Timoney, Maria Teresa; Oza, Karishma K; Mullins, Elizabeth; Cohan, Deborah L; Wright, Rodney L

    2016-11-01

    Pregnancy may increase a woman's susceptibility to HIV. Maternal HIV acquisition during pregnancy and lactation is associated with increased perinatal and lactational HIV transmission. There are no published reports of preexposure prophylaxis use after the first trimester of pregnancy or during lactation. The purpose of this study was to report the use of preexposure prophylaxis and to identify gaps in HIV prevention services for women who were at substantial risk of HIV preconception and during pregnancy and lactation at 2 United States medical centers. Chart review was performed on women who were identified as "at significant risk" for HIV acquisition preconception (women desiring pregnancy) and during pregnancy and lactation at 2 medical centers in San Francisco and New York from 2010-2015. Women were referred to specialty clinics for women who were living with or were at substantial risk of HIV. Twenty-seven women who were identified had a median age of 27 years. One-half of the women had unstable housing, 22% of the women had ongoing intimate partner violence, and 22% of the women had active substance use. Twenty-six women had a male partner living with HIV, and 1 woman had a male partner who had sex with men. Of the partners who were living with HIV, 73% (19/26) were receiving antiretroviral therapy, and 42% (11/26) had documented viral suppression. Thirty-nine percent (10/26) of partners had known detectable virus, and 19% (5/26) had unknown viral loads. Women were identified by clinicians, health educators, and health departments. Approximately one-third of the women were identified preconception (8/27); the majority of the women were identified during pregnancy (18/27) with a median gestational age of 20 weeks (interquartile range, 11-23), and 1 woman was identified in the postpartum period. None of the pregnant referrals had received safer conception counseling to reduce HIV transmission. Twenty-six percent of all women (7/27) were eligible for

  19. Differences in Awareness of Pre-exposure Prophylaxis and Post-exposure Prophylaxis Among Groups At-Risk for HIV in New York State: New York City and Long Island, NY, 2011-2013.

    Science.gov (United States)

    Walters, Suzan M; Rivera, Alexis V; Starbuck, Lila; Reilly, Kathleen H; Boldon, Nyasha; Anderson, Bridget J; Braunstein, Sarah

    2017-07-01

    Pre-exposure prophylaxis (PrEP) to reduce the risk of HIV was approved in 2012 and post-exposure prophylaxis (PEP) in 2005. We report the differences in awareness of PrEP/PEP and factors associated with awareness by examining 3 risk groups (men who have sex with men (MSM), people who inject drugs, and high-risk heterosexuals). National HIV Behavioral Surveillance system data collected in New York City (NYC) and Long Island, NY in 2011-2013 were used. Logistic regressions by region were developed to estimate adjusted associations [Adjusted Odds Ratios (AOR)] and determine differences in awareness of PrEP/PEP. Awareness of PrEP/PEP was low for all groups. In multivariate analysis controlling for sociodemographic factors, noninjection drug use, HIV status, and exposure to HIV prevention, males who inject drugs in NYC had significantly decreased odds of PrEP/PEP awareness [AOR: 0.45; confidence interval (CI): 0.25 to 0.81] compared with MSM. MSM aged 18-29 years had increased awareness of PrEP (AOR: 2.94; 95% CI 1.11 to 7.80). On Long Island, females who inject drugs (AOR: 0.18; 95% CI: 0.05 to 0.62), males who inject drugs (AOR: 0.14; 95% CI: 0.05 to 0.39), female heterosexuals (AOR: 0.25; 95% CI: 0.11 to 0.59), and male heterosexuals (AOR: 0.32; 95% CI: 0.14 to 0.73) had significantly decreased odds of PrEP/PEP awareness. Black MSM had increased awareness of PrEP (AOR: 4.08 CI:1.21 to 13.73). Large proportions of groups at-risk for HIV were unaware of PrEP/PEP. When comparing risk groups to MSM, we found MSM to have greater awareness in both regions. On Long Island, people who inject drugs and heterosexuals were far less likely to have PrEP/PEP awareness than in NYC. On Long Island, Black MSM had increased PrEP awareness and in NYC MSM aged 18-29 had increased PrEP awareness. These findings suggest that awareness may be spreading through networks and highlight the importance of targeted educational and prevention efforts by group and region.

  20. Alignment of adherence and risk for HIV acquisition in a demonstration project of pre-exposure prophylaxis among HIV serodiscordant couples in Kenya and Uganda: a prospective analysis of prevention-effective adherence.

    Science.gov (United States)

    Haberer, Jessica E; Kidoguchi, Lara; Heffron, Renee; Mugo, Nelly; Bukusi, Elizabeth; Katabira, Elly; Asiimwe, Stephen; Thomas, Katherine K; Celum, Connie; Baeten, Jared M

    2017-07-25

    Adherence is essential for pre-exposure prophylaxis (PrEP) to protect against HIV acquisition, but PrEP use need not be life-long. PrEP is most efficient when its use is aligned with periods of risk - a concept termed prevention-effective adherence. The objective of this paper is to describe prevention-effective adherence and predictors of adherence within an open-label delivery project of integrated PrEP and antiretroviral therapy (ART) among HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project). We offered PrEP to HIV-uninfected participants until the partner living with HIV had taken ART for ≥6 months (a strategy known as "PrEP as a bridge to ART"). The level of adherence sufficient to protect against HIV was estimated in two ways: ≥4 and ≥6 doses/week (per electronic monitoring). Risk for HIV acquisition was considered high if the couple reported sex with 25 years, older male partners and desire for relationship success. Predictors of not achieving sufficient adherence were no longer being a couple, delayed PrEP initiation, >6 months  of follow-up, ART use >6 months  by the partner living with HIV and problem alcohol use. Over three-quarters of participant-visits by HIV-uninfected partners in serodiscordant couples achieved prevention-effective adherence with PrEP. Greater adherence was observed during months with HIV risk and the strongest predictor of achieving sufficient adherence was sexual activity.

  1. Pre-exposure Prophylaxis Use by Breastfeeding HIV-Uninfected Women: A Prospective Short-Term Study of Antiretroviral Excretion in Breast Milk and Infant Absorption.

    Directory of Open Access Journals (Sweden)

    Kenneth K Mugwanya

    2016-09-01

    Full Text Available As pre-exposure prophylaxis (PrEP becomes more widely used in heterosexual populations, an important consideration is its safety in infants who are breastfed by women taking PrEP. We investigated whether tenofovir and emtricitabine are excreted into breast milk and then absorbed by the breastfeeding infant in clinically significant concentrations when used as PrEP by lactating women.We conducted a prospective short-term, open-label study of daily oral emtricitabine-tenofovir disoproxil fumarate PrEP among 50 HIV-uninfected breastfeeding African mother-infant pairs between 1-24 wk postpartum (ClinicalTrials.gov Identifier: NCT02776748. The primary goal was to quantify the steady-state concentrations of tenofovir and emtricitabine in infant plasma ingested via breastfeeding. PrEP was administered to women through daily directly observed therapy (DOT for ten consecutive days and then discontinued thereafter. Non-fasting peak and trough samples of maternal plasma and breast milk were obtained at drug concentration steady states on days 7 and 10, and a single infant plasma sample was obtained on day 7. Peak blood and breast milk samples were obtained 1-2 h after the maternal DOT PrEP dose, while maternal trough samples were obtained at the end of the PrEP dosing interval (i.e., 23 to 24 h after maternal DOT PrEP dose. Tenofovir and emtricitabine concentrations were quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS assays. Of the 50 mother-infant pairs enrolled, 48% were ≤12 wk and 52% were 13-24 wk postpartum, and median maternal age was 25 y (interquartile range [IQR] 22-28. During study follow-up, the median (IQR daily reported frequency of infant breastfeeding was 15 times (12 to 18 overall, 16 (14 to 19 for the ≤12 weeks, and 14 (12 to 17 for the 13-24 wk infant age groups. Overall, median (IQR time-averaged peak concentrations in breast milk were 3.2 ng/mL (2.3 to 4.7 for tenofovir and 212.5 ng/mL (140.0 to 405.0 for

  2. Awareness, discussion and non-prescribed use of HIV pre-exposure prophylaxis among persons living with HIV/AIDS in Italy: a Nationwide, cross-sectional study among patients on antiretrovirals and their treating HIV physicians.

    Science.gov (United States)

    Palummieri, Antonio; De Carli, Gabriella; Rosenthal, Éric; Cacoub, Patrice; Mussini, Cristina; Puro, Vincenzo

    2017-11-28

    Before Pre-Exposure Prophylaxis (PrEP) was officially recommended and made available, a few surveys among gay and bisexual men, and persons living with HIV/AIDS (PLWHA), identified an informal use of antiretrovirals (ARVs) for PrEP among HIV-negative individuals. Before PrEP availability in Italy, we aimed to assess whether PLWHA in Italy shared their ARVs with HIV-negative individuals, whether they knew people who were on PrEP, and describe the level of awareness and discussion on this preventive measure among them and people in their close circle. Two anonymous questionnaires investigating personal characteristics and PrEP awareness, knowledge, and experience were proposed to HIV specialists and their patients on ARVs in a one-week, cross-sectional survey (December 2013-January 2014). Among PLWHA, a Multivariable Logistic Regression analysis was conducted to identify factors associated with PrEP discussion with peers (close circle and/or HIV associations), and experience (use in close circle and/or personal ARV sharing). Eighty-seven specialists in 31 representative Infectious Diseases departments administered the questionnaire to 1405 PLWHA. Among specialists, 98% reported awareness, 65% knew the dosage schedule, and 14% had previously suggested or prescribed PrEP. Among PLWHA, 45.6% were somehow aware, discussed or had direct or indirect experience of PrEP: 38% "had heard" of PrEP, 24% were aware of studies in HIV-negative individuals demonstrating a risk reduction through the use of ARVs, 22% had discussed PrEP, 12% with peers; 9% reported PrEP use in close circle and 1% personal ARV sharing. Factors predictive of either PrEP discussion with peers or experience differed between men and women, but across all genders were mainly related to having access to information, with HIV association membership being the strongest predictor. At a time and place where there were neither official information nor proposals or interventions to guide public policies on PrEP in

  3. Safety, adherence and acceptability of intermittent tenofovir/emtricitabine as HIV pre-exposure prophylaxis (PrEP among HIV-uninfected Ugandan volunteers living in HIV-serodiscordant relationships: a randomized, clinical trial.

    Directory of Open Access Journals (Sweden)

    Freddie M Kibengo

    Full Text Available BACKGROUND: Efficacy of oral pre-exposure prophylaxis (PrEP in prevention of HIV acquisition has been evaluated using a daily regimen. However, adherence to long term daily medication is rarely perfect. Intermittent regimen may be a feasible alternative. Preclinical studies have demonstrated effectiveness of intermittent PrEP in SHIV prevention among animals. However, little is known about intermittent PrEP regimens. DESIGN: Seventy two HIV-uninfected volunteers in HIV serodiscordant couple relationships in Uganda were randomly assigned to receive daily oral Tenofovir/Emtricitabine (TDF/FTC-Truvada or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day oral TDF/FTC or placebo in a 2:1:2:1 ratio. Volunteers and study staff were blinded to drug assignment, but not to regimen assignment. METHODS: Volunteers were followed for 4 months after randomization, with monthly clinical and laboratory safety assessments and comprehensive HIV risk reduction services. Adherence was monitored using medication event monitoring system (MEMS and self-report. Sexual activity data were collected via daily short text message (SMS and self-report. HIV-specific immune responses were assessed by IFN-γ ELISPOT. RESULTS: Both daily and intermittent oral TDF/FTC regimens were well tolerated. Median MEMS adherence rates were 98% (IQR: 93-100 for daily PrEP regimen, 91% (IQR: 73-97 for fixed intermittent dosing and 45% (IQR: 20-63 for post-coital dosing. SMS response rate was 74%, but increased to 80% after excluding server outages; results may have been affected by the novelty of this measure. The majority of volunteers expressed willingness with no particular preference for either regimen. CONCLUSIONS: Both daily and intermittent oral PrEP dosing regimens were safe. Adherence was high for daily and fixed intermittent dosing; post-coital dosing was associated with poor adherence. Fixed intermittent PrEP regimens may be

  4. Sexual partnerships and considerations for HIV antiretroviral pre-exposure prophylaxis utilization among high-risk substance using men who have sex with men.

    Science.gov (United States)

    Mimiaga, Matthew J; Closson, Elizabeth F; Kothary, Vishesh; Mitty, Jennifer A

    2014-01-01

    Men who have sex with men (MSM) remain at great risk of HIV in the United States, representing 65 % of incident HIV infections. One factor contributing to the high rate of HIV infection among MSM is use of "recreational" drugs that are highly associated with unprotected anal sex. Pre-exposure chemoprophylaxis (PrEP) is a novel biomedical HIV prevention strategy that has the potential to reduce HIV transmission in MSM. Main and casual sex partners play a role in HIV prevention efforts for MSM. The study aimed to qualitatively explore the perceived influences of sexual relationships on promoting and inhibiting PrEP use among high-risk MSM who report regular drug use. Semi-structured qualitative interviews were conducted with 40 participants recruited in Boston, Massachusetts. Data were analyzed using descriptive qualitative analysis. Casual partners presented a distinct set of concerns from primary partnerships. MSM generally viewed main partners as a potential source of support for taking PrEP. Given their informal and often temporary nature, PrEP disclosure to casual partners was considered unnecessary. HIV-related stigma and substance use were also perceived as barriers to discussing PrEP use with casual partners. MSM articulated a high degree of personal agency regarding their ability to take PrEP. Findings suggest that behavioral interventions to improve PrEP utilization and adherence for high-risk MSM should be tailored to sex partner type and the parameters established between sex partners. Approaches to PrEP disclosure and partner engagement should be informed by the relative benefits and limitations characterized by these different types of relationships.

  5. Preferences for Long-Acting Pre-exposure Prophylaxis (PrEP), Daily Oral PrEP, or Condoms for HIV Prevention Among U.S. Men Who Have Sex with Men.

    Science.gov (United States)

    Greene, George J; Swann, Greg; Fought, Angela J; Carballo-Diéguez, Alex; Hope, Thomas J; Kiser, Patrick F; Mustanski, Brian; D'Aquila, Richard T

    2017-05-01

    HIV prevention method preferences were evaluated among 512 U.S. men who have sex with men (MSM; median age: 22 years). Approximately 90 % consistently preferred one option across pairwise comparisons of condoms, daily oral pre-exposure prophylaxis (PrEP), and long-acting PrEP delivered via either an injectable or one of two types of PrEP implants differing in visibility. Condoms were most frequently preferred (33.8 %), followed by non-visible implants (21.5 %), and oral PrEP (17.0 %); HIV risk was reported by more choosing implants. In a follow-up question comparing the four PrEP options only, daily oral pills and non-visible implants were most frequently preferred (35.5 and 34.3 %, respectively), followed by injections (25.2 %) and visible implants (4.3 %). An inductive, open-coding approach determined that convenience, duration of protection, and privacy were the most commonly cited reasons for a PrEP method choice, and associated with self-report of HIV risk. Tailoring PrEP product development to privacy and other concerns important to those at highest HIV risk may improve HIV prevention.

  6. A Multi-US City Assessment of Awareness and Uptake of Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Black Men and Transgender Women Who Have Sex with Men.

    Science.gov (United States)

    Eaton, Lisa A; Matthews, Derrick D; Driffin, Daniel D; Bukowski, Leigh; Wilson, Patrick A; Stall, Ron D

    2017-07-01

    The HIV epidemic among Black men and transgender women who have sex with men (BMTW) demands an urgent public health response. HIV point prevalence among this population ranges from 25 to 43%-a rate far exceeding any other group. Pre-exposure prophylaxis (PrEP) for HIV prevention is a very promising prevention tool; however, its full potential to slow the epidemic has yet to be realized. For the current study, random time-location sampling at Black Gay Pride Events was used to collect data from N = 1274 BMTW, from five US cities, reporting HIV-negative/unknown status. In-field HIV testing was also provided to participants. Participants were assessed on awareness and use of PrEP, health care factors, HIV testing history, psychosocial variables, and sex behaviors. About one third of participants were aware of PrEP (39%), and a small percentage of participants were users of PrEP (4.6%). In multivariable analyses, being in a relationship, testing for HIV in the past 6 months, and others being aware of one's sexuality were positively associated with PrEP awareness. Higher levels of internalized homophobia and greater numbers of female sex partners were positively associated with PrEP use, while education and condom use were negatively associated. Based on study findings, messaging and uptake of PrEP needs greater expansion and requires novel approaches for scale-up. Improving linkage to HIV testing services is likely critical for engaging BMTW with PrEP. The potential for PrEP to slow the HIV epidemic is high; however, we must strengthen efforts to ensure universal availability and uptake.

  7. Ambiguity, ambivalence, and apprehensions of taking HIV-1 pre-exposure prophylaxis among male couples in San Francisco: a mixed methods study.

    Directory of Open Access Journals (Sweden)

    Parya Saberi

    Full Text Available We conducted a mixed-methods study to examine serodiscordant and seroconcordant (HIV-positive/HIV-positive male couples' PrEP awareness, concerns regarding health care providers offering PrEP to the community, and correlates of PrEP uptake by the HIV-negative member of the couple.Qualitative sub-study included one-on-one interviews to gain a deeper understanding of participants' awareness of and experiences with PrEP and concerns regarding health care providers offering PrEP to men who have sex with men (MSM. Quantitative analyses consisted of a cross-sectional study in which participants were asked about the likelihood of PrEP uptake by the HIV-negative member of the couple and level of agreement with health care providers offering PrEP to anyone requesting it.We used multivariable regression to examine associations between PrEP questions and covariates of interest and employed an inductive approach to identify key qualitative themes.Among 328 men (164 couples, 62% had heard about PrEP, but approximately one-quarter were mistaking it with post-exposure prophylaxis. The majority of participants had low endorsement of PrEP uptake and 40% were uncertain if health care providers should offer PrEP to anyone requesting it. Qualitative interviews with 32 men suggest that this uncertainty likely stems from concerns regarding increased risk compensation. Likelihood of future PrEP uptake by the HIV-negative member of the couple was positively associated with unprotected insertive anal intercourse but negatively correlated with unprotected receptive anal intercourse.Findings suggest that those at greatest risk may not be receptive of PrEP. Those who engage in moderate risk express more interest in PrEP; however, many voice concerns of increased risk behavior in tandem with PrEP use. Results indicate a need for further education of MSM communities and the need to determine appropriate populations in which PrEP can have the highest impact.

  8. Ambiguity, ambivalence, and apprehensions of taking HIV-1 pre-exposure prophylaxis among male couples in San Francisco: a mixed methods study.

    Science.gov (United States)

    Saberi, Parya; Gamarel, Kristi E; Neilands, Torsten B; Comfort, Megan; Sheon, Nicolas; Darbes, Lynae A; Johnson, Mallory O

    2012-01-01

    We conducted a mixed-methods study to examine serodiscordant and seroconcordant (HIV-positive/HIV-positive) male couples' PrEP awareness, concerns regarding health care providers offering PrEP to the community, and correlates of PrEP uptake by the HIV-negative member of the couple. Qualitative sub-study included one-on-one interviews to gain a deeper understanding of participants' awareness of and experiences with PrEP and concerns regarding health care providers offering PrEP to men who have sex with men (MSM). Quantitative analyses consisted of a cross-sectional study in which participants were asked about the likelihood of PrEP uptake by the HIV-negative member of the couple and level of agreement with health care providers offering PrEP to anyone requesting it. We used multivariable regression to examine associations between PrEP questions and covariates of interest and employed an inductive approach to identify key qualitative themes. Among 328 men (164 couples), 62% had heard about PrEP, but approximately one-quarter were mistaking it with post-exposure prophylaxis. The majority of participants had low endorsement of PrEP uptake and 40% were uncertain if health care providers should offer PrEP to anyone requesting it. Qualitative interviews with 32 men suggest that this uncertainty likely stems from concerns regarding increased risk compensation. Likelihood of future PrEP uptake by the HIV-negative member of the couple was positively associated with unprotected insertive anal intercourse but negatively correlated with unprotected receptive anal intercourse. Findings suggest that those at greatest risk may not be receptive of PrEP. Those who engage in moderate risk express more interest in PrEP; however, many voice concerns of increased risk behavior in tandem with PrEP use. Results indicate a need for further education of MSM communities and the need to determine appropriate populations in which PrEP can have the highest impact.

  9. Access to healthcare, HIV/STI testing, and preferred pre-exposure prophylaxis providers among men who have sex with men and men who engage in street-based sex work in the US.

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    Kristen Underhill

    Full Text Available Pre-exposure prophylaxis (PrEP is a promising strategy for HIV prevention among men who have sex with men (MSM and men who engage in sex work. But access will require routine HIV testing and contacts with healthcare providers. This study investigated men's healthcare and HIV testing experiences to inform PrEP implementation.We conducted 8 focus groups (n = 38 in 2012 and 56 in-depth qualitative interviews in 2013-14 with male sex workers (MSWs (n = 31 and other MSM (n = 25 in Providence, RI. MSWs primarily met clients in street-based sex work venues. Facilitators asked participants about access to healthcare and HIV/STI testing, healthcare needs, and preferred PrEP providers.MSWs primarily accessed care in emergency rooms (ERs, substance use clinics, correctional institutions, and walk-in clinics. Rates of HIV testing were high, but MSWs reported low access to other STI testing, low insurance coverage, and unmet healthcare needs including primary care, substance use treatment, and mental health services. MSM not engaging in sex work were more likely to report access to primary and specialist care. Rates of HIV testing among these MSM were slightly lower, but they reported more STI testing, more insurance coverage, and fewer unmet needs. Preferred PrEP providers for both groups included primary care physicians, infectious disease specialists, and psychiatrists. MSWs were also willing to access PrEP in substance use treatment and ER settings.PrEP outreach efforts for MSWs and other MSM should engage diverse providers in many settings, including mental health and substance use treatment, ERs, needle exchanges, correctional institutions, and HIV testing centers. Access to PrEP will require financial assistance, but can build on existing healthcare contacts for both populations.

  10. Access to healthcare, HIV/STI testing, and preferred pre-exposure prophylaxis providers among men who have sex with men and men who engage in street-based sex work in the US.

    Science.gov (United States)

    Underhill, Kristen; Morrow, Kathleen M; Colleran, Christopher M; Holcomb, Richard; Operario, Don; Calabrese, Sarah K; Galárraga, Omar; Mayer, Kenneth H

    2014-01-01

    Pre-exposure prophylaxis (PrEP) is a promising strategy for HIV prevention among men who have sex with men (MSM) and men who engage in sex work. But access will require routine HIV testing and contacts with healthcare providers. This study investigated men's healthcare and HIV testing experiences to inform PrEP implementation. We conducted 8 focus groups (n = 38) in 2012 and 56 in-depth qualitative interviews in 2013-14 with male sex workers (MSWs) (n = 31) and other MSM (n = 25) in Providence, RI. MSWs primarily met clients in street-based sex work venues. Facilitators asked participants about access to healthcare and HIV/STI testing, healthcare needs, and preferred PrEP providers. MSWs primarily accessed care in emergency rooms (ERs), substance use clinics, correctional institutions, and walk-in clinics. Rates of HIV testing were high, but MSWs reported low access to other STI testing, low insurance coverage, and unmet healthcare needs including primary care, substance use treatment, and mental health services. MSM not engaging in sex work were more likely to report access to primary and specialist care. Rates of HIV testing among these MSM were slightly lower, but they reported more STI testing, more insurance coverage, and fewer unmet needs. Preferred PrEP providers for both groups included primary care physicians, infectious disease specialists, and psychiatrists. MSWs were also willing to access PrEP in substance use treatment and ER settings. PrEP outreach efforts for MSWs and other MSM should engage diverse providers in many settings, including mental health and substance use treatment, ERs, needle exchanges, correctional institutions, and HIV testing centers. Access to PrEP will require financial assistance, but can build on existing healthcare contacts for both populations.

  11. Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

    Science.gov (United States)

    Zablotska, Iryna B; Selvey, Christine; Guy, Rebecca; Price, Karen; Holden, Jo; Schmidt, Heather-Marie; McNulty, Anna; Smith, David; Jin, Fengyi; Amin, Janaki; Cooper, David A; Grulich, Andrew E

    2018-02-02

    The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals. EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW. EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV

  12. The intention to use HIV-pre-exposure prophylaxis (PrEP) among men who have sex with men in Switzerland: testing an extended explanatory model drawing on the unified theory of acceptance and use of technology (UTAUT).

    Science.gov (United States)

    Nideröst, Sibylle; Gredig, Daniel; Hassler, Benedikt; Uggowitzer, Franziska; Weber, Patrick

    2018-01-01

    The aim of this study was to determine the intention to use pre-exposure prophylaxis (PrEP) when available and to identify predictors of the intention to use PrEP among men who have sex with men (MSM) living in Switzerland. The theoretical model drew on the Unified Theory of Acceptance and Use of Technology and considered additional variables related specifically to PrEP, HIV protection and the resources of MSM. For data collection, we used an anonymous, standardized self-administered online questionnaire. In 2015, we gathered a convenience sample of 556 HIV-negative MSM living in Switzerland. We analyzed the data using descriptive and bivariate statistics and used structural equation modeling to test the hypothesized model. Predictors of respondents' moderate intention to use PrEP were performance expectancy, effort expectancy, perceived social influence, concerns about using PrEP, attitudes toward condom use, negative experiences of condom use and age. These variables were predicted by HIV protection-related aspects and resources. The findings provide insights into the complex dynamic underlying the intention to use PrEP.

  13. A Missed Opportunity for U.S. Perinatal Human Immunodeficiency Virus Elimination: Pre-exposure Prophylaxis During Pregnancy.

    Science.gov (United States)

    Fruhauf, Timothee; Coleman, Jenell S

    2017-10-01

    To estimate the proportion of women at increased risk of sexual human immunodeficiency virus (HIV) acquisition during pregnancy in a high HIV incidence urban setting to identify those who may be eligible for pre-exposure prophylaxis. We conducted a retrospective cohort study of women who received prenatal care at a large academic center in 2012. Univariable analyses and multiple logistic regression models were built to identify correlates for pre-exposure prophylaxis eligibility. Among 1,637 pregnant women, mean age was 27.6 years (SD 6.3), 59.7% were African American, and 56.0% were single. Based on the Centers for Disease Control and Prevention's guidelines, more than 10% of women were at increased risk for HIV acquisition during pregnancy and eligible for pre-exposure prophylaxis. Younger [adjusted odds ratio (OR) 0.9/1-year increase, 95% CI 0.8-0.9], single (adjusted OR 2.4, 95% CI 1.2-4.8), African American women (adjusted OR 3.3, 95% CI 1.6-6.7) with higher parity (adjusted OR 1.3/one-child increase, 95% CI 1.1-1.5), and who smoked regularly during pregnancy (adjusted OR 1.8, 95% CI 1.0-3.0) had greater odds of being eligible for pre-exposure prophylaxis at any time during pregnancy. Pregnancy is a vulnerable period during which some heterosexual women in urban settings have a high risk for HIV acquisition and stand to benefit from pre-exposure prophylaxis.

  14. High acceptability of HIV pre-exposure prophylaxis but challenges in adherence and use: qualitative insights from a phase I trial of intermittent and daily PrEP in at-risk populations in Kenya.

    Science.gov (United States)

    Van der Elst, Elisabeth Maria; Mbogua, Judie; Operario, Don; Mutua, Gaudensia; Kuo, Caroline; Mugo, Peter; Kanungi, Jennifer; Singh, Sagri; Haberer, Jessica; Priddy, Frances; Sanders, Eduard Joachim

    2013-07-01

    This paper used qualitative methods to explore experiences of men who have sex with men and female sex workers in Nairobi and Mtwapa, Kenya, who used oral pre-exposure prophylaxis (PrEP) for HIV prevention as part of a four-month trial of safety, acceptability and adherence. Fifty-one of 72 volunteers who took part in a randomized, placebo-controlled, blinded trial that compared daily and intermittent dosage of PrEP underwent qualitative assessments after completing the trial. Analyses identified three themes: (i) acceptability of PrEP was high, i.e. side effects were experienced early in the study but diminished over time, however characteristics of pills could improve comfort and use; (ii) social impacts such as stigma, rumors, and relationship difficulties due to being perceived as HIV positive were prevalent; (iii) adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work. These themes resonated across dosing regimens and gender, and while most participants favored the intermittent dosing schedule, those in the intermittent group noted particular challenges in adhering to the post-coital dose. Culturally appropriate and consistent counseling addressing these issues may be critical for PrEP effectiveness.

  15. Perceptions among Dutch men who have sex with men and their willingness to use rectal microbicides and oral pre-exposure prophylaxis to reduce HIV risk--a preliminary study.

    Science.gov (United States)

    Marra, Elske; Hankins, Catherine A

    2015-01-01

    Oral pre-exposure prophylaxis (PrEP) with antiretroviral (ARV) tablets and topical PrEP or microbicides containing ARV drugs could help to reduce HIV incidence. These methods hold promise for men who have sex with men (MSM) who are at higher risk of acquiring HIV. This mixed-methods study in the Netherlands explored perceptions of MSM and their willingness to use oral PrEP and rectal microbicides (RM) if made available. Recruited through social media (Facebook and Twitter), 108 MSM completed online questionnaires. Seven of them consented to discuss the survey results in semi-structured interviews. Survey participants preferred a RM that could be applied before and after anal intercourse (60.8%) to daily oral PrEP (20.3%). This preference was based on anticipated user friendliness, hypothetically fewer expected adverse events, and perceptions that RM would be less likely to be confused with ARVs for treatment. Those who preferred oral PrEP had stronger beliefs in the effectiveness of pills, perceived its use as easy, and viewed not requiring sexual partner awareness as advantages. No predictive factors were found for the choice of one prevention method over the other. Although Dutch MSM perceive both oral and topical PrEP positively, many barriers exist to the introduction of these products in the Netherlands. These include lack of regulatory approval of oral PrEP, no proven efficacy as yet for RM, and strong HIV stigma within the MSM population. In-depth qualitative research is needed to further explore the perceptions of MSM to inform implementation of programmes should these HIV prevention methods become available.

  16. "Since both of us are using antiretrovirals, we have been supportive to each other": facilitators and barriers of pre-exposure prophylaxis use in heterosexual HIV serodiscordant couples in Kisumu, Kenya.

    Science.gov (United States)

    Patel, Rena C; Stanford-Moore, Gaelen; Odoyo, Josephine; Pyra, Maria; Wakhungu, Imeldah; Anand, Keerthana; Bukusi, Elizabeth A; Baeten, Jared M; Brown, Joelle M

    2016-01-01

    Since 2015, the World Health Organization recommends pre-exposure prophylaxis (PrEP) for all persons at substantial risk for HIV, including HIV-uninfected partners in serodiscordant relationships in resource-limited settings. As PrEP moves from clinical trials to real-world use, understanding facilitators of and barriers to PrEP initiation and adherence is critical to successful PrEP implementation and rollout. We conducted 44 in-depth individual or couple interviews with 63 participants (30 without HIV and 33 with HIV) enrolled in the Partners Demonstration Project in Kisumu, Kenya, between August and September 2014. The semi-structured interviews discussed the following: 1) perceived advantages and disadvantages of antiretroviral therapy (ART)/PrEP; 2) reasons for accepting or declining ART/PrEP and 3) influence of prevention of transmission to partner or infant on ART/PrEP use. Transcripts from the interviews were iteratively analyzed using inductive content analysis. Our study identified three key factors that may facilitate initiation of PrEP in this population. First, participants using PrEP felt reduced stress and increased trust in their HIV serodiscordant relationships. Second, greater community-wide knowledge of PrEP was thought to likely increase PrEP acceptance. Third, greater education and counselling by providers on PrEP use was also considered to likely increase the adoption of PrEP. We also identified three key barriers to initiation of and adherence to PrEP. First, most participants who declined PrEP expressed doubts about the relative additional effectiveness of PrEP in combination with other prevention tools. Second, perceived stigma related to PrEP use was an important barrier to PrEP initiation. Third, many struggled with overcoming perceived side effects or logistical challenges of taking daily PrEP, particularly when they themselves were not ill. Leveraging the facilitators and overcoming barriers to PrEP uptake may enhance the successful

  17. Effects of Pre-exposure Prophylaxis for the Prevention of HIV Infection on Sexual Risk Behavior in Men Who Have Sex with Men: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Traeger, Michael W; Schroeder, Sophia E; Wright, Edwina J; Hellard, Margaret E; Cornelisse, Vincent J; Doyle, Joseph S; Stoové, Mark A

    2018-03-02

    HIV pre-exposure prophylaxis (PrEP) is effective in reducing HIV risk in men who have sex with men (MSM). However concerns remain that risk compensation in PrEP users may lead to decreased condom use and increased incidence of sexually transmitted infections (STIs). We assessed the impact of PrEP on sexual risk outcomes in MSM. We conducted a systematic review of open-label trials and observational studies published to August 2017 reporting sexual risk outcomes (STI diagnoses, condom use, number of sexual partners) in the context of daily oral PrEP use in HIV-negative MSM and transgender women. Pooled effect estimates were calculated using random-effects meta-analysis and a qualitative review and risk of bias assessment were performed. Sixteen observational studies and one open-label trial met selection criteria. Eight studies with 4388 participants reported STI prevalence and 13 studies with 5008 participants reported change in condom use. PrEP use was associated with a significant increase in rectal chlamydia (odds ratio [OR]=1.59; 95%CI 1.19-2.13; p=0.002; heterogeneity I 2=23%) and an increase in any STI diagnosis (OR=1.24; 95%CI 0.99-1.54; p=0.059; I 2=50%). The association of PrEP use with STI diagnoses was stronger in later studies. Most studies showed evidence of an increase in condomless sex among PrEP users. Findings highlight the importance of efforts to minimize STIs among PrEP users and their sexual partners. Monitoring of risk compensation among MSM in the context of PrEP scale-up is needed to assess the impact of PrEP on the sexual health of MSM and to inform preventive strategies.

  18. Passing the baton: Community-based ethnography to design a randomized clinical trial on the effectiveness of oral pre-exposure prophylaxis for HIV prevention among Black men who have sex with men.

    Science.gov (United States)

    Garcia, Jonathan; Colson, Paul W; Parker, Caroline; Hirsch, Jennifer S

    2015-11-01

    Although HIV interventions and clinical trials increasingly report the use of mixed methods, studies have not reported on the process through which ethnographic or qualitative findings are incorporated into RCT designs. We conducted a community-based ethnography on social and structural factors that may affect the acceptance of and adherence to oral pre-exposure prophylaxis (PrEP) among Black men who have sex with men (BMSM). We then devised the treatment arm of an adherence clinical trial drawing on findings from the community-based ethnography. This article describes how ethnographic findings informed the RCT and identifies distilled themes and findings that could be included as part of an RCT. The enhanced intervention includes in-person support groups, online support groups, peer navigation, and text message reminders. By describing key process-related facilitators and barriers to conducting meaningful mixed methods research, we provide important insights for the practice of designing clinical trials for 'real-world' community settings. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Barriers to uptake and use of pre-exposure prophylaxis (PrEP) among communities most affected by HIV in the UK: findings from a qualitative study in Scotland.

    Science.gov (United States)

    Young, Ingrid; Flowers, Paul; McDaid, Lisa M

    2014-11-20

    To explore the acceptability of pre-exposure prophylaxis (PrEP) among gay, bisexual and men who have sex with men (MSM) and migrant African communities in Scotland, UK. Consecutive mixed qualitative methods consisting of focus groups (FGs) and in-depth interviews (IDIs) explored PrEP acceptability. Data were digitally recorded, transcribed and analysed thematically to identify anticipated and emerging themes. Participants were recruited through community sexual health and outreach support services, and from non-sexual health settings across Scotland. Inclusion criteria included identification as either MSM and/or from migrant African communities; 18 years and older; living in Scotland at the time of participation. 7 FGs were conducted (n=33): 5 with MSM (n=22) and 2 mixed-sex groups with African participants (n=11, women=8), aged 18-75 years. 34 IDIs were conducted with MSM (n=20) and African participants (n=14, women=10), aged 19-60 years. The sample included participants who were HIV-positive and HIV-negative or untested (HIV-positive FG participants, n=22; HIV-positive IDI participants, n=17). Understandings of PrEP effectiveness and concerns about maintaining regular adherence were identified as barriers to potential PrEP uptake and use. Low perception of HIV risk due to existing risk management strategies meant few participants saw themselves as PrEP candidates. Participants identified risk of other sexually transmitted infections and pregnancy as a concern which PrEP did not address for either themselves or their sexual partners. PrEP emerged as a contentious issue because of the potentially negative implications it had for HIV prevention. Many participants viewed PrEP as problematic because they perceived that others would stop using condoms if PrEP was to become available. PrEP implementation needs to identify appropriate communication methods in the context of diverse HIV literacy; address risk-reduction concerns and; demonstrate how PrEP can be part of a

  20. Reactions and Receptivity to Framing HIV Prevention Message Concepts About Pre-Exposure Prophylaxis for Black and Latino Men Who Have Sex with Men in Three Urban US Cities.

    Science.gov (United States)

    Mimiaga, Matthew J; Closson, Elizabeth F; Battle, Shanice; Herbst, Jeffrey H; Denson, Damian; Pitts, Nicole; Holman, Jeremy; Landers, Stewart; Mansergh, Gordon

    2016-10-01

    Men who have sex with men (MSM) of color are disproportionately affected by HIV in the United States. Pre-exposure prophylaxis (PrEP) using antiretroviral medications is a newer biomedical prevention modality with established efficacy for reducing the risk of acquiring HIV. We conducted formative qualitative research to explore audience reactions and receptivity to message concepts on PrEP as part of the development of prevention messages to promote PrEP awareness among black and Latino MSM in the United States. In 2013, 48 black and 42 Latino (total study sample = 90) mixed HIV serostatus MSM from Chicago, Ft. Lauderdale, and Kansas City participated in either an individual interview or focus group discussion. Men were recruited online and at community-based organizations in each city. We elicited feedback on the comprehensibility, credibility, and relevance of two draft messages on PrEP. The messages included efficacy estimates from iPrEx, a phase III clinical trial to ascertain whether the antiretroviral medication tenofovir/emtricitabine disoproxil fumarate (commercially known as Truvada ® ) could safely and effectively prevent HIV acquisition through sex among MSM and transgender women. With participants' consent, the interviews and focus groups were recorded and transcribed. The data were then summarized and analyzed using a qualitative descriptive approach. The majority of men were unfamiliar with PrEP. It was suggested that additional information about the medication and clinical trials establishing efficacy was needed to enhance the legitimacy and relevancy of the messages. Participants sought to form an opinion of PrEP that was grounded in their own interpretation of the efficacy data. However, confusion about nonadherence among clinical trial subjects and individual versus average risk limited comprehension of these messages. Thematic overlaps suggest that message believability was connected to participants' ability to derive meaning from the Pr

  1. From subjects to relations: Bioethics and the articulation of postcolonial politics in the Cambodia Pre-Exposure Prophylaxis trial.

    Science.gov (United States)

    Grant, Jenna M

    2016-04-01

    Controversies about global clinical trials, particularly HIV trials, tend to be framed in terms of ethics. In this article, I explore debates about ethics in the Cambodia Pre-Exposure Prophylaxis trial, which was designed to test the safety and efficacy of tenofovir as a prevention for HIV infection. Bringing together studies of public participation in science with studies of bioethics, I show how activists around the Cambodian Pre-Exposure Prophylaxis trial circulated and provoked debates about standards of research ethics, as opposed to research methodology. This postcolonial bioethics was configured through the circulation of and debate about ethics guidelines, and historically and culturally specific relations of vulnerability and responsibility between foreigners and Cambodians and between Cambodian leaders and Cambodian subjects. I argue that this shift in the object of ethical concern, from the experimental human subject to the relation between subjects and researchers, illustrates how a postcolonial field of articulation reformulates classical bioethics.

  2. A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection

    OpenAIRE

    Morin, Stephen; Arnold, EA; Hazelton, P; Lane, T; Christopoulos, KA; Galindo, GR; Steward, WT; Morin, SF

    2012-01-01

    Background: A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily.

  3. High pre-exposure prophylaxis uptake and early adherence among men who have sex with men and transgender women at risk for HIV Infection: the PrEP Brasil demonstration project.

    Science.gov (United States)

    Hoagland, Brenda; Moreira, Ronaldo I; De Boni, Raquel B; Kallas, Esper G; Madruga, José Valdez; Vasconcelos, Ricardo; Goulart, Silvia; Torres, Thiago S; Marins, Luana M S; Anderson, Peter L; Luz, Paula M; Costa Leite, Iuri da; Liu, Albert Y; Veloso, Valdilea G; Grinsztejn, Beatriz

    2017-04-06

    The efficacy of pre-exposure prophylaxis (PrEP) in preventing sexual acquisition of human immunodeficiency virus (HIV) is well established. Little is known about the feasibility of PrEP implementation in middle-income settings with concentrated epidemics among men who have sex with men (MSM) and transgender women (TGW). PrEP Brasil is a prospective, multicentre, open-label demonstration project assessing PrEP delivery in the context of the Brazilian Public Health System. HIV-uninfected MSM and TGW in 3 referral centres in Rio de Janeiro and São Paulo were evaluated for eligibility and offered 48 weeks of daily emtricitabine/tenofovir for PrEP. Concentrations of tenofovir diphosphate in dried blood spot samples (DBS) at week 4 after enrolment (early adherence) were measured. Predictors of drug levels were assessed using ordinal logistic regression models considering the DBS drug level as a 3 level variable (<350 fmol/punch, ≥350-699 fmol/punch and ≥700 fmol/punch). 1,270 individuals were assessed for participation; n = 738 were potentially eligible and n = 450 were offered PrEP (PrEP uptake was 60.9%). Eligible but not enrolled individuals were younger, had lower HIV risk perception and had lower PrEP awareness. At week 4, 424 participants (of the 450 enrolled) had DBS TFV-DP concentrations, 94.1% in the protective range (≥350 fmol/punch, consistent with ≥2 pills per week), and 78% were in the highly protective range (≥700 fmol/punch, ≥4 pills per week). Participants with ≥12 years of schooling had 1.9 times the odds (95%CI 1.10-3.29) of a higher versus lower drug level than participants with <12 years of schooling. Condomless receptive anal intercourse in the prior 3 months was also associated with higher drug levels (adjusted OR = 1.78; 95% CI 1.08-2.94). The high uptake and early adherence indicate that PrEP for high-risk MSM and TGW can be successfully delivered in the context of the Brazilian Public Health System. Interventions to

  4. Facilitators and Barriers of Antiretroviral Therapy Initiation among HIV Discordant Couples in Kenya: Qualitative Insights from a Pre-Exposure Prophylaxis Implementation Study.

    Directory of Open Access Journals (Sweden)

    Rena C Patel

    Full Text Available The World Health Organization now recommends antiretroviral therapy (ART initiation for all HIV-infected individuals regardless of CD4 cell count or disease status. Understanding the facilitators and barriers to initiation of and adherence to ART is essential to successful scale-up of "universal" ART.To investigate facilitators and barriers to ART initiation, we conducted 44 in-depth individual or couple interviews with 63 participants (33 participants with HIV and 30 without HIV already enrolled in a prospective implementation study of oral antiretroviral-based prevention in Kisumu, Kenya between August and September 2014. A semi-structured interview guided discussions on: 1 perceived advantages and disadvantages of ART; 2 reasons for accepting or declining ART initiation; and 3 influence of prevention of transmission to partner or infant influencing ART use. Transcripts from the interviews were iteratively analyzed using inductive content analysis.HIV-infected participants indicated that living a healthier life, preventing HIV transmission to others, and appearing "normal" or "healthy" again facilitated their initiation of ART. While appearing "normal" allowed these individuals to interact with their communities without stigmatization, they also perceived community opposition to their initiating ART, because appearing "normal" again prevented community members from easily identifying infected individuals in their community. Denial of diagnosis, disclosure stigma, perceived side-effects, and challenges in obtaining refills were additional barriers to ART initiation.Community perceptions play an important role in both facilitating and inhibiting ART initiation. Perceived stigma, including perceived community opposition to widespread ART use, is an important barrier to ART initiation. Addressing such barriers, while capitalizing on facilitators, to ART initiation should be central to universal ART scale-up efforts.

  5. Knowledge, Indications and Willingness to Take Pre-Exposure Prophylaxis among Transwomen in San Francisco, 2013.

    Directory of Open Access Journals (Sweden)

    Erin C Wilson

    Full Text Available Safe and effective HIV prevention strategies are needed for transwomen. Transwomen in the US have a 34 times greater odds of being infected with HIV than all adults age 15-49, and in San Francisco, California 42.4% of transwomen are estimated to be infected with HIV. Pre-exposure prophylaxis (PrEP is the first biomedical intervention with promise for reducing HIV acquisition in transwomen. However, little is known about whether transwomen know about PrEP, are taking PrEP and would be good candidates for PrEP based on their risk profile and behaviors. A population-based dataset was analyzed to determine how many transwomen in San Francisco knew about PrEP by the end of 2013 - more than a year after iPrex results demonstrated efficacy of PrEP in preventing HIV. We found that of 233 transwomen, only 13.7% had heard of PrEP. Transwomen who were living with HIV compared to those who were HIV-negative, and those who recently injected drugs compared to non-injection drug users were more likely to have heard of PrEP. Based on CDC guidelines for PrEP among MSM and IDU, 45 (30.2% transwomen of the 149 HIV-negative transwomen in the sample were candidates for PrEP. This estimate based on CDC criteria is arguably low. Given that almost half of transwomen in San Francisco are living with HIV, this findings points to a need for further consideration of PrEP criteria that are specific and tailored to the risks for HIV faced by transwomen that are different from MSM and injection drug users. Research to scale up access and test the effectiveness of PrEP for transwomen is also urgently needed.

  6. Functional Knowledge of Pre-Exposure Prophylaxis for HIV Prevention Among Participants in a Web-Based Survey of Sexually Active Gay, Bisexual, and Other Men Who Have Sex With Men: Cross-Sectional Study

    Science.gov (United States)

    2018-01-01

    Background Awareness of pre-exposure prophylaxis (PrEP) for HIV prevention is increasing, but little is known about the functional knowledge of PrEP and its impact on willingness to use PrEP. Objective The objective of this study was to assess the functional knowledge of PrEP among a sample of gay, bisexual, and other men who have sex with men (MSM) participating in a Web-based survey of sexually active MSM. Methods Men at least 18 years old, residing in the United States, and reporting sex with a man in the previous 6 months were recruited through social networking websites. PrEP functional knowledge included the following 4 questions (1) efficacy of consistent PrEP use, (2) inconsistent PrEP use and effectiveness, (3) PrEP and condom use, and (4) effectiveness at reducing sexually transmitted infections (STIs). Ordinal logistic regression was used to identify respondent characteristics associated with PrEP functional knowledge. In a subsample of participants responding to HIV prevention questions, we compared willingness to use PrEP by response to PrEP functional knowledge using logistic regression analysis adjusted for age, race and ethnicity, and education level. Results Among 573 respondents, PrEP knowledge was high regarding adherence (488/573, 85.2%), condom use (532/573, 92.8%), and STIs (480/573, 83.8%), but only 252/573 (44.0%) identified the correct efficacy. Lower functional PrEP knowledge was associated with minority race/ethnicity (P=.005), lower education (P=.01), and not having an HIV test in the past year (P=.02). Higher PrEP knowledge was associated with willingness to use PrEP (P=.009). Younger age was not associated with higher PrEP functional knowledge or willingness to use PrEP. Conclusions PrEP knowledge was generally high in our study, including condom use and consistent use but may be lacking in higher risk MSM. The majority of respondents did not correctly identify PrEP efficacy with consistent use, which could impact motivation to seek

  7. A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP in clinical settings to prevent HIV infection.

    Directory of Open Access Journals (Sweden)

    Emily A Arnold

    Full Text Available A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC can reduce HIV acquisition among men who have sex with men (MSM and transgender (TG women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States.Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time.Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations.While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor Pr

  8. Safety and adherence to intermittent pre-exposure prophylaxis (PrEP for HIV-1 in African men who have sex with men and female sex workers.

    Directory of Open Access Journals (Sweden)

    Gaudensia Mutua

    Full Text Available Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM and female sex workers (FSW.MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS. Sexual activity data were collected via daily text message (SMS queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003, while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen.Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens.ClinicalTrials.gov NCT00971230.

  9. A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection.

    Science.gov (United States)

    Arnold, Emily A; Hazelton, Patrick; Lane, Tim; Christopoulos, Katerina A; Galindo, Gabriel R; Steward, Wayne T; Morin, Stephen F

    2012-01-01

    A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States. Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time. Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations. While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their

  10. Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers.

    Science.gov (United States)

    Mutua, Gaudensia; Sanders, Eduard; Mugo, Peter; Anzala, Omu; Haberer, Jessica E; Bangsberg, David; Barin, Burc; Rooney, James F; Mark, David; Chetty, Paramesh; Fast, Patricia; Priddy, Frances H

    2012-01-01

    Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW). MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen. Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens. ClinicalTrials.gov NCT00971230.

  11. Healthcare Provider Contact and Pre-exposure Prophylaxis in Baltimore Men Who Have Sex With Men

    Science.gov (United States)

    Raifman, Julia R.G.; Flynn, Colin; German, Danielle

    2018-01-01

    Introduction Pre-exposure prophylaxis (PrEP) safely and effectively prevents HIV in populations at high risk, including men who have sex with men (MSM). PrEP scale-up depends upon primary care providers and community-based organizations (CBOs) sharing PrEP information. This study aimed to determine whether healthcare provider or CBO contact was associated with PrEP awareness among Baltimore MSM. Methods This study used 2014 Baltimore MSM National HIV Behavioral Surveillance data, which included data on health care, HIV and sexually transmitted infection testing, and receipt of condoms from CBOs. In 2015, associations were estimated between healthcare contacts and PrEP awareness through logistic regression models controlling for age, race, and education and clustering by venue. Comparative analyses were conducted with HIV testing as outcome. Results There were 401 HIV-negative participants, of whom 168 (42%) were aware of PrEP. Visiting a healthcare provider in the past 12 months, receiving an HIV test from a provider, and having a sexually transmitted infection test in the past 12 months were not significantly associated with PrEP awareness. PrEP awareness was associated with being out to a healthcare provider (OR = 2.97, 95% CI=1.78, 4.96, p<0.001); being tested for HIV (OR=1.50, 95% CI = 1.06, 2.13, p = 0.023); and receiving condoms from an HIV/AIDS CBO (OR = 2.59, 95% CI = 1.43, 4.64, p = 0.001). By contrast, HIV testing was significantly associated with most forms of healthcare contact. Conclusions PrEP awareness is not associated with most forms of healthcare contact, highlighting the need for guidelines and trainings to support provider discussion of PrEP with MSM. PMID:27662698

  12. [PrEP Forum: an on-line debate on pre-exposure prophylaxis in Brazil].

    Science.gov (United States)

    Queiroz, Artur Acelino Francisco Luz Nunes; Sousa, Alvaro Francisco Lopes de

    2017-11-21

    This study aimed to identify health-promoting contents focused on HIV/Aids prevention in messages posted in a Facebook group for debates on the use of pre-exposure prophylaxis (PrEP). This was a prospective observational study using systematic non-participant observation. From July 2015 to June 2016, all the posts in the group were catalogued and formed a corpus. Everything was processed in IRaMuTeQ and analyzed by descending hierarchical classification. The collected data were grouped in three classes: (1) HIV/Aids prevention: discussing prophylaxis, treatment, target public, and side effects; (2) universal access to PrEP in Brazil: discussing government responsibilities; (3) on-line purchase of truvada: exposing a situation of vulnerability. The findings call attention to a potential public health problem and provide backing for understanding facilitators and barriers to the use of PrEP in Brazil through the identification of health-promoting content linked to individual, social, and institutional markers.

  13. Awareness and willingness to use HIV pre-exposure prophylaxis among men who have sex with men in low- and middle-income countries: a systematic review and meta-analysis

    Science.gov (United States)

    Yi, Siyan; Tuot, Sovannary; Mwai, Grace W; Ngin, Chanrith; Chhim, Kolab; Pal, Khoundyla; Igbinedion, Ewemade; Holland, Paula; Choub, Sok Chamreun; Mburu, Gitau

    2017-01-01

    Abstract Introduction: To facilitate provision of pre-exposure prophylaxis (PrEP) in low- and middle-income countries (LMIC), a better understanding of potential demand and user preferences is required. This review assessed awareness and willingness to use oral PrEP among men who have sex with men (MSM) in LMIC. Methods: Electronic literature search of Cochrane library, Embase, PubMed, PsychINFO, CINHAL, Web of Science, and Google Scholar was conducted between July and September 2016. Reference lists of relevant studies were searched, and three authors contacted for additional data. Non-peer reviewed publications were excluded. Studies were screened for inclusion, and relevant data abstracted, assessed for bias, and synthesized. Results: In total, 2186 records were identified, of which 23 studies involving 14,040 MSM from LMIC were included. The proportion of MSM who were aware of PrEP was low at 29.7% (95% CI: 16.9–44.3). However, the proportion willing to use PrEP was higher, at 64.4% (95% CI: 53.3–74.8). Proportions of MSM aware of PrEP was <50% in 11 studies and 50–70% in 3 studies, while willingness to use PrEP was <50% in 6 studies, 50–70% in 9 studies, and over 80% in 5 studies. Several factors affected willingness to use PrEP. At the individual domain, poor knowledge of PrEP, doubts about its effectiveness, fear of side effects, low perception of HIV risk, and the need to adhere or take medicines frequently reduced willingness to use PrEP, while PrEP education and motivation to maintain good health were facilitators of potential use. Demographic factors (education, age, and migration) influenced both awareness and willingness to use PrEP, but their effects were not consistent across studies. At the social domain, anticipated stigma from peers, partners, and family members related to sexual orientation, PrEP, or HIV status were barriers to potential use of PrEP, while partner, peer, and family support were facilitators of potential use. At the

  14. The Use of Online Posts to Identify Barriers to and Facilitators of HIV Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex with Men: A Comparison to a Systematic Review of the Peer-Reviewed Literature.

    Science.gov (United States)

    Hannaford, Alisse; Lipshie-Williams, Madeleine; Starrels, Joanna L; Arnsten, Julia H; Rizzuto, Jessica; Cohen, Phillip; Jacobs, Damon; Patel, Viraj V

    2018-04-01

    Pre-exposure prophylaxis (PrEP) remains an under-utilized HIV prevention tool among men who have sex with men (MSM). To more comprehensively elucidate barriers and facilitators to PrEP use among US MSM, we conducted a systematic review of peer-reviewed published articles and content analysis of online posts about PrEP. We searched peer-reviewed databases (Medline, Web of Science, Google Scholar) using MESH headings and keywords about PrEP and/or HIV prevention from 2005 to 2015. We included original studies among MSM in the US that reported on barriers, facilitators, or other factors related to PrEP use. We also searched online posts and associated comments (news articles, opinion pieces, blogs and other social media posts) in diverse venues (Facebook, Slate Outward, Huffington Post Gay Voices, Queerty, and My PrEP Experience blog) to identify posts about PrEP. We used content analysis to identify themes and compare potential differences between the peer-reviewed literature and online posts. We identified 25 peer-reviewed articles and 28 online posts meeting inclusion criteria. We identified 48 unique barriers and 46 facilitators to using PrEP. These 94 themes fit into six overarching categories: (1) access (n = 14), (2) attitudes/beliefs (n = 24), (3) attributes of PrEP (n = 13), (4) behaviors (n = 11), (5) sociodemographic characteristics (n = 8), and (6) social network (n = 6). In all categories, analysis of online posts resulted in identification of a greater number of unique themes. Thirty-eight themes were identified in the online posts that were not identified in the peer-reviewed literature. We identified barriers and facilitators to PrEP in online posts that were not identified in a systematic review of the peer-reviewed literature. By incorporating data both from a systematic review of peer-reviewed articles and from online posts, we have identified salient and novel information about barriers to and facilitators of PrEP use. Traditional

  15. Self-Perception of HIV Risk and Candidacy for Pre-Exposure Prophylaxis Among Men Who Have Sex with Men Testing for HIV at Commercial Sex Venues in New York City.

    Science.gov (United States)

    Gallagher, Timothy; Link, Lauren; Ramos, Michael; Bottger, Edward; Aberg, Judith; Daskalakis, Demetre

    2014-09-01

    The purpose of this study was to evaluate the ability of men who have sex with men (MSM) testing for HIV at commercial sex venues to assess the following: their candidacy for pre-exposure chemoprophylaxis (PrEP) as defined by meeting entry criteria for the iPrEx (Iniciativa Profilaxis Pre-Exposición) phase III clinical trial of PrEP, and their perception of their own HIV risk and candidacy for PrEP. Interviewers surveyed 629 MSM at three NYC commercial sex venues from June 2011 through June 2012. Questions focused on demographics, sexual activity, and drug use in the three months prior to testing, as well as perceived risk of HIV acquisition and perceived candidacy for PrEP use. Data were analyzed by Chi square and Fisher's exact test. Results show that a majority of clients (80.3%) met entry criteria for the iPrEX. Most of these men (78.0%), however, did not perceive their risk to be significant enough to warrant PrEP use (P=.000). Factors were identified which associated with a risk perception that correlated with eligibility for iPrEX.

  16. PrEP (Pre-Exposure Prophylaxis) 101

    Science.gov (United States)

    ... than 70%. Your risk of getting HIV from sex can be even lower if you combine PrEP with condoms and other prevention methods. Download PrEP 101 Consumer Info Sheet Vital Signs Fact Sheet on Daily Pill Can Prevent HIV (PrEP) Expand All Collapse All Video Introductions to PrEP What is PrEP? A Brief ...

  17. Distinguishing hypothetical willingness from behavioral intentions to initiate HIV pre-exposure prophylaxis (PrEP): Findings from a large cohort of gay and bisexual men in the U.S.

    Science.gov (United States)

    Rendina, H Jonathon; Whitfield, Thomas H F; Grov, Christian; Starks, Tyrel J; Parsons, Jeffrey T

    2017-01-01

    Much of the data on the acceptability of HIV Pre-Exposure Prophylaxis (PrEP) is based on willingness to take PrEP (i.e., hypothetical receptivity) rather than actual intentions (i.e., planned behavioral action) to do so. We sought to examine differences between hypothetical willingness and behavioral intentions to begin PrEP in a national sample of gay and bisexual men (GBM) across the U.S. We utilized data collected in 2015 to examine differences between those Unwilling (42.6% n = 375), Willing but not intending (41.4%, n = 365), and willing and Intending to take PrEP (15.9%, n = 140) in a multivariable, multinomial logistic regression. Men with less education had higher odds of Intending to take PrEP. Compared to men unsure about PrEP's efficacy, those who believed PrEP was at least 90% efficacious had higher odds of Intending to take PrEP. Those who saw themselves as appropriate candidates for PrEP had higher odds of Intending to take PrEP while those who saw themselves as inappropriate candidates for PrEP had lower odds of Intending to take PrEP in comparison to men unsure if they were appropriate candidates. Increased motivation for condom non-use because of perceived sexual pressure by partners was associated with higher odds of Intending to take PrEP. The groups did not differ by risk behavior nor recent STI diagnosis. Overall, the distinction between willingness and intentions to take PrEP was meaningful and may help explain disparities between PrEP acceptability and uptake. While much of the literature has focused on hypothetical willingness to take PrEP, these results highlight the importance of simultaneously assessing willingness and intentions when examining correspondence with uptake and developing interventions to increase PrEP uptake. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Effects of naloxone distribution alone or in combination with addiction treatment with or without pre-exposure prophylaxis for HIV prevention in people who inject drugs: a cost-effectiveness modelling study.

    Science.gov (United States)

    Uyei, Jennifer; Fiellin, David A; Buchelli, Marianne; Rodriguez-Santana, Ramon; Braithwaite, R Scott

    2017-03-01

    In the USA, an epidemic of opioid overdose deaths is occurring, many of which are from heroin. Combining naloxone distribution with linkage to addiction treatment or pre-exposure prophylaxis (PrEP) for HIV prevention through syringe service programmes has the potential to save lives and be cost-effective. We estimated the outcomes and cost-effectiveness of five alternative strategies: no additional intervention, naloxone distribution, naloxone distribution plus linkage to addiction treatment, naloxone distribution plus PrEP, and naloxone distribution plus linkage to addiction treatment and PrEP. We developed a decision analytical Markov model to simulate opioid overdose, HIV incidence, overdose-related deaths, and HIV-related deaths in people who inject drugs in Connecticut, USA. Model input parameters were derived from published sources. We compared each strategy with no intervention, as well as simultaneously considering all strategies. Sensitivity analysis was done for all variables. Linkage to addiction treatment was referral to an opioid treatment programme for methadone. Endpoints were survival, life expectancy, quality-adjusted life-years (QALYs), number and percentage of overdose deaths averted, number of HIV-related deaths averted, total costs (in 2015 US$) associated with each strategy, and incremental cost per QALY gained. In the base-case analysis, compared with no additional intervention, the naloxone distribution strategy yielded an incremental cost-effectiveness ratio (ICER) of $323 per QALY, and naloxone distribution plus linkage to addiction treatment was cost saving compared with no additional intervention (greater effectiveness and less expensive). The most efficient strategies (ie, those conferring the greatest health benefit for a particular budget) were naloxone distribution combined with linkage to addiction treatment (cost saving), and naloxone distribution combined with PrEP and linkage to addiction treatment (ICER $95 337 per QALY) at a

  19. Limited SHIV env diversification in macaques failing oral antiretroviral pre-exposure prophylaxis.

    Science.gov (United States)

    Zheng, Qi; Ruone, Susan; Switzer, William M; Heneine, Walid; García-Lerma, J Gerardo

    2012-05-09

    Pre-exposure prophylaxis (PrEP) with daily Truvada [a combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)] is a novel HIV prevention strategy recently found to prevent HIV transmission among men who have sex with men and heterosexual couples. Acute infection in adherent persons who fail PrEP will inevitably occur under concurrent antiretroviral therapy, thus raising questions regarding the potential impact of PrEP on early viral dynamics. We investigated viral evolution dynamics in a macaque model of PrEP consisting of repeated rectal exposures to SHIV162P3 in the presence of PrEP. Four macaques were infected during daily or intermittent PrEP with FTC or FTC/TDF, and five were untreated controls. SHIV env sequence evolution was monitored by single genome amplification with phylogenetic and sequence analysis. Mean nucleotide divergence from transmitted founder viruses calculated 17 weeks (range = 12-20) post peak viremia was significantly lower in PrEP failures than in control animals (7.2 × 10-3 compared to 1.6 × 10-2 nucleotide substitutions per site per year, respectively, p diversification during early infection might enhance immune control by slowing the selection of escape mutants.

  20. PrEP Chicago: A randomized controlled peer change agent intervention to promote the adoption of pre-exposure prophylaxis for HIV prevention among young Black men who have sex with men.

    Science.gov (United States)

    Young, Lindsay E; Schumm, Phil; Alon, Leigh; Bouris, Alida; Ferreira, Matthew; Hill, Brandon; Khanna, Aditya S; Valente, Thomas W; Schneider, John A

    2018-02-01

    Advances in biomedical prevention strategies such as pre-exposure prophylaxis (PrEP) represent a new opportunity for reducing HIV incidence among young Black men who have sex with men, for whom the number of new HIV infections continues to rise. However, studies have documented low rates of PrEP uptake in this community. Research suggests that the peer networks of young Black men who have sex with men play important roles in their sexual health decisions. PrEP Chicago is a randomized controlled trial network intervention designed to increase PrEP uptake among young Black men who have sex with men living in Chicago. The aims of this study are twofold. Aim 1 is to estimate the effectiveness of a peer change agent intervention for (1) increasing the number of referrals made to a PrEP information line, (2) increasing the rate of PrEP adoption among non-participant peers, and (3) increasing PrEP knowledge, attitudes, and intentions among participants. Aim 2 is to determine the individual and network variables that explain peer change agent effectiveness. PrEP Chicago is a social network intervention that utilizes the influence of peer change agents to link young Black men who have sex with men in Chicago to PrEP. Young Black men who have sex with men were recruited using respondent-driven sampling. Once screened for eligibility, participants were randomly assigned to either one of two treatment sequences: (1) intervention treatment in Year 1 followed by a minimal contact attention control in Year 2 or (2) the minimal contact attention control in Year 1 followed by treatment in Year 2. The treatment consists of a PrEP/peer change agent training workshop followed by booster calls for 12 months. The attention control consists of a sex diary activity designed to help participants assess sexual risk. Psychosocial, sexual health, and network data are collected from all participants at baseline and at 12- and 24-month follow-ups. In total, 423 participants aged 18-35 have

  1. Misunderstanding of Pre-Exposure Prophylaxis Use Among Men Who Have Sex with Men: Public Health and Policy Implications

    OpenAIRE

    Kurtz, Steven P.; Buttram, Mance E.

    2016-01-01

    Abstract Purpose: Street markets in antiretroviral medications for HIV have been documented, but sources of demand are not well understood. We report unexpected findings from qualitative research suggesting that some demand is for informal pre-exposure prophylaxis (PrEP). Methods: Focus groups with young men who have sex with men (N?=?31) yielded information on their understanding and use of PrEP. Results: Of those who had heard of it, few understood PrEP to be a physician-prescribed regimen;...

  2. Ethical considerations in developing an evidence base for pre-exposure prophylaxis in pregnant women.

    Science.gov (United States)

    Sullivan, Kristen A; Lyerly, Anne D

    2017-12-14

    Though many women in need of access to HIV preventive regimes are pregnant, there is a dearth of data to guide these care decisions. While oral pre-exposure prophylaxis (PrEP) has been shown to prevent HIV infection in numerous high-risk populations, pregnant women have been excluded from all major prospective trials. We propose for ethical examination a theoretical trial-a prospective, observational study of PrEP for pregnant women at risk for HIV in sub-Saharan Africa-highlighting an ethical tradeoff that characterizes issues faced for advancing research in pregnancy. On the one hand, an "opportunistic" study design has certain ethical advantages: as formally construed, the research activity usually begins after decisions to use PrEP during pregnancy are made in the clinical setting. This minimizes research risks and avoids ethical problems that a randomized controlled trial (RCT) comparing PrEP to placebo would entail, particularly withholding care proven beneficial in other populations. On the other hand, observational studies yield less precise information than RCTs. This raises a broader question about the pace of research with pregnant women, as it typically takes many years after a drug's approval for use in the general population to determine safety of the medication in pregnancy. Such delays can have the effect of making it impossible to ethically conduct an RCT with pregnant women, reducing the likelihood that the research community is able to obtain robust, pregnancy-specific evidence. While an observational cohort is potentially the most ethically and scientifically justified research design to study PrEP in pregnancy, earlier involvement of pregnant women in studies of newer preventives may lead to evidence that is more timely and robust.

  3. Integrating Antiretroviral Strategies for Human Immunodeficiency Virus Prevention: Post- and Pre-Exposure Prophylaxis and Early Treatment.

    Science.gov (United States)

    Grant, Robert M; Smith, Dawn K

    2015-12-01

    Best practices for integrating human immunodeficiency virus (HIV) testing and antiretroviral interventions for prevention and treatment are suggested based on research evidence and existing normative guidance. The goal is to provide high-impact prevention services during periods of substantial risk. Antiretroviral medications are recommended for postexposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP), and treatment of HIV infection. We reviewed research evidence and current normative guidelines to identify best practices for integrating these high-impact prevention strategies. More sensitive HIV tests used for screening enable earlier diagnosis and treatment of HIV infection, more appropriate counseling, and help limit drug resistance. A fully suppressive PEP regimen should be initiated based on exposure history or physical findings when sensitive diagnostic testing is delayed or not available and antibody tests are negative. Transitions from PEP to PrEP are often warranted because HIV exposure events may continue to occur. This algorithmic approach to integrating PEP, PrEP, and early treatment decisions may increase the uptake of these interventions by a greater number and diversity of knowledgeable healthcare providers.

  4. Pre-exposure Prophylaxis Awareness Among Gay and Other Men who have Sex with Men in Vancouver, British Columbia, Canada.

    Science.gov (United States)

    Lachowsky, Nathan J; Lin, Sally Y; Hull, Mark W; Cui, Zishan; Sereda, Paul; Jollimore, Jody; Rich, Ashleigh; Montaner, Julio S G; Roth, Eric A; Hogg, Robert S; Moore, David M

    2016-07-01

    Men who have sex with men (MSM) account for approximately half of Canada's new HIV infections. Pre-exposure prophylaxis (PrEP), a recently established and effective HIV prevention tool for MSM is currently not approved nor publicly funded. We recruited MSM via respondent-driven sampling to complete a self-administered computer-based interview. Stratified by HIV status, multivariable logistic regression identified factors associated with PrEP awareness. Of 673 participants, 102/500 (20.9 %) HIV-negative and 63/173 (26.5 %) HIV-positive men were aware of PrEP, but none had used it. One third of PrEP-aware MSM spoke about it with friends or sex partners. Self-declared knowledge was limited. Factors associated with PrEP awareness varied by HIV status, but included greater HAART optimism for HIV-negative MSM. Among HIV-negative MSM, being PrEP unaware was associated with younger age, not always having condoms, and preferring receptive versus insertive anal sex. Future longitudinal research should identify early adopters of PrEP and its associated impacts.

  5. Misunderstanding of Pre-Exposure Prophylaxis Use Among Men Who Have Sex with Men: Public Health and Policy Implications.

    Science.gov (United States)

    Kurtz, Steven P; Buttram, Mance E

    2016-12-01

    Street markets in antiretroviral medications for HIV have been documented, but sources of demand are not well understood. We report unexpected findings from qualitative research suggesting that some demand is for informal pre-exposure prophylaxis (PrEP). Focus groups with young men who have sex with men (N = 31) yielded information on their understanding and use of PrEP. Of those who had heard of it, few understood PrEP to be a physician-prescribed regimen; most believed it to be a pill taken before and/or after sex and acquired on the street or through HIV-positive friends. Implications for PrEP rollout and public health policy are discussed.

  6. ?How I Wish This Thing Was Initiated 100 Years Ago!? Willingness to Take Daily Oral Pre-Exposure Prophylaxis among Men Who Have Sex with Men in Kenya

    OpenAIRE

    Karuga, Robinson Njoroge; Njenga, Serah Nduta; Mulwa, Rueben; Kilonzo, Nduku; Bahati, Prince; O?reilley, Kevin; Gelmon, Lawrence; Mbaabu, Stephen; Wachihi, Charles; Githuka, George; Kiragu, Michael

    2016-01-01

    Background The MSM population in Kenya contributes to 15% of HIV incidence. This calls for innovative HIV prevention interventions. Pre-exposure prophylaxis (PrEP) has been efficacious in preventing HIV among MSM in trials. There is limited data on the willingness to take daily oral PrEP in sub-Sahara Africa. PrEP has not been approved for routine use in most countries globally. This study aimed to document the willingness to take PrEP and barriers to uptake and adherence to PrEP in Kenya. Th...

  7. Perceived Advantages and Disadvantages of Using Pre-Exposure Prophylaxis (PrEP) among Sexually Active Black Women

    Science.gov (United States)

    Bond, Keosha T.; Gunn, Alana J.

    2017-01-01

    Knowledge of pre-exposure prophylaxis (PrEP) continues to remain scarce among Black women who are disproportionally affected by HIV in the United States. A thematic analysis of open-ended questions from a sample of Black women (n=119) who completed a mix-methods, online, e-health study was conducted to examine the perceived advantages and disadvantages of using PrEP. Being a female controlled method, empowerment, option for women with risky sex partners, and serodiscordant couples were advantages described. Disadvantages of PrEP were identified as the complexity of the choice, encouragement of sex with risky partners, increased burden, promotion of unprotected sex, and newness of the drug. PMID:28725660

  8. 'On December 1, 2015, sex changes. Forever': Pre-exposure prophylaxis and the pharmaceuticalisation of the neoliberal sexual subject.

    Science.gov (United States)

    Thomann, Matthew

    2018-08-01

    The global scale-up of AIDS treatment initiatives during the first decade of the twenty-first century has been referred to as a kind of 'pharmaceuticalisation' of public health, a trend that is now building in the area of HIV prevention. This paper traces the emergence and increased uptake of pre-exposure prophylaxis (PrEP), antiretroviral medications that can keep HIV negative individuals from becoming infected, placing it within the broader (re)casting of HIV prevention as a medical and technological problem that has been central to the recent 'end of AIDS' discourse. While HIV prevention discourses have been grounded in a neoliberal calculus of individual responsibility since the late 1990s, PrEP constitutes a pharmaceutical extension of the responsibilised sexual subject. Central to this extension are the acknowledgment of one's risk and a willingness to take pre-emptive medical action to secure a future without HIV. For men who have sex with men, a population heavily targeted for biomedical interventions in the United States, PrEP marks a shift in moral discourses of what it means to be a responsible sexual subject. Characteristics of the pharmaceutical extension of the neoliberal sexual subject are explored through an examination of a New York City-based PrEP promotional campaign.

  9. Post-Exposure Prophylaxis (PEP)

    Science.gov (United States)

    ... Child Transmission of HIV Post-Exposure Prophylaxis (PEP) Pre-Exposure Prophylaxis (PrEP) HIV Treatment HIV Treatment: The Basics Just ... to HIV frequently. Another HIV prevention method, called pre-exposure prophylaxis or PrEP, is when people at high risk ...

  10. Evaluating the impact of prioritization of antiretroviral pre-exposure prophylaxis (PrEP) in New York City

    Science.gov (United States)

    Kessler, Jason; Myers, Julie E.; Nucifora, Kimberly A.; Mensah, Nana; Toohey, Christopher; Khademi, Amin; Cutler, Blayne; Braithwaite, R. Scott

    2015-01-01

    Objective To compare the value and effectiveness of different prioritization strategies of pre-exposure prophylaxis (PrEP) in New York City (NYC). Design Mathematical modeling utilized as clinical trial is not feasible. Methods Using a model accounting for both sexual and parenteral transmission of HIV we compare different prioritization strategies (PPS) for PrEP to two scenarios—no PrEP and PrEP for all susceptible at-risk individuals. The PPS included PrEP for all MSM, only high-risk MSM, high-risk heterosexuals, and injection drug users, and all combinations of these four strategies. Outcomes included HIV infections averted, and incremental cost effectiveness (per-infection averted) ratios. Initial assumptions regarding PrEP included a 44% reduction in HIV transmission, 50% uptake in the prioritized population and an annual cost per person of $9,762. Sensitivity analyses on key parameters were conducted. Results Prioritization to all MSM results in a 19% reduction in new HIV infections. Compared to PrEP for all persons at-risk this PPS retains 79% of the preventative effect at 15% of the total cost. PrEP prioritized to only high-risk MSM results in a reduction in new HIV infections of 15%. This PPS retains 60% of the preventative effect at 6% of the total cost. There are diminishing returns when PrEP utilization is expanded beyond this group. Conclusions PrEP implementation is relatively cost-inefficient under our initial assumptions. Our results suggest that PrEP should first be promoted among MSM who are at particularly high-risk of HIV acquisition. Further expansion beyond this group may be cost-effective, but is unlikely to be cost-saving. PMID:25493594

  11. Using a network-based approach and targeted maximum likelihood estimation to evaluate the effect of adding pre-exposure prophylaxis to an ongoing test-and-treat trial.

    Science.gov (United States)

    Balzer, Laura; Staples, Patrick; Onnela, Jukka-Pekka; DeGruttola, Victor

    2017-04-01

    Several cluster-randomized trials are underway to investigate the implementation and effectiveness of a universal test-and-treat strategy on the HIV epidemic in sub-Saharan Africa. We consider nesting studies of pre-exposure prophylaxis within these trials. Pre-exposure prophylaxis is a general strategy where high-risk HIV- persons take antiretrovirals daily to reduce their risk of infection from exposure to HIV. We address how to target pre-exposure prophylaxis to high-risk groups and how to maximize power to detect the individual and combined effects of universal test-and-treat and pre-exposure prophylaxis strategies. We simulated 1000 trials, each consisting of 32 villages with 200 individuals per village. At baseline, we randomized the universal test-and-treat strategy. Then, after 3 years of follow-up, we considered four strategies for targeting pre-exposure prophylaxis: (1) all HIV- individuals who self-identify as high risk, (2) all HIV- individuals who are identified by their HIV+ partner (serodiscordant couples), (3) highly connected HIV- individuals, and (4) the HIV- contacts of a newly diagnosed HIV+ individual (a ring-based strategy). We explored two possible trial designs, and all villages were followed for a total of 7 years. For each village in a trial, we used a stochastic block model to generate bipartite (male-female) networks and simulated an agent-based epidemic process on these networks. We estimated the individual and combined intervention effects with a novel targeted maximum likelihood estimator, which used cross-validation to data-adaptively select from a pre-specified library the candidate estimator that maximized the efficiency of the analysis. The universal test-and-treat strategy reduced the 3-year cumulative HIV incidence by 4.0% on average. The impact of each pre-exposure prophylaxis strategy on the 4-year cumulative HIV incidence varied by the coverage of the universal test-and-treat strategy with lower coverage resulting in a larger

  12. An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis.

    Science.gov (United States)

    Dolling, David I; Desai, Monica; McOwan, Alan; Gilson, Richard; Clarke, Amanda; Fisher, Martin; Schembri, Gabriel; Sullivan, Ann K; Mackie, Nicola; Reeves, Iain; Portman, Mags; Saunders, John; Fox, Julie; Bayley, Jake; Brady, Michael; Bowman, Christine; Lacey, Charles J; Taylor, Stephen; White, David; Antonucci, Simone; Gafos, Mitzy; McCormack, Sheena; Gill, Owen N; Dunn, David T; Nardone, Anthony

    2016-03-24

    Pre-exposure prophylaxis (PrEP) has proven biological efficacy to reduce the sexual acquisition of the human immunodeficiency virus (HIV). The PROUD study found that PrEP conferred higher protection than in placebo-controlled trials, reducing HIV incidence by 86 % in a population with seven-fold higher HIV incidence than expected. We present the baseline characteristics of the PROUD study population and place the findings in the context of national sexual health clinic data. The PROUD study was designed to explore the real-world effectiveness of PrEP (tenofovir-emtricitabine) by randomising HIV-negative gay and other men who have sex with men (GMSM) to receive open-label PrEP immediately or after a deferral period of 12 months. At enrolment, participants self-completed two baseline questionnaires collecting information on demographics, sexual behaviour and lifestyle in the last 30 and 90 days. These data were compared to data from HIV-negative GMSM attending sexual health clinics in 2013, collated by Public Health England using the genitourinary medicine clinic activity database (GUMCAD). The median age of participants was 35 (IQR: 29-43). Typically participants were white (81 %), educated at a university level (61 %) and in full-time employment (72 %). Of all participants, 217 (40 %) were born outside the UK. A sexually transmitted infection (STI) was reported to have been diagnosed in the previous 12 months in 330/515 (64 %) and 473/544 (87 %) participants reported ever having being diagnosed with an STI. At enrolment, 47/280 (17 %) participants were diagnosed with an STI. Participants reported a median (IQR) of 10 (5-20) partners in the last 90 days, a median (IQR) of 2 (1-5) were condomless sex acts where the participant was receptive and 2 (1-6) were condomless where the participant was insertive. Post-exposure prophylaxis had been prescribed to 184 (34 %) participants in the past 12 months. The number of STI diagnoses was high compared to those reported in

  13. Cultural conundrums: the ethics of epidemiology and the problems of population in implementing pre-exposure prophylaxis.

    Science.gov (United States)

    Fiereck, Kirk

    2015-04-01

    The impending implementation of pre-exposure prophylaxis (PrEP) has prompted complicated bioethical and public health ethics concerns regarding the moral distribution of antiretroviral medications (ARVs) to ostensibly healthy populations as a form of HIV prevention when millions of HIV-positive people still lack access to ARVs globally. This manuscript argues that these questions are, in part, concerns over the ethics of the knowledge production practices of epidemiology. Questions of distribution, and their attendant cost-benefit calculations, will rely on a number of presupposed, and therefore, normatively cultural assumptions within the science of epidemiology specifically regarding the ability of epidemiologic surveillance to produce accurate maps of HIV throughout national populations. Specifically, ethical questions around PrEP will focus on who should receive ARVs given the fact that global demand will far exceed supply. Given that sexual transmission is one of the main modes of HIV transmission, these questions of 'who' are inextricably linked to knowledge about sexual personhood. As a result, the ethics of epidemiology, and how the epidemiology of HIV in particular conceives, classifies and constructs sexual populations will become a critical point of reflection and contestation for bioethicists, health activists, physicians, nurses, and researchers in the multi-disciplinary field of global health. This paper examines how cultural conundrums within the fields of bioethics and public health ethics are directly implicated within the ethics of PrEP, by analyzing the problems of population inaugurated by the construction of the men who have sex with men (MSM) epidemiologic category in the specific national context of South Africa. © 2013 John Wiley & Sons Ltd.

  14. Adolescent Human Immunodeficiency Virus Care Providers’ Attitudes Toward the Use of Oral Pre-Exposure Prophylaxis in Youth

    Science.gov (United States)

    Zimet, Gregory; Lally, Michelle; Kahn, Jessica A.

    2016-01-01

    Abstract Oral pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) prevention is currently indicated for use in adults in the United States and may soon be indicated for minor adolescents. However, implementation of PrEP use among minors may present unique barriers. We conducted 15 individual, semi-structured interviews among US clinicians caring for HIV-infected and at-risk youth. The theory-driven interview guide assessed demographics, perceived role of oral PrEP in HIV prevention among adolescents, perceived barriers to and facilitating factors for use of PrEP in adolescents, and clinician-reported likelihood of prescribing PrEP. Transcripts were analyzed using framework analysis. Overall, clinicians viewed PrEP as a time-limited intervention that is one part of a comprehensive approach to HIV prevention among adolescents. Perceived barriers to prescribing to minors included concerns about: confidentiality, legality of minors consenting to PrEP without parental involvement, ability of minors to understand the risks/benefits of PrEP, the possible impact of PrEP on bone accrual, off-label use of PrEP medication in minors, and the high costs associated with PrEP use. Clinician-reported facilitating factors for prescribing PrEP to youth included educating communities and other clinicians about PrEP, ensuring adequate financial resources and infrastructure for delivering PrEP, developing formal guidance on effective behavioral interventions that should be delivered with PrEP, and gaining personal experience with prescribing PrEP. Clinicians indicated greater comfort with prescribing PrEP to adults versus minors. For PrEP to become more widely available to youth at risk for HIV infection, barriers that are unique to PrEP use in minors must be addressed. PMID:27410497

  15. The Pre-Exposure Prophylaxis-Stigma Paradox: Learning from Canada's First Wave of PrEP Users.

    Science.gov (United States)

    Grace, Daniel; Jollimore, Jody; MacPherson, Paul; Strang, Matthew J P; Tan, Darrell H S

    2018-01-01

    With the emergence of daily oral tenofovir disoproxil fumarate and emtricitabine-based pre-exposure prophylaxis (PrEP) use in Canada, questions have emerged concerning the impacts of this HIV prevention tool on gay men's social and sexual lives. We conducted small focus groups and individual qualitative interviews with 16 gay men in Toronto who were part of the 'first wave' of Canadian PrEP users. Participants were on PrEP for at least one year as part of a demonstration project (November 2014-June 2016). These participants accessed PrEP before regulatory approval by Health Canada in February 2016. The mean age of participants was 37.6 years (SD 11.02); 94% completed secondary education, and 69% were white. Sex-stigma emerged as a complex theme in men's accounts of PrEP use across three overlapping domains: (1) PrEP-related stigma, including discussions of concealment and stigma from friends, family, and sexual partners, (2) PrEP as a perceived tool for combating HIV-related stigma, where some men said that they no longer discussed HIV status with sexual partners, and (3) PrEP as illuminating structural stigma, where it was attributed to unmasking stigma related to sex and sexuality. For some participants, PrEP has allowed for liberating sex and a self-described return to normalcy-normal, exciting, pleasurable sex that was no longer reliant on condom use. Paradoxically, some men said that PrEP use both led them to experience stigmatizing reactions within their social and sexual networks, while also helping to remove stigma, shame, and fear related to HIV, sexuality, and sex with gay men living with HIV.

  16. Assessing the need for a pre-exposure prophylaxis programme using the social media app Grindr®.

    Science.gov (United States)

    Hampel, B; Kusejko, K; Braun, D L; Harrison-Quintana, J; Kouyos, R; Fehr, J

    2017-11-01

    HIV pre-exposure prophylaxis (PrEP) is not approved in Switzerland and therefore must be paid for by the users themselves. We conducted a survey to find out whether men who have sex with men (MSM) in Switzerland are already taking PrEP, or are considering using it, and whether it is being taken under medical supervision or not. Grindr® is a geosocial networking app for MSM. Between 5 and 24 January 2017, users of the app who were located in Switzerland by a global positioning system (GPS) were asked to participate in a ten-question survey on PrEP use. Of the 2455 people who took part in the survey, 1893 were included in the analysis. Eighty-two participants (4.3%) reported that they were currently taking PrEP, 64 of whom (78%) said that they were under medical supervision. Seven PrEP users (9%) declared that they had not taken an HIV test within the previous 12 months. Nine hundred and forty-four (49.9%) were considering taking PrEP in the next 6 months, and 1474 (77.9%) were considering taking it at some point in the future. In an online survey carried out among sexually active MSM in Switzerland, only a minority of the individuals approached responded that they were currently using PrEP. However, the majority of participants were considering taking PrEP in the future. We identified a substantial proportion of PrEP users taking PrEP outside a medical setting. Hence, a national programme facilitating access to medical care and providing PrEP is urgently needed. © 2017 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.

  17. Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa.

    Directory of Open Access Journals (Sweden)

    Ariane van der Straten

    Full Text Available In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF, we explored socio-cultural and contextual factors that influenced participants' experience of daily vaginal gel and oral tablet regimens in VOICE.In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41, serial ethnographic interviews (n = 21, or focus group discussions (n = 40. Audiotaped interviews were transcribed, translated, and coded thematically for analysis.Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use.Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women's perceptions of trial

  18. Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa.

    Science.gov (United States)

    van der Straten, Ariane; Stadler, Jonathan; Montgomery, Elizabeth; Hartmann, Miriam; Magazi, Busiswe; Mathebula, Florence; Schwartz, Katie; Laborde, Nicole; Soto-Torres, Lydia

    2014-01-01

    In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants' experience of daily vaginal gel and oral tablet regimens in VOICE. In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis. Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use. Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women's perceptions of trial participation and

  19. WHO guidance grounded in a comprehensive approach to sexual and reproductive health and human rights: topical pre-exposure prophylaxis.

    Science.gov (United States)

    Lusti-Narasimhan, Manjula; Khosla, Rajat; Baggaley, Rachel; Temmerman, Marleen; McGrory, Elizabeth; Farley, Tim

    2014-01-01

    Two new microbicide products based on topical (vaginal) application of antiretroviral drugs - 1% tenofovir gel and the dapivirine ring - are currently in late-stage clinical testing, and results on their safety and effectiveness are expected to become available in early 2015. WHO guidelines on the use of topical pre-exposure prophylaxis (topical PrEP) are important in order to ensure that these new prevention products are optimally used. Given that these new topical PrEP products are designed to be woman initiated and will likely be delivered in reproductive health settings, it is important to ensure that the guidance be framed in the context of comprehensive sexual and reproductive health and human rights. In addition to the safety and effectiveness data resulting from clinical trials, and the regulatory approval required for new products, the WHO normative guidelines on the use of topical PrEP will be essential for rapid roll-out in countries. Human rights standards and principles provide a framework for the provision of woman-initiated HIV prevention products. These include addressing issues related to the gender inequities which are linked to the provision of HIV-prevention, treatment and care for young girls and women. Effective programming for women and girls must therefore be based on understanding the local, social and community contexts of the AIDS epidemic in the country, and adapting HIV strategies and programmes accordingly. Such a framework therefore is needed not only to ensure optimal uptake of these new products by women and girls but also to address sociocultural barriers to women's and girls' access to these products.

  20. Willingness to use pre-exposure prophylaxis among Black and White men who have sex with men in Atlanta, Georgia.

    Science.gov (United States)

    Rolle, Charlotte-Paige; Rosenberg, Eli S; Luisi, Nicole; Grey, Jeremy; Sanchez, Travis; Del Rio, Carlos; Peterson, John L; Frew, Paula M; Sullivan, Patrick S; Kelley, Colleen F

    2017-08-01

    PrEP willingness may be different among black and white men who have sex with men (MSM) given known disparities in HIV incidence, sociodemographic factors, and healthcare access between these groups. We surveyed 482 black and white HIV-negative MSM in Atlanta, GA about their willingness to use pre-exposure prophylaxis (PrEP) and facilitators and barriers to PrEP willingness. Overall, 45% (215/482) of men indicated interest in using PrEP. Engaging in recent unprotected anal intercourse (UAI) was the only factor significantly associated with PrEP willingness in multivariate analyses (OR 1.73, 95% CI 1.13, 2.65). Willing men identified "extra protection" against HIV as the most common reason for interest in using PrEP, whereas unwilling men most commonly cited not wanting to take medication daily, and this reason was more common among white MSM (42.3% of white MSM vs. 28.9% of black MSM, p = 0.04). Most men indicated willingness to use PrEP if cost was <50 dollars/month; however, more black MSM indicated willingness to use PrEP only if cost were free (17.9% of white MSM vs. 25.9% of black MSM, p = 0.03). Overall, these data are useful to scale up PrEP interventions targeting at-risk MSM in Atlanta and highlight the need for implementation of low cost-programs, which will be especially important for black MSM.

  1. Implementation of pre-exposure prophylaxis for human immunodeficiency virus infection: progress and emerging issues in research and policy.

    Science.gov (United States)

    Cáceres, Carlos F; Borquez, Annick; Klausner, Jeffrey D; Baggaley, Rachel; Beyrer, Chris

    2016-01-01

    In this article, we present recent evidence from studies focused on the implementation, effectiveness and cost-effectiveness of pre-exposure prophylaxis (PrEP) for HIV infection; discuss PrEP scale-up to date, including the observed levels of access and policy development; and elaborate on key emerging policy and research issues to consider for further scale-up, with a special focus on lower-middle income countries. The 2015 WHO Early Release Guidelines for HIV Treatment and Prevention reflect both scientific evidence and new policy perspectives. Those guidelines present a timely challenge to health systems for the scaling up of not only treatment for every person living with HIV infection but also the offer of PrEP to those at substantial risk. Delivery and uptake of both universal antiretroviral therapy (ART) and PrEP will require nation-wide commitment and could reinvigorate health systems to develop more comprehensive "combination prevention" programmes and support wider testing linked to both treatments and other prevention options for populations at highest risk who are currently not accessing services. Various gaps in current health systems will need to be addressed to achieve strategic scale-up of PrEP, including developing prioritization strategies, strengthening drug regulations, determining cost and funding sources, training health providers, supporting user adherence and creating demand. The initial steps in the scale-up of PrEP globally suggest feasibility, acceptability and likely impact. However, to prevent setbacks in less well-resourced settings, countries will need to anticipate and address challenges such as operational and health systems barriers, drug cost and regulatory policies, health providers' openness to prescribing PrEP to populations at substantial risk, demand and legal and human rights issues. Emerging problems will require creative solutions and will continue to illustrate the complexity of PrEP implementation.

  2. Acceptability of pre-exposure prophylaxis among men who have sex with men and transgender women in Northern Thailand.

    Directory of Open Access Journals (Sweden)

    Daniel Yang

    Full Text Available Northern Thailand has a high burden HIV epidemic among MSM and TG. Oral pre-exposure prophylaxis (PrEP with tenofovir-emtricitabine has demonstrated efficacy in preventing HIV among MSM and TG in Chiang Mai, Thailand. Determinants of PrEP acceptability are needed to gauge the potential uptake of this prevention strategy.From January to February 2012, 238 MSM and TG participants, who self-reported as HIV-uninfected or of unknown status, completed a self-administered survey on hand-held computers. Participants were recruited by venue-day-time sampling and asked to rate their likelihood of using oral PrEP for HIV prevention with an efficacy of 50%. PrEP acceptability was defined as being "very likely" to use PrEP. Odds ratios and 95% CIs were calculated to identify correlates of acceptability.131 MSM and 107 TG responded, with mean ages of 23.7 and 21.8, respectively. 24% of MSM engaged primarily in receptive anal sex vs. 74% of TG. 21% of MSM and 44% of TG reported regular medication use. Prior awareness of PrEP was high at 66% among both MSM and TG respondents. 41% of MSM and 37% of TG were "very likely" to use PrEP. Among MSM, factors associated with PrEP acceptability included a prior history of STIs (AOR 4.6; 95%CIs 1.7-12.6, previous HIV testing (AOR 2.4 95%CIs 1.1-5.3, regularly planned sex (AOR 2.8 95%CIs 1.1-7.2, and infrequent sex (AOR 2.9 95%CIs 1.3-6.3. Among TG, factors associated with acceptability included prior awareness of PrEP (AOR 3.3; 95%CIs 1.2-9.0 and having private insurance (AOR 5.0; 95%CIs 1.3-19.0.MSM and TG in Northern Thailand are distinct groups in terms of sexual behaviors, patterns of medication use, and correlates of PrEP acceptability. Efforts to maximize PrEP uptake should include expanded HIV testing services and the provision of financial subsidies to reduce the cost of PrEP.

  3. WHO guidance grounded in a comprehensive approach to sexual and reproductive health and human rights: topical pre-exposure prophylaxis

    OpenAIRE

    Lusti-Narasimhan, Manjula; Khosla, Rajat; Baggaley, Rachel; Temmerman, Marleen; McGrory, Elizabeth; Farley, Tim

    2014-01-01

    Introduction: Two new microbicide products based on topical (vaginal) application of antiretroviral drugs – 1% tenofovir gel and the dapivirine ring – are currently in late-stage clinical testing, and results on their safety and effectiveness are expected to become available in early 2015. WHO guidelines on the use of topical pre-exposure prophylaxis (topical PrEP) are important in order to ensure that these new prevention products are optimally used. Discussion: Given that these new topical ...

  4. Long-acting rilpivirine as potential pre-exposure prophylaxis for HIV-1 prevention (the MWRI-01 study): an open-label, phase 1, compartmental, pharmacokinetic and pharmacodynamic assessment.

    Science.gov (United States)

    McGowan, Ian; Dezzutti, Charlene S; Siegel, Aaron; Engstrom, Jarret; Nikiforov, Alexiy; Duffill, Kathryn; Shetler, Cory; Richardson-Harman, Nicola; Abebe, Kaleab; Back, David; Else, Laura; Egan, Deidre; Khoo, Saye; Egan, James E; Stall, Ronald; Williams, Peter E; Rehman, Khaleel K; Adler, Amy; Brand, Rhonda M; Chen, Beatrice; Achilles, Sharon; Cranston, Ross D

    2016-12-01

    Long-acting injectable antiretroviral agents are being developed for HIV-1 prevention. The MWRI-01 study was done to characterise the safety, acceptability, and pharmacokinetic and pharmacodynamic profile of long-acting rilpivirine. We did a phase 1 open-label study at the University of Pittsburgh. We enrolled healthy individuals (aged 18-45 years) who were seronegative for HIV-1. Participants were assigned alternately one intramuscular dose of either 1200 mg or 600 mg long-acting rilpivirine, beginning with the 1200 mg dose. We obtained plasma specimens, genital and rectal fluids, and tissue samples (rectal, cervical, and vaginal) before and after exposure to long-acting rilpivirine for assessment of pharmacokinetics and ex-vivo biopsy challenge with HIV-1. Our primary objective was to characterise product safety, and the analysis included all enrolled participants. This trial is registered with ClinicalTrials.gov, number NCT01656018. 36 participants were enrolled into the study, of whom 24 were women and 12 men. 12 women and six men received each dose. 204 adverse events were reported among the 36 participants, of which 200 (98%) were grade 1-2. The most common adverse event was injection site reaction. All grade 3 and 4 adverse events were deemed not related to rilpivirine. Geometric mean (90% CI) concentrations in plasma of rilpivirine at day 28 post dose were 53 ng/mL (38-67) in women and 43 ng/mL (23-63) in men for the 1200 mg dose and 28 ng/mL (19-37) in women and 17 ng/mL (9-24) in men for the 600 mg dose. The tissue-to-plasma ratio for rilpivirine in rectal tissue was about two-fold higher than in vaginal and cervical tissue (1·10-1·53 vs 0·61-0·72 and 0·50-0·71, respectively). Exposure to long-acting rilpivirine suppressed viral replication significantly in rectal tissue (psuppression persisted for up to 4 months. By contrast, no viral suppression was seen in cervical or vaginal tissue. Ongoing research will characterise longer term safety and

  5. Sexually transmitted infections and pre-exposure prophylaxis: challenges and opportunities among men who have sex with men in the US.

    Science.gov (United States)

    Scott, Hyman M; Klausner, Jeffrey D

    2016-01-01

    Pre-Exposure Prophylaxis (PrEP) has shown high efficacy in preventing human immunodeficiency virus (HIV) infection among men who have sex with men (MSM) in several large clinical trials, and more recently in "real world" reports of clinical implementation and a PrEP demonstration project. Those studies also demonstrated high bacterial sexually transmitted infection (STI) incidence and raised the discussion of how PrEP may impact STI control efforts, especially in the setting of increasing Neisseria gonorrhoeae antimicrobial resistance and the increase in syphilis cases among MSM. Here, we discuss STIs as a driver of HIV transmission risk among MSM, and the potential opportunities and challenges for STI control afforded by expanded PrEP implementation among high-risk MSM.

  6. Decline in bone mass with tenofovir disoproxil fumarate/emtricitabine is associated with hormonal changes in the absence of renal impairment when used by HIV uninfected adolescent boys and young men for HIV pre-exposure

    Science.gov (United States)

    Background. We aimed to define the relative importance of renal and endocrine changes in tenofovir disoproxil fumarate (TDF)-related bone toxicity. Methods. In a study of daily TDF/emtricitabine (FTC) pre-exposure prophylaxis (PrEP) in HIV uninfected young men who have sex with men, we measured ch...

  7. Perceived Advantages and Disadvantages of Using Pre-Exposure Prophylaxis (PrEP) among Sexually Active Black Women: An Exploratory Study.

    Science.gov (United States)

    Bond, Keosha T; Gunn, Alana J

    2016-01-01

    Knowledge of pre-exposure prophylaxis (PrEP) continues to remain scarce among Black women who are disproportionally affected by HIV in the United States. A thematic analysis of open-ended questions from a sample of Black women (n=119) who completed a mix-methods, online, e-health study was conducted to examine the perceived advantages and disadvantages of using PrEP. Being a female controlled method, empowerment, option for women with risky sex partners, and serodiscordant couples were advantages described. Disadvantages of PrEP were identified as the complexity of the choice, encouragement of sex with risky partners, increased burden, promotion of unprotected sex, and newness of the drug.

  8. Current perspectives in HIV post-exposure prophylaxis

    Directory of Open Access Journals (Sweden)

    Sultan B

    2014-10-01

    Full Text Available Binta Sultan,1,2 Paul Benn,1 Laura Waters1 1Department of Genitourinary Medicine, Mortimer Market Centre, Central and North West London NHS Foundation Trust, London, UK; 2Centre for Sexual Health and HIV Research, University College London, London, UK Abstract: The incidence of human immunodeficiency virus (HIV infection continues to rise among core groups and efforts to reduce the numbers of new infections are being redoubled. Post-exposure prophylaxis (PEP is the use of short-term antiretroviral therapy (ART to reduce the risk of acquisition of HIV infection following exposure. Current guidelines recommend a 28-day course of ART within 36–72 hours of exposure to HIV. As long as individuals continue to be exposed to HIV there will be a role for PEP in the foreseeable future. Nonoccupational PEP, the vast majority of which is for sexual exposure (PEPSE, has a significant role to play in HIV prevention efforts. Awareness of PEP and its availability for both clinicians and those who are eligible to receive it are crucial to ensure that PEP is used to its full potential in any HIV prevention strategy. In this review, we provide current evidence for the use of PEPSE, assessment of the risk of HIV transmission, indications for PEP, drug regimens, and management of patients started on PEP. We summarize national and international guidelines for the use of PEPSE. We explore the place of PEP within the wider strategy of reducing HIV incidence rates in the era of treatment as prevention and pre-exposure prophylaxis. We also consider the implications of recent data from interventional and observational studies demonstrating significant reductions in the risk of HIV transmission within a serodiscordant relationship if the HIV-positive partner is taking effective ART upon PEP guidelines. Keywords: post-exposure prophylaxis, pre-exposure prophylaxis, treatment as prevention, human immunodeficiency virus

  9. Human Resource Challenges to Integrating HIV Pre-Exposure ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    These challenges paralleled current challenges related to integration of antiretroviral therapy (ART) and ..... is not additional work but is rather another HIV ... should be added to performance contracts (terms of ... stress and burnout, difficulty adhering to time- ... Similarly, the role of ... (diploma level) nursing officers or clinical.

  10. Influences of geo-spatial location on pre-exposure prophylaxis use in South Africa: positioning microbicides for better product uptake.

    Science.gov (United States)

    Govender, Eliza M; Mansoor, Leila E; Abdool Karim, Quarraisha

    2017-06-01

    Young women bear a disproportionately high burden of HIV infection in sub-Saharan Africa, prioritising pre-exposure prophylaxis (PrEP) can be an integral part of HIV prevention combination strategies. Women initiated HIV prevention technology options will require consistent adherence, an imperative for product effectiveness. With several PrEP clinical trials underway; exploring women's acceptability to advances in HIV prevention technologies can better facilitate demand creation for future PrEP roll out. This study utilised the opportunity of post-trial access to CAPRISA 008 women (trial) and non-trial women from three geo-spatial settings (urban, rural and peri-urban) to identify microbicide acceptability and how product associations of microbicides can influence future HIV prevention choices. Six participatory workshops using participatory action research with art-based activities and discussion groups were conducted in KwaZulu-Natal with 104 women from various geo-spatial locations and social status to understand microbicide acceptability and product associations. The data were analysed using thematic analysis. The study found that women's acceptability and product association of the tenofovir gel microbicide differed according to rural and urban areas. Most urban women identified confidence, sexiness and classiness as key associations that will encourage microbicide acceptability and use, while rural women identified respect, responsibility and confidence as the key product associations, with increased focus on the individual and collective family/community benefits of product acceptance and use. Urban-rural differences suggest a market segmentation that is contextualised to be locally responsive to promote HIV prevention technologies. Various sexual encounters further determined the types of HIV prevention technologies women would consider. In line with WHO's recommendation that PrEP should be an additional prevention choice for people at risk of HIV, this

  11. Intranasal Administration of Maleic Anhydride-Modified Human Serum Albumin for Pre-Exposure Prophylaxis of Respiratory Syncytial Virus Infection

    Directory of Open Access Journals (Sweden)

    Zhiwu Sun

    2015-02-01

    Full Text Available Respiratory syncytial virus (RSV is the leading cause of pediatric viral respiratory tract infections. Neither vaccine nor effective antiviral therapy is available to prevent and treat RSV infection. Palivizumab, a humanized monoclonal antibody, is the only product approved to prevent serious RSV infection, but its high cost is prohibitive in low-income countries. Here, we aimed to identify an effective, safe, and affordable antiviral agent for pre-exposure prophylaxis (PrEP of RSV infection in children at high risk. We found that maleic anhydride (ML-modified human serum albumin (HSA, designated ML-HSA, exhibited potent antiviral activity against RSV and that the percentages of the modified lysines and arginies in ML- are correlated with such anti-RSV activity. ML-HSA inhibited RSV entry and replication by interacting with viral G protein and blocking RSV attachment to the target cells, while ML-HAS neither bound to F protein, nor inhibited F protein-mediated membrane fusion. Intranasal administration of ML-HSA before RSV infection resulted in significant decrease of the viral titers in the lungs of mice. ML-HSA shows promise for further development into an effective, safe, affordable, and easy-to-use intranasal regimen for pre-exposure prophylaxis of RSV infection in children at high risk in both low- and high-income countries.

  12. Awareness and Willingness to Use Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex with Men and Transgender Women in Brazil.

    Science.gov (United States)

    Hoagland, Brenda; De Boni, Raquel B; Moreira, Ronaldo I; Madruga, José Valdez; Kallas, Esper G; Goulart, Silvia Pereira; Cerqueira, Natalia; Torres, Thiago S; Luz, Paula M; Fernandes, Nilo Martinez; Liu, Albert Y; Grinsztejn, Beatriz; Veloso, Valdilea G

    2017-05-01

    Antiretroviral pre-exposure prophylaxis (PrEP) is recommended to prevent HIV infection among high-risk men who have sex with men (MSM) though not available in Brazil where the HIV epidemic persists unabated in this group. This cross-sectional study describes PrEP awareness and willingness and associated factors among MSM and transvestite/transgender women (trans women) pre-screened for the PrEP Brasil study. Awareness was reported by 61.3 % of the participants and was associated with age, education, site, study period and prior HIV testing. Most participants (82.1 %) were willing to use PrEP, which was associated with site, study period, number of male condomless anal sexual partners and anal sex with HIV positive/unknown partners. PrEP information is need among young and less educated individuals. Willingness to use PrEP was high and future studies should be conducted to confirm PrEP acceptability and the characteristics of the population who chose to adopt this intervention.

  13. 'WTF is PrEP?': attitudes towards pre-exposure prophylaxis among men who have sex with men and transgender women in New York City.

    Science.gov (United States)

    Thomann, Matthew; Grosso, Ashley; Zapata, Richard; Chiasson, Mary Ann

    2017-10-06

    In the USA, gay and other men who have sex with men and transgender women are disproportionately affected by HIV. Uptake of pre-exposure prophylaxis (PrEP), anti-retroviral therapy to prevent HIV-negative individuals from seroconverting if exposed to HIV, by members of this population remains low, particularly among African-Americans. We conducted two focus groups to assess responses to an online social media campaign focusing on PrEP use in New York City. We designed, produced and disseminated the campaign to address knowledge of PrEP; its physical and psychological side effects; and psychosocial barriers related to PrEP adherence and sex shaming. Focus group participants demonstrated a relatively high knowledge of PrEP, although considerable concern remained about side effects, particularly among Black participants. Participants suggested that stigma against PrEP users was declining as PrEP use became more common, but stigma remained, particularly for those not using condoms. Many focus group participants reported distrust of medical providers and were critical of the commodification of HIV prevention by the pharmaceutical industry. Participants reported that those in romantic relationships confronted unique issues regarding PrEP, namely suspicions of infidelity. Finally, Black participants spoke of the need for more tailored and sensitive representations of Black gay men in future programmes and interventions.

  14. Pre-Exposure Prophylaxis (PrEP) Use and Condomless Anal Sex: Evidence of Risk Compensation in a Cohort of Young Men Who Have Sex with Men.

    Science.gov (United States)

    Newcomb, Michael E; Moran, Kevin; Feinstein, Brian A; Forscher, Emily; Mustanski, Brian

    2018-04-01

    Young men who have sex with men (YMSM) are disproportionately impacted by HIV. Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition. It remains unclear if PrEP use increases rates of condomless sex (ie, risk compensation), which may increase risk of infection if PrEP adherence is not optimal. This study aimed to examine whether PrEP use and PrEP adherence were associated with change in sexual risk behaviors in a large longitudinal cohort of YMSM reporting on multiple sexual partnerships over time. Data were obtained from the first 3 visits of an ongoing cohort study of YMSM in Chicago (analytic N = 953; 14.1% HIV-positive at baseline). Participants reported up to 4 sexual partnerships at each visit, including sexual behavior, PrEP use, and PrEP adherence within partnerships. YMSM reported higher rates of receptive condomless anal sex (CAS) in partnerships during which they were on PrEP compared with those when they were not on PrEP. This association was consistent across both HIV-negative and HIV-positive participants reporting on partnerships with both perceived HIV-negative/unknown and HIV-positive partners. The rate of receptive CAS was higher in PrEP nonadherent partnerships compared with non-PrEP partnerships. The rate of receptive CAS was also higher in PrEP nonadherent than adherent partnerships, but this was not statistically significant. These analyses provide compelling data suggesting that YMSM are engaging in risk compensation when on PrEP. If rates of receptive CAS are highest among YMSM who are PrEP nonadherent, PrEP as a prevention strategy could fail to curb HIV incidence among YMSM.

  15. "How I Wish This Thing Was Initiated 100 Years Ago!" Willingness to Take Daily Oral Pre-Exposure Prophylaxis among Men Who Have Sex with Men in Kenya.

    Science.gov (United States)

    Karuga, Robinson Njoroge; Njenga, Serah Nduta; Mulwa, Rueben; Kilonzo, Nduku; Bahati, Prince; O'reilley, Kevin; Gelmon, Lawrence; Mbaabu, Stephen; Wachihi, Charles; Githuka, George; Kiragu, Michael

    2016-01-01

    The MSM population in Kenya contributes to 15% of HIV incidence. This calls for innovative HIV prevention interventions. Pre-exposure prophylaxis (PrEP) has been efficacious in preventing HIV among MSM in trials. There is limited data on the willingness to take daily oral PrEP in sub-Sahara Africa. PrEP has not been approved for routine use in most countries globally. This study aimed to document the willingness to take PrEP and barriers to uptake and adherence to PrEP in Kenya. The findings will inform the design of a PrEP delivery program as part of the routine HIV combination prevention. Eighty MSM were recruited in 2 Counties in December 2013. Quantitative data on sexual behaviour and willingness to take PrEP were collected using semi-structured interviews and analysed using SPSS. Qualitative data on knowledge of PrEP, motivators and barriers to uptake and adherence to PrEP were collected using in-depth interviews and FGDs and analysed using Nvivo. Analysis of data in willingness to take PrEP was conducted on the HIV negative participants (n = 55). 83% of MSM were willing to take daily oral HIV PrEP. Willingness to take PrEP was higher among the bi-sexual and younger men. Motivators for taking PrEP were the need to stay HIV negative and to protect their partners. History of poor medication adherence, fear of side effects and HIV stigma were identified as potential barriers to adherence. Participants were willing to buy PrEP at a subsidized price. There is willingness to take PrEP among MSM in Kenya and there is need to invest in targeted education and messaging on PrEP to enhance adherence, proper use and reduce stigma in the general population and among policy makers.

  16. "How I Wish This Thing Was Initiated 100 Years Ago!" Willingness to Take Daily Oral Pre-Exposure Prophylaxis among Men Who Have Sex with Men in Kenya.

    Directory of Open Access Journals (Sweden)

    Robinson Njoroge Karuga

    Full Text Available The MSM population in Kenya contributes to 15% of HIV incidence. This calls for innovative HIV prevention interventions. Pre-exposure prophylaxis (PrEP has been efficacious in preventing HIV among MSM in trials. There is limited data on the willingness to take daily oral PrEP in sub-Sahara Africa. PrEP has not been approved for routine use in most countries globally. This study aimed to document the willingness to take PrEP and barriers to uptake and adherence to PrEP in Kenya. The findings will inform the design of a PrEP delivery program as part of the routine HIV combination prevention.Eighty MSM were recruited in 2 Counties in December 2013. Quantitative data on sexual behaviour and willingness to take PrEP were collected using semi-structured interviews and analysed using SPSS. Qualitative data on knowledge of PrEP, motivators and barriers to uptake and adherence to PrEP were collected using in-depth interviews and FGDs and analysed using Nvivo. Analysis of data in willingness to take PrEP was conducted on the HIV negative participants (n = 55.83% of MSM were willing to take daily oral HIV PrEP. Willingness to take PrEP was higher among the bi-sexual and younger men. Motivators for taking PrEP were the need to stay HIV negative and to protect their partners. History of poor medication adherence, fear of side effects and HIV stigma were identified as potential barriers to adherence. Participants were willing to buy PrEP at a subsidized price.There is willingness to take PrEP among MSM in Kenya and there is need to invest in targeted education and messaging on PrEP to enhance adherence, proper use and reduce stigma in the general population and among policy makers.

  17. Factors influencing uptake of pre-exposure prophylaxis: some qualitative insights from an intervention study of men who have sex with men in China.

    Science.gov (United States)

    Liu, Chunxing; Ding, Yingying; Ning, Zhen; Gao, Meiyang; Liu, Xing; Wong, Frank Y; He, Na

    2018-02-01

    Pre-exposure prophylaxis (PrEP) is a biomedical approach for preventing the acquisition of HIV in populations at substantial risk for HIV. However, its uptake among men who have sex with men (MSM) is low in China. The study aimed to identify factors that might influence MSM's uptake and use of PrEP. In-depth interviews were conducted with 32 self-identified MSM from a PrEP intervention study evaluating daily oral tenofovir disoproxil fumarate (TDF) to prevent HIV infection. Of these men, 11 were presently using the 'TDF' group; 8 from the 'change-over' group (i.e. initially used PrEP but subsequently quitted); and 13 from the non-user group. Data were analysed using thematic approach. Perception of low HIV risk, mistrust of the national PrEP program, and concerns of side effects were the main reasons for not wanting to use PrEP. Also, lack of main sexual partner's support, difficulties in adhering to the daily TDF regimen, and the inconvenient schedules in securing the medicine were the major reasons for not wanting to use or quitting the use of PrEP. On the other hand, perceived high HIV risk, beliefs in efficacy of PrEP, and worries of transmitting HIV to families were the major motives for PrEP uptake. Findings suggest that PrEP implementation strategies should first address issues including but not limited to accurate self-assessment of HIV risk, mistrust and limited knowledge about medical trials and PrEP, and ease of accessing PrEP.

  18. Pre-exposure prophylaxis (PrEP) for men who have sex with men in Europe: review of evidence for a much needed prevention tool.

    Science.gov (United States)

    Reyniers, Thijs; Hoornenborg, Elske; Vuylsteke, Bea; Wouters, Kristien; Laga, Marie

    2017-08-01

    In many Western countries with good coverage of antiretroviral treatment (ART) programmes the annual number of HIV infections is still high and not (yet) declining among men who have sex with men (MSM). This might indicate that antiretroviral treatment roll-out alone will not turn around the course of the epidemic and that new, additional tools are needed. Antiretrovirals used as prevention tools for people not yet infected with HIV, such as pre-exposure prophylaxis (PrEP) could be such important additional tools. PrEP is a new type of biomedical prevention, which involves the use of antiretrovirals before, during and after (periods of) sexual exposure to HIV. In this review, we will focus on PrEP as a new prevention tool for MSM at high risk in Europe, including its evidence for effectiveness, challenges for implementation, ongoing European demonstration studies; as well as how PrEP relates to other existing prevention tools. In light of European Medicines Agency's recent recommendation for approval of PrEP we briefly review the potential implications. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  19. Home-based pre-exposure prophylaxis (PrEP services for gay and bisexual men: An opportunity to address barriers to PrEP uptake and persistence.

    Directory of Open Access Journals (Sweden)

    Steven A John

    Full Text Available Gay, bisexual, and other men who have sex with men (GBM are disproportionately affected by the HIV epidemic. Despite the promise of pre-exposure prophylaxis (PrEP in reducing HIV transmission risk, barriers for uptake and persistence exist. We sought to identify whether GBM in a nationwide cohort who have not yet initiated PrEP (n = 906 would prefer to get PrEP-related care from a primary care provider (PCP compared to a specialist clinic or provider. We then sought to identify their level of interest and factors associated with preference for using home-based PrEP services (i.e., HB-PrEP, defined to participants as conducting HIV/STI self-testing from home with PrEP prescription mailing after an initial in-person clinic visit. We examined the associations of demographics, sexual HIV transmission risk, concern about frequent medical checkups associated with PrEP, health care access, and PrEP intentions with preferences for healthcare provider type and HB-PrEP. Concern about frequent medical checkups were associated with preferring a PCP for PrEP-related care, but men who perceived a barrier to bringing up the topic of PrEP with a doctor preferred a specialist clinic or provider more than a PCP. HB-PrEP was more appealing for younger men and those engaged in sexual HIV transmission risk, suggesting HB-PrEP could help reach GBM most vulnerable to HIV and in need of PrEP. HB-PrEP expansion has potential to increase PrEP uptake and persistence among GBM, particularly for men with barriers to clinic-based care and higher intentions to initiate PrEP. Clinical guidelines regarding HB-PrEP are needed to expand its use.

  20. Truvada (emtricitabine/tenofovir) pre-exposure prophylaxis roll-out ...

    African Journals Online (AJOL)

    Research Council show that women aged 15 - 25 years are most at risk of contracting HIV.[1] This report appears to have been one of the catalysts in prompting the Higher Education and Training HIV/. AIDS Programme (HEAIDS) and the National Department of Health to roll out Truvada to university and college students, ...

  1. The Promise of Pre-Exposure Prophylaxis for Black Men Who Have Sex with Men: An Ecological Approach to Attitudes, Beliefs, and Barriers

    Science.gov (United States)

    Parker, Caroline M.; Parker, Richard G.; Wilson, Patrick A.; Garcia, Jonathan; Hirsch, Jennifer S.

    2016-01-01

    Abstract Research has demonstrated the clinical effectiveness of pre-exposure prophylaxis (PrEP) for HIV prevention, but little is known about how factors at the individual-, interpersonal-, community-, and structural levels impact PrEP use for black men who have sex with men (BMSM). We advance existing work by examining how all levels of the ecological framework must be addressed for PrEP to be successfully implemented as an effective HIV prevention approach. We interviewed 31 BMSM three times each and 17 community stakeholders once each; interviews were taped, transcribed, and analyzed using the constant comparative method. Factors that influence how BMSM experienced PrEP emerged across all levels of the ecological framework: At the individual level, respondents were wary of giving medication to healthy people and of the potential side-effects. At the interpersonal level, BMSM believed that PrEP use would discourage condom use and that PrEP should only be one option for HIV prevention, not the main option. At the community level, men described not trusting the pharmaceutical industry and described PrEP as an option for others, not for themselves. At the structural level, BMSM talked about HIV and sexuality-related stigmas and how they must overcome those before PrEP engagement. BMSM are a key population in the US National HIV/AIDS Strategy, yet few individuals believe that PrEP would be personally helpful. Our research indicates the urgent need to raise awareness and address structural stigma and policies that could be substantial barriers to the scale-up and implementation of PrEP-related services. PMID:27220036

  2. Antiretroviral Drug Activity in Macaques Infected during Pre-Exposure Prophylaxis Has a Transient Effect on Cell-Associated SHIV DNA Reservoirs.

    Directory of Open Access Journals (Sweden)

    Mian-Er Cong

    Full Text Available Pre-exposure prophylaxis (PrEP with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF is a novel HIV prevention strategy. Suboptimal PrEP adherence and HIV infection creates an opportunity for continued antiretroviral drug activity during undiagnosed infection. We previously showed that macaques infected with SHIV during PrEP with FTC/TDF display reduced acute plasma viremias and limited virus diversity. We investigated the effect of PrEP on acute SHIV DNA dynamics and on the size of the persistent virus reservoir in lymphoid tissues.Cell-associated SHIV DNA levels in PBMCs were measured in 8 macaques infected during PrEP with FTC/TDF or single-agent TAF and was compared to those seen in untreated infections (n = 10. PrEP breakthrough infections continued treatment with 1-2 weekly drug doses to model suboptimal drug exposure during undiagnosed HIV infection in humans. SHIV DNA was also measured in lymphoid tissues collected from FTC/TDF PrEP breakthroughs after 1 year of infection.Compared to untreated controls, PrEP infections had reduced plasma RNA viremias both at peak and throughout weeks 1-12 (p<0.005. SHIV DNA levels were also reduced at peak and during the first 12 weeks of infection (p<0.043 but not throughout weeks 12-20. At 1 year, SHIV DNA reservoirs in lymphoid tissues were similar in size among macaques that received PrEP or placebo.Antiviral drug activity due to PrEP limits acute SHIV replication but has only a transient effect on cell-associated SHIV DNA levels. Our model suggests that suboptimal drug exposure in persons that are taking PrEP and become infected with HIV may not be sufficient to reduce the pool of HIV-infected cells, and that treatment intensification may be needed to sustain potential virological benefits from the PrEP regimen.

  3. Urine assay for tenofovir to monitor adherence in real time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis.

    Science.gov (United States)

    Koenig, H C; Mounzer, K; Daughtridge, G W; Sloan, C E; Lalley-Chareczko, L; Moorthy, G S; Conyngham, S C; Zuppa, A F; Montaner, L J; Tebas, P

    2017-07-01

    Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is approved for pre-exposure prophylaxis (PrEP) against HIV infection. Adherence is critical for the success of PrEP, but current adherence measurements are inadequate for real-time adherence monitoring. We developed and validated a urine assay to measure tenofovir (TFV) to objectively monitor adherence to PrEP. We developed a urine assay using high-performance liquid chromatography coupled to tandem mass spectrometry with high sensitivity/specificity for TFV that allowed us to determine TFV concentrations in log 10 categories between 0 and 10 000 ng/mL. We validated the assay in three cohorts: (1) HIV-positive subjects with undetectable viral loads on a TDF/FTC-based regimen, (2) healthy HIV-negative subjects who received a single dose of TDF/FTC, and (3) HIV-negative subjects receiving daily TDF/FTC as PrEP for 24 weeks. The urine assay detected TFV with greater sensitivity than plasma-based measures and with a window of measurements within 7 days of the last TDF/FTC dose. Based on the urine log-linear clearance after the last dose and its concordance with all detectable plasma levels, a urine TFV concentration > 1000 ng/mL was identified as highly predictive of the presence of TFV in plasma at > 10 ng/mL. The urine assay was able to distinguish high and low adherence patterns within the last 48 h (> 1000 ng/mL versus 10-1000 ng/mL), as well as nonadherence (< 10 ng/mL) extended over at least 1 week prior to measurement. We provide proof of concept that a semiquantitative urine assay measuring levels of TFV could be further developed into a point-of-care test and be a useful tool to monitor adherence to PrEP. © 2017 British HIV Association.

  4. Acceptability of Daily Use of Free Oral Pre-exposure Prophylaxis (PrEP) Among Transgender Women Sex Workers in Shenyang, China.

    Science.gov (United States)

    Wang, Zixin; Lau, Joseph T F; Yang, Xueying; Cai, Yong; Gross, Danielle L; Ma, Tiecheng; Liu, Yan

    2017-12-01

    This study investigated the acceptability of daily use of free oral pre-exposure prophylaxis (PrEP) and associated factors among transgender women sex workers in Shenyang, China, following a briefing on PrEP. A total of 183 HIV negative or sero-status unknown participants completed the cross-sectional survey. The prevalence of acceptability of daily use of free oral PrEP was 61.2%. Adjusting for education level and monthly income, variables on negative attitudes toward PrEP (i.e., having concerns about the side-effects of PrEP) [Adjusted odds ratios (AOR): 0.26], perceived subjective norms (i.e., perceiving support from male partners to take PrEP) (AOR: 2.08), and perceived behavioral control (e.g., perceiving complete control over using PrEP) (AOR: 2.10-16.72) were significantly associated with acceptability of daily use of free oral PrEP. In addition, experiencing violence during sex work, perceived risk of contracting HIV from clients and probable anxiety were also significant. Future PrEP promotion campaigns should consider these factors.

  5. Use of Pre-exposure Prophylaxis (PrEP) in Young Men Who Have Sex with Men is Associated with Race, Sexual Risk Behavior and Peer Network Size.

    Science.gov (United States)

    Kuhns, Lisa M; Hotton, Anna L; Schneider, John; Garofalo, Robert; Fujimoto, Kayo

    2017-05-01

    Pre-exposure prophylaxis (PrEP) is efficacious to prevent HIV infection, however, uptake among young men who have sex with men (YMSM) is relatively low. The purpose of this study was to describe PrEP use and related factors in a representative sample of YMSM in two cities, Chicago and Houston. YMSM, ages 16-29, were recruited via respondent-driven sampling (RDS) from 2014 to 2016. Correlates of PrEP uptake were assessed in weighted multivariable logistic regression models. A total of 12.2% of participants (of 394) reported ever taking PrEP; Black YMSM had the lowest rates of uptake (4.7%) and Whites the highest (29.5%). In a multivariable regression model, having an HIV positive sex partner, reporting recent group sex, peer network size, and city (Chicago) were significantly and positively associated with use of PrEP, while Black race was negatively associated with it. Given evidence of racial/ethnic disparities in PrEP uptake in this study, further research is needed to identify potential mechanisms of action and points of intervention.

  6. Prioritizing Risk in Preparation for a Demonstration Project: A Mixed Methods Feasibility Study of Oral Pre-Exposure Prophylaxis (PREP) among Female Sex Workers in South India.

    Science.gov (United States)

    Reza-Paul, Sushena; Lazarus, Lisa; Doshi, Monika; Hafeez Ur Rahman, Syed; Ramaiah, Manjula; Maiya, Raviprakash; Ms, Venugopal; Venukumar, K T; Sundararaman, Sundar; Becker, Marissa; Moses, Stephen; Lorway, Robert

    2016-01-01

    HIV prevalence among female sex workers (FSWs) in India remains well above the national average. Pre-exposure prophylaxis (PrEP), a new HIV prevention technology, may help to reduce HIV incidence, but there is a dearth of research that can inform the potential scale-up of PrEP in India. In partnership with Ashodaya Samithi, a local sex worker collective, we conducted a feasibility study to assess acceptance of a planned PrEP demonstration project, willingness to use PrEP, and recommendations for project roll-out among FSWs in southern Karnataka. From January-April 2015, 6 focus group discussions, 47 in-depth interviews, and 427 interviewer-administered questionnaires were completed by female sex workers. All participants were 18 years of age or older and practiced sex work. Qualitative data were coded for key themes and emergent categories. Univariate descriptive analysis was employed to summarise the quantitative data. Qualitative. PrEP was described as an exciting new prevention technology that places control in the hands of FSWs and provides a "double safety" in combination with condom use. Participants expressed agreement that women who may experience more HIV risk in their occupational environments should be prioritized for enrollment into a demonstration project. Quantitative. 406 participants (95%) expressed interest in PrEP. Participants prioritized the inclusion of FSWs under the age of 25 (79%), those who do not use condoms when clients offer more money (58%), who do not consistently use condoms with regular partners (57%), who drink alcohol regularly (49%), and who do not use condoms consistently with clients (48%). This feasibility study indicated strong interest in PrEP and a desire to move forward with the demonstration project. Participants expressed their responses in terms of public health discourses surrounding risk, pointing to the importance of situating PrEP scale up within the trusted spaces of community-based organizations as a means of

  7. Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men

    OpenAIRE

    Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.

    2014-01-01

    The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while o...

  8. Who Will Use Pre-Exposure Prophylaxis (PrEP) and Why?: Understanding PrEP Awareness and Acceptability amongst Men Who Have Sex with Men in the UK ? A Mixed Methods Study

    OpenAIRE

    Frankis, Jamie; Young, Ingrid; Flowers, Paul; McDaid, Lisa

    2016-01-01

    Background:\\ud Recent clinical trials suggest that pre-exposure prophylaxis (PrEP) may reduce HIV transmission by up to 86% for men who have sex with men (MSM), whilst relatively high levels of PrEP acceptability have been reported to date. This study examines PrEP awareness amongst sub-groups of MSM communities and acceptability amongst MSM in a low prevalence region (Scotland, UK), using a mixed methods design.\\ud Methods:\\ud Quantitative surveys of n = 690 MSM recruited online via social a...

  9. Women’s Experiences with Oral and Vaginal Pre-Exposure Prophylaxis: The VOICE-C Qualitative Study in Johannesburg, South Africa

    Science.gov (United States)

    van der Straten, Ariane; Stadler, Jonathan; Montgomery, Elizabeth; Hartmann, Miriam; Magazi, Busiswe; Mathebula, Florence; Schwartz, Katie; Laborde, Nicole; Soto-Torres, Lydia

    2014-01-01

    Background In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants’ experience of daily vaginal gel and oral tablet regimens in VOICE. Methods In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis. Results Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support–from partners and significant others–and the relationship tradeoffs entailed by using the products appear to discourage adequate product use. Conclusions Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that

  10. Poppers and PrEP: Use of Pre-exposure Prophylaxis Among Men Who Have Sex with Men Who Use Inhaled Nitrites.

    Science.gov (United States)

    Hambrick, H Rhodes; Park, Su Hyun; Schneider, John A; Mayer, Kenneth H; Carrico, Adam W; Sherman, Scott E; Duncan, Dustin T

    2018-05-09

    Men who have sex with men (MSM) commonly use inhaled nitrites, or poppers, though their use is a risk factor HIV seroconversion. Pre-exposure prophylaxis, or PrEP, is effective for HIV prevention, but is not widely used, and little is known regarding PrEP use and acceptability among MSM who use inhaled nitrites. We surveyed 580 MSM in Paris, France in 2016 about popper use, sexual behaviors including condomless anal intercourse (CAI), serosorting, and sexual positioning, PrEP use, PrEP candidacy, and interest in alternate PrEP delivery modalities. We included 444 HIV negative participants for the current study. 46.2% reported popper use in the prior 3 months. Using multivariate adjusted logistic regression, we found that popper users were more likely than non-users to consider themselves candidates for PrEP [adjusted relative risk ratio (aRRR) = 2.73; 95% CI 1.54-4.83], but they were not more likely to be current (aRRR = 1.54; 95% CI 0.71-3.33) or past (aRRR = 1.37; 95% CI 0.44-4.28) PrEP users. Mediation analyses indicated that increased CAI and serosorting partly explained the relationship between popper use and PrEP candidacy. There was considerable interest in alternate proposed PrEP delivery modalities, particularly long-acting injectable PrEP [adjusted risk ratio (aRR) = 1.43; 95% CI 1.15-1.79].

  11. Pre-Exposure Prophylaxis: A Narrative Review of Provider Behavior and Interventions to Increase PrEP Implementation in Primary Care.

    Science.gov (United States)

    Silapaswan, Andrew; Krakower, Douglas; Mayer, Kenneth H

    2017-02-01

    Since FDA approval of HIV pre-exposure prophylaxis (PrEP) for HIV prevention, attention has been focused on PrEP implementation. The CDC estimates that 1.2 million U.S. adults might benefit from PrEP, but only a minority are using PrEP, so there is a significant unmet need to increase access for those at risk for HIV. Given the large numbers of individuals who have indications for PrEP, there are not enough practicing specialists to meet the growing need for providers trained in providing PrEP. Moreover, since PrEP is a preventive intervention for otherwise healthy individuals, primary care providers (PCPs) should be primary prescribers of PrEP. There are important clinical considerations that providers should take into account when planning to prescribe PrEP, which are highlighted in the clinical case discussed. A growing body of research also suggests that some providers may be cautious about prescribing PrEP because of concerns regarding its "real-world" effectiveness, anticipated unintended consequences associated with its use, and ambiguity as to who should prescribe it. This review summarizes findings from studies that have assessed prescriber behavior regarding provision of PrEP, and offers recommendations on how to optimize PrEP implementation in primary care settings. Development and dissemination of educational interventions for PCPs and potential PrEP users are needed, including improved methods to assist clinicians in identifying appropriate PrEP candidates, and programs to promote medication adherence and access to social and behavioral health services. PCPs are well-positioned to prescribe PrEP and coordinate health-related services to improve the sexual health of their patients, but tailored educational programs are needed.

  12. Differing Experiences with Pre-Exposure Prophylaxis in Boston Among Lesbian, Gay, Bisexual, and Transgender Specialists and Generalists in Primary Care: Implications for Scale-Up.

    Science.gov (United States)

    Krakower, Douglas S; Ware, Norma C; Maloney, Kevin M; Wilson, Ira B; Wong, John B; Mayer, Kenneth H

    2017-07-01

    The Centers for Disease Control and Prevention estimates that one in four sexually active men who have sex with men (MSM) could decrease their HIV risk by using HIV pre-exposure prophylaxis (PrEP). Because many MSM access healthcare from primary care providers (PCPs), these clinicians could play an important role in providing access to PrEP. Semistructured qualitative interviews were conducted with 31 PCPs in Boston, MA, to explore how they approach decisions about prescribing PrEP to MSM and their experiences with PrEP provision. Purposive sampling included 12 PCPs from an urban community health center specializing in the care of lesbian, gay, bisexual, and transgender persons ("LGBT specialists") and 19 PCPs from a general academic medical center ("generalists"). Analyses utilized an inductive approach to identify emergent themes. Both groups of PCPs approached prescribing decisions about PrEP as a process of informed decision-making with patients. Providers would defer to patients' preferences if they were unsure about the appropriateness of PrEP. LGBT specialists and generalists were at vastly different stages of adopting PrEP into practice. For LGBT specialists, PrEP was a disruptive innovation that rapidly became normative in practice. Generalists had limited experience with PrEP; however, they desired succinct decision-support tools to help them achieve proficiency, because they considered preventive medicine to be central to their professional role. As generalists vastly outnumber LGBT specialists in the United States, interventions to support PrEP provision by generalists could accelerate the scale-up of PrEP for MSM nationally, which could in turn decrease HIV incidence for this priority population.

  13. SEXUAL PRACTICES AMONG MEN WHO HAVE SEX WITH MEN IN CHIANG MAI, THAILAND: PART OF THE ANTIRETROVIRAL PRE-EXPOSURE PROPHYLAXIS TRIAL.

    Science.gov (United States)

    Tangmunkongvorakul, Arunrat; Chariyalertsak, Suwat; Amico, K Rivet; Guptarak, Marisa; Saokhieo, Pongpun; Sangangamsakun, Thirayut; Songsupa, Radchanok; McMahan, Vanessa; Grant, Robert

    2016-05-01

    This study aimed to gain a better understanding of the association between participation in a blinded antiretroviral pre-exposure prophylaxis (PrEP) clinical trial and sexual practices among men who have sex with men and transgender women. This study utilized both quantitative and qualitative methodologies. Data included reported PrEP medication adherence and sexual behavior among 114 study participants. Forty-six participants took part in qualitative data collection, 32 were interviewed and 14 participated in one of three focus group discussions. The average percentage of study medication adherence, number of sex partners and rates of sex without a condom were calculated. For qualitative data, content analysis was used to identify repeated normative themes, some of which arose spontaneously from interview interactions. Participants at the Chiang Mai site reported good adherence to the study medication. The sexual risk behavior of these participants had decreased by their final study visit; this was unrelated to level of adherence. Qualitative findings describe sexual practices that were highly contextual; participants used risk assessments to determine sex practices. Condoms were used with casual partners but not necessarily with primary partners. Our findings suggest that while PrEP is an exciting new development for HIV prevention, it must be paired with behavioral interventions to fully address sexual risk among this population. Interventions should provide this population with skills to negotiate condom use with their primary partners as well as in situations in which their sexual partners do not support condom use.

  14. Reporting pre-exposure prophylaxis use in Craigslist personal advertisements among men seeking sex with men in the United States.

    Science.gov (United States)

    Hill, Brandon J; Bak, Trevor; VandeVusse, Alicia; Rosentel, Kris

    2017-08-01

    This study describes the self-reported use of pre-exposure prophylaxis (PrEP) in the personal advertisements of men seeking sex with men in the United States on the online classified advertisement site, Craigslist. Overall self-reported PrEP use was low (0.20%; 95% confidence interval (CI)=0.18-0.22). However, PrEP use in personal ads was described in conjunction with seeking sexual risk behaviours including 'bareback' sex (22.7%; 95% CI=17.7-27.7%) and sex with substance use (26.8%; 95% CI=21.5-32.1%). Only 4.0% of personal ads sought safe sex (3.3%; 95% CI=1.2-5.4%) or required condoms (0.7%; 95% CI=-0.3-1.7%). Our findings underscore the need for increased public PrEP awareness, particularly among men seeking sex with men, as well as the importance of healthcare providers emphasising sexually transmissible infection prevention behaviours (i.e. condom use) used in conjunction with PrEP.

  15. Should travellers to rabies-endemic countries be pre-exposure vaccinated? An assessment of post-exposure prophylaxis and pre-exposure prophylaxis given to Danes travelling to rabies-endemic countries 2000-12.

    Science.gov (United States)

    Christiansen, Annette H; Rodriguez, Anna B; Nielsen, Jens; Cowan, Susan A

    2016-04-01

    Since 2000, a steady increase of vaccines used for both rabies Post-exposure prophylaxis (PEP) and rabies Pre-exposure prophylaxis (PrEP) given to Danish travellers was observed. This study aims to evaluate whether the increase of PEP and PrEP was due to increased travelling, increased awareness of the need for PrEP, or more animal bites per travel, leading to more PEP being administered, in order to assess the need for changing the recommendations. We also described in which countries Danish travelers most frequently reported possible exposure to rabies, and evaluated the timeliness of rabies PEP, including rabies immunoglobulin (RIG). We included all Danes reported to the National Database for Rabies Treatment as having started rabies PEP either abroad or after returning to Denmark, between 2000 and 2012. Data on the yearly number of Danish travelers from 2004 to 2012 to Thailand were collected to calculate the incidence of animal bites at this destination. We also included data on rabies vaccines sold for PrEP or for booster vaccination in Denmark. PEP after possible exposure to rabies abroad increased yearly by 8.8 %. Likewise vaccines sold for PrEP increased by 8.2% annually. The number of Danish travelers to Thailand increased by 7.3% per year, resulting in a stable incidence of animal bites per 100,000 travelers. Seventy-five % started PEP in the country of exposure, while only 10 % received RIG. The yearly increase in PEP and PrEP are parallel to the yearly increase in number of travelers, and can thus be explained by the increased rate of traveling, and not by a rise in awareness of rabies risk or more bites per traveler.Even short term travelers should be given the option of including PrEP in their travel immunisation program, as PEP and especially RIG is not always available in rabies-endemic countries. © International Society of Travel Medicine, 2016. All rights reserved. Published by Oxford University Press. For permissions, please e-mail: journals.permissions@oup.com.

  16. Prioritizing Risk in Preparation for a Demonstration Project: A Mixed Methods Feasibility Study of Oral Pre-Exposure Prophylaxis (PREP among Female Sex Workers in South India.

    Directory of Open Access Journals (Sweden)

    Sushena Reza-Paul

    Full Text Available HIV prevalence among female sex workers (FSWs in India remains well above the national average. Pre-exposure prophylaxis (PrEP, a new HIV prevention technology, may help to reduce HIV incidence, but there is a dearth of research that can inform the potential scale-up of PrEP in India. In partnership with Ashodaya Samithi, a local sex worker collective, we conducted a feasibility study to assess acceptance of a planned PrEP demonstration project, willingness to use PrEP, and recommendations for project roll-out among FSWs in southern Karnataka.From January-April 2015, 6 focus group discussions, 47 in-depth interviews, and 427 interviewer-administered questionnaires were completed by female sex workers. All participants were 18 years of age or older and practiced sex work. Qualitative data were coded for key themes and emergent categories. Univariate descriptive analysis was employed to summarise the quantitative data.Qualitative. PrEP was described as an exciting new prevention technology that places control in the hands of FSWs and provides a "double safety" in combination with condom use. Participants expressed agreement that women who may experience more HIV risk in their occupational environments should be prioritized for enrollment into a demonstration project. Quantitative. 406 participants (95% expressed interest in PrEP. Participants prioritized the inclusion of FSWs under the age of 25 (79%, those who do not use condoms when clients offer more money (58%, who do not consistently use condoms with regular partners (57%, who drink alcohol regularly (49%, and who do not use condoms consistently with clients (48%.This feasibility study indicated strong interest in PrEP and a desire to move forward with the demonstration project. Participants expressed their responses in terms of public health discourses surrounding risk, pointing to the importance of situating PrEP scale up within the trusted spaces of community-based organizations as a means

  17. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP.

    Directory of Open Access Journals (Sweden)

    Albert Y Liu

    Full Text Available Pre-exposure prophylaxis (PrEP trials using tenofovir-based regimens have demonstrated that high levels of adherence are required to evaluate efficacy; the incorporation of objective biomarkers of adherence in trial design has been essential to interpretation, given the inaccuracy of self-report. Antiretroviral measurements in scalp hair have been useful as a marker of long-term exposure in the HIV treatment setting, and hair samples are relatively easy and inexpensive to collect, transport, and store for analysis. To evaluate the relationship between dose and tenofovir concentrations in hair, we examined the dose proportionality of tenofovir in hair in healthy, HIV-uninfected adults.A phase I, crossover pharmacokinetic study was performed in 24 HIV-negative adults receiving directly-observed oral tenofovir tablets administered 2, 4, and 7 doses/week for 6 weeks, with a ≥3-week break between periods. Small samples of hair were collected after each six-week period and analyzed for tenofovir concentrations. Geometric-mean-ratios compared levels between each pair of dosing conditions. Intensive plasma pharmacokinetic studies were performed during the daily-dosing period to calculate areas-under-the-time-concentration curves (AUCs.Over 90% of doses were observed per protocol. Median tenofovir concentrations in hair increased monotonically with dose. A log-linear relationship was seen between dose and hair levels, with an estimated 76% (95% CI 60-93% increase in hair level per 2-fold dose increase. Tenofovir plasma AUCs modestly predicted drug concentrations in hair.This study found a strong linear relationship between frequency of dosing and tenofovir levels in scalp hair. The analysis of quantitative drug levels in hair has the potential to improve adherence measurement in the PrEP field and may be helpful in determining exposure thresholds for protection and explaining failures in PrEP trials. Hair measures for adherence monitoring may also

  18. Antiretroviral pre-exposure prophylaxis preferences among men who have sex with men in Vietnam: results from a nationwide cross-sectional survey.

    Science.gov (United States)

    Oldenburg, Catherine E; Le, Bao; Huyen, Hoang Thi; Thien, Dinh Duc; Quan, Nguyen Hoang; Biello, Katie B; Nunn, Amy; Chan, Philip A; Mayer, Kenneth H; Mimiaga, Matthew J; Colby, Donn

    2016-07-22

    Background: The HIV/AIDS epidemic in Vietnam is concentrated in subgroups of the population, including men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) is a viable strategy for HIV prevention, but knowledge about and preferences for PrEP delivery among Vietnamese MSM are not well understood. Methods: In 2015, an online survey was conducted with recruitment via social networking websites for MSM and peer recruitment. A description of daily oral, long-acting injectable, and rectal microbicide formulations of PrEP was provided to participants. Participants were asked about their prior awareness of and interest in PrEP, and ranked their most preferred PrEP modality. Multivariable logistic regression models were used to assess factors associated with having heard of PrEP and preference for each PrEP modality. Results: Of 548 participants who answered demographic and PrEP-related questions, 26.8% had previously heard of PrEP and most (65.7%) endorsed rectal microbicides as their most preferred PrEP delivery modality. Commonly-cited perceived barriers to uptake of PrEP included concern about side-effects, perception about being HIV positive, and family or friends finding out about their sexual behaviour. In multivariable models, older participants less often endorsed rectal microbicides (adjusted odds ratio (AOR) 0.95 per year, 95% confidence interval (CI) 0.91-0.99) and more often endorsed long-acting injectables (AOR 1.08 per year, 95% CI 1.03 to 1.14) as their preferred PrEP modality. Participants who were willing to pay more for PrEP less often endorsed rectal microbicides (AOR 0.81, 95% CI 0.72-0.92) and more often endorsed long-acting injectables (AOR 1.17, 95% CI 1.01-1.35) and daily oral pills (AOR 1.16, 95% CI 1.00-1.35) as their preferred form of PrEP. Conclusions: A variety of PrEP modalities were acceptable to MSM in Vietnam, but low knowledge of PrEP may be a barrier to implementation.

  19. Potential impact of pre-exposure prophylaxis for female sex workers and men who have sex with men in Bangalore, India: a mathematical modelling study.

    Science.gov (United States)

    Mitchell, Kate M; Prudden, Holly J; Washington, Reynold; Isac, Shajy; Rajaram, Subramanian P; Foss, Anna M; Terris-Prestholt, Fern; Boily, Marie-Claude; Vickerman, Peter

    2016-01-01

    In Bangalore, new HIV infections of female sex workers and men who have sex with men continue to occur, despite high condom use. Pre-exposure prophylaxis (PrEP) has high anti-HIV efficacy for men who have sex with men. PrEP demonstration projects are underway amongst Indian female sex workers. We estimated the impact and efficiency of prioritizing PrEP to female sex workers and/or men who have sex with men in Bangalore. A mathematical model of HIV transmission and treatment for female sex workers, clients, men who have sex with men and low-risk groups was parameterized and fitted to Bangalore data. The proportion of transmission attributable (population attributable fraction) to commercial sex and sex between men was calculated. PrEP impact (infections averted, life-years gained) and efficiency (life-years gained/infections averted per 100 person-years on PrEP) were estimated for different levels of PrEP adherence, coverage and prioritization strategies (female sex workers, high-risk men who have sex with men, both female sex workers and high-risk men who have sex with men, or female sex workers with lower condom use), under current conditions and in a scenario with lower baseline condom use amongst key populations. Population attributable fractions for commercial sex and sex between men have declined over time, and they are predicted to account for 19% of all new infections between 2016 and 2025. PrEP could prevent a substantial proportion of infections amongst female sex workers and men who have sex with men in this setting (23%/27% over 5/10 years, with 60% coverage and 50% adherence), which could avert 2.9%/4.3% of infections over 5/10 years in the whole Bangalore population. Impact and efficiency in the whole population was greater if female sex workers were prioritized. Efficiency increased, but impact decreased, if only female sex workers with lower condom use were given PrEP. Greater impact and efficiency was predicted for the scenario with lower condom use

  20. Pre-exposure Prophylaxis (PrEP) Use, Seroadaptation, and Sexual Behavior Among Men Who Have Sex with Men, San Francisco, 2004-2014.

    Science.gov (United States)

    Chen, Yea-Hung; Snowden, Jonathan M; McFarland, Willi; Raymond, H Fisher

    2016-12-01

    The Food and Drug Administration approved pre-exposure prophylaxis (PrEP) to prevent HIV infection, and the Centers for Disease Control and Prevention has presented PrEP as a prevention option for groups at high risk such as men who have sex with men (MSM). Intervention data provide some information on how PrEP affects sexual behavior of MSM in trials, open label extensions, or clinics. However, it is unclear whether sexual risk and preventive behavioral patterns are changing in the population as a whole as PrEP becomes more widely available, whether due to PrEP use or other factors. We examined trends in PrEP use, numbers of condomless anal sex partners, consistent condom use, and seroadaptive strategies in San Francisco-a city which has actively promoted PrEP-using data from National HIV Behavioral Surveillance (NHBS). NHBS recruited 1211, 383, 373, and 268 HIV-negative MSM in 2004, 2008, 2011, and 2014, respectively. PrEP use increased from zero in 2004, 2008, and 2011 to 9.6 % in 2014. The proportion of men with no condomless anal sex partners dropped from 60.6 % in 2004, to 58.2 % in 2008, to 54.2 % in 2011, to 40.2 % in 2014. Consistent condom use decreased from 36.8 % in 2004, and 30.5 % in 2008 and 2011, to 18.3 % in 2014. PrEP's introduction and scale-up enters in a pre-existing trend of decreasing condom use and increasing sexually transmitted infections among MSM which may be accelerating in recent years. While PrEP use should be scaled up as a prevention option among those who would benefit most, we believe that public health officials need to be realistic about the possibility that condom use could very well continue to decline as PrEP use increases, and to an extent that may not be directly or indirectly offset by PrEP.

  1. Role of the pharmacist in pre-exposure chemoprophylaxis (PrEP therapy for HIV prevention

    Directory of Open Access Journals (Sweden)

    Clauson KA

    2009-03-01

    Full Text Available With a global estimate of 2.5 million new infections of HIV occurring yearly, discovering novel methods to help stem the spread of the virus is critical. The use of antiretroviral chemoprophylaxis for preventing HIV after accidental or occupational exposure and in maternal to fetal transmission has become a widely accepted method to combat HIV. Based on this success, pre-exposure chemoprophylaxis (PrEP is being explored in at-risk patient populations such as injecting drug users, female sex workers and men who have sex with men. This off-label and unmonitored use has created a need for education and intervention by pharmacists and other healthcare professionals. Pharmacists should educate themselves on PrEP and be prepared to counsel patients about their means of obtaining it (e.g. borrowing or sharing medications and ordering from disreputable Internet pharmacies. They should also be proactive about medication therapy management in these patients due to clinically important drug interactions with PrEP medications. Only one trial exploring the safety and efficacy of tenofovir as PrEP has been completed thus far. However, five ongoing trials are in various stages and two additional studies are scheduled for the near future. Unfortunately, studies in this arena have met with many challenges that have threatened to derail progress. Ethical controversy surrounding post-trial care of participants who seroconvert during studies, as well as concerns over emerging viral resistance and logistical site problems, have already halted several PrEP trials. Information about these early trials has already filtered down to affected individuals who are experimenting with this unproven therapy as an “evening before pill”. The potential for PrEP is promising; however, more extensive trials are necessary to establish its safety and efficacy. Pharmacists are well-positioned to play a key role in helping patients make choices about PrEP, managing their therapy

  2. Transmission of chimeric HIV by mating in conventional mice: prevention by pre-exposure antiretroviral therapy and reduced susceptibility during estrus

    Directory of Open Access Journals (Sweden)

    Eran Hadas

    2013-09-01

    Heterosexual transmission accounts for the majority of new human immunodeficiency virus (HIV cases worldwide. The current approach to investigate HIV heterosexual transmission in animals involves application of virus stock to the vaginal surface, a method that does not reproduce the physiological conditions of vaginal intercourse that influence the rate of transmission. We have previously described efficient infection of conventional mice using EcoHIV/NL4-3 and EcoHIV/NDK, chimeric HIV molecular clones constructed to express all HIV structural and regulatory genes except envelope, which is replaced by a rodent-tropic envelope gene. Here we investigated whether EcoHIV/NDK-infected male mice transmit virus to females during coitus, and the sensitivity of this transmission to HIV pre-exposure prophylaxis and the estrus state. Our general approach was to allow mating between EcoHIV/NDK-infected male mice and uninfected females for 1–7 nights. At 1–6 weeks after mating, mice were euthanized and virus burdens were measured by quantitative PCR (qPCR amplification of HIV RNA or DNA in peritoneal macrophages, inguinal lymph node cells, spleen cells or vas deferens, or by ELISA for antibodies to HIV Gag. We found that 70–100% of female mice mated to EcoHIV/NDK-infected males acquired infection. Pericoital treatment of females with either 2′,3′-dideoxcytidine (ddC or tenofovir largely prevented their EcoHIV/NDK infection by mating (P<0.05 and P<0.003, respectively. In males, T cells were dispensable for virus transmission. The rate of EcoHIV/NDK sexual transmission to females in estrus declined sharply (P=0.003 but their infection by injection was unaffected, indicating that the local environment in the female reproductive tract influences susceptibility to HIV. We conclude that this system of EcoHIV/NDK transmission during mouse mating reproduces key features of heterosexual transmission of HIV in humans and can be used to investigate its biology and control.

  3. original article assessment of hiv post-exposure prophylaxis use

    African Journals Online (AJOL)

    user

    showing the clear picture about HIV post exposure prophylaxis in the work place were non-existent. ... formal (separate) HIV post-exposure prophylaxis centre with proper guideline was non-existent in ..... related challenges at work and home.

  4. Facilitators and Barriers to Pre-Exposure Prophylaxis Willingness Among Young Men Who Have Sex with Men Who Use Geosocial Networking Applications in California.

    Science.gov (United States)

    Holloway, Ian W; Tan, Diane; Gildner, Jennifer L; Beougher, Sean C; Pulsipher, Craig; Montoya, Jorge A; Plant, Aaron; Leibowitz, Arleen

    2017-12-01

    While correlates of pre-exposure prophylaxis (PrEP) uptake have been explored among older men who have sex with men (MSM), less is known about the facilitators and barriers that encourage uptake among younger MSM (YMSM). This study explores the association between willingness to take PrEP and demographic characteristics, sexual risk, and substance use, and attitudinal factors among YMSM in California who use geosocial networking applications (GSN apps). Based on survey data from YMSM recruited through GSN apps (n = 687), PrEP willingness was positively associated with Hispanic ethnicity [adjusted odds ratio (aOR): 1.73; confidence interval (CI): 1.01-2.98; p = 0.046], concerns about drug effects (aOR: 0.46; CI: 0.33-0.65; p < 0.001), medical mistrust (aOR: 0.71; CI: 0.53-0.96; p < 0.001), and concerns about adherence (aOR: 0.65; CI: 0.49-0.89; p = 0.005). PrEP willingness was positively associated with medium (aOR: 1.87; CI: 1.14-3.07; p = 0.014) and high concern (aOR: 1.84; CI: 1.13-3.01; p < 0.001) about contracting HIV and perceived benefits of taking PrEP (aOR: 2.59; CI: 1.78-3.78; p < 0.001). In addition to emphasizing the benefits of using PrEP, campaigns that address concerns regarding adherence and side effects may increase interest in and demand for PrEP among YMSM. More opportunities are needed to educate YMSM about PrEP, including addressing their concerns about this new prevention strategy. Providers should speak openly and honestly to YMSM considering PrEP about what to do if side effects occur and how to handle missed doses. Outreach using GSN apps for PrEP education and screening may be an effective way to reach YMSM.

  5. WHO guidance grounded in a comprehensive approach to sexual and reproductive health and human rights: topical pre-exposure prophylaxis

    OpenAIRE

    Geary, Cynthia W; Bukusi, Elizabeth A; Geary, Cynthia W; Bukusi, Elizabeth A; van der Straten, Ariane; Stadler, Jonathan; Luecke, Ellen; Laborde, Nicole; Hartmann, Miriam; Montgomery, Elizabeth T; Corneli, Amy L; McKenna, Kevin; Headley, Jennifer; Ahmed, Khatija; Odhiambo, Jacob

    2014-01-01

    Introduction Risk perception is a core construct in many behaviour change theories in public health. Individuals who believe they are at risk of acquiring an illness may be more likely to engage in behaviours to reduce that risk; those who do not feel at risk may be unlikely to engage in risk reduction behaviours. Among participants who seroconverted in two FEM-PrEP sites – Bondo, Kenya, and Pretoria, South Africa – we explored perceived HIV risk and worry about acquiring HIV prior to HIV inf...

  6. Willingness to Use Pre-Exposure Prophylaxis (PrEP): An Empirical Test of the Information-Motivation-Behavioral Skills (IMB) Model among High-Risk Drug Users in Treatment.

    Science.gov (United States)

    Shrestha, Roman; Altice, Frederick L; Huedo-Medina, Tania B; Karki, Pramila; Copenhaver, Michael

    2017-05-01

    Evidence from recent pre-exposure prophylaxis (PrEP) trials has demonstrated its safety and efficacy in significantly reducing the risk of HIV acquisition for those who are at considerable risk of acquiring HIV infection. With a rapid increase in the amount of research on the efficacy of PrEP for HIV prevention, complementary research on the willingness to use PrEP has grown, especially among MSM, but limited research has been focused among people who use drugs (PWUD). As part of the formative process, we utilized the information-motivation-behavioral skills (IMB) model of health behavior change to characterize and guide intervention development for promoting willingness to use PrEP among high-risk PWUD. The analysis included 400 HIV-negative high-risk PWUD enrolled in a community-based methadone maintenance treatment who reported drug- and/or sex-related HIV risk behaviors in the past 6-months. Analyses revealed support for the IMB model as PrEP-related behavioral skills were found to mediate the influence of PrEP-related information and motivation on willingness to use PrEP. The results provide evidence as to the utility of the IMB model to increase willingness to use PrEP among high-risk PWUD. It therefore makes an important contribution to our understanding of the applicability of theoretically-grounded models of willingness to use PrEP among high-risk PWUD, who are one of the key risk populations who could benefit from the use of PrEP.

  7. [Willingness and influencing factors of using pre-exposure prophylaxis among 301 men have sex with men in Wuhan city, 2015].

    Science.gov (United States)

    Xie, P Y; Wang, X; Liu, P L; Tan, X D; Zhou, W

    2017-11-06

    Objective: To understand willingness and influencing factors of using pre-exposure prophylaxis (Pr-EP) among men who have sex with men (MSM). Methods: Snow ball sampling was employed to recruit MSM in the social spaces (like bars and bathrooms) with focused activities by MSM and internet (QQ and Wechat) in Wuhan between August and November, 2015. 304 MSM were considered eligible when they were self-identified MSM and has had sex with men in the previous 12 months, over the age of 18 and have full civil liability. On-site and online questionnaire surveys were conducted by self-designed questionnaires to collect information including demographic characteristics, sexual risks and practices, awareness of PrEP, and willingness to use PrEP. A total of 301 qualified questionnaires were obtained. Multivariate logistic regression models were constructed to identify factors associated with willingness to use Pr-EP. Results: The mean age of surveyed MSM were (27.51±8.31) years, between18-61. 149 on-site survey, online were152; 131 MSM have regular homosexual partners, 170 MSM have not regular homosexual partners. Only 17.28% (52/301) had heard of Pr-EP before this survey, 18.32% (24/130) had heard of Pr-EP among those who had regular homosexual partners and those who had not accounted for 16.47% (28/170). 74.42% (224/301) had willingness to use Pr-EP after they knew Pr-EP was safe and effective through the survey. The proportion among those who had regular homosexual partners was 74.05%(74), and the proportion among those who had not was 74.71% (127); Among those who had regular homosexual partners, results suggested that those who were married/cohabiting were more likely to report a willingness to use PrEP compared to unmarried/divorced or widowed ( OR= 5.60), compared with homosexual, heterosexuality was associated with decreased odds of willingness to use Pr-EP ( OR= 0.22), compared with HIV status of sexual partner was negative or uncertain, positive infection status was

  8. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug- and sex-related behaviors among high-risk drug users on methadone treatment.

    Science.gov (United States)

    Shrestha, Roman; Karki, Pramila; Altice, Frederick L; Huedo-Medina, Tania B; Meyer, Jaimie P; Madden, Lynn; Copenhaver, Michael

    2017-04-01

    Although people who use drugs (PWUD) are key populations recommended to receive pre-exposure prophylaxis (PrEP) to prevent HIV, few data are available to guide PrEP delivery in this underserved group. We therefore examined the willingness to initiate PrEP and the anticipation of HIV risk reduction while on PrEP among high-risk PWUD. In a cross-sectional study of 400 HIV-negative, opioid dependent persons enrolled in a methadone program and reporting recent risk behaviors, we examined independent correlates of being willing to initiate PrEP. While only 72 (18%) were aware of PrEP, after being given a description of it, 251 (62.7%) were willing to initiate PrEP. This outcome was associated with having neurocognitive impairment (aOR=3.184, p=0.004) and higher perceived HIV risk (aOR=8.044, p<0.001). Among those willing to initiate PrEP, only 12.5% and 28.2%, respectively, indicated that they would always use condoms and not share injection equipment while on PrEP. Consistent condom use was associated with higher income (aOR=8.315, p=0.016), always using condoms with casual partners (aOR=6.597, p=0.001), and inversely associated with ongoing drug injection (aOR=0.323, p=0.027). Consistent safe injection, however, was inversely associated with age (aOR=0.948, p=0.035), ongoing drug injection (aOR=0.342, p<0.001), and perceived HIV risk (aOR=0.191, p=0.019). While willingness to initiate PrEP was high and correlated with being at elevated risk for HIV, anticipated higher risk behaviors in this group even while on PrEP suggests that the next generation of HIV prevention approaches may need to combine biomedical and behavioral components to sustain HIV risk reduction over time. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil.

    Science.gov (United States)

    Grangeiro, Alexandre; Couto, Márcia Thereza; Peres, Maria Fernanda; Luiz, Olinda; Zucchi, Eliana Miura; de Castilho, Euclides Ayres; Estevam, Denize Lotufo; Alencar, Rosa; Wolffenbüttel, Karina; Escuder, Maria Mercedes; Calazans, Gabriela; Ferraz, Dulce; Arruda, Érico; Corrêa, Maria da Gloria; Amaral, Fabiana Rezende; Santos, Juliane Cardoso Villela; Alvarez, Vivian Salles; Kietzmann, Tiago

    2015-08-25

    Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods. A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group-individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group-individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV. This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil society members by means of newspapers, electronic media and scientific journals

  10. Protecting children from rabies with education and pre-exposure prophylaxis: A school-based campaign in El Nido, Palawan, Philippines.

    Science.gov (United States)

    Deray, Raffy; Rivera, Cesar; Gripon, Shiela; Ulanday, Corazon; Roces, Maria Concepcion; Amparo, Anna Charinna; Attlan, Michael; Demont, Clarisse; Kieffer, Alexia; Miranda, Mary Elizabeth

    2018-01-01

    Rabies remains endemic in the Philippines. A study was conducted in El Nido, Palawan, Philippines to: (i) detect the true incidence of animal bites in school children aged 5-14 years using active surveillance and compare these data to estimates from the existing passive surveillance system, (ii) evaluate the impact of rabies prevention education and pre-exposure prophylaxis (PrEP) on animal bite incidence, and (iii) assess the health economic impact of the interventions. A cohort of 4,700 school children was followed-up for any suspect rabies exposures between January 2011 and December 2012. Data on animal bite incidence from the study cohort were compared to that obtained from a review of consultation records at the Animal Bite Treatment Center (ABTC). PrEP was offered to children in all 27 public elementary schools in El Nido (in January to February 2012). Teachers were given a manual for integrating rabies in the public elementary school curriculum during the school year 2012-13. Active surveillance of the cohort revealed a higher incidence of suspect rabies exposures than that from passive surveillance. Despite a decrease in the number of Category III bites, there was no significant decrease in overall bite incidence as a result of the interventions. However, there was an increase in rabies awareness among school children in all grade levels. There was also a high level of acceptability of PrEP. Children who received PrEP and subsequently were bitten only needed two booster doses for post-exposure prophylaxis, resulting in substantial cost-savings. The true burden of animal bites remains underestimated in ABTC records. PrEP is advantageous in selected population groups, i.e. school-aged children in rabies endemic areas with limited access to animal and human rabies prevention services. Educating school children is beneficial. Strengthening veterinary interventions to target the disease at source is important.

  11. Correlates of Awareness of and Willingness to Use Pre-exposure Prophylaxis (PrEP) in Gay, Bisexual, and Other Men Who Have Sex with Men Who Use Geosocial-Networking Smartphone Applications in New York City.

    Science.gov (United States)

    Goedel, William C; Halkitis, Perry N; Greene, Richard E; Duncan, Dustin T

    2016-07-01

    Geosocial-networking smartphone applications are commonly used by gay, bisexual, and other men who have sex with men (MSM) to meet sexual partners. The purpose of the current study was to evaluate awareness of and willingness to use pre-exposure prophylaxis (PrEP) among MSM who use geosocial-networking smartphone applications residing in New York City. Recruitment utilizing broadcast advertisements on a popular smartphone application for MSM yielded a sample of 152 HIV-uninfected MSM. Multivariable models were used to assess demographic and behavioral correlates of awareness of and willingness to use PrEP. Most participants (85.5 %) had heard about PrEP but few (9.2 %) reported current use. Unwillingness to use PrEP was associated with concerns about side effects (PR = 0.303; 95 % CI 0.130, 0.708; p = 0.006). Given that more than half (57.6 %) of participants were willing to use PrEP, future research is needed to elucidate both individual and structural barriers to PrEP use among MSM.

  12. Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men.

    Science.gov (United States)

    Underhill, Kristen; Morrow, Kathleen M; Operario, Don; Mayer, Kenneth H

    2014-02-01

    The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.

  13. Participant experiences and facilitators and barriers to pill use among men who have sex with men in the iPrEx pre-exposure prophylaxis trial in San Francisco.

    Science.gov (United States)

    Gilmore, Hailey J; Liu, Albert; Koester, Kimberly Ann; Amico, K Rivet; McMahan, Vanessa; Goicochea, Pedro; Vargas, Lorena; Lubensky, David; Buchbinder, Susan; Grant, Robert

    2013-10-01

    In 2010, the iPrEx study demonstrated efficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) pre-exposure prophylaxis (PrEP) in reducing HIV acquisition among men who have sex with men. Adherence to study product was critical for PrEP efficacy, and varied considerably, with FTC/TDF detection rates highest in the United States. We conducted a qualitative study to gain insights into the experiences of iPrEx participants in San Francisco (SF) where there was high confirmed adherence, to understand individual and contextual factors influencing study product use in this community. In 2009 and 2011, we conducted focus groups and in-depth interviews in 36 and 16 SF iPrEx participants, respectively. Qualitative analyses indicate that participants joined the study out of altruism. They had a clear understanding of study product use, and pill taking was facilitated by establishing or building on an existing routine. Participants valued healthcare provided by the study and relationships with staff, whom they perceived as nonjudgmental, and found client-centered counseling to be an important part of the PrEP package. This facilitated pill taking and accurate reporting of missed doses. Adherence barriers included changes in routine, side effects/intercurrent illnesses, and stress. Future PrEP adherence interventions should leverage existing routines and establish client-centered relationships/ environments to support pill taking and promote accurate reporting.

  14. Who Will Use Pre-Exposure Prophylaxis (PrEP) and Why?: Understanding PrEP Awareness and Acceptability amongst Men Who Have Sex with Men in the UK – A Mixed Methods Study

    Science.gov (United States)

    Frankis, Jamie; Young, Ingrid; Flowers, Paul; McDaid, Lisa

    2016-01-01

    Background Recent clinical trials suggest that pre-exposure prophylaxis (PrEP) may reduce HIV transmission by up to 86% for men who have sex with men (MSM), whilst relatively high levels of PrEP acceptability have been reported to date. This study examines PrEP awareness amongst sub-groups of MSM communities and acceptability amongst MSM in a low prevalence region (Scotland, UK), using a mixed methods design. Methods Quantitative surveys of n = 690 MSM recruited online via social and sociosexual media were analysed using descriptive statistics and multivariate logistic regression. In addition, n = 10 in-depth qualitative interviews with MSM were analysed thematically. Results Under one third (29.7%) of MSM had heard of PrEP, with awareness related to living in large cities, degree level education, commercial gay scene use and reporting an HIV test in the last year. Just under half of participants (47.8%) were likely to use PrEP if it were available but there was no relationship between PrEP acceptability and previous PrEP awareness. Younger men (18–25 years) and those who report higher risk UAI were significantly more likely to say they would use PrEP. Qualitative data described specific PrEP scenarios, illustrating how risk, patterns of sexual practice and social relationships could affect motivation for and nature of PrEP use. Conclusion These findings suggest substantial interest PrEP amongst MSM reporting HIV risk behaviours in Scotland. Given the Proud results, there is a strong case to investigate PrEP implementation within the UK. However, it appears that disparities in awareness have already emerged along traditional indicators of inequality. Our research identifies the need for comprehensive support when PrEP is introduced, including a key online component, to ensure equity of awareness across diverse MSM communities (e.g. by geography, education, gay scene use and HIV proximity), as well as to responding to the diverse informational and sexual health

  15. Who Will Use Pre-Exposure Prophylaxis (PrEP) and Why?: Understanding PrEP Awareness and Acceptability amongst Men Who Have Sex with Men in the UK--A Mixed Methods Study.

    Science.gov (United States)

    Frankis, Jamie; Young, Ingrid; Flowers, Paul; McDaid, Lisa

    2016-01-01

    Recent clinical trials suggest that pre-exposure prophylaxis (PrEP) may reduce HIV transmission by up to 86% for men who have sex with men (MSM), whilst relatively high levels of PrEP acceptability have been reported to date. This study examines PrEP awareness amongst sub-groups of MSM communities and acceptability amongst MSM in a low prevalence region (Scotland, UK), using a mixed methods design. Quantitative surveys of n = 690 MSM recruited online via social and sociosexual media were analysed using descriptive statistics and multivariate logistic regression. In addition, n = 10 in-depth qualitative interviews with MSM were analysed thematically. Under one third (29.7%) of MSM had heard of PrEP, with awareness related to living in large cities, degree level education, commercial gay scene use and reporting an HIV test in the last year. Just under half of participants (47.8%) were likely to use PrEP if it were available but there was no relationship between PrEP acceptability and previous PrEP awareness. Younger men (18-25 years) and those who report higher risk UAI were significantly more likely to say they would use PrEP. Qualitative data described specific PrEP scenarios, illustrating how risk, patterns of sexual practice and social relationships could affect motivation for and nature of PrEP use. These findings suggest substantial interest PrEP amongst MSM reporting HIV risk behaviours in Scotland. Given the Proud results, there is a strong case to investigate PrEP implementation within the UK. However, it appears that disparities in awareness have already emerged along traditional indicators of inequality. Our research identifies the need for comprehensive support when PrEP is introduced, including a key online component, to ensure equity of awareness across diverse MSM communities (e.g. by geography, education, gay scene use and HIV proximity), as well as to responding to the diverse informational and sexual health needs of all MSM communities.

  16. Who Will Use Pre-Exposure Prophylaxis (PrEP and Why?: Understanding PrEP Awareness and Acceptability amongst Men Who Have Sex with Men in the UK--A Mixed Methods Study.

    Directory of Open Access Journals (Sweden)

    Jamie Frankis

    Full Text Available Recent clinical trials suggest that pre-exposure prophylaxis (PrEP may reduce HIV transmission by up to 86% for men who have sex with men (MSM, whilst relatively high levels of PrEP acceptability have been reported to date. This study examines PrEP awareness amongst sub-groups of MSM communities and acceptability amongst MSM in a low prevalence region (Scotland, UK, using a mixed methods design.Quantitative surveys of n = 690 MSM recruited online via social and sociosexual media were analysed using descriptive statistics and multivariate logistic regression. In addition, n = 10 in-depth qualitative interviews with MSM were analysed thematically.Under one third (29.7% of MSM had heard of PrEP, with awareness related to living in large cities, degree level education, commercial gay scene use and reporting an HIV test in the last year. Just under half of participants (47.8% were likely to use PrEP if it were available but there was no relationship between PrEP acceptability and previous PrEP awareness. Younger men (18-25 years and those who report higher risk UAI were significantly more likely to say they would use PrEP. Qualitative data described specific PrEP scenarios, illustrating how risk, patterns of sexual practice and social relationships could affect motivation for and nature of PrEP use.These findings suggest substantial interest PrEP amongst MSM reporting HIV risk behaviours in Scotland. Given the Proud results, there is a strong case to investigate PrEP implementation within the UK. However, it appears that disparities in awareness have already emerged along traditional indicators of inequality. Our research identifies the need for comprehensive support when PrEP is introduced, including a key online component, to ensure equity of awareness across diverse MSM communities (e.g. by geography, education, gay scene use and HIV proximity, as well as to responding to the diverse informational and sexual health needs of all MSM communities.

  17. Preparing for the Rollout of Pre-Exposure Prophylaxis (PrEP: A Vignette Survey to Identify Intended Sexual Behaviors among Women in Kenya and South Africa if Using PrEP.

    Directory of Open Access Journals (Sweden)

    Amy Corneli

    Full Text Available Several clinical trials have demonstrated the efficacy of pre-exposure prophylaxis (PrEP in reducing HIV risk. One concern with introducing PrEP is whether users will engage in riskier sexual behaviors.We assessed the effect that PrEP may have on sexual risk behaviors by administering a survey to 799 women in Bondo, Kenya, and Pretoria, South Africa. Participants were asked about their sexual behavior intentions twice--once as if they were taking PrEP and once as if they were not taking PrEP--within four risk situations (vignettes. They responded using a 5-point ordinal scale. We used a series of linear mixed effects models with an unstructured residual covariance matrix to estimate the between- and within-subject differences in the mean likelihood of engaging in risky sexual behavior across the PrEP and non-PrEP contexts. We also calculated the total percentage of participants who reported a greater likelihood of engaging in risky sexual behavior if taking PrEP than if not taking PrEP, by vignette.We found statistically significant differences in the mean likelihood of engaging in risky sexual behavior with the between-subject comparison (-0.17, p < 0.01 and with the within-subject comparison (-0.31, p < 0.001. Depending on the vignette, 27% to 40% of participants reported a greater likelihood of engaging in risky sexual behavior if taking PrEP than if not taking PrEP.Our findings indicate that modest increases in risky sexual behavior could occur with PrEP. Although responses from the majority of participants suggest they would not be more likely to engage in risky sexual behavior if they took PrEP, a substantial proportion might. Programs rolling out PrEP should be prepared to assist similar women in making informed choices about reducing their risk of HIV and about their sexual health beyond HIV prevention.

  18. Experiences of HIV postexposure prophylaxis (PEP) among highly exposed men who have sex with men (MSM).

    Science.gov (United States)

    Palich, Romain; Martin-Blondel, Guillaume; Cuzin, Lise; Le Talec, Jean-Yves; Boyer, Pierre; Massip, Patrice; Delobel, Pierre

    2017-11-01

    HIV postexposure prophylaxis (PEP) is indicated after sexual exposure with high risk of transmission. Men who have sex with men (MSM) are the main target of PEP. The aim of our study was to investigate the experience and shortcomings of PEP among people with a high risk of HIV exposure. Subjects with ongoing follow-up for HIV infection and PEP history were selected for the qualitative study. Semistructured interviews were conducted at the patients' homes. They were audio-recorded, transcribed and deidentified before data analysis, double coding and thematic analysis with an inductive approach. Twenty-three patients were eligible for the qualitative study. Thirteen interviews were carried out. All patients were 20-60-year-old MSM. The median time between PEP and HIV diagnosis was 3.3 years (interquartile range (IQR) 25-75 =0.9-4.9). Many participants reported negative PEP experiences: awkward access to the PEP clinic, uneasiness and shame in the hospital setting, unpleasant interaction and moral disapprobation from the medical staff, treatment intolerance and prevention messages that were 'inconsistent with real life' CONCLUSION: Our data highlight PEP management failures among its target population that may have compromised any subsequent attempts to seek out PEP. Practitioners should be more aware of MSM sexual contexts and practices. PEP consultations should provide the opportunity to discuss prevention strategies with highly exposed HIV-negative subjects, which may include pre-exposure prophylaxis. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Review of HIV Pre exposure prophylaxis (PrEP) and example of HIV PrEP Toolkit

    Science.gov (United States)

    2017-08-28

    at Initiation of Sexual Activity Correct & Consistent Condom Use Prevention of mother-to- child transmission July 16, 2012: FDA approves...Okulicz JF, Medicine 2016 PrEP Utilization in a Managed Care System (Kaiser Permanente) 1200 ~ 1045 1000 . 800 600 . 400 200 0 835 657 0

  20. Post-exposure prophylaxis | Smith | Southern African Journal of HIV ...

    African Journals Online (AJOL)

    Southern African Journal of HIV Medicine. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 2, No 1 (2001) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register. Post-exposure prophylaxis. C Smith. Abstract.

  1. High HIV incidence in men who have sex with men attending for postexposure prophylaxis: a service evaluation.

    Science.gov (United States)

    Whitlock, G; McCormack, C; Fearnley, J; McOwan, A

    2017-05-01

    There are limited outcome data for men who have sex with men (MSM) who have received HIV postexposure prophylaxis (PEP). The objective of this service evaluation was to determine HIV incidence and repeat PEP use among MSM PEP recipients in London, UK. Retrospective electronic case-note review of all MSM who were prescribed PEP between January and April 2013 at a central London sexual health service. 530 MSM received PEP between 1 January and 30 June 2013. Of these, 449 had more than 30 days subsequent follow-up at our service. Median age was 31 years. PEP indication was unprotected anal intercourse, 98% (receptive 88% and insertive 10%) and other, 2%. Up to 1 November 2015, total follow-up was 756 person-years. 183 users received repeat PEP. The total number of repeat PEP courses was 442. 57 MSM newly acquired HIV: the HIV incidence was 7.6 per 100 person-years. PEP was associated with a high risk of subsequent HIV seroconversion in this cohort; this group may be appropriate candidates for pre-exposure prophylaxis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. LepVax, a defined subunit vaccine that provides effective pre-exposure and post-exposure prophylaxis of M. leprae infection.

    Science.gov (United States)

    Duthie, Malcolm S; Pena, Maria T; Ebenezer, Gigi J; Gillis, Thomas P; Sharma, Rahul; Cunningham, Kelly; Polydefkis, Michael; Maeda, Yumi; Makino, Masahiko; Truman, Richard W; Reed, Steven G

    2018-01-01

    Sustained elimination of leprosy as a global health concern likely requires a vaccine. The current standard, BCG, confers only partial protection and precipitates paucibacillary (PB) disease in some instances. When injected into mice with the T helper 1 (Th1)-biasing adjuvant formulation Glucopyranosyl Lipid Adjuvant in stable emulsion (GLA-SE), a cocktail of three prioritized antigens (ML2055, ML2380 and ML2028) reduced M. leprae infection levels. Recognition and protective efficacy of a single chimeric fusion protein incorporating these antigens, LEP-F1, was confirmed in similar experiments. The impact of post-exposure immunization was then assessed in nine-banded armadillos that demonstrate a functional recapitulation of leprosy. Armadillos were infected with M. leprae 1 month before the initiation of post-exposure prophylaxis. While BCG precipitated motor nerve conduction abnormalities more rapidly and severely than observed for control infected armadillos, motor nerve injury in armadillos treated three times, at monthly intervals with LepVax was appreciably delayed. Biopsy of cutaneous nerves indicated that epidermal nerve fiber density was not significantly altered in M. leprae -infected animals although Remak Schwann cells of the cutaneous nerves in the distal leg were denser in the infected armadillos. Importantly, LepVax immunization did not exacerbate cutaneous nerve involvement due to M. leprae infection, indicating its safe use. There was no intraneural inflammation but a reduction of intra axonal edema suggested that LepVax treatment might restore some early sensory axonal function. These data indicate that post-exposure prophylaxis with LepVax not only appears safe but, unlike BCG, alleviates and delays the neurologic disruptions caused by M. leprae infection.

  3. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa.

    Directory of Open Access Journals (Sweden)

    Jessica E Haberer

    Full Text Available Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation.Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda, we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to 80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort.The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary.

  4. Preexposure Prophylaxis for HIV Infection among African Women

    Science.gov (United States)

    Van Damme, Lut; Corneli, Amy; Ahmed, Khatija; Agot, Kawango; Lombaard, Johan; Kapiga, Saidi; Malahleha, Mookho; Owino, Fredrick; Manongi, Rachel; Onyango, Jacob; Temu, Lucky; Monedi, Modie Constance; Mak’Oketch, Paul; Makanda, Mankalimeng; Reblin, Ilse; Makatu, Shumani Elsie; Saylor, Lisa; Kiernan, Haddie; Kirkendale, Stella; Wong, Christina; Grant, Robert; Kashuba, Angela; Nanda, Kavita; Mandala, Justin; Fransen, Katrien; Deese, Jennifer; Crucitti, Tania; Mastro, Timothy D.; Taylor, Douglas

    2013-01-01

    BACKGROUND Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. METHODS In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF–FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF–FTC in preventing HIV acquisition and to evaluate safety. RESULTS HIV infections occurred in 33 women in the TDF–FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P = 0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF–FTC group (P = 0.04, P<0.001, and P = 0.03, respectively). Rates of drug discontinuation because of hepatic or renal abnormalities were higher in the TDF–FTC group (4.7%) than in the placebo group (3.0%, P = 0.051). Less than 40% of the HIV-uninfected women in the TDF–FTC group had evidence of recent pill use at visits that were matched to the HIV-infection window for women with seroconversion. The study was stopped early, on April 18, 2011, because of lack of efficacy. CONCLUSIONS Prophylaxis with TDF–FTC did not significantly reduce the rate of HIV infection and was associated with increased rates of side effects, as compared with placebo. Despite substantial counseling efforts, drug adherence appeared to be low. (Supported by the U.S. Agency for International Development and others; FEM-PrEP ClinicalTrials.gov number, NCT00625404.) PMID:22784040

  5. HIV/AIDS conspiracy beliefs and intention to adopt preexposure prophylaxis among black men who have sex with men in Los Angeles.

    Science.gov (United States)

    Brooks, Ronald A; Allen, Vincent C; Regan, Rotrease; Mutchler, Matt G; Cervantes-Tadeo, Ramon; Lee, Sung-Jae

    2018-03-01

    In the United States, black men who have sex with men (MSM) are the group most affected by the HIV/AIDS epidemic. Pre-exposure prophylaxis (PrEP) is an important new HIV prevention strategy that may help reduce new HIV infections among black MSM. This analysis examined the association between HIV/AIDS conspiracy beliefs and intentions to adopt PrEP among 224 black MSM. The likelihood of adopting PrEP was assessed and more than half (60%) of the study population indicated a high intention to adopt PrEP. HIV/AIDS genocidal and treatment-related conspiracies were assessed using scales previously validated with black MSM. Almost two-thirds (63%) endorsed at least one of eight HIV/AIDS conspiracy beliefs presented. In multivariable analyses, black MSM who agreed with the genocidal or treatment-related conspiracy beliefs scales had a lower intention to adopt PrEP (Adjusted Odds Ratio [AOR] = 0.73, 95% CI = 0.54, 0.99 and AOR = 0.36, 95% CI = 0.23, 0.55, respectively). Our findings indicate that preexisting HIV/AIDS conspiracy beliefs may deter some black MSM from adopting PrEP. We suggest strategies PrEP implementers may want to employ to address the influence that HIV/AIDS conspiracy beliefs may have on the adoption of PrEP among black MSM, a population disproportionately affected by HIV/AIDS.

  6. Pre-Exposure Prophylaxis (PrEP)

    Science.gov (United States)

    ... Español El VIH es una amenaza de salud grave para las comunidades latinas, quienes se encuentran en gran desventaja respecto de la incidencia de esta enfermedad en los Estados Unidos. Según los CDC, en ...

  7. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa.

    Science.gov (United States)

    Haberer, Jessica E; Baeten, Jared M; Campbell, James; Wangisi, Jonathan; Katabira, Elly; Ronald, Allan; Tumwesigye, Elioda; Psaros, Christina; Safren, Steven A; Ware, Norma C; Thomas, Katherine K; Donnell, Deborah; Krows, Meighan; Kidoguchi, Lara; Celum, Connie; Bangsberg, David R

    2013-01-01

    Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation. Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda), we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants--all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%-100%, pmarriage were associated with >80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort. The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary.

  8. Knowledge regarding postexposure prophylaxis of HIV among nurses

    Directory of Open Access Journals (Sweden)

    Dhital PS

    2017-04-01

    Full Text Available Puja Sharma Dhital,1 Sarojini Sharma,2 Pratik Poudel,3 Pankaj Raj Dhital4 1Adult Health Nursing, Nepal Polytechnic Institute, College of Nursing, 2Adult Health Nursing, BP Koirala Memorial Cancer Hospital, 3Department of Radiology, College of Medical Sciences, Bharatpur, 4Department of Agricultural Extension and Rural Sociology, Agriculture and Forestry University, Rampur, Nepal Abstract: Fifty nurses working in BP Koirala Memorial Cancer Hospital, Bharatpur, were selected by probability simple random sampling technique for determining the knowledge level about postexposure prophylaxis (PEP of HIV among nurses during 2014. A descriptive design, semistructured self-administered questionnaire was used for the study. The study showed that 48% of respondents had knowledge on the meaning of PEP, only 39.39% respondents were aware of the first aid management getting needle prick injury, 60% were aware of the best time to start PEP of HIV and 56% respondents had knowledge about the time schedule of HIV test after exposure. Although the respondents answered most of the questions correctly, they had knowledge deficit in certain areas. The respondents’ knowledge in this regard needs to be improved with time-to-time awareness program and periodic training, which ultimately helps to decrease the transmission of disease and reduces mortality and morbidity. Keywords: needle prick injury, transmission, PEP, HIV 

  9. Oral preexposure prophylaxis to prevent HIV infection: clinical and public health implications.

    Science.gov (United States)

    Baker, Jonathan; OʼHara, Kevin Michael

    2014-12-01

    This article reviews the use of combination emtricitabine (FTC)/tenofovir as preexposure prophylaxis (PrEP) for HIV-negative patients at high risk of acquiring HIV, including heterosexual men and women, men who have sex with men, and IV drug users. When used with classic prevention strategies such as condoms, PrEP has been found effective in reducing the risk of HIV transmission.

  10. Choice in HIV testing: the acceptability and anticipated use of a self ...

    African Journals Online (AJOL)

    Combination HIV prevention is being widely promoted by funders. This strategy aims to offer HIV prevention choices that can be selected and combined to decrease HIV risk in ways that fit with each individual's situation. Treatment as prevention and pre-exposure prophylaxis are two new evidence-based strategies to ...

  11. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission.

    Science.gov (United States)

    Kumwenda, Newton I; Hoover, Donald R; Mofenson, Lynne M; Thigpen, Michael C; Kafulafula, George; Li, Qing; Mipando, Linda; Nkanaunena, Kondwani; Mebrahtu, Tsedal; Bulterys, Marc; Fowler, Mary Glenn; Taha, Taha E

    2008-07-10

    Effective strategies are urgently needed to reduce mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) through breast-feeding in resource-limited settings. Women with HIV-1 infection who were breast-feeding infants were enrolled in a randomized, phase 3 trial in Blantyre, Malawi. At birth, the infants were randomly assigned to one of three regimens: single-dose nevirapine plus 1 week of zidovudine (control regimen) or the control regimen plus daily extended prophylaxis either with nevirapine (extended nevirapine) or with nevirapine plus zidovudine (extended dual prophylaxis) until the age of 14 weeks. Using Kaplan-Meier analyses, we assessed the risk of HIV-1 infection among infants who were HIV-1-negative on DNA polymerase-chain-reaction assay at birth. Among 3016 infants in the study, the control group had consistently higher rates of HIV-1 infection from the age of 6 weeks through 18 months. At 9 months, the estimated rate of HIV-1 infection (the primary end point) was 10.6% in the control group, as compared with 5.2% in the extended-nevirapine group (P<0.001) and 6.4% in the extended-dual-prophylaxis group (P=0.002). There were no significant differences between the two extended-prophylaxis groups. The frequency of breast-feeding did not differ significantly among the study groups. Infants receiving extended dual prophylaxis had a significant increase in the number of adverse events (primarily neutropenia) that were deemed to be possibly related to a study drug. Extended prophylaxis with nevirapine or with nevirapine and zidovudine for the first 14 weeks of life significantly reduced postnatal HIV-1 infection in 9-month-old infants. (ClinicalTrials.gov number, NCT00115648.) 2008 Massachusetts Medical Society

  12. Factors associated with coverage of cotrimoxazole prophylaxis in HIV-exposed children in South Africa.

    Science.gov (United States)

    Moodley, Dhayendre; Reddy, Leanne; Mahungo, Wisani; Masha, Rebotile

    2013-01-01

    The World Health Organisation and the Joint United Nations Programme in 2006 reaffirmed the earlier recommendation of 2000 that all HIV-exposed infants in resource-poor countries should commence cotrimoxazole (CTX) prophylaxis at 6-weeks of life. CTX prophylaxis should be continued until the child is confirmed HIV-uninfected and there is no further exposure to breastmilk transmission. We determined CTX coverage and explored factors associated with CTX administration in HIV-exposed infants at a primary health clinic in South Africa. In a cross-sectional study of HIV-exposed infants 6-18 months of age attending a child immunisation clinic, data from the current visit and previous visits related to CTX prophylaxis, feeding practice and infant HIV testing were extracted from the child's immunisation record. Further information related to the administration of CTX prophylaxis was obtained from an interview with the child's mother. One-third (33.0%) HIV-exposed infants had not initiated CTX at all and breastfed infants were more likely to have commenced CTX prophylaxis as compared to their non-breastfed counterparts (78.7% vs 63.4%) (p = 0.008). Availability of infant's HIV status was strongly associated with continuation or discontinuation of CTX after 6 months of age or after breastfeeding cessation. Maternal self-reports indicated that only 52.5% (95%CI 47.5-57.5) understood the reason for CTX prophylaxis, 126 (47%) did not dose during weekends; 55 (21%) dosed their infants 3 times a day and 70 (26%) dosed their infants twice daily. A third of HIV-exposed children attending a primary health care facility in this South African setting did not receive CTX prophylaxis. Not commencing CTX prophylaxis was strongly associated with infants not breastfeeding and unnecessary continued exposure to CTX in this paediatric population was due to limited availability of early infant diagnosis. Attendance at immunization clinics can be seen as missed opportunities for early

  13. Factors associated with coverage of cotrimoxazole prophylaxis in HIV-exposed children in South Africa.

    Directory of Open Access Journals (Sweden)

    Dhayendre Moodley

    Full Text Available BACKGROUND: The World Health Organisation and the Joint United Nations Programme in 2006 reaffirmed the earlier recommendation of 2000 that all HIV-exposed infants in resource-poor countries should commence cotrimoxazole (CTX prophylaxis at 6-weeks of life. CTX prophylaxis should be continued until the child is confirmed HIV-uninfected and there is no further exposure to breastmilk transmission. We determined CTX coverage and explored factors associated with CTX administration in HIV-exposed infants at a primary health clinic in South Africa. METHODS: In a cross-sectional study of HIV-exposed infants 6-18 months of age attending a child immunisation clinic, data from the current visit and previous visits related to CTX prophylaxis, feeding practice and infant HIV testing were extracted from the child's immunisation record. Further information related to the administration of CTX prophylaxis was obtained from an interview with the child's mother. RESULTS: One-third (33.0% HIV-exposed infants had not initiated CTX at all and breastfed infants were more likely to have commenced CTX prophylaxis as compared to their non-breastfed counterparts (78.7% vs 63.4% (p = 0.008. Availability of infant's HIV status was strongly associated with continuation or discontinuation of CTX after 6 months of age or after breastfeeding cessation. Maternal self-reports indicated that only 52.5% (95%CI 47.5-57.5 understood the reason for CTX prophylaxis, 126 (47% did not dose during weekends; 55 (21% dosed their infants 3 times a day and 70 (26% dosed their infants twice daily. CONCLUSION: A third of HIV-exposed children attending a primary health care facility in this South African setting did not receive CTX prophylaxis. Not commencing CTX prophylaxis was strongly associated with infants not breastfeeding and unnecessary continued exposure to CTX in this paediatric population was due to limited availability of early infant diagnosis. Attendance at immunization

  14. Regimen Change: Gilead's TAF Drugs Toppling TDFs in HIV Treatment.

    Science.gov (United States)

    Reinke, Thomas

    2017-09-01

    Truvada is getting a new lease on life as a preventive agent. It is the only drug approved to prevent HIV infections, and Truvada is the key pharmaceutical component of pre-exposure prophylaxis, which is aimed at preventing, rather than treating, HIV infection and transmission.

  15. Prophylaxis and treatment of HIV-1 infection in pregnancy - Swedish Recommendations 2017.

    Science.gov (United States)

    Navér, Lars; Albert, Jan; Carlander, Christina; Flamholc, Leo; Gisslén, Magnus; Karlström, Olof; Svedhem-Johansson, Veronica; Sönnerborg, Anders; Westling, Katarina; Yilmaz, Aylin; Pettersson, Karin

    2018-01-24

    Prophylaxis and treatment with antiretroviral drugs have resulted in a very low rate of mother-to-child transmission (MTCT) of HIV during recent years. Registration of new antiretroviral drugs, modification of clinical praxis, updated general treatment guidelines and increasing knowledge about MTCT have necessitated regular revisions of the recommendations for 'Prophylaxis and treatment of HIV-1 infection in pregnancy'. The Swedish Reference Group for Antiviral Therapy (RAV) has updated the recommendations from 2013 at an expert meeting 19 September 2017. In the new text, current treatment guidelines for non-pregnant are considered. The most important revisions are that: (1) Caesarean section and infant prophylaxis with three drugs are recommended when maternal HIV RNA >150 copies/mL (previously >50 copies/mL). The treatment target of undetectable HIV RNA remains unchanged <50 copies/mL; (2) Obstetric management and mode of delivery at premature rupture of the membranes and rupture of the membranes at full term follow the same procedures as in HIV negative women; (3) Vaginal delivery is recommended to a well-treated woman with HIV RNA <150 copies/mL regardless of gestational age, if no obstetric contraindications are present; (4) Treatment during pregnancy should begin as soon as possible and should continue after delivery; (5) Ongoing well-functioning HIV treatment at pregnancy start should usually be retained; (6) Recommended drugs and drug combinations have been updated.

  16. PrEP-dossier : Pre-Expositie Profylaxe voor hiv-negatieven in Nederland

    NARCIS (Netherlands)

    Urbanus AT; Blom C; Zantkuijl P; David S; P&B; I&V

    2017-01-01

    In October 2016, the Minister for Health, Welfare and Sport requested advice from the Health Council of the Netherlands on the use of medication to prevent HIV infection (pre-exposure prophylaxis, or PrEP) in people with an increased risk of HIV. The National Institute for Public Health and the

  17. Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis. Vol. 47/No. RR-7

    National Research Council Canada - National Science Library

    Chiarello, Linda

    1998-01-01

    ...); it includes recommendations for HlV post exposure prophylaxis (PEP) and discusses the scientific rationale for PEP The decision to recommend HIV postexposure prophylaxis must take into account the nature of the exposure (ag...

  18. 3. cotrimoxazole prophylaxis compliance among hiv exposed infants

    African Journals Online (AJOL)

    Esem

    reported that their spouses knew about their HIV status and 65.7% said that they felt free to give their child cotrimoxazole in public.61.8% of the respondents did not know that there was a social support group for mothers/caretakers of HIV exposed infants in their community and 74.5% stated that there were misconceptions ...

  19. Post exposure prophylaxis of HIV transmission after occupational ...

    African Journals Online (AJOL)

    2010-03-19

    Mar 19, 2010 ... Triple therapy use increased over time and was more frequent ... in Malawi and other countries in sub-Saharan Africa than .... The percentage of expatriate elective students that received triple .... HIV negative source patients.

  20. Enhanced Prophylaxis plus Antiretroviral Therapy for Advanced HIV Infection in Africa.

    Science.gov (United States)

    Hakim, James; Musiime, Victor; Szubert, Alex J; Mallewa, Jane; Siika, Abraham; Agutu, Clara; Walker, Simon; Pett, Sarah L; Bwakura-Dangarembizi, Mutsa; Lugemwa, Abbas; Kaunda, Symon; Karoney, Mercy; Musoro, Godfrey; Kabahenda, Sheila; Nathoo, Kusum; Maitland, Kathryn; Griffiths, Anna; Thomason, Margaret J; Kityo, Cissy; Mugyenyi, Peter; Prendergast, Andrew J; Walker, A Sarah; Gibb, Diana M

    2017-07-20

    In sub-Saharan Africa, among patients with advanced human immunodeficiency virus (HIV) infection, the rate of death from infection (including tuberculosis and cryptococcus) shortly after the initiation of antiretroviral therapy (ART) is approximately 10%. In this factorial open-label trial conducted in Uganda, Zimbabwe, Malawi, and Kenya, we enrolled HIV-infected adults and children 5 years of age or older who had not received previous ART and were starting ART with a CD4+ count of fewer than 100 cells per cubic millimeter. They underwent simultaneous randomization to receive enhanced antimicrobial prophylaxis or standard prophylaxis, adjunctive raltegravir or no raltegravir, and supplementary food or no supplementary food. Here, we report on the effects of enhanced antimicrobial prophylaxis, which consisted of continuous trimethoprim-sulfamethoxazole plus at least 12 weeks of isoniazid-pyridoxine (coformulated with trimethoprim-sulfamethoxazole in a single fixed-dose combination tablet), 12 weeks of fluconazole, 5 days of azithromycin, and a single dose of albendazole, as compared with standard prophylaxis (trimethoprim-sulfamethoxazole alone). The primary end point was 24-week mortality. A total of 1805 patients (1733 adults and 72 children or adolescents) underwent randomization to receive either enhanced prophylaxis (906 patients) or standard prophylaxis (899 patients) and were followed for 48 weeks (loss to follow-up, 3.1%). The median baseline CD4+ count was 37 cells per cubic millimeter, but 854 patients (47.3%) were asymptomatic or mildly symptomatic. In the Kaplan-Meier analysis at 24 weeks, the rate of death with enhanced prophylaxis was lower than that with standard prophylaxis (80 patients [8.9% vs. 108 [12.2%]; hazard ratio, 0.73; 95% confidence interval [CI], 0.55 to 0.98; P=0.03); 98 patients (11.0%) and 127 (14.4%), respectively, had died by 48 weeks (hazard ratio, 0.76; 95% CI, 0.58 to 0.99; P=0.04). Patients in the enhanced-prophylaxis group had

  1. Methodological Issues in Sampling the Local Immune System of the Female Genital Tract in the Context of HIV Prevention Trials

    NARCIS (Netherlands)

    Jespers, Vicky; Francis, Suzanna C.; van de Wijgert, Janneke; Crucitti, Tania

    2011-01-01

    The spread of HIV continues unabated in the most vulnerable populations of the world. HIV prevention methods, such as a vaginal microbicide, a mucosal vaccine, pre-exposure prophylaxis or a vaccine, are urgently needed in the fight against new infections. We must make a commitment to supporting

  2. Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated.

    Science.gov (United States)

    Aizire, Jim; Fowler, Mary Glenn; Wang, Jing; Shetty, Avinash K; Stranix-Chibanda, Lynda; Kamateeka, Moreen; Brown, Elizabeth R; Bolton, Steve G; Musoke, Philippa M; Coovadia, Hoosen

    2012-01-28

    Nevirapine and cotrimoxazole are associated with hematologic toxicities and skin-rash. Safety of their concurrent use for prophylaxis over extended periods among HIV-exposed uninfected infants has not been previously assessed. Secondary data analysis of the 'HIV Prevention Trials Network-046 protocol' (version 2.0), a phase-III, randomized, placebo-controlled trial that assessed efficacy and safety of nevirapine prophylaxis against breast milk transmission of HIV-1. Trial infants received 6-month study nevirapine/placebo, and standard-of-care peripartum single-dose nevirapine+/- zidovudine 'tail', and cotrimoxazole prophylaxis from 6 weeks through breastfeeding cessation. Adverse events were monitored using United States Division of AIDS Toxicity Tables (2004). Risk of neutropenia, anemia and skin-rash in the cotrimoxazole + nevirapine and the cotrimoxazole + placebo groups were compared using negative-binomial regression. Incidence of neutropenia and/or anemia, and skin-rash was highest during the first 6 weeks of life and declined, thereafter, regardless of study group. Time to first adverse event after 6 weeks was similar in cotrimoxazole + nevirapine and cotrimoxazole + placebo groups: hazard ratio (95% confidence interval) was 1.26 (0.96-1.66) for neutropenia and/or anemia (all grades), 1.27 (0.80-2.03) for neutropenia and/or anemia (grade ≥3) and 1.16 (0.46-2.90) for skin-rash (grade ≥2). There were no statistically significant differences in immediate (6 weeks-6 months) and long-term (6-12 months) adverse event risk among infants on cotrimoxazole + nevirapine versus cotrimoxazole + placebo. Extended nevirapine and cotrimoxazole prophylaxis through 6 months of age among HIV-exposed uninfected infants did not appear to increase the immediate or long-term risk of neutropenia, anemia or skin-rash. Concurrent use beyond 6 months, however, needs to be evaluated.

  3. The cost and impact of scaling up pre-exposure prophylaxis for HIV prevention: a systematic review of cost-effectiveness modelling studies

    NARCIS (Netherlands)

    Gomez, Gabriela B.; Borquez, Annick; Case, Kelsey K.; Wheelock, Ana; Vassall, Anna; Hankins, Catherine

    2013-01-01

    Cost-effectiveness studies inform resource allocation, strategy, and policy development. However, due to their complexity, dependence on assumptions made, and inherent uncertainty, synthesising, and generalising the results can be difficult. We assess cost-effectiveness models evaluating expected

  4. HIV post-exposure prophylaxis and antiretroviral therapy for adults ...

    African Journals Online (AJOL)

    condition with HIV-infected patients living longer and consequently undergoing more surgical procedures. The current belief is ... Improvement in quality of life. • Preservation of future therapeutic options – poor ... condition, with patients living longer, so the risk of transmission to health care workers has potentially increased.

  5. hiv testing and arv prophylaxis for newborns without their mothers

    African Journals Online (AJOL)

    2008-06-19

    Jun 19, 2008 ... change. For example, in circumstances where a woman refuses HIV testing after birth, a health care worker could launch an urgent court .... 1 and 2 of the World Health Organization prevention ... rights be sacrificed because political commitment and leadership in the epidemic has been lacking. In short,.

  6. [Consensus Document on post-exposure prophylaxis against HIV, HBV and HCV in adults and children].

    Science.gov (United States)

    2016-02-01

    This consensus document is an update of occupational and non-occupational prophylaxis guidelines in HIV-patients, promoting appropriate use of them, from the standpoint of care. This document has been approved by expert panel of SPNS, GESIDA, SEMST and different scientific societies related, after reviewing the results of efficacy and safety clinical trials, cohort and pharmacokinetic studies published in biomedical journals (PubMed and Embase) or presented at conferences and different guidelines. The strength of the recommendation and gradation of their evidence are based on the GRADE system. We have developed recommendations for assessing the risk of transmission in different types of exposure situations in which post-exposure prophylaxis should be recommended, special circumstances to consider, patterns of antiretroviral with the start and duration of early monitoring of tolerance and adherence to treatment, the subsequent monitoring of exposed persons regardless of whether they received post-exposure prophylaxis or not, and the need of psychological support. These new guidelines updated previous recommendations regarding occupational post-exposure prophylaxis and non-occupational, in adults and children. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  7. HIV Preexposure Prophylaxis and Condomless Sex: Disentangling Personal Values From Public Health Priorities.

    Science.gov (United States)

    Calabrese, Sarah K; Underhill, Kristen; Mayer, Kenneth H

    2017-10-01

    Daily HIV preexposure prophylaxis (PrEP) is an effective form of HIV protection that remains unknown and inaccessible for many people in the United States despite receiving federal approval over five years ago. PrEP is supported by the public health community, but forgoing condoms while taking PrEP has proven controversial; this controversy may be contributing to the lag in PrEP uptake. We argue that limiting PrEP access based on anticipated or actual sexual behavior contradicts the goals of public health research and practice and is not scientifically justified. As evidence for the effectiveness of novel forms of biomedical HIV protection emerges, public health professionals need to accept new definitions of "protected sex" and ensure that their personal values do not override empirical evidence when determining public health priorities.

  8. Positive benefits: preventive impact of post-exposure prophylaxis awareness among those with diagnosed HIV.

    Science.gov (United States)

    Dodds, C

    2008-04-01

    To consider the extent to which those presenting for post-exposure prophylaxis (PEP) after sexual risk had been encouraged to do so by their PEP-aware partners with (diagnosed) HIV. Thirty men who had completed the 2005 UK Gay Men's Sex Survey who said they had ever tried to get PEP took part in a 30 minute telephone interview. Fifteen men in the sample described a sexual exposure incident where they had knowledge that their partner was diagnosed with having HIV. Of these, only five knew about their partner's HIV diagnosis prior to sexual contact. The remaining 10 sought PEP because their sexual partner revealed his positive status following potential sexual exposure. Our analysis revealed that word of mouth from friends, sexual partners and health professionals played a key role in men's knowledge about the existence of PEP. It is important for HIV and sexual health specialists to ensure that PEP information is not only targeted at those who are tested negative for HIV or are untested but also to people with diagnosed HIV.

  9. Role of tenofovir alafenamide (TAF) in the treatment and prophylaxis of HIV and HBV infections.

    Science.gov (United States)

    De Clercq, Erik

    2018-07-01

    Tenofovir (TFV) is the cornerstone of the treatment and prophylaxis of HIV infections. It has been routinely used in its prodrug form TDF (tenofovir disoproxil fumarate) combined with emtricitabine ((-)FTC) and other antiretroviral agents. TDF has now been replaced by TAF (tenofovir alafenamide) which allows better uptake by the lymphoid tissue. In combination with elvitegravir (E), cobicistat (C), emtricitabine (F), TAF can be advocated as an STR (single tablet regimen, Genvoya®) for the treatment of HIV infections. In this combination, E and C may in the future be replaced by bictegravir. The prophylaxis of HIV infection is momentarily based upon Truvada®, the combination of F with TDF, which in the future may also be replaced by TAF. TAF (Vemlidy®) has also replaced TDF (Viread®) for the treatment of hepatitis B virus (HBV) infections. Both TDF and TAF offer little or no risk for virus-drug resistance. As compared to TDF, TAF limits the risk for nephrotoxicity and loss of bone mineral density. What remains to be settled, however, before the universal use of TAF could be recommended, is its safety during pregnancy and its applicability in the treatment of tuberculosis, in combination with rifampicin. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Malaria, sickle cell disease, HIV, and co-trimoxazole prophylaxis: An observational study

    Directory of Open Access Journals (Sweden)

    Ewurama D.A. Owusu

    2018-04-01

    Full Text Available Objectives: This observational study recorded the malaria and sickle cell disease (SCD profile of people living with HIV/AIDS (PLHA and determined whether prophylactic co-trimoxazole (CTX and the haemoglobin S (Hb S allele influenced malaria episodes. Methods: Sickling status, malaria episodes, and HIV type, as well as other data, were extracted retrospectively from the clinical records of 1001 patients attending the antiretroviral therapy clinic at Ridge Regional Hospital in Accra, Ghana between 2010 and 2015. Finger-prick capillary blood of returning patients (n = 501 was tested for the haemoglobin (Hb level and malaria, after information on malaria prevention methods was obtained through the administration of a questionnaire. Results: The use of insecticide-treated mosquito nets was low (22.8%. CTX prophylaxis showed no significant influence on the overall number of malaria episodes from 2010 to 2015; however, it did show a statistically significant relationship (p = 0.026 with the time elapsed since the last malaria episode. Even though 19% of participants possessed Hb S, it had no influence on malaria episodes. Conclusions: Hb S did not influence malaria in PLHA. Further studies in Hb SS and Hb SC are needed, as there are suggestions of increased frequency and severity of malaria. The impact of CTX prophylaxis on this cohort will be insightful. Keywords: Malaria, HIV, Sickle cell disease, Co-trimoxazole, Ghana

  11. Early infant diagnosis and post-exposure prophylaxis for HIV- exposed infants.

    Science.gov (United States)

    Gawde, Nilesh Chandrakant

    2016-01-01

    Recent scientific evidence suggests that early initiation of antiretroviral therapy (ART) among infants exposed perinatally to HIV has beneficial effects on their health and survival, and may even induce remission. This has led to the roll-out of early infant diagnosis (EID) of HIV and early treatment. Also, there is talk of using ART as post-exposure prophylaxis (PEP) to prevent mother-to-child transmission. EID involves carrying out diagnostic tests before initiating ART. In India, current programme design of centralised diagnosis has been resulting in poor access to diagnosis and treatment. To save the lives of HIV-infected infants, it is important to prevent delay. Another issue to be kept in mind is that the results of HIV tests may turn negative after the initiation of ART. This could be due to viral remission induced by ART or false positive initial results. Differentiating between the two is difficult. To deal with such cases, we need to develop a clinical algorithm and tools for capacity-building in counselling. The use of ART as PEP is expected to encounter further challenges. Between ART as PEP and EID, the later has advantages from an ethical perspective. There is a need to address the ethical issues within the EID programme by strengthening the current mechanisms for protecting the rights of HIV-exposed infants.

  12. Rape and HIV post-exposure prophylaxis: addressing the dual epidemics in South Africa.

    Science.gov (United States)

    Kim, Julia C; Martin, Lorna J; Denny, Lynette

    2003-11-01

    In South Africa, a country notable for both a rapidly escalating AIDS epidemic and high levels of sexual violence, the issue of HIV post-exposure prophylaxis (PEP) following rape has recently come to the fore, and a policy supporting provision of PEP has been approved by the national government. This paper compares the conditions for providing PEP in Europe and North America with the conditions faced by two initiatives in South Africa, one serving a primarily rural base, and one urban. It is based on a review of the literature on sexual violence in South Africa and use of PEP following occupational and non-occupational exposure. It incorporates perspectives from in-depth interviews in 2000 with 18 key informants, including survivors of sexual violence, gender and HIV activists, domestic violence NGOs, rape crisis centres, physicians, lawyers, researchers and HIV/AIDS advisors in the Department of Health. The paper argues that given the scientific evidence for PEP, and the nature of the dual epidemics of HIV and sexual violence in South Africa, the public health and social justice rationale for implementing PEP equals and indeed exceeds that put forward in industrialised countries. However, delays in accessing PEP caused by the public justice system and lack of training for service providers constitute significant obstacles to effective implementation. In this respect, provision of PEP presents an opportunity to reform and strengthen existing services for post-rape care and to link attention to the epidemic of sexual violence to HIV/AIDS prevention.

  13. Prophylaxis for Pneumocystis pneumonia (PCP) in non-HIV immunocompromised patients.

    Science.gov (United States)

    Stern, Anat; Green, Hefziba; Paul, Mical; Vidal, Liat; Leibovici, Leonard

    2014-10-01

    Pneumocystis pneumonia (PCP) is a disease affecting immunocompromised patients. PCP among these patients is associated with significant morbidity and mortality. To assess the effectiveness of PCP prophylaxis among non-HIV immunocompromised patients; and to define the type of immunocompromised patient for whom evidence suggests a benefit for PCP prophylaxis. Electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 1), MEDLINE and EMBASE (to March 2014), LILACS (to March 2014), relevant conference proceedings; and references of identified trials. Randomised controlled trials (RCTs) or quasi-RCTs comparing prophylaxis with an antibiotic effective against PCP versus placebo, no intervention, or antibiotic(s) with no activity against PCP; and trials comparing different antibiotics effective against PCP among immunocompromised non-HIV patients. We only included trials in which Pneumocystis infections were available as an outcome. Two review authors independently assessed risk of bias in each trial and extracted data from the included trials. We contacted authors of the included trials to obtain missing data. The primary outcome was documented PCP infections. Risk ratios (RR) with 95% confidence intervals (CI) were estimated and pooled using the random-effects model. Thirteen trials performed between the years 1974 and 2008 were included, involving 1412 patients. Four trials included 520 children with acute lymphoblastic leukemia and the remaining trials included adults with acute leukemia, solid organ transplantation or autologous bone marrow transplantation. Compared to no treatment or treatment with fluoroquinolones (inactive against Pneumocystis), there was an 85% reduction in the occurrence of PCP in patients receiving prophylaxis with trimethoprim/sulfamethoxazole, RR of 0.15 (95% CI 0.04 to 0.62; 10 trials, 1000 patients). The evidence was graded as moderate due to possible risk of bias. PCP

  14. Prevention Strategies Against HIV Transmission: A Proactive Approach.

    Science.gov (United States)

    Carrion, Antonio J; Miles, Jovan D; Mosley, Juan F; Smith, Lillian L; Prather, April S; Gurley, Marcus M; Phan, Linh D; Everton, Emily C

    2018-02-01

    Human immunodeficiency virus (HIV) has now transformed into a manageable chronic condition. Highly active antiretroviral therapy (HAART) has proven efficacious at controlling the disease progression. Based on compelling evidence, the Department of Health and Human Services (DHHS) and the Infectious Disease Society of America (IDSA) developed guidelines for the management of persons infected with HIV. However, there are approximately 50 000 new cases of HIV in the United States each year. In this article, we review proactive methods to reduce the transmission of HIV, which include reinforcing patient education, gel-coated condoms that destroy HIV, HIV vaccinations, and adequately utilizing pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP). Further development and consistent utilization of innovative prevention tools can significantly reduce the incidence of HIV infections regardless of HIV status.

  15. Syphilis Predicts HIV Incidence Among Men and Transgender Women Who Have Sex With Men in a Preexposure Prophylaxis Trial

    Science.gov (United States)

    Solomon, Marc M.; Mayer, Kenneth H.; Glidden, David V.; Liu, Albert Y.; McMahan, Vanessa M.; Guanira, Juan V.; Chariyalertsak, Suwat; Fernandez, Telmo; Grant, Robert M.; Bekker, Linda-Gail; Buchbinder, Susan; Casapia, Martin; Chariyalertsak, Suwat; Guanira, Juan; Kallas, Esper; Lama, Javier; Mayer, Kenneth; Montoya, Orlando; Schechter, Mauro; Veloso, Valdiléa

    2014-01-01

    Background. Syphilis infection may potentiate transmission of human immunodeficiency virus (HIV). We sought to determine the extent to which HIV acquisition was associated with syphilis infection within an HIV preexposure prophylaxis (PrEP) trial and whether emtricitabine/tenofovir (FTC/TDF) modified that association. Methods. The Preexposure Prophylaxis Initiative (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily FTC/TDF or placebo. Syphilis prevalence at screening and incidence during follow-up were measured. Hazard ratios for the effect of incident syphilis on HIV acquisition were calculated. The effect of FTC/TDF on incident syphilis and HIV acquisition was assessed. Results. Of 2499 individuals, 360 (14.4%) had a positive rapid plasma reagin test at screening; 333 (92.5%) had a positive confirmatory test, which did not differ between the arms (FTC/TDF vs placebo, P = .81). The overall syphilis incidence during the trial was 7.3 cases per 100 person-years. There was no difference in syphilis incidence between the study arms (7.8 cases per 100 person-years for FTC/TDF vs 6.8 cases per 100 person-years for placebo, P = .304). HIV incidence varied by incident syphilis (2.8 cases per 100 person-years for no syphilis vs 8.0 cases per 100 person-years for incident syphilis), reflecting a hazard ratio of 2.6 (95% confidence interval, 1.6–4.4; P < .001). There was no evidence for interaction between randomization to the FTC/TDF arm and incident syphilis on HIV incidence. Conclusions. In HIV-seronegative MSM, syphilis infection was associated with HIV acquisition in this PrEP trial; a syphilis diagnosis should prompt providers to offer PrEP unless otherwise contraindicated. PMID:24928295

  16. Similar HIV protection from four weeks of zidovudine versus nevirapine prophylaxis among formula-fed infants in Botswana

    Directory of Open Access Journals (Sweden)

    Kathleen M. Powis

    2018-03-01

    Full Text Available Background: The World Health Organization HIV guidelines recommend either infant zidovudine (ZDV or nevirapine (NVP prophylaxis for the prevention of intrapartum motherto-child HIV transmission (MTCT among formula-fed infants. No study has evaluated the comparative efficacy of infant prophylaxis with twice daily ZDV versus once daily NVP in exclusively formula-fed HIV-exposed infants.   Methods: Using data from the Mpepu Study, a Botswana-based clinical trial investigating whether prophylactic co-trimoxazole could improve infant survival, retrospective analyses of MTCT events and Division of AIDS (DAIDS Grade 3 or Grade 4 occurrences of anaemia or neutropenia were performed among infants born full-term (≥ 37 weeks gestation, with a birth weight ≥ 2500 g and who were formula-fed from birth. ZDV infant prophylaxis was used from Mpepu Study inception. A protocol modification mid-way through the study led to the subsequent use of NVP infant prophylaxis.   Results: Among infants qualifying for this secondary retrospective analysis, a total of 695 (52% infants received ZDV, while 646 (48% received NVP from birth for at least 25 days but no more than 35 days. Confirmed intrapartum HIV infection occurred in two (0.29% ZDV recipients and three (0.46% NVP recipients (p = 0.68. Anaemia occurred in 19 (2.7% ZDV versus 12 (1.9% NVP (p = 0.36 recipients. Neutropenia occurred in 28 (4.0% ZDV versus 21 (3.3% NVP recipients (p = 0.47.   Conclusions: Both ZDV and NVP resulted in low intrapartum transmission rates and no significant differences in severe infant haematologic toxicity (DAIDS Grade 3 or Grade 4 among formula-fed full-term infants with a birthweight ≥ 2500 g.

  17. Clinical use of vaginal or rectally applied microbicides in patients suffering from HIV/AIDS

    OpenAIRE

    Gupta, Satish; Vinu,Nutan

    2013-01-01

    Satish Kumar Gupta, Nutan Reproductive Cell Biology Laboratory, National Institute of Immunology, New Delhi, India Abstract: Microbicides, primarily used as topical pre-exposure prophylaxis, have been proposed to prevent sexual transmission of HIV. This review covers the trends and challenges in the development of safe and effective microbicides to prevent sexual transmission of HIV. Initial phases of microbicide development used such surfactants as nonoxynol-9 (N-9), C13G, and sodium lauryl...

  18. Soap and water prophylaxis for limiting genital ulcer disease and HIV-1 infection in men in sub-Saharan Africa.

    Science.gov (United States)

    O'Farrell, N

    1993-08-01

    In general, East, Central and Southern Africa appear to be worse affected by HIV-1 infection than West Africa. So far there is little evidence to suggest that differences in either sexual behaviour or numbers of sexual partners could account for this disparity. Two risk factors in men for acquiring HIV-1, that tend to vary along this geographical divide, are lack of circumcision and genital ulcer disease (GUD) which are much less common in West Africa. Although uncircumcised men with GUD are an important high frequency HIV-1 transmitter core group, few interventions have targeted such individuals. Given the recent expansion in AIDS-related technologies, is it possible that methods effective in limiting GUD in the preantibiotic era have been overlooked? During the first and second world wars, chancroid, the commonest cause of GUD in Africa today, was controlled successfully with various prophylactics including soap and water. Many parts of Africa are undergoing social upheaval against a background of violence, and in this environment soap and water prophylaxis would now seem to merit re-evaluation as an intervention for preventing both GUD and HIV-1 in uncircumcised men. By facilitating healing of traumatic, inflammatory and infected penile lesions, pre- and post-exposure prophylaxis with soap and water could be a cheap and effective method for decreasing the risks of acquiring GUD and HIV in this vulnerable group of uncircumcised men.

  19. Knowledge and uptake of occupational post-exposure prophylaxis amongst nurses caring for people living with HIV

    Directory of Open Access Journals (Sweden)

    Lufuno Makhado

    2016-03-01

    Full Text Available Background: Nurses caring for people living with HIV (PLWH are at higher risk of exposure to the human immunodeficiency virus (HIV by needle sticks, cuts, getting body fluids in their eyes or mouth and skin when bruised or affected by dermatitis. Objectives: To determine knowledge, insight and uptake of occupational post-exposure prophylaxis (OPEP amongst nurses caring for PLWH. Method: A cross-sectional descriptive design was used in this study. Stratified random sampling was used to sample 240 nurses. The study was conducted in a regional hospital in Limpopo province. Both parametric and non-parametric statistics were employed to analyse data. Results: A total of 233 nurses participated in the study. Sixty per cent (n = 138 of all nurses had a situation at work when they thought that they were infected by HIV and 100 (43% nurses had experienced the situation once or more in the past 12 month. Approximately 40% did not know what PEP (post-exposure prophylaxis is, and 22% did not know or were not sure if it was available in the hospital. Only few participants (n = 68, 29% had sought PEP and most (n = 37, 54% of them did not receive PEP when they needed it. There was a significant association between the knowledge and availability of PEP (r = 0.622. Conclusion: The study recommend an urgent need for policy makers in the health sector to put in place policies, guidelines and programmes that will rapidly scale up PEP services in health care settings, so that preventable occupationally acquired HIV infection can be minimised amongst nurses. Keywords: Post-Exposure Prophylaxis; Nurses; HIV, Occupational Exposure; PLWH

  20. Preexposure prophylaxis will have a limited impact on HIV-1 drug resistance in sub-Saharan Africa: a comparison of mathematical models

    NARCIS (Netherlands)

    van de Vijver, David A. M. C.; Nichols, Brooke E.; Abbas, Ume L.; Boucher, Charles A. B.; Cambiano, Valentina; Eaton, Jeffrey W.; Glaubius, Robert; Lythgoe, Katrina; Mellors, John; Phillips, Andrew; Sigaloff, Kim C.; Hallett, Timothy B.

    2013-01-01

    Preexposure prophylaxis (PrEP) with tenofovir and emtricitabine can prevent new HIV-1 infections, but there is a concern that use of PrEP could increase HIV drug resistance resulting in loss of treatment options. We compared standardized outcomes from three independent mathematical models simulating

  1. Birth prevalence of congenital cytomegalovirus among infants of HIV-infected women on prenatal antiretroviral prophylaxis in South Africa.

    Science.gov (United States)

    Manicklal, S; van Niekerk, A M; Kroon, S M; Hutto, C; Novak, Z; Pati, S K; Chowdhury, N; Hsiao, N Y; Boppana, S B

    2014-05-01

    A high rate of congenital cytomegalovirus (CMV) has been documented in human immunodeficiency virus (HIV)-exposed infants in industrialized settings, both in the pre- and post-highly active antiretroviral therapy (HAART) era. Only limited data on the birth prevalence of congenital CMV among infants of HIV-infected women on prenatal antiretroviral (ARV) prophylaxis are available from sub-Saharan Africa, despite a high prevalence of both infections. We evaluated the prevalence of congenital CMV in HIV-exposed infants in the Western Cape, South Africa. HIV-infected mothers were recruited in the immediate postnatal period at a referral maternity hospital between April and October 2012. Maternal and infant clinical data and newborn saliva swabs were collected. Saliva swabs were assayed by real-time polymerase chain reaction for CMV. Data were analyzed using univariate and multivariate logistic regression analyses to determine specific demographic, maternal, and newborn characteristics associated with congenital CMV. CMV was detected in 22 of 748 newborn saliva swabs (2.9%; 95% confidence interval [CI], 1.9%-4.4%). Overall, 96% of mothers used prenatal ARV prophylaxis (prenatal zidovudine, 43.9%; HAART, 52.1%). Maternal age, gestational age, prematurity (CMV-infected and -uninfected infants. Maternal CD4 count CMV (adjusted odds ratio, 2.9; 95% CI, 1.2-7.3). A negative correlation between CMV load in saliva and maternal CD4 count was observed (r = -0.495, n = 22, P = .019). The birth prevalence of congenital CMV was high despite prenatal ARV prophylaxis, and was associated with advanced maternal immunosuppression.

  2. United States family planning providers' knowledge of and attitudes towards preexposure prophylaxis for HIV prevention: a national survey.

    Science.gov (United States)

    Seidman, Dominika; Carlson, Kimberly; Weber, Shannon; Witt, Jacki; Kelly, Patricia J

    2016-05-01

    The Centers for Disease Control and Prevention defines HIV prevention as a core family planning service. The HIV community identified family planning visits as key encounters for women to access preexposure prophylaxis (PrEP) for HIV prevention. No studies explore US family planning providers' knowledge of and attitudes towards PrEP. We conducted a national survey of clinicians to understand barriers and facilitators to PrEP implementation in family planning. Family planning providers recruited via website postings, national meetings, and email completed an anonymous survey in 2015. Descriptive statistics were performed. Among 604 respondents, 495 were eligible for analysis and 342 were potential PrEP prescribers (physicians, nurse practitioners, midwives or physicians assistants). Among potential prescribers, 38% correctly defined PrEP [95% confidence interval (CI): 32.5-42.8], 37% correctly stated the efficacy of PrEP (95% CI: 32.0-42.4), and 36% chose the correct HIV test after a recent exposure (95% CI: 30.6-40.8). Characteristics of those who answered knowledge questions correctly included age less than 35 years, practicing in the Northeast or West, routinely offering HIV testing, providing rectal sexually transmitted infection screening or having seen any PrEP guidelines. Even among providers in the Northeast and West, the proportion of respondents answering questions correctly was less than 50%. Thirty-six percent of respondents had seen any PrEP guidelines. Providers identified lack of training as the main barrier to PrEP implementation; 87% wanted PrEP education. To offer comprehensive HIV prevention services, family planning providers urgently need training on PrEP and HIV testing. US family planning providers have limited knowledge about HIV PrEP and HIV testing, and report lack of provider training as the main barrier to PrEP provision. Provider education is needed to ensure that family planning clients access comprehensive HIV prevention methods

  3. Update on microbicide research and development-seeking new HIV prevention tools for women

    Directory of Open Access Journals (Sweden)

    Mertenskoetter T

    2011-01-01

    Full Text Available Abstract Women and girls are especially vulnerable to HIV infection in sub-Saharan Africa, and in some of those countries, prevalence among young women can be up to 3 times higher than among men of the same age. Effective HIV prevention options for women are clearly needed in this setting. Several ARV-based vaginal microbicides are currently in development for prevention of HIV transmission to women and are discussed here. The concept of pre-exposure prophylaxis for the prevention of HIV transmission to women is introduced.

  4. Sex Differences in HIV Infection.

    Science.gov (United States)

    Scully, Eileen P

    2018-04-01

    This review will outline the multilevel effects of biological sex on HIV acquisition, pathogenesis, treatment response, and prospects for cure. Potential mechanisms will be discussed along with future research directions. HIV acquisition risk is modified by sex hormones and the vaginal microbiome, with the latter acting through both inflammation and local metabolism of pre-exposure prophylaxis drugs. Female sex associates with enhanced risk for non-AIDS morbidities including cardiovascular and cerebrovascular disease, suggesting different inflammatory profiles in men and women. Data from research on HIV cure points to sex differences in viral reservoir dynamics and a direct role for sex hormones in latency maintenance. Biological sex remains an important variable in determining the risk of HIV infection and subsequent viral pathogenesis, and emerging data suggest sex differences relevant to curative interventions. Recruitment of women in HIV clinical research is a pathway to both optimize care for women and to identify novel therapeutics for use in both men and women.

  5. Pregnancy Outcomes in HIV-Infected Women Receiving Long-Term Isoniazid Prophylaxis for Tuberculosis and Antiretroviral Therapy

    Directory of Open Access Journals (Sweden)

    Allan W. Taylor

    2013-01-01

    Full Text Available Objective. While 6- to 12-month courses of isoniazid for tuberculosis prevention are considered safe in pregnant women, the effects of longer-term isoniazid prophylaxis or isoniazid in combination with antiretroviral therapy (ART are not established in human-immunodeficiency-virus-(HIV- infected women who experience pregnancy during the course of therapy. Design. Nested study of pregnancy outcomes among HIV-infected women participating in a placebo-controlled, TB-prevention trial using 36 months daily isoniazid. Pregnancy outcomes were collected by interview and record review. Results. Among 196 pregnant women, 103 (52.6% were exposed to isoniazid during pregnancy; all were exposed to antiretroviral drugs. Prior to pregnancy they had received a median of 341 days (range 1–1095 of isoniazid. We observed no isoniazid-associated hepatitis or other severe isoniazid-associated adverse events in the 103 women. Pregnancy outcomes were 132 term live births, 42 premature births, 11 stillbirths, 8 low birth weight, 6 spontaneous abortions, 4 neonatal deaths, and 1 congenital abnormality. In a multivariable model, neither isoniazid nor ART exposure during pregnancy was significantly associated with adverse pregnancy outcome (adjusted odds ratios 0.6, 95% CI: 0.3–1.1 and 1.8, 95% CI 0.9–3.6, resp.. Conclusions. Long-term isoniazid prophylaxis was not associated with adverse pregnancy outcomes, such as preterm delivery, even in the context of ART exposure.

  6. Use of Antiretroviral HIV Post-Exposure Prophylaxis in Sexually Abused Children and Adolescents Treated in an Inner-City Pediatric Emergency Department

    Science.gov (United States)

    Fajman, Nancy; Wright, Richelle

    2006-01-01

    Background: In 2002, Georgia had the United States' eighth highest number of persons living with AIDS. Human immunodeficiency virus (HIV) transmission as a result of sexual abuse is uncommon but definitely occurs. In certain circumstances of sexual abuse, antiretroviral post-exposure prophylaxis (ARV-PEP) has been suggested as a means to decrease…

  7. The latest evidence for possible HIV-1 curative strategies.

    Science.gov (United States)

    Pham, Hanh Thi; Mesplède, Thibault

    2018-01-01

    Human immunodeficiency virus type 1 (HIV-1) infection remains a major health issue worldwide. In developed countries, antiretroviral therapy has extended its reach from treatment of people living with HIV-1 to post-exposure prophylaxis, treatment as prevention, and, more recently, pre-exposure prophylaxis. These healthcare strategies offer the epidemiological tools to curve the epidemic in rich settings and will be concomitantly implemented in developing countries. One of the remaining challenges is to identify an efficacious curative strategy. This review manuscript will focus on some of the current curative strategies aiming at providing a sterilizing or functional cure to HIV-1-positive individuals. These include the following: early treatment initiation in post-treatment controllers as a long-term HIV-1 remission strategy, latency reversal, gene editing with or without stem cell transplantation, and antibodies against either the viral envelope protein or the host integrin α4β7.

  8. Addressing the dual health epidemics of HIV and sexual abuse among children and adolescents in Kenya: uptake of HIV counseling and post-exposure prophylaxis

    Directory of Open Access Journals (Sweden)

    Ajema C

    2017-12-01

    Full Text Available Carolyne Ajema,1 Charity Mbugua,2 Peter Memiah,3 Camille Wood,3 Courtney Cook,4 Ronald Kotut,2 Lina Digolo1 1Research and Strategic Information Department, LVCT Health, Nairobi, Kenya; 2Post Rape Care Department, LVCT Health, Nairobi, Kenya; 3Department of Public Health, University of West Florida, University Parkway, Pensacola, FL, USA; 4Biology Department, University of West Florida, University Parkway, Pensacola, FL, USA Purpose: Child sexual abuse and HIV are key health challenges in Kenya. In 2015, LVCT Health conducted a study aimed at assessing the quality of HIV-related services offered to child survivors of sexual violence in public health facilities.Materials and methods: A qualitative data collection approach was utilized. Qualitative data were collected through in-depth interviews with 31 providers. Quantitative methods included a retrospective review of 164 records of child survivors of rape who had accessed services 6 months prior to the commencement of the study. SPSS Version 22 was used in the descriptive analysis of the medical records. Client exit interviews and observation data were analyzed using MS Excel. In-depth interviews were analyzed using a thematic analytical approach.Results: Twenty-seven percent (n=164 survivors were documented to have received the first dose of postexposure prophylaxis (PEP. Providers did not conduct HIV pre- and posttest counseling for the survivors. There were no longitudinal follow-up mechanisms to ensure child survivors initiated on PEP adhered to the treatment plan. Less than 30% of survivors returned to the facility for PEP adherence counseling and follow-up HIV testing. Twenty providers cited capacity gaps in undertaking HIV risk assessment for child survivors. Limited availability of PEP is a barrier to HIV prevention, as most departments only offer services between 8 am and 5 pm. HIV tests were only available on weekdays before 5 pm. PEP being out of stock remains a barrier to HIV

  9. Executive summary of the consensus document on post-exposure prophylaxis against HIV, HBV and HCV in adults and children.

    Science.gov (United States)

    Polo Rodriguez, Rosa; Lozano, Fernando; González de Castro, Pedro; Jiménez, Ma Alonso; Miró, Oscar; Ramón Blanco, Jose; Moreno, David; Dueñas, Carlos; Muñoz Platón, Enriqueta; Fernández Escribano, Marina; Sanz Sanz, Jesús; Fumaz, Carmina; Santos, Ignacio; García, Federico; Téllez, Ma Jesús; González Montero, Raúl; Vals Jimenez, Ma Victoria; Losa, Juan Emilio; Valle Robles, Ma Luisa; Iribarren, Jose Antonio; Ortega, Enrique

    2016-02-01

    Post-exposure prophylaxis (PEP) can be a secondary measure to prevent infection by human immunodeficiency virus (HIV) when primary prevention has failed. PEP is advised for people with sporadic and exceptional risk exposure to HIV. This consensus document about occupational and non-occupational PEP recommendations aims to be a technical document for healthcare professionals. Its main objective is to facilitate the appropriate use of PEP. To this end, some recommendations have been established to assess the risk of transmission in different types of exposure, situations where PEP should be recommended, special circumstances to take into account, antiretroviral (ARV) guidelines including start and end of the treatment, early monitoring of tolerance and adherence to the treatment, subsequent monitoring of people exposed, independently of having received PEP or not, and need of psychological support. This document is intended for all professionals who work in clinical practice in the field of HIV infection. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  10. Acceptability and preferences for safer conception HIV prevention strategies: a qualitative study.

    Science.gov (United States)

    Schwartz, Sheree R; West, Nora; Phofa, Rebecca; Yende, Nompumelelo; Sanne, Ian; Bassett, Jean; Van Rie, Annelies

    2016-10-01

    Safer conception strategies to reduce the HIV transmission risk include antiretroviral therapy for HIV-positive partners, pre-exposure prophylaxis for HIV-negative partners, condomless sex limited to fertile periods, and home-based self-insemination. Resistance to taking treatment or cultural concerns may limit uptake of strategies and intervention success. Understanding the acceptability and preferences between different approaches is important to optimise service delivery. Between February and July 2013, 42 adults (21 HIV-positive and 21 HIV-negative) receiving primary care at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, participated in focus group discussions or in-depth interviews. Themes were analysed using a grounded theory approach. Acceptability of antiretroviral-based strategies varied. Concerns over side effects, antiretroviral treatment duration and beliefs that treatment is only for the sick were common barriers; however, desperation for a child was noted as a facilitator for uptake. HIV-negative men and HIV-positive women had favourable attitudes towards self-insemination, though paternity and safety concerns were raised. Self-insemination was generally preferred over pre-exposure prophylaxis by HIV-negative men, and antiretroviral-based strategies were preferred by couples with HIV-negative female partners, despite concerns raised about condomless sex while virally suppressed. Knowledge about the fertile window was low. A strong counselling component will be required for effective uptake and adherence to safer conception services. © The Author(s) 2016.

  11. Improving HIV post-exposure prophylaxis rates after pediatric acute sexual assault.

    Science.gov (United States)

    Schilling, Samantha; Deutsch, Stephanie A; Gieseker, Rebecca; Molnar, Jennifer; Lavelle, Jane M; Scribano, Philip V

    2017-07-01

    The purpose of our study was to increase the rate of children with appropriate HIV-PEP regimens among those diagnosed with sexual assault in The Children's Hospital of Philadelphia Emergency Department (ED). The outcome measure was the percent of patients receiving correct HIV-PEP. We retrospectively reviewed 97 charts over 31 months to define the baseline rate of children receiving appropriate HIV-PEP regimens (pre QI-implementation period: 2/2012-8/2014). Among children in which HIV-PEP was indicated following sexual assault, 40% received the recommended 28-day course. Root cause analysis indicated prescribing errors accounted for 87% of patients not receiving appropriate HIV-PEP. Process drivers included standardizing care coordination follow-up calls to elicit specific information about HIV-PEP, ED educational initiatives targeted at HIV-PEP prescribing, revision of the clinical pathway to specify indicated duration of HIV-PEP, and revision of the order set to auto-populate the number of days for the HIV-PEP prescription. During the QI-implementation period (9/2014-4/2015), the rate of appropriate HIV-PEP increased to 64% (median 60%) and the average number of days between incorrect HIV-PEP regimens was 24.5. Post QI-implementation (5/2015-3/2016), the rate of appropriate HIV-PEP increased to 84% (median 100%) and the average number of days between incorrect HIV-PEP regimens increased to 78.4. A multifaceted quality improvement process improved the rate of receipt of appropriate HIV-PEP regimens for pediatric victims of sexual assault. Decision support tools are instrumental in sustaining ideal care delivery, but require ongoing evaluation and improvement in order to remain optimally effective. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Prevalence of malaria and anaemia among HIV infected pregnant women receiving co-trimoxazole prophylaxis in Tanzania: a cross sectional study in Kinondoni Municipality.

    Science.gov (United States)

    Manyanga, Vicent P; Minzi, Omary; Ngasala, Billy

    2014-04-24

    HIV-infected pregnant women are particularly more susceptible to the deleterious effects of malaria infection particularly anaemia. In order to prevent opportunistic infections and malaria, a policy of daily co-trimoxazole prophylaxis without the standard Suphadoxine-Pyrimethamine intermittent preventive treatment (SP-IPT) was introduced to all HIV infected pregnant women in the year 2011. However, there is limited information about the effectiveness of this policy. This was a cross sectional study conducted among HIV-infected pregnant women receiving co-trimoxazole prophylaxis in eight public health facilities in Kinondoni Municipality from February to April 2013. Blood was tested for malaria infection and anaemia (haemoglobin anaemia. Pearson chi-square test, Fischer's exact test and multivariate logistic regression were used in the statistical analysis. This study enrolled 420 HIV infected pregnant women. The prevalence of malaria infection was 4.5%, while that of anaemia was 54%. The proportion of subjects with poor adherence to co-trimoxazole was 50.5%. As compared to HIV infected pregnant women with good adherence to co-trimoxazole prophylaxis, the poor adherents were more likely to have a malaria infection (Adjusted Odds Ratio, AOR = 6.81, 95% CI = 1.35-34.43, P = 0.02) or anaemia (AOR = 1.75, 95% CI = 1.03-2.98, P = 0.039). Other risk factors associated with anaemia were advanced WHO clinical stages, current malaria infection and history of episodes of malaria illness during the index pregnancy. The prevalence of malaria was low; however, a significant proportion of subjects had anaemia. Good adherence to co-trimoxazole prophylaxis was associated with reduction of both malaria infection and anaemia among HIV infected pregnant women.

  13. Challenges facing effective implementation of co-trimoxazole prophylaxis in children born to HIV-infected mothers in the public health facilities.

    Science.gov (United States)

    Kamuhabwa, Appolinary Ar; Manyanga, Vicky

    2015-01-01

    If children born to HIV-infected mothers are not identified early, approximately 30% of them will die within the first year of life due to opportunistic infections. In order to prevent morbidity and mortality due to opportunistic infections in children, the World Health Organization recommends the use of prophylaxis using co-trimoxazole. However, the challenges affecting effective implementation of this policy in Tanzania have not been documented. In this study, we assessed the challenges facing the provision of co-trimoxazole prophylaxis among children born to HIV-infected mothers in the public hospitals of Dar es Salaam, Tanzania. Four hundred and ninety-eight infants' PMTCT (Prevention of Mother-to-Child Transmission of HIV) register books for the past 2 years were reviewed to obtain information regarding the provision of co-trimoxazole prophylaxis. One hundred and twenty-six health care workers were interviewed to identify success stories and challenges in the provision of co-trimoxazole prophylaxis in children. In addition, 321 parents and guardians of children born to HIV-infected mothers were interviewed in the health facilities. Approximately 80% of children were initiated with co-trimoxazole prophylaxis within 2 months after birth. Two hundred and ninety-one (58.4%) children started using co-trimoxazole within 4 weeks after birth. Majority (n=458, 91.8%) of the children were prescribed 120 mg of co-trimoxazole per day, whereas 39 (7.8%) received 240 mg per day. Only a small proportion (n=1, 0.2%) of children received 480 mg/day. Dose determination was based on the child's age rather than body weight. Parents and guardians reported that 42 (13.1%) children had missed one or more doses of co-trimoxazole during the course of prophylaxis. The majority of health care workers (89.7%) reported that co-trimoxazole is very effective for the prevention of opportunistic infections among children, but frequent shortage of co-trimoxazole in the health facilities was

  14. Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention

    OpenAIRE

    Palanee-Phillips, Thesla; Schwartz, Katie; Brown, Elizabeth R.; Govender, Vaneshree; Mgodi, Nyaradzo; Kiweewa, Flavia Matovu; Nair, Gonasagrie; Mhlanga, Felix; Siva, Samantha; Bekker, Linda-Gail; Jeenarain, Nitesha; Gaffoor, Zakir; Martinson, Francis; Makanani, Bonus; Naidoo, Sarita

    2015-01-01

    Introduction Women in sub-Saharan Africa are a priority population for evaluation of new biomedical HIV-1 prevention strategies. Antiretroviral pre-exposure prophylaxis is a promising prevention approach; however, clinical trials among young women using daily or coitally-dependent products have found low adherence. Antiretroviral-containing vaginal microbicide rings, which release medication over a month or longer, may reduce these adherence challenges. Methods ASPIRE (A Study to Prevent Infe...

  15. High prevalence of syndemic health problems in patients seeking post-exposure prophylaxis for sexual exposures to HIV.

    Directory of Open Access Journals (Sweden)

    Steven A Morrison

    Full Text Available The standard clinical approach to non-occupational HIV post-exposure prophylaxis (nPEP focuses on biomedical aspects of the intervention, but may overlook co-occurring or 'syndemic' psychosocial problems that reinforce future vulnerability to HIV. We therefore sought to determine the prevalence of syndemic health problems in a cohort of Ontario nPEP patients, and explored the relationship between syndemic burden and HIV risk.Between 07/2013-08/2016, we distributed a self-administered questionnaire to patients presenting to three clinics in Toronto and Ottawa seeking nPEP for sexual HIV exposures. We used validated screening tools to estimate the prevalence of depression (CES-D score ≥16, harmful alcohol use (AUDIT ≥8, problematic drug use (DUDIT ≥6 men/≥2 women, and sexual compulsivity (SCS ≥24 among men who have sex with men (MSM respondents. In exploratory analyses, we examined the relationships between syndemic conditions using univariable logistic regression models, and the relationship between syndemic count (total number of syndemic conditions per participant and HIV risk, as estimated by the HIRI-MSM score, using linear regression models.The 186 MSM included in the analysis had median age 31 (IQR = 26-36, including 87.6% having a college/undergraduate degree or higher. Overall, 53.8% screened positive for depression, 34.4% for harmful alcohol use, 30.1% for problematic drug use, and 16.1% for sexual compulsivity. Most participants (74.2% had at least one syndemic condition and 46.8% had more than one. Exploratory analyses suggested positive associations between depression and harmful alcohol use (OR = 2.11, 95%CI = 1.13, 3.94 and between harmful alcohol use and problematic drug use (OR = 1.22, 95%CI = 0.65, 2.29. Syndemic count was associated with increased HIRI-MSM risk scores in univariable (2.2, 95%CI = 1.0, 3.3 per syndemic condition and multivariable (2.1, 95%CI = 0.6, 3.6 linear regression models.The prevalence of syndemic

  16. A Closer Look at Racism and Heterosexism in Medical Students' Clinical Decision-Making Related to HIV Pre-Exposure Prophylaxis (PrEP): Implications for PrEP Education.

    Science.gov (United States)

    Calabrese, Sarah K; Earnshaw, Valerie A; Krakower, Douglas S; Underhill, Kristen; Vincent, Wilson; Magnus, Manya; Hansen, Nathan B; Kershaw, Trace S; Mayer, Kenneth H; Betancourt, Joseph R; Dovidio, John F

    2018-04-01

    Social biases among healthcare providers could limit PrEP access. In this survey study of 115 US medical students, we examined associations between biases (racism and heterosexism) and PrEP clinical decision-making and explored prior PrEP education as a potential buffer. After viewing a vignette about a PrEP-seeking MSM patient, participants reported anticipated patient behavior (condomless sex, extra-relational sex, and adherence), intention to prescribe PrEP to the patient, biases, and background characteristics. Minimal evidence for racism affecting clinical decision-making emerged. In unadjusted analyses, heterosexism indirectly affected prescribing intention via all anticipated behaviors, tested as parallel mediators. Participants expressing greater heterosexism more strongly anticipated increased risk behavior and adherence problems, which were associated with lower prescribing intention. The indirect effect via condomless sex remained significant adjusting for background characteristics. Prior PrEP education did not buffer any indirect effects. Heterosexism may compromise PrEP provision to MSM and should be addressed in PrEP-related medical education.

  17. Explaining the Efficacy of Pre-exposure Prophylaxis (PrEP) for HIV Prevention: A Qualitative Study of Message Framing and Messaging Preferences Among US Men Who have Sex with Men.

    Science.gov (United States)

    Underhill, Kristen; Morrow, Kathleen M; Colleran, Christopher; Calabrese, Sarah K; Operario, Don; Salovey, Peter; Mayer, Kenneth H

    2016-07-01

    We investigated message comprehension and message framing preferences for communicating about PrEP efficacy with US MSM. We conducted eight focus groups (n = 38) and n = 56 individual interviews with MSM in Providence, RI. Facilitators probed comprehension, credibility, and acceptability of efficacy messages, including percentages, non-numerical paraphrases, efficacy ranges versus point estimates, and success- versus failure-framed messages. Our findings indicated a range of comprehension and operational understandings of efficacy messages. Participants tended to prefer percentage-based and success-framed messages, although preferences varied for communicating about efficacy using a single percentage versus a range. Participants reported uncertainty about how to interpret numerical estimates, and many questioned whether trial results would predict personal effectiveness. These results suggest that providers and researchers implementing PrEP may face challenges in communicating with users about efficacy. Efforts to educate MSM about PrEP should incorporate percentage-based information, and message framing decisions may influence message credibility and overall PrEP acceptability.

  18. The Danish PEP registry: experience with the use of postexposure prophylaxis (PEP) following sexual exposure to HIV from 1998 to 2006

    DEFF Research Database (Denmark)

    Lunding, Suzanne; Katzenstein, Terese L; Kronborg, Gitte

    2010-01-01

    BACKGROUND: Studies indicate that antiretroviral postexposure prophylaxis (PEP) after sexual exposure to HIV reduce the risk of infection considerably. Since 1998 PEP after sexual HIV exposure within the preceding 24 hours, has been available in Denmark. PEP can only be prescribed at clinical...... centers with specialists experienced in HIV treatment. The objective of this study is to describe the use of PEP after sexual exposure from 1998 to 2006. METHODS: The Danish PEP registry collects data from all cases of PEP use in Denmark after exposure to HIV through a structured questionnaire. RESULTS......: There were 374 cases of PEP use after sexual exposure. The incidence increased from 5 cases in 1997 to 87 in 2006. PEP was used by heterosexuals (40%) as well as men who have sex with men (57%). The HIV-status of the source was unknown in 41% of the cases of which 90% involved a source belonging to a high...

  19. The use of HIV post-exposure prophylaxis in forensic medicine following incidents of sexual violence in Hamburg, Germany: a retrospective study.

    Science.gov (United States)

    Ebert, Julia; Sperhake, Jan Peter; Degen, Olaf; Schröder, Ann Sophie

    2018-05-18

    In Hamburg, Germany, the initiation of HIV post-exposure prophylaxis (HIV PEP) in cases of sexual violence is often carried out by forensic medical specialists (FMS) using the city's unique Hamburg Model. FMS-provided three-day HIV PEP starter packs include a combination of raltegravir and emtricitabine/tenofovir. This study aimed to investigate the practice of offering HIV PEP, reasons for discontinuing treatment, patient compliance, and whether or not potential perpetrators were tested for HIV. We conducted a retrospective study of forensic clinical examinations carried out by the Hamburg Department of Legal Medicine following incidents of sexual violence from 2009 to 2016. One thousand two hundred eighteen incidents of sexual violence were reviewed. In 18% of these cases, HIV PEP was initially prescribed by the FMS. HIV PEP indication depended on the examination occurring within 24 h after the incident, no/unknown condom use, the occurrence of ejaculation, the presence of any injury, and the perpetrator being from population at high risk for HIV. Half of the HIV PEP recipients returned for a reevaluation of the HIV PEP indication by an infectious disease specialist, and just 16% completed the full month of treatment. Only 131 potential perpetrators were tested for HIV, with one found to be HIV positive. No HIV seroconversion was registered among the study sample. Provision of HIV PEP by an FMS after sexual assault ensures appropriate and prompt care for victims. However, patient compliance and completion rates are low. HIV testing of perpetrators must be carried out much more rigorously.

  20. Use of combination neonatal prophylaxis for the prevention of mother-to-child transmission of HIV infection in European high-risk infants.

    Science.gov (United States)

    Chiappini, Elena; Galli, Luisa; Giaquinto, Carlo; Ene, Luminita; Goetghebuer, Tessa; Judd, Ali; Lisi, Catiuscia; Malyuta, Ruslan; Noguera-Julian, Antoni; Ramos, Jose Tomas; Rojo-Conejo, Pablo; Rudin, Christoph; Tookey, Pat; de Martino, Maurizio; Thorne, Claire

    2013-03-27

    To evaluate use of combination neonatal prophylaxis (CNP) in infants at high risk for mother-to-child transmission (MTCT) of HIV in Europe and investigate whether CNP is more effective in preventing MTCT than single drug neonatal prophylaxis (SNP). Individual patient-data meta-analysis across eight observational studies. Factors associated with CNP receipt and with MTCT were explored by logistic regression using data from nonbreastfed infants, born between 1996 and 2010 and at high risk for MTCT. In 5285 mother-infant pairs, 1463 (27.7%) had no antenatal or intrapartum antiretroviral prophylaxis, 915 (17.3%) had only intrapartum prophylaxis and 2907 (55.0%) mothers had detectable delivery viral load despite receiving antenatal antiretroviral therapy. Any neonatal prophylaxis was administered to 4623 (87.5%) infants altogether; 1105 (23.9%) received CNP. Factors significantly associated with the receipt of CNP were later calendar birth year, no elective caesarean section, maternal CD4 cell count less than 200 cells/μl, maternal delivery viral load more than 1000 copies/ml, no antenatal antiretroviral therapy, receipt of intrapartum single-dose nevirapine and cohort. After adjustment, absence of neonatal prophylaxis was associated with higher risk of MTCT compared to neonatal prophylaxis [adjusted odds ratio (aOR) 2.29; 95% confidence interval (95% CI) 1.46-2.59; P use is increasing and associated with presence of MTCT risk factors. The finding of no observed difference in MTCT risk between one drug and CNP may reflect residual confounding or the fact that CNP may be effective only in a subgroup of infants rather than the whole population of high-risk infants.

  1. Virus load in chimpanzees infected with human immunodeficiency virus type 1: effect of pre-exposure vaccination

    NARCIS (Netherlands)

    ten Haaft, P.; Cornelissen, M.; Goudsmit, J.; Koornstra, W.; Dubbes, R.; Niphuis, H.; Peeters, M.; Thiriart, C.; Bruck, C.; Heeney, J. L.

    1995-01-01

    Many reports indicate that a long-term asymptomatic state following human immunodeficiency virus type 1 (HIV-1) infection is associated with a low amount of circulating virus. To evaluate the possible effect of stabilizing a low virus load by non-sterilizing pre-exposure vaccination, a quantitative

  2. Hepatitis A outbreak in HIV-infected MSM and in PrEP-using MSM despite a high level of immunity, Lyon, France, January to June 2017.

    Science.gov (United States)

    Charre, Caroline; Ramière, Christophe; Roque-Afonso, Anne-Marie; Chidiac, Christian; Zoulim, Fabien; Godinot, Matthieu; Koffi, Joseph; Scholtès, Caroline; Livrozet, Jean-Michel; Hav Lyon Study Group; Cotte, Laurent

    2017-11-01

    Since 2016, an increase in the number of hepatitis A cases affecting mainly men who have sex with men (MSM) has been reported in low endemic countries in Europe. We calculated the attack rate in Lyon, France, in populations considered at high-risk: HIV-infected MSM and HIV-negative MSM receiving HIV pre-exposure prophylaxis (PrEP). In these populations, high level of immunity did not prevent the outbreak, indicating that vaccination should be reinforced, particularly in younger individuals.

  3. Human Resource Challenges to Integrating HIV Pre-Exposure ...

    African Journals Online (AJOL)

    PrEP) into public health systems. In Bondo and Kisumu, Kenya, we conducted interviews with 16 district and provincial public health stakeholders and held consultations with 18 provincial and 23 national public health stakeholders on topics ...

  4. The role of drugs in HIV prevention

    Science.gov (United States)

    Kembaren, T.

    2018-03-01

    WHO reports 36.7 million people are living with Human Immunodeficiency Virus (HIV) worldwide by 2016 with about 1.8 million new infections each year. It will be a specific health problem for the world in both developed and developing countries so it is necessary strategies to reduce HIV transmission to the community. HIV transmission in people with risk factors is largely determined by the amount of virus in the blood of people who are the source of infection. Antiretroviral (ARV) therapy has long been used in HIV patients, which serves to suppress viral replication so that the patient’s immunity increases; opportunistic infections are resolved and prolong the lifespan and lower transmission rates. In the HIV Prevention Trials Network (HPTN) study 052 there was a 96% reduction in transmission in earlier antiretroviral. ARV is also used in the prevention of transmission in people exposed to HIV virus that is Postexposure Prophylaxis as well as in people at risk before exposure (Pre-exposure Prophylaxis). Three prevention strategies with the provision of ARV is expected to be guided as a means of prevention of transmission in addition to behavioral changes has long been declared since the beginning of the HIV epidemic.

  5. Challenges facing effective implementation of co-trimoxazole prophylaxis in children born to HIV-infected mothers in the public health facilities

    Directory of Open Access Journals (Sweden)

    Kamuhabwa AAR

    2015-10-01

    Full Text Available Appolinary AR Kamuhabwa,1 Vicky Manyanga21Unit of Pharmacology and Therapeutics, 2Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, TanzaniaBackground: If children born to HIV-infected mothers are not identified early, approximately 30% of them will die within the first year of life due to opportunistic infections. In order to prevent morbidity and mortality due to opportunistic infections in children, the World Health Organization recommends the use of prophylaxis using co-trimoxazole. However, the challenges affecting effective implementation of this policy in Tanzania have not been documented.Aim: In this study, we assessed the challenges facing the provision of co-trimoxazole prophylaxis among children born to HIV-infected mothers in the public hospitals of Dar es Salaam, Tanzania.Methodology: Four hundred and ninety-eight infants' PMTCT (Prevention of Mother-to-Child Transmission of HIV register books for the past 2 years were reviewed to obtain information regarding the provision of co-trimoxazole prophylaxis. One hundred and twenty-six health care workers were interviewed to identify success stories and challenges in the provision of co-trimoxazole prophylaxis in children. In addition, 321 parents and guardians of children born to HIV-infected mothers were interviewed in the health facilities.Results: Approximately 80% of children were initiated with co-trimoxazole prophylaxis within 2 months after birth. Two hundred and ninety-one (58.4% children started using co-trimoxazole within 4 weeks after birth. Majority (n=458, 91.8% of the children were prescribed 120 mg of co-trimoxazole per day, whereas 39 (7.8% received 240 mg per day. Only a small proportion (n=1, 0.2% of children received 480 mg/day. Dose determination was based on the child's age rather than body weight. Parents and guardians reported that 42 (13.1% children had missed one or more doses of co

  6. HIV Prevention Among Transgender Populations: Knowledge Gaps and Evidence for Action.

    Science.gov (United States)

    Poteat, Tonia; Malik, Mannat; Scheim, Ayden; Elliott, Ayana

    2017-08-01

    The purpose of this review is to summarize the available evidence-based HIV prevention interventions tailored for transgender people. A limited number of evidence-based HIV prevention interventions have been tested with transgender populations. Most existing interventions target behavior change among transgender women, with only one HIV prevention program evaluated for transgender men. Studies addressing biomedical interventions for transgender women are ongoing. Few interventions address social and structural barriers to HIV prevention, such as stigma, discrimination, and poverty. Evidence-based multi-level interventions that address the structural, biomedical, and behavioral risks for HIV among transgender populations, including transgender men, are needed to address disparities in HIV prevalence. Future research should address not only pre-exposure prophylaxis uptake and condom use but also structural barriers that limit access to these prevention strategies.

  7. Impact of pharmacy technician-centered medication reconciliation on optimization of antiretroviral therapy and opportunistic infection prophylaxis in hospitalized patients with HIV/AIDS.

    Science.gov (United States)

    Siemianowski, Laura A; Sen, Sanchita; George, Jomy M

    2013-08-01

    This study aimed to examine the role of a pharmacy technician-centered medication reconciliation (PTMR) program in optimization of medication therapy in hospitalized patients with HIV/AIDS. A chart review was conducted for all inpatients that had a medication reconciliation performed by the PTMR program. Adult patients with HIV and antiretroviral therapy (ART) and/or the opportunistic infection (OI) prophylaxis listed on the medication reconciliation form were included. The primary objective is to describe the (1) number and types of medication errors and (2) the percentage of patients who received appropriate ART. The secondary objective is a comparison of the number of medication errors between standard mediation reconciliation and a pharmacy-led program. In the PTMR period, 55 admissions were evaluated. In all, 50% of the patients received appropriate ART. In 27of the 55 admissions, there were 49 combined ART and OI-related errors. The most common ART-related errors were drug-drug interactions. The incidence of ART-related medication errors that included drug-drug interactions and renal dosing adjustments were similar between the pre-PTMR and PTMR groups (P = .0868). Of the 49 errors in the PTMR group, 18 were intervened by a medication reconciliation pharmacist. A PTMR program has a positive impact on optimizing ART and OI prophylaxis in patients with HIV/AIDS.

  8. The effect of daily co-trimoxazole prophylaxis on natural development of antibody-mediated immunity against P. falciparum malaria infection in HIV-exposed uninfected Malawian children.

    Directory of Open Access Journals (Sweden)

    Herbert Longwe

    Full Text Available Co-trimoxazole prophylaxis, currently recommended in HIV-exposed, uninfected (HEU children as protection against opportunistic infections, also has some anti-malarial efficacy. We determined whether daily co-trimoxazole prophylaxis affects the natural development of antibody-mediated immunity to blood-stage Plasmodium falciparum malaria infection.Using an enzyme-linked immunosorbent assay, we measured antibodies to 8 Plasmodium falciparum antigens (AMA-1, MSP-119, MSP-3, PfSE, EBA-175RII, GLURP R0, GLURP R2 and CSP in serum samples from 33 HEU children and 31 HIV-unexposed, uninfected (HUU children, collected at 6, 12 and 18 months of age.Compared to HIV-uninfected children, HEU children had significantly lower levels of specific IgG against AMA-1 at 6 months (p = 0.001, MSP-119 at 12 months (p = 0.041 and PfSE at 6 months (p = 0.038, 12 months (p = 0.0012 and 18 months (p = 0.0097. No differences in the IgG antibody responses against the rest of the antigens were observed between the two groups at all time points. The breadth of specificity of IgG response was reduced in HEU children compared to HUU children during the follow up period.Co-trimoxazole prophylaxis seems to reduce IgG antibody responses to P. falciparum blood stage antigens, which could be as a result of a reduction in exposure of those children under this regime. Although antibody responses were regarded as markers of exposure in this study, further studies are required to establish whether these responses are correlated in any way to clinical immunity to malaria.

  9. The effect of daily co-trimoxazole prophylaxis on natural development of antibody-mediated immunity against P. falciparum malaria infection in HIV-exposed uninfected Malawian children.

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    Longwe, Herbert; Jambo, Kondwani C; Phiri, Kamija S; Mbeye, Nyanyiwe; Gondwe, Thandile; Hall, Tom; Tetteh, Kevin K A; Drakeley, Chris; Mandala, Wilson L

    2015-01-01

    Co-trimoxazole prophylaxis, currently recommended in HIV-exposed, uninfected (HEU) children as protection against opportunistic infections, also has some anti-malarial efficacy. We determined whether daily co-trimoxazole prophylaxis affects the natural development of antibody-mediated immunity to blood-stage Plasmodium falciparum malaria infection. Using an enzyme-linked immunosorbent assay, we measured antibodies to 8 Plasmodium falciparum antigens (AMA-1, MSP-119, MSP-3, PfSE, EBA-175RII, GLURP R0, GLURP R2 and CSP) in serum samples from 33 HEU children and 31 HIV-unexposed, uninfected (HUU) children, collected at 6, 12 and 18 months of age. Compared to HIV-uninfected children, HEU children had significantly lower levels of specific IgG against AMA-1 at 6 months (p = 0.001), MSP-119 at 12 months (p = 0.041) and PfSE at 6 months (p = 0.038), 12 months (p = 0.0012) and 18 months (p = 0.0097). No differences in the IgG antibody responses against the rest of the antigens were observed between the two groups at all time points. The breadth of specificity of IgG response was reduced in HEU children compared to HUU children during the follow up period. Co-trimoxazole prophylaxis seems to reduce IgG antibody responses to P. falciparum blood stage antigens, which could be as a result of a reduction in exposure of those children under this regime. Although antibody responses were regarded as markers of exposure in this study, further studies are required to establish whether these responses are correlated in any way to clinical immunity to malaria.

  10. Stakeholder Engagement in HIV Cure Research: Lessons Learned from Other HIV Interventions and the Way Forward.

    Science.gov (United States)

    Lo, Ying-Ru; Chu, Carissa; Ananworanich, Jintanat; Excler, Jean-Louis; Tucker, Joseph D

    2015-07-01

    Clinical and basic science advances have raised considerable hope for achieving an HIV cure by accelerating research. This research is dominated primarily by issues about the nature and design of current and future clinical trials. Stakeholder engagement for HIV cure remains in its early stages. Our analysis examines timing and mechanisms of historical stakeholder engagement in other HIV research areas for HIV-uninfected individuals [vaccine development and pre-exposure prophylaxis (PrEP)], and HIV-infected individuals (treatment as prevention, prevention of mother-to-child transmission, and treatment of acute HIV infection) and articulate a plan for HIV cure stakeholder engagement. The experience from HIV vaccine development shows that early engagement of stakeholders helped manage expectations, mitigating the failure of several vaccine trials, while paving the way for subsequent trials. The relatively late engagement of HIV stakeholders in PrEP research may partly explain some of the implementation challenges. The treatment-related stakeholder engagement was strong and community-led from the onset and helped translation from research to implementation. We outline five steps to initiate and sustain stakeholder engagement in HIV cure research and conclude that stakeholder engagement represents a key investment in which stakeholders mutually agree to share knowledge, benefits, and risk of failure. Effective stakeholder engagement prevents misconceptions. As HIV cure research advances from early trials involving subjects with generally favorable prognosis to studies involving greater risk and uncertainty, success may depend on early and deliberate engagement of stakeholders.

  11. HIV-Positive Women Taking Lifelong Antiretroviral Therapy Report Better Adherence Than Women Taking Short-Course Prophylaxis During and After Pregnancy Under PMTCT Program Option A in Lusaka, Zambia.

    Science.gov (United States)

    Hampanda, Karen M; Abuogi, Lisa L; Ahmed, Yusuf

    2017-01-01

    HIV-positive women's adherence to antiretrovirals is critical for prevention of mother-to-child transmission. We aimed to establish if mothers taking triple lifelong antiretroviral therapy report higher adherence compared to mothers taking short-course prophylaxis under Option A in Lusaka, Zambia. In this clinic-based cross-sectional study, we interviewed 320 HIV-positive mothers at a large public health facility in Lusaka in 2014. Participants reported adherence using a visual analog scale. Multiple logistic regression models were used to determine the adjusted odds of adherence by mother's prescribed regimen. Women taking lifelong triple antiretroviral therapy report higher adjusted odds of adherence during pregnancy, postpartum, and to giving the infant prophylaxis compared to women to women taking short-course prophylaxis. Women on lifelong therapy may have better adherence compared to women on short course prophylaxis because they knew their positive status for longer or were symptomatic with HIV-related disease. The lifelong therapy regimen may be easier for women to follow, particularly because they are required to give the infant prophylaxis for a shorter duration of time. Our results indicate that lifelong triple antiretroviral therapy has the potential to promote better drug adherence during and after pregnancy among women living with HIV in sub-Saharan Africa, compared to short-course antiretroviral regimens.

  12. Differences in knowledge, attitudes and behaviors of Israeli HIV-uninfected gay men in HIV-discordant vs. concordant steady relationships.

    Science.gov (United States)

    Tairy, Daniel; Levy, Itzchak; Turner, Dan; Livnat, Yuval; Mor, Zohar

    2018-06-01

    HIV-discordant gay male couples may play an important role in HIV-transmissions. This cross-sectional study compared the knowledge, attitudes and sexual behaviors of HIV-uninfected gay men, between those in HIV-discordant and those in HIV-concordant steady relationships. Anonymous questionnaires were distributed electronically in designated gay-related internet sites and in AIDS-clinics in 2015. The dependent variable was defined as a steady relationship of an HIV-uninfected man with an HIV-infected partner. Risky sexual behavior was defined as unprotected anal intercourse (UAI) with a sex partner whose HIV-status was either positive or unknown. Of 2,319 responders, 460 (20%) were HIV-uninfected gay men in steady relationships, of whom 72 were in HIV-discordant relationships and 388 were in HIV-concordant relationships. Those in HIV-discordant relationships presented better established knowledge regarding HIV-transmission, more lenient attitudes regarding UAI, and reported being involved in riskier sexual behavior, both within and outside their steady relationship compared to men in HIV-concordant relationships. UAI was performed by 48% of the HIV-discordant couples and was associated with the use of sero-positioning strategy and with achieving undetectable viral-load. These findings reflect the complexity of constant use of condoms during long-term sero-discordant relationships. Targeted interventions for HIV-prevention in HIV-discordant couples should be employed for balancing the partners' desire for intimacy and sexual pleasure in the relationship, while reducing the risk for acquiring HIV. ART: Antiretroviral therapy; PEP: Post exposure prophylaxis; PrEP: Pre exposure prophylaxis; STI: Sexually transmitted infections; UAI: Unprotected anal intercourse.

  13. Nurturing the Continuum of HIV Testing, Treatment and Prevention Matrix Cascade in Reducing HIV Transmission.

    Science.gov (United States)

    Yah, Clarence S

    2017-11-01

    Despite the shift in antiretroviral therapy (ARVs) eligibility cascade from CD4 ≤ 200 to CD4 ≤ 350 to CD4 ≤ 500 mm 3 , HIV related morbidity and mortality continue to escalate annually, as do HIV infections. The new paradigm of treatment for all HIV positives individual irrespective of CD4 count may significantly reduce HIV and related illnesses. The author assumes that all HIV infected partners should be eligible for HIV treatment and care, irrespective of CD4 count. A second assumption is that high risk HIV negative partners have free access to continuum of HIV pre-exposure prophylaxis (PrEP), post exposure prophylaxis (PEP) and other prevention packages. A literature review search was used to extract evidence-based ARVs-HIV treatment and prevention interventions among HIV positives and high risk partners respectively. Only articles published in English and indexed in journal nuclei were used for the study. The information was used to nurture understanding of HIV treatment and prevention approaches as well as HIV incidence multiplier effect among HIV serodiscordant partners. The imputed HIV incident reference was assumed at 1.2 per 100 person-years (2). This was based on the imputation that retention in care, adherence and other predetermined factors are functions of an effective health care delivery system. The model showed a reduced HIV transmission from 1.2 per 100 person-years to 1.032 per 100 person-years in 6 months. The average threshold period of HIV suppressed partners on ARVs to an undetectable level. The combined multiplier protective-effect probability of transmitting HIV from HIV positive partners on ARVs-suppressed viremic load to HIV negative partners on PrEP/PEP-prevention was detected at 86. The model showed a significant reduction in HIV incidence. Placing serodiscordant sexual partners in HIV treatment and prevention plays a significant role in reducing and controlling HIV infection. Therefore, the policy of enrolling all HIV positives

  14. Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana.

    Science.gov (United States)

    Tetteh, Raymond A; Nartey, Edmund T; Lartey, Margaret; Mantel-Teeuwisse, Aukje K; Leufkens, Hubert G M; Nortey, Priscilla A; Dodoo, Alexander N O

    2015-06-20

    There is strong evidence that post-exposure prophylaxis (PEP) with antiretroviral drugs in the timely management of occupational exposures sustained by healthcare workers decreases the risk of HIV infection and PEP is now widely used. Antiretroviral drugs have well documented toxicities and produce adverse events in patients living with HIV/AIDS. In the era of "highly active antiretroviral therapy", non-adherence to treatment has been closely linked to the occurrence of adverse events in HIV patients and this ultimately influences treatment success but the influence of adverse events on adherence during PEP is less well studied. Following the introduction of a HIV post-exposure prophylaxis program in the Korle-Bu Teaching Hospital in January 2005, the incidence of adverse events and adherence were documented in occupationally-exposed healthcare workers (HCWs) and healthcare students (HCSs). Cohort event monitoring was used in following-up on exposed HCWs/HCSs for the two study outcomes; adverse events and adherence. All adverse events reported were grouped by MedDRA system organ classification and then by preferred term according to prophylaxis regimen. Adherence was determined by the completion of prophylaxis schedule. Cox proportional regression analysis was applied to determine the factors associated with the cohort study outcomes. Differences in frequencies were tested using the Chi square test and p < 0.05 was considered statistically significant. A total of 228 exposed HCWs/HCSs were followed up during the study, made up of 101 exposed HCWs/HCSs administered lamivudine/zidovudine (3TC/AZT) for 3 days; 75 exposed HCWs/HCSs administered lamivudine/zidovudine (3TC/AZT) for 28 days; and 52 exposed HCWs/HCSs administered lamivudine/zidovudine/lopinavir-ritonavir (3TC/AZT/LPV-RTV) for 28 days. The frequency of adverse events was 28% (n = 28) in exposed HCWs/HCSs administered 3TC/AZT for 3 days, 91% (n = 68) in exposed HCWs/HCSs administered 3TC/AZT for

  15. Pre-exposure to wheel running disrupts taste aversion conditioning.

    Science.gov (United States)

    Salvy, Sarah-Jeanne; Pierce, W David; Heth, Donald C; Russell, James C

    2002-05-01

    When rats are given access to a running wheel after drinking a flavored solution, they subsequently drink less of that flavor solution. It has been suggested that running produces a conditioned taste aversion (CTA). This study explored whether CTA is eliminated by prior exposure to wheel running [i.e., unconditioned stimulus (UCS) pre-exposure effect]. The rats in the experimental group (UW) were allowed to wheel run for 1 h daily for seven consecutive days of pre-exposure. Rats in the two other groups had either access to locked wheels (LW group) or were maintained in their home cages (HC group) during the pre-exposure days. All rats were then exposed to four paired and four unpaired trials using a "ABBAABBA" design. Conditioning trials were composed of one flavored liquid followed by 60-min access to wheel running. For the unpaired trials, rats received a different flavor not followed by the opportunity to run. All rats were then initially tested for water consumption followed by tests of the two flavors (paired or unpaired) in a counterbalanced design. Rats in the UW group show no CTA to the liquid paired with wheel running, whereas LW and HC groups developed CTA. These results indicate that pre-exposure to wheel running (i.e., the UCS), eliminates subsequent CTA.

  16. A randomized noninferiority trial of standard versus enhanced risk reduction and adherence counseling for individuals receiving post-exposure prophylaxis following sexual exposures to HIV.

    Science.gov (United States)

    Roland, Michelle E; Neilands, Torsten B; Krone, Melissa R; Coates, Thomas J; Franses, Karena; Chesney, Margaret A; Kahn, James S; Martin, Jeffrey N

    2011-07-01

    The National HIV/AIDS Strategy proposes to scale-up post-exposure prophylaxis (PEP). Intensive risk reduction and adherence counseling appear to be effective but are resource intensive. Identifying simpler interventions that maximize the HIV prevention potential of PEP is critical. A randomized noninferiority study comparing 2 (standard) or 5 (enhanced) risk reduction counseling sessions was performed. Adherence counseling was provided in the enhanced arm. We measured changes in unprotected sexual intercourse acts at 12 months, compared with baseline; HIV acquisition; and PEP adherence. Outcomes were stratified by degree of baseline risk. We enrolled 457 individuals reporting unprotected intercourse within 72 h with an HIV-infected or at-risk partner. Participants were 96% male and 71% white. There were 1.8 and 2.3 fewer unprotected sex acts in the standard and enhanced groups. The maximum potential risk difference, reflected by the upper bound of the 95% confidence interval, was 3.9 acts. The difference in the riskier subset may have been as many as 19.6 acts. The incidence of HIV seroconversion was 2.9% and 2.6% among persons randomized to standard and enhanced counseling, respectively, with a maximum potential difference of 3.4%. The absolute and maximal HIV seroconversion incidence was 9.9% and 20.4% greater in the riskier group randomized to standard, compared with enhanced, counseling. Adherence outcomes were similar, with noninferiority in the lower risk group and concerning differences among the higher-risk group. Risk assessment is critical at PEP initiation. Standard counseling is only noninferior for individuals with lower baseline risk; thus, enhanced counseling should be targeted to individuals at higher risk. © The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.

  17. Maternal CD4+ cell count decline after interruption of antiretroviral prophylaxis for the prevention of mother-to-child transmission of HIV.

    Science.gov (United States)

    Ekouevi, Didier; Abrams, Elaine J; Schlesinger, Malka; Myer, Landon; Phanuphak, Nittaya; Carter, Rosalind J

    2012-01-01

    We evaluated maternal CD4+ cell count (CD4+) decline after PMTCT prophylaxis in a multi-country HIV care program. Analysis was restricted to antiretroviral therapy (ART)-naive, HIV-infected pregnant women with CD4+ ≥250 cells/mm(3) at enrollment. Single-dose nevirapine (sd-NVP) or short-course antiretroviral prophylaxis (sc-ARVp) with zidovudine (AZT) or AZT + lamivudine (3TC) was initiated in 11 programs while 2 programs offered triple-drug antiretroviral prophylaxis (tARVp) (AZT+3TC+ NVP or nelfinavir). All regimens were stopped at delivery. CD4+ decline was defined as proportion of women who declined to CD4+ cells/mm(3) or cells/mm(3) at 24 months. Weibull regression was used for multivariable analysis. A total of 1,393 women with enrollment CD4+ ≥250 cells/mm(3) initiated tARVp (172; 12%) or sc-ARVp (532; 38%) during pregnancy or received intrapartum sd-NVP (689; 50%). At enrollment, maternal median age was 27 years (interquartile range (IQR) 23-30), median CD4+ was 469 cells/mm(3) (IQR: 363-613). At 24 months post-delivery, the cumulative probability of CD4+ decline to cells/mm(3) was 12% (95% CI: 10-14). Among a subgroup of 903 women with CD4+ ≥400 cells at enrollment, the 24 month cumulative probability of decline to CD4+ cells/mm(3) was 28%; (95% CI: 25-32). Lower antepartum CD4+ was associated with higher probability of CD4+ decline to cells/mm(3): 46% (CD4+400-499 cells/mm(3)) vs. 19% (CD4+ ≥500 cells/mm(3)). After adjusting for age, enrollment CD4+ and WHO stage, women who received tARVp or sd-NVP were twice as likely to experience CD4+ decline to cells/mm(3) within 24 months than women receiving sc-ARVp (adjusted hazard ratio: 2.2; 95% CI: 1.5-3.2, pcell count to ART eligibility thresholds by 24 months postpartum was common among women receiving PMTCT prophylaxis during pregnancy and/or delivery.

  18. Occupational Health Update: Focus on Preventing the Acquisition of Infections with Pre-exposure Prophylaxis and Postexposure Prophylaxis.

    Science.gov (United States)

    Weber, David J; Rutala, William A

    2016-09-01

    Health care personnel are commonly exposed to infectious agents via sharp injuries (eg, human immunodeficiency virus, hepatitis B virus, and hepatitis C virus), direct patient care (eg, pertussis and meningococcus), and the contaminated environment (eg, Clostridium difficile). An effective occupational program is a key aspect of preventing acquisition of an infection by offering the following: (1) education of health care personnel regarding proper handling of sharps, early identification and isolation of potentially infectious patients, and hand hygiene; (2) assuring immunity to vaccine-preventable diseases; and, (3) immediate availability of a medical evaluation after a nonprotected exposure to an infectious disease. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Biomedical Approaches to HIV Prevention in Women.

    Science.gov (United States)

    Heumann, Christine L

    2018-04-17

    Effective HIV prevention techniques for women are of critical importance, as nearly half of all HIV infections globally are in women. This article reviews the recent literature on biomedical approaches to HIV prevention in women. In trials in which women were adherent to oral pre-exposure prophylaxis (PrEP), PrEP was equally efficacious in men and women. However, in studies of oral PrEP exclusively in women, adherence was low, and it was not efficacious. In trials of topical PrEP, including vaginal tenofovir gel and the monthly dapivirine ring, efficacy was also dependent upon adherence. Treatment as prevention (TasP) is a very effective HIV prevention strategy, though limited in that it is not controlled by the HIV-uninfected partner. Adherence is an important factor in the efficacy of biomedical interventions for HIV prevention in women; continued research is needed to identify the most efficacious and acceptable agents for women. Oral PrEP is currently recommended for the following groups of HIV-negative women: heterosexual women in ongoing sexual relationships with a partner infected with or at substantial risk of HIV infection and women who inject drugs and share injection or drug preparation equipment.

  20. HIV Incidence and Predictors of Incident HIV among Men Who Have Sex with Men Attending a Sexual Health Clinic in Melbourne, Australia.

    Directory of Open Access Journals (Sweden)

    King T Cheung

    Full Text Available The aim of this study was to determine the risk factors for HIV infection and the incidence in men who have sex with men (MSM. It is important to identify subgroups of MSM in which preventive interventions such as pre-exposure prophylaxis (PrEP offered at the time of their last negative test would be considered cost-effective.We conducted a retrospective cohort study of MSM attending Melbourne Sexual Health Centre (MSHC during 2007-2013 with at least two HIV tests within 12 months of each other. Demographic characteristics, sexual and other behaviours, and bacterial sexually transmitted infection (STI diagnoses were extracted from the date of the last negative HIV test. HIV incidence rate (IR per 100 person-years for each risk factor was calculated.Of the 13907 MSM who attended MSHC, 5256 MSM had at least two HIV tests and were eligible, contributing 6391 person-years follow-up. 81 new HIV diagnoses were identified within 12 months of an HIV negative test with an incidence of 1.3 (95% CI: 1.0-1.6 per 100 person-years. Significant associations with subsequent HIV infection were: rectal gonorrhea (HIV IR: 3.4 95% CI: 2.1-5.2, rectal chlamydia (HIV IR: 2.6 95% CI: 1.7-3.7, inconsistent condom use (HIV IR: 2.1 95% CI: 1.6-2.7, use of post-exposure prophylaxis (HIV IR: 2.3 95% CI: 1.7-3.1, and injecting drug use (HIV IR: 8.5 95% CI: 3.4-17.5.The incidence of HIV was above 2.0% in subgroups of MSM with specific characteristics at the last HIV negative test. PrEP is considered cost effective at this incidence and could potentially be used along with other preventive interventions for these individuals in more than half of the population.

  1. African American Clergy Perspectives About the HIV Care Continuum: Results From a Qualitative Study in Jackson, Mississippi.

    Science.gov (United States)

    Nunn, Amy; Parker, Sharon; McCoy, Katryna; Monger, Mauda; Bender, Melverta; Poceta, Joanna; Harvey, Julia; Thomas, Gladys; Johnson, Kendra; Ransome, Yusuf; Sutten Coats, Cassandra; Chan, Phil; Mena, Leandro

    2018-01-01

    Mississippi has some of the most pronounced racial disparities in HIV infection in the country; African Americans comprised 37% of the Mississippi population but represented 80% of new HIV cases in 2015. Improving outcomes along the HIV care continuum, including linking and retaining more individuals and enhancing adherence to medication, may reduce the disparities faced by African Americans in Mississippi. Little is understood about clergy's views about the HIV care continuum. We assessed knowledge of African American pastors and ministers in Jackson, Mississippi about HIV and the HIV care continuum. We also assessed their willingness to promote HIV screening and biomedical prevention technologies as well as efforts to enhance linkage and retention in care with their congregations. Four focus groups were conducted with 19 African American clergy. Clergy noted pervasive stigma associated with HIV and believed they had a moral imperative to promote HIV awareness and testing; they provided recommendations on how to normalize conversations related to HIV testing and treatment. Overall, clergy were willing to promote and help assist with linking and retaining HIV positive individuals in care but knew little about how HIV treatment can enhance prevention or new biomedical technologies such as pre-exposure prophylaxis (PrEP). Clergy underscored the importance of building coalitions to promote a collective local response to the epidemic. The results of this study highlight important public health opportunities to engage African American clergy in the HIV care continuum in order to reduce racial disparities in HIV infection.

  2. The History of the HIV/AIDS Epidemic in Africa.

    Science.gov (United States)

    Kagaayi, Joseph; Serwadda, David

    2016-08-01

    HIV testing of African immigrants in Belgium showed that HIV existed among Africans by 1983. However, the epidemic was recognized much later in most parts of sub-Saharan Africa (SSA) due to stigma and perceived fear of possible negative consequences to the countries' economies. This delay had devastating mortality, morbidity, and social consequences. In countries where earlier recognition occurred, political leadership was vital in mounting a response. The response involved establishment of AIDS control programs and research on the HIV epidemiology and candidate preventive interventions. Over time, the number of effective interventions has grown; the game changer being triple antiretroviral therapy (ART). ART has led to a rapid decline in HIV-related morbidity and mortality in addition to prevention of onward HIV transmission. Other effective interventions include safe male circumcision, pre-exposure prophylaxis, and post-exposure prophylaxis. However, since none of these is sufficient by itself, delivering a combination package of these interventions is important for ending the HIV epidemic as a public health threat.

  3. Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence.

    Science.gov (United States)

    Newman, Peter A; Rubincam, Clara

    2014-12-01

    Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS' good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences.

  4. "I never thought that it would happen … " Experiences of HIV seroconverters among HIV-discordant partnerships in a prospective HIV prevention study in Kenya.

    Science.gov (United States)

    Ngure, Kenneth; Vusha, Sophie; Mugo, Nelly; Emmanuel-Fabula, Mira; Ngutu, Mariah; Celum, Connie; Baeten, Jared M; Heffron, Renee

    2016-12-01

    In spite of access to behavioral and biomedical HIV prevention strategies, HIV transmission occurs. For HIV-serodiscordant couples, prevention programs can be tailored to address individual and couples' needs to preserve their relationship while minimizing HIV risk. Programs for serodiscordant couples may benefit from learning from experiences of couples who transmit HIV. We conducted 20 individual in-depth interviews with 10 initially HIV-serodiscordant couples who transmitted HIV during prospective follow-up at a peri-urban research site in Thika, Kenya. Data were analyzed inductively to identify situations that led to prevention failure and coping mechanisms. Inconsistent condom use driven by low HIV risk perception and alcohol use often preceded seroconversion while persistent blame frequently hindered couples' communication soon after seroconversion. In this emerging era of antiretroviral-based HIV prevention, couples' counseling can capitalize on opportunities to foster a supportive environment to discuss initiation and adherence to time-limited pre-exposure prophylaxis and lifelong antiretroviral therapy, in addition to strategies to reduce alcohol use, diffuse blame, and use condoms.

  5. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-infected women receiving cotrimoxazole prophylaxis: a multicenter randomized placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Raquel González

    2014-09-01

    Full Text Available BACKGROUND: Intermittent preventive treatment in pregnancy (IPTp with sulfadoxine-pyrimethamine (SP is recommended for malaria prevention in HIV-negative pregnant women, but it is contraindicated in HIV-infected women taking daily cotrimoxazole prophylaxis (CTXp because of potential added risk of adverse effects associated with taking two antifolate drugs simultaneously. We studied the safety and efficacy of mefloquine (MQ in women receiving CTXp and long-lasting insecticide treated nets (LLITNs. METHODS AND FINDINGS: A total of 1,071 HIV-infected women from Kenya, Mozambique, and Tanzania were randomized to receive either three doses of IPTp-MQ (15 mg/kg or placebo given at least one month apart; all received CTXp and a LLITN. IPTp-MQ was associated with reduced rates of maternal parasitemia (risk ratio [RR], 0.47 [95% CI 0.27-0.82]; p=0.008, placental malaria (RR, 0.52 [95% CI 0.29-0.90]; p=0.021, and reduced incidence of non-obstetric hospital admissions (RR, 0.59 [95% CI 0.37-0.95]; p=0.031 in the intention to treat (ITT analysis. There were no differences in the prevalence of adverse pregnancy outcomes between groups. Drug tolerability was poorer in the MQ group compared to the control group (29.6% referred dizziness and 23.9% vomiting after the first IPTp-MQ administration. HIV viral load at delivery was higher in the MQ group compared to the control group (p=0.048 in the ATP analysis. The frequency of perinatal mother to child transmission of HIV was increased in women who received MQ (RR, 1.95 [95% CI 1.14-3.33]; p=0.015. The main limitation of the latter finding relates to the exploratory nature of this part of the analysis. CONCLUSIONS: An effective antimalarial added to CTXp and LLITNs in HIV-infected pregnant women can improve malaria prevention, as well as maternal health through reduction in hospital admissions. However, MQ was not well tolerated, limiting its potential for IPTp and indicating the need to find alternatives with

  6. Implementation and Operational Research: A Cost-Effective, Clinically Actionable Strategy for Targeting HIV Preexposure Prophylaxis to High-Risk Men Who Have Sex With Men.

    Science.gov (United States)

    Ross, Eric L; Cinti, Sandro K; Hutton, David W

    2016-07-01

    Preexposure prophylaxis (PrEP) is effective at preventing HIV infection among men who have sex with men (MSM), but there is uncertainty about how to identify high-risk MSM who should receive PrEP. We used a mathematical model to assess the cost-effectiveness of using the HIV Incidence Risk Index for MSM (HIRI-MSM) questionnaire to target PrEP to high-risk MSM. We simulated strategies of no PrEP, PrEP available to all MSM, and eligibility thresholds set to HIRI-MSM scores between 5 and 45, in increments of 5 (where a higher score predicts greater HIV risk). Based on the iPrEx, IPERGAY, and PROUD trials, we evaluated PrEP efficacies from 44% to 86% and annual costs from $5900 to 8700. We designate strategies with incremental cost-effectiveness ratio (ICER) ≤$100,000/quality-adjusted life-year (QALY) as "cost-effective." Over 20 years, making PrEP available to all MSM is projected to prevent 33.5% of new HIV infections, with an ICER of $1,474,000/QALY. Increasing the HIRI-MSM score threshold reduces the prevented infections, but improves cost-effectiveness. A threshold score of 25 is projected to be optimal (most QALYs gained while still being cost-effective) over a wide range of realistic PrEP efficacies and costs. At low cost and high efficacy (IPERGAY), thresholds of 15 or 20 are optimal across a range of other input assumptions; at high cost and low efficacy (iPrEx), 25 or 30 are generally optimal. The HIRI-MSM provides a clinically actionable means of guiding PrEP use. Using a score of 25 to determine PrEP eligibility could facilitate cost-effective use of PrEP among high-risk MSM who will benefit from it most.

  7. Assessing HIV Stigma on Prevention Strategies for Black Men Who Have Sex with Men in the United States.

    Science.gov (United States)

    Sang, Jordan M; Matthews, Derrick D; Meanley, Steven P; Eaton, Lisa A; Stall, Ron D

    2018-06-02

    The deleterious effects of HIV stigma on HIV+ Black MSM care continuum outcomes have been well-documented. How HIV stigma shapes HIV prevention for HIV- persons in this community is poorly understood. We sought to test the relationship of HIV stigma with HIV- Black MSM on HIV testing, pre-exposure prophylaxis (PrEP) awareness, and PrEP use. We recruited 772 participants at Black Pride events across five US cities in 2016. Multivariable logistic regression models assessed the association of external HIV stigma on prevention outcomes adjusting for sociodemographic variables. Stigma was positively associated with PrEP awareness (AOR = 1.34; 95% CI = 1.09, 1.66; p value = 0.005), and not associated with PrEP use or HIV testing in our sample. These findings highlight the complex nature of HIV stigma among BMSM and include results for PrEP, which can affect uptake other prevention methods. We support anti-HIV stigma efforts and advise further exploration on HIV stigma among BMSM and prevention outcomes.

  8. Malaria prophylaxis

    African Journals Online (AJOL)

    Malaria D:lay still be contracted despite good cOD:lpliance with ... true that prophylaxis is always better than no prophy- laxis, nor is ... If used during pregnancy, a folic acid supplement ... include folate deficiency, agranulocytosis, illegaloblastic.

  9. Linking HIV-Negative Youth to Prevention Services in 12 U.S. Cities: Barriers and Facilitators to Implementing the HIV Prevention Continuum.

    Science.gov (United States)

    Doll, Mimi; Fortenberry, J Dennis; Roseland, Denise; McAuliff, Kathleen; Wilson, Craig M; Boyer, Cherrie B

    2018-04-01

    Linkage of HIV-negative youth to prevention services is increasingly important with the development of effective pre-exposure prophylaxis that complements behavioral and other prevention-focused interventions. However, effective infrastructure for delivery of prevention services does not exist, leaving many programs to address HIV prevention without data to guide program development/implementation. The objective of this study was to provide a qualitative description of barriers and facilitators of linkage to prevention services among high-risk, HIV-negative youth. Thematic analysis of structured interviews with staff implementing linkage to prevention services programs for youth aged 12-24 years. Twelve adolescent medicine HIV primary care programs as part of larger testing research program focused on young sexual minority men of color. The study included staff implementing linkage to prevention services programs along with community-based HIV testing programs. The main outcomes of the study were key barriers/facilitators to linkage to prevention services. Eight themes summarized perspectives on linkage to prevention services: (1) relationships with community partners, (2) trust between providers and youth, (3) youth capacity to navigate prevention services, (4) pre-exposure prophylaxis specific issues, (5) privacy issues, (6) gaps in health records preventing tailored services, (7) confidentiality of care for youth accessing services through parents'/caretakers' insurance, and (8) need for health-care institutions to keep pace with models that prioritize HIV prevention among at-risk youth. Themes are discussed in the context of factors that facilitated/challenged linkage to prevention services. Several evidence-based HIV prevention tools are available; infrastructures for coordinated service delivery to high-risk youth have not been developed. Implementation of such infrastructures requires attention to community-, provider-, and youth-related issues. Copyright

  10. Getting PrEPared for HIV Prevention Navigation: Young Black Gay Men Talk About HIV Prevention in the Biomedical Era.

    Science.gov (United States)

    Mutchler, Matt G; McDavitt, Bryce; Ghani, Mansur A; Nogg, Kelsey; Winder, Terrell J A; Soto, Juliana K

    2015-09-01

    Biomedical HIV prevention strategies, such as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), represent new opportunities to reduce critically high HIV infection rates among young black men who have sex with men (YBMSM). We report results of 24 dyadic qualitative interviews (N=48), conducted in Los Angeles, CA, exploring how YBMSM and their friends view PrEP and PEP. Interviews were analyzed using a grounded theory approach. Participants had widely divergent levels of knowledge about these prevention methods. Misconceptions and mistrust regarding PrEP were common, and concerns were expressed about PrEP-related stigma and the potential for gossip among peers who might assume a person on PrEP was HIV-positive. Yet participants also framed PrEP and PEP as valuable new options within an expanded "tool kit" of HIV prevention strategies that created possibilities for preventing new HIV infections, dating men with a different HIV status, and decreased anxiety about exposure to HIV. We organized themes around four main areas: (1) information and misinformation about biomedical HIV prevention; (2) expectations about PrEP, sexual behavior, and stigma; (3) gossip, disclosure, and "spreading the word" about PrEP and PEP; and (4) the roles of PrEP and PEP in an expanded HIV prevention tool kit. The findings suggest a need for guidance in navigating the increasingly complex array of HIV-prevention options available to YBMSM. Such "prevention navigation" could counter misconceptions and address barriers, such as stigma and mistrust, while helping YBMSM make informed selections from among expanded HIV prevention options.

  11. Pre-exposure to moving form enhances static form sensitivity.

    Directory of Open Access Journals (Sweden)

    Thomas S A Wallis

    Full Text Available BACKGROUND: Motion-defined form can seem to persist briefly after motion ceases, before seeming to gradually disappear into the background. Here we investigate if this subjective persistence reflects a signal capable of improving objective measures of sensitivity to static form. METHODOLOGY/PRINCIPAL FINDINGS: We presented a sinusoidal modulation of luminance, masked by a background noise pattern. The sinusoidal luminance modulation was usually subjectively invisible when static, but visible when moving. We found that drifting then stopping the waveform resulted in a transient subjective persistence of the waveform in the static display. Observers' objective sensitivity to the position of the static waveform was also improved after viewing moving waveforms, compared to viewing static waveforms for a matched duration. This facilitation did not occur simply because movement provided more perspectives of the waveform, since performance following pre-exposure to scrambled animations did not match that following pre-exposure to smooth motion. Observers did not simply remember waveform positions at motion offset, since removing the waveform before testing reduced performance. CONCLUSIONS/SIGNIFICANCE: Motion processing therefore interacts with subsequent static visual inputs in a way that can improve performance in objective sensitivity measures. We suggest that the brief subjective persistence of motion-defined forms that can occur after motion offsets is a consequence of the decay of a static form signal that has been transiently enhanced by motion processing.

  12. Multi-level Correlates of Safer Conception Methods Awareness and Attitudes Among Ugandan HIV Clients with Fertility Intentions.

    Science.gov (United States)

    Wagner, Glenn J; Woldetsadik, Mahlet A; Beyeza-Kashesya, Jolly; Goggin, Kathy; Mindry, Deborah; Finocchario-Kessler, Sarah; Khanakwa, Sarah; Wanyenze, Rhoda K

    2016-03-01

    Many people living with HIV desire childbearing, but low cost safer conception methods (SCM) such as timed unprotected intercourse (TUI) and manual self-insemination (MSI) are rarely used. We examined awareness and attitudes towards SCM, and the correlates of these constructs among 400 HIV clients with fertility intentions in Uganda. Measures included awareness, self-efficacy, and motivation regarding SCM, as well as demographics, health management, partner and provider characteristics. Just over half knew that MSI (53%) and TUI (51%) reduced transmission risk during conception, and 15% knew of sperm washing and pre-exposure prophylaxis. In separate regression models for SCM awareness, motivation, and self-efficacy, nearly all independent correlates were related to the partner, including perceived willingness to use SCM, knowledge of respondent's HIV status, HIV-seropositivity, marriage and equality in decision making within the relationship. These findings suggest the importance of partners in promoting SCM use and partner inclusion in safer conception counselling.

  13. Sexual Assault: A Report on Human Immunodeficiency Virus Postexposure Prophylaxis

    Directory of Open Access Journals (Sweden)

    William F. Griffith

    2010-01-01

    Full Text Available The objective of this report is to describe an urban county hospital human immunodeficiency virus (HIV infection prevention protocol offering prophylactic combination antiretroviral medications to female victims of sexual assault. A retrospective chart review was conducted from June, 2007 through June, 2008 of 151 women who were prescribed antiretroviral prophylaxis by protocol. All women receiving HIV prophylaxis initially screened HIV seronegative. Of the 58 women who reported taking any HIV prophylaxis, 36 (62% were HIV screened at 12 and/or 24 weeks and none had HIV seroconverted. Although the initiation of an HIV post exposure prophylaxis protocol for sexual assault in a county hospital population is feasible, patient follow-up for counseling and HIV serostatus evaluation is an identified barrier

  14. Preliminary evidence of HIV seroconversion among HIV-negative men who have sex with men taking non-prescribed antiretroviral medication for HIV prevention in Miami, Florida, USA.

    Science.gov (United States)

    Buttram, Mance E; Kurtz, Steven P

    2017-04-01

    Background Limited information suggests that men who have sex with men (MSM) are informally obtaining antiretroviral medication (ARVs) and using them for HIV pre-exposure prophylaxis (PrEP). Data are drawn from an on-going study examining the use of non-prescribed ARVs for PrEP. To date, 24 qualitative interviews have been conducted with HIV-negative, substance-using MSM living in Miami, Florida, USA. Data are presented from two participants who reported HIV seroconversion while using non-prescribed ARVs for PrEP. Preliminary data indicate that some young MSM: (i) lack awareness of and accurate information about the efficacious use of PrEP; (ii) obtain non-prescribed ARVs from HIV-positive sex partners and use these medications for PrEP in a way that does not provide adequate protection against HIV infection or cohere with established guidelines; and (iii) engage in multiple HIV transmission risk behaviours, including condomless anal sex and injection drug use. The informal, non-prescribed and non-medically supervised use of ARVs for HIV prevention has the potential to undermine the protective benefits of PrEP and leave men unprotected against HIV transmission and at risk for ARV resistance.

  15. Minor drug-resistant HIV type-1 variants in breast milk and plasma of HIV type-1-infected Ugandan women after nevirapine single-dose prophylaxis.

    Science.gov (United States)

    Pilger, Daniel; Hauser, Andrea; Kuecherer, Claudia; Mugenyi, Kizito; Kabasinguzi, Rose; Somogyi, Sybille; Harms, Gundel; Kunz, Andrea

    2011-01-01

    Nevirapine single-dose (NVP-SD) reduces mother-to-child transmission of HIV type-1 (HIV-1), but frequently induces resistance mutations in the HIV-1 genome. Little is known about drug-resistant HIV-1 variants in the breast milk of women who have taken NVP-SD. Blood and breast milk samples of 39 HIV-1-infected Ugandan women were taken 6-12 weeks after NVP-SD intake. Samples were analysed by population sequencing and allele-specific real-time PCR (AS-PCR) with detection limits for NVP-resistant HIV-1 variants (K103N and Y181C) of D n = 5, G n = 2 and C n = 1). A total of 7 (37%) and 10 (53%) women carried NVP-resistant virus in breast milk and plasma, respectively. Overall, 71% (5/7) women with NVP-resistant HIV-1 in breast milk displayed >1 drug-resistant variant. Resistance in breast milk was higher at week 6 (6/13 samples [46%]) compared with week 12 (1/6 samples [17%]). In total, 10 drug-resistant populations harbouring the K103N and/or Y181C mutation were detected in the 19 breast milk samples; 7 (70%) were caused by resistant minorities (< 5% of the total HIV-1 population). In the four women with drug-resistant virus in both plasma and breast milk, the mutation patterns differed between the two compartments. Minor populations of drug-resistant HIV-1 were frequently found in breast milk of Ugandan women after exposure to NVP-SD. Further studies need to explore the role of minor drug-resistant variants in the postnatal transmission of (resistant) HIV-1.

  16. Exposure Prophylaxis

    African Journals Online (AJOL)

    opsig

    health care workers who report exposure to HIV at work whether given PEP or not ... breast milk, amniotic fluid, cerebrospinal fluid, pericardial fluid ... or skin lesions [1]. Other body fluid like sweat, tears, saliva, urine and stool do not contain significant quantities of HIV unless there is blood mixed with them[1,2]. HIV is not ...

  17. The informal use of antiretroviral medications for HIV prevention by men who have sex with men in South Florida: initiation, use practices, medications and motivations.

    Science.gov (United States)

    Buttram, Mance E

    2018-01-23

    Limited data suggest that some gay and other men who have sex with men are using antiretroviral medications informally, without a prescription, for HIV prevention. This qualitative study examined this phenomenon among gay and other men who have sex with men in South Florida. Participants initiated informal antiretroviral medication use as a means of protecting each other and because of the confidence in knowledge of antiretroviral medications shared by their friends and sex partners. The most commonly used medications included Truvada and Stribild. Motivations for use included condom avoidance, risk reduction, and fear of recent HIV exposure. Participants described positive and negative sentiments related to informal use, including concerns about informal antiretroviral medications offering sufficient protection against HIV, and limited knowledge about pre-exposure prophylaxis (PrEP). Because the antiretroviral medications used for PrEP have the potential to prevent HIV infection, future research must consider the informal antiretroviral medication use and related concerns, including adherence, diversion and viral resistance.

  18. Widow cleansing and inheritance among the Luo in Kenya: the need for additional women-centred HIV prevention options.

    Science.gov (United States)

    Perry, Brian; Oluoch, Lennah; Agot, Kawango; Taylor, Jamilah; Onyango, Jacob; Ouma, Lilian; Otieno, Caroline; Wong, Christina; Corneli, Amy

    2014-01-01

    The customs of widow cleansing and widow inheritance are practiced in several communities throughout sub-Saharan Africa. In the Nyanza Province of Kenya, according to tradition, Luo widows are expected to engage in sexual intercourse with a "cleanser," without the use of a condom, in order to remove the impurity ascribed to her after her husband's death. Luo couples, including widows, are also expected to engage in sex preceding specific agricultural activities, building homes, funerals, weddings, and other significant cultural and social events. Widows who are inherited for the purpose of fulfilling cultural obligation have a higher prevalence of HIV than those who remain un-inherited or are inherited for the purpose of companionship. As part of a larger descriptive qualitative study to inform study procedures for FEM-PrEP, an HIV prevention pre-exposure prophylaxis clinical trial, we conducted 15 semi-structured interviews (SSIs) with widows, 15 SSIs with inheritors, and four focus group discussions with widows in the Bondo and Rarieda districts in Nyanza Province to explore the HIV risk context within widow cleansing and inheritance practices. Thematic qualitative analysis was used to analyze the data. The majority of widows reported in the demographic questionnaire being inherited, and most widows in the SSIs described participating in the cleansing ritual. We identified two main themes related to HIV prevention within the context of widow cleansing and inheritance: 1) widows must balance limiting their risk for HIV infection with meeting cultural expectations and ensuring that their livelihood needs are met, and 2) sexual abstinence undermines cultural expectations in widowhood while the use of condoms is deemed inappropriate in fulfilling culturally prescribed sexual rituals, and is often beyond the widow's ability to negotiate. Women-controlled HIV prevention methods such as antiretroviral-based oral pre-exposure prophylaxis, vaginal gels, and vaginal rings

  19. Microbial Pre-exposure and Vectorial Competence of Anopheles Mosquitoes

    Directory of Open Access Journals (Sweden)

    Constentin Dieme

    2017-12-01

    Full Text Available Anopheles female mosquitoes can transmit Plasmodium, the malaria parasite. During their aquatic life, wild Anopheles mosquito larvae are exposed to a huge diversity of microbes present in their breeding sites. Later, adult females often take successive blood meals that might also carry different micro-organisms, including parasites, bacteria, and viruses. Therefore, prior to Plasmodium ingestion, the mosquito biology could be modulated at different life stages by a suite of microbes present in larval breeding sites, as well as in the adult environment. In this article, we highlight several naturally relevant scenarios of Anopheles microbial pre-exposure that we assume might impact mosquito vectorial competence for the malaria parasite: (i larval microbial exposures; (ii protist co-infections; (iii virus co-infections; and (iv pathogenic bacteria co-infections. In addition, significant behavioral changes in African Anopheles vectors have been associated with increasing insecticide resistance. We discuss how these ethological modifications may also increase the repertoire of microbes to which mosquitoes could be exposed, and that might also influence their vectorial competence. Studying Plasmodium–Anopheles interactions in natural microbial environments would efficiently contribute to refining the transmission risks.

  20. Tenofovir Disoproxil Fumarate Fails to Prevent HIV Acquisition or the Establishment of a Viral Reservoir: Two Case Reports.

    Science.gov (United States)

    Fox, Julie; Brady, Michael; Alexander, Hannah; Davies, Olubanke; Robinson, Nicola; Pace, Mathew; Else, Laura; Cason, John; Khoo, Saye; Back, David; Fidler, Sarah; Frater, John

    2016-03-01

    The use of antiretrovirals as pre-exposure prophylaxis (PrEP) is highly efficacious in HIV prevention. The World Health Organization recently recommended Truvada(®) (Gilead Sciences, Inc.) or tenofovir disoproxil fumarate (TDF) for high-risk individuals, with limited data for single-agent TDF PrEP in men who have sex with men (MSM). We report two cases of TDF PrEP failure in MSM who had received long-term TDF for hepatitis B infection and had therapeutic levels of drug immediately after HIV acquisition. Rapid antiretroviral intensification at diagnosis of acute HIV infection failed to limit immune dysfunction or prevent the establishment of a viral reservoir.

  1. Fertility Intentions, Pregnancy, and Use of PrEP and ART for Safer Conception Among East African HIV Serodiscordant Couples.

    Science.gov (United States)

    Heffron, Renee; Thomson, Kerry; Celum, Connie; Haberer, Jessica; Ngure, Kenneth; Mugo, Nelly; Bukusi, Elizabeth; Katabira, Elly; Odoyo, Josephine; Bulya, Nulu; Asiimwe, Stephen; Tindimwebwa, Edna; Baeten, Jared M

    2017-09-11

    African HIV serodiscordant couples often desire pregnancy, despite sexual HIV transmission risk during pregnancy attempts. Pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) reduce HIV risk and can be leveraged for safer conception but how well these strategies are used for safer conception is not known. We conducted an open-label demonstration project of the integrated delivery of PrEP and ART among 1013 HIV serodiscordant couples from Kenya and Uganda followed quarterly for 2 years. We evaluated fertility intentions, pregnancy incidence, the use of PrEP and ART during peri-conception, and peri-conception HIV incidence. At enrollment, 80% of couples indicated a desire for more children. Pregnancy incidence rates were 18.5 and 18.7 per 100 person years among HIV-uninfected and HIV-infected women, and higher among women who recently reported fertility intention (adjusted odds ratio 3.43, 95% CI 2.38-4.93) in multivariable GEE models. During the 6 months preceding pregnancy, 82.9% of couples used PrEP or ART and there were no HIV seroconversions. In this cohort with high pregnancy rates, integrated PrEP and ART was readily used by HIV serodiscordant couples, including during peri-conception periods. Widespread scale-up of safer conception counseling and services is warranted to respond to strong desires for pregnancy among HIV-affected men and women.

  2. Systemic administration of antiretrovirals prior to exposure prevents rectal and intravenous HIV-1 transmission in humanized BLT mice.

    Directory of Open Access Journals (Sweden)

    Paul W Denton

    2010-01-01

    Full Text Available Successful antiretroviral pre-exposure prophylaxis (PrEP for mucosal and intravenous HIV-1 transmission could reduce new infections among targeted high-risk populations including discordant couples, injection drug users, high-risk women and men who have sex with men. Targeted antiretroviral PrEP could be particularly effective at slowing the spread of HIV-1 if a single antiretroviral combination were found to be broadly protective across multiple routes of transmission. Therefore, we designed our in vivo preclinical study to systematically investigate whether rectal and intravenous HIV-1 transmission can be blocked by antiretrovirals administered systemically prior to HIV-1 exposure. We performed these studies using a highly relevant in vivo model of mucosal HIV-1 transmission, humanized Bone marrow/Liver/Thymus mice (BLT. BLT mice are susceptible to HIV-1 infection via three major physiological routes of viral transmission: vaginal, rectal and intravenous. Our results show that BLT mice given systemic antiretroviral PrEP are efficiently protected from HIV-1 infection regardless of the route of exposure. Specifically, systemic antiretroviral PrEP with emtricitabine and tenofovir disoproxil fumarate prevented both rectal (Chi square = 8.6, df = 1, p = 0.003 and intravenous (Chi square = 13, df = 1, p = 0.0003 HIV-1 transmission. Our results indicate that antiretroviral PrEP has the potential to be broadly effective at preventing new rectal or intravenous HIV transmissions in targeted high risk individuals. These in vivo preclinical findings provide strong experimental evidence supporting the potential clinical implementation of antiretroviral based pre-exposure prophylactic measures to prevent the spread of HIV/AIDS.

  3. The effect of nicotine pre-exposure on demand for cocaine and sucrose in male rats.

    Science.gov (United States)

    Schwartz, Lindsay P; Kearns, David N; Silberberg, Alan

    2018-06-01

    The aim of the present study was to determine how nicotine pre-exposure affects the elasticity of demand for intravenous cocaine and for sucrose pellets in adult male rats. In Experiment 1, demand for cocaine was assessed in rats that had nicotine in their drinking water. Nicotine pre-exposure significantly decreased rats' willingness to defend cocaine consumption as the price (measured as the number of responses per cocaine infusion) increased compared with a control group with no nicotine pre-exposure. That is, nicotine increased the elasticity of demand for cocaine infusions. Experiment 2 repeated the first experiment, but with rats working for sucrose pellets instead of cocaine. Nicotine pre-exposure had no effect on the elasticity of demand for sucrose. This pattern of results suggests that nicotine pre-exposure can reduce the reinforcing effects of cocaine, but not sucrose, in adult male rats.

  4. Achieving pregnancy safely for HIV-serodiscordant couples: a social ecological approach.

    Science.gov (United States)

    Saleem, Haneefa T; Narasimhan, Manjulaa; Denison, Julie A; Kennedy, Caitlin E

    2017-03-08

    The recognition and fulfilment of the sexual and reproductive health and rights (SRHR) of all individuals and couples affected by HIV, including HIV-serodiscordant couples, requires intervention strategies aimed at achieving safe and healthy pregnancies and preventing undesired pregnancies. Reducing risk of horizontal and vertical transmission and addressing HIV-related infertility are key components of such interventions. In this commentary, we present challenges and opportunities for achieving safe pregnancies for serodiscordant couples through a social ecological lens. At the individual level, knowledge (e.g. of HIV status, assisted reproductive technologies) and skills (e.g. adhering to antiretroviral therapy or pre-exposure prophylaxis) are important. At the couple level, communication between partners around HIV status disclosure, fertility desires and safer pregnancy is required. Within the structural domain, social norms, stigma and discrimination from families, community and social networks influence individual and couple experiences. The availability and quality of safer conception and fertility support services within the healthcare system remains essential, including training for healthcare providers and strengthening integration of SRHR and HIV services. Policies, legislation and funding can improve access to SRHR services. A social ecological framework allows us to examine interactions between levels and how interventions at multiple levels can better support HIV-serodiscordant couples to achieve safe pregnancies. Strategies to achieve safer pregnancies should consider interrelated challenges at different levels of a social ecological framework. Interventions across multiple levels, implemented concurrently, have the potential to maximize impact and ensure the full SRHR of HIV-serodiscordant couples.

  5. Burden and characteristics of HIV infection among female sex workers in Kampala, Uganda - a respondent-driven sampling survey.

    Science.gov (United States)

    Hladik, Wolfgang; Baughman, Andrew L; Serwadda, David; Tappero, Jordan W; Kwezi, Rachel; Nakato, Namakula D; Barker, Joseph

    2017-06-10

    Sex workers in Uganda are at significant risk for HIV infection. We characterized the HIV epidemic among Kampala female sex workers (FSW). We used respondent-driven sampling to sample FSW aged 15+ years who reported having sold sex to men in the preceding 30 days; collected data through audio-computer assisted self-interviews, and tested blood, vaginal and rectal swabs for HIV, syphilis, neisseria gonorrhea, chlamydia trachomatis, and trichomonas vaginalis. A total of 942 FSW were enrolled from June 2008 through April 2009. The overall estimated HIV prevalence was 33% (95% confidence intervals [CI] 30%-37%) and among FSW 25 years or older was 44%. HIV infection is associated with low levels of schooling, having no other work, never having tested for HIV, self-reported genital ulcers or sores, and testing positive for neisseria gonorrhea or any sexually transmitted infections (STI). Two thirds (65%) of commercial sex acts reportedly were protected by condoms; one in five (19%) FSW reported having had anal sex. Gender-based violence was frequent; 34% reported having been raped and 24% reported having been beaten by clients in the preceding 30 days. One in three FSW in Kampala is HIV-infected, suggesting a severe HIV epidemic in this population. Intensified interventions are warranted to increase condom use, HIV testing, STI screening, as well as antiretroviral treatment and pre-exposure prophylaxis along with measures to overcome gender-based violence.

  6. Burden and characteristics of HIV infection among female sex workers in Kampala, Uganda – a respondent-driven sampling survey

    Directory of Open Access Journals (Sweden)

    Wolfgang Hladik

    2017-06-01

    Full Text Available Abstract Background Sex workers in Uganda are at significant risk for HIV infection. We characterized the HIV epidemic among Kampala female sex workers (FSW. Methods We used respondent-driven sampling to sample FSW aged 15+ years who reported having sold sex to men in the preceding 30 days; collected data through audio-computer assisted self-interviews, and tested blood, vaginal and rectal swabs for HIV, syphilis, neisseria gonorrhea, chlamydia trachomatis, and trichomonas vaginalis. Results A total of 942 FSW were enrolled from June 2008 through April 2009. The overall estimated HIV prevalence was 33% (95% confidence intervals [CI] 30%-37% and among FSW 25 years or older was 44%. HIV infection is associated with low levels of schooling, having no other work, never having tested for HIV, self-reported genital ulcers or sores, and testing positive for neisseria gonorrhea or any sexually transmitted infections (STI. Two thirds (65% of commercial sex acts reportedly were protected by condoms; one in five (19% FSW reported having had anal sex. Gender-based violence was frequent; 34% reported having been raped and 24% reported having been beaten by clients in the preceding 30 days. Conclusions One in three FSW in Kampala is HIV-infected, suggesting a severe HIV epidemic in this population. Intensified interventions are warranted to increase condom use, HIV testing, STI screening, as well as antiretroviral treatment and pre-exposure prophylaxis along with measures to overcome gender-based violence.

  7. "I Did Not Want to Give Birth to a Child Who has HIV": Experiences Using PrEP During Pregnancy Among HIV-Uninfected Kenyan Women in HIV-Serodiscordant Couples.

    Science.gov (United States)

    Pintye, Jillian; Beima-Sofie, Kristin M; Kimemia, Grace; Ngure, Kenneth; Trinidad, Susan Brown; Heffron, Renee A; Baeten, Jared M; Odoyo, Josephine; Mugo, Nelly; Bukusi, Elizabeth A; Kelley, Maureen C; John-Stewart, Grace C

    2017-11-01

    The perceptions, motivations, and beliefs of HIV-uninfected women about pre-exposure prophylaxis (PrEP) use during pregnancy can influence its uptake and adherence. This study elicited the views of HIV-uninfected women with personal experience taking PrEP during pregnancy. Qualitative interviews were conducted with HIV-uninfected women who had personal experience taking PrEP while pregnant. Semistructured interviews were conducted with 21 HIV-uninfected Kenyan women in HIV-serodiscordant couples enrolled in an open-label PrEP demonstration project who became pregnant while using PrEP and continued PrEP through their pregnancy. Interviews were audio-recorded and transcribed into English. A qualitative descriptive analysis was performed, using a constant comparison approach to identify key themes related to PrEP use in pregnancy. Desire to remain HIV uninfected and have an HIV-free infant were strong motivators influencing continued use of PrEP during pregnancy. Supporting HIV-infected partners and childbearing within an HIV-serodiscordant relationship were also motivators. Women had challenges distinguishing normal pregnancy symptoms from PrEP side effects and were concerned that observed side effects could be signs of danger for the infant related to PrEP exposure. Health care providers were important conduits of knowledge about PrEP, and continuity of PrEP providers throughout pregnancy facilitated adherence. HIV-uninfected women in HIV-serodiscordant couples were motivated to use PrEP during pregnancy to remain HIV uninfected and to have an HIV-free child but had concerns about side effects. Health care providers will be important for PrEP messaging and adherence support in this unique population.

  8. Focus on the therapeutic efficacy of 3BNC117 against HIV-1: In vitro studies, in vivo studies, clinical trials and challenges.

    Science.gov (United States)

    Liu, Zhi-Jun; Bai, Jing; Liu, Feng-Li; Zhang, Xiang-Yang; Wang, Jing-Zhang

    2017-11-01

    3BNC117, which was discovered in 2011, is a broadly neutralizing antibody (bNAb) and specifically neutralizes the human immunodeficiency virus type-1 (HIV-1) by targeting the CD4-binding site. This is the first comprehensive review that focuses on the role of 3BNC117 in the prevention of HIV-1 and acquired immune deficiency syndrome (AIDS). Briefly, 3BNC117 neutralizes many HIV/SHIV strains in vitro, blocks HIV-1 acquisition in animal models via a pre-exposure prophylaxis, alleviates HIV-1-associated viremia via a post-exposure therapeutic effect, prevents the establishment of latent HIV-1 reservoirs, and induces both humoral and cellular anti-HIV immune responses in vivo. The outcomes of Phase I and Phase IIa clinical trials in 2015 and 2016 showed the safety, tolerability, and therapeutic efficacy of 3BNC117 in HIV-1-infected human individuals. Nevertheless, anti-3BNC117 antibodies and HIV-1 strains resistant to 3BNC117 pose clinical challenges to immunotherapy with 3BNC117, so potential strategies for optimizing the potency of 3BNC117 are suggested here. Predictably, HIV-1 prevention and AIDS treatment will benefit from combinational immunotherapies with 3BNC117 and other pharmaceuticals (bNAbs, antiretroviral medicines, viral inducers, etc.) in the near future. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Nevirapine, sodium concentration and HIV-1 RNA in breast milk and plasma among HIV-infected women receiving short-course antiretroviral prophylaxis

    DEFF Research Database (Denmark)

    Salado-Rasmussen, Kirsten; Theilgaard, Zahra Persson; Chiduo, Mercy G.

    2015-01-01

    and breast milk after intrapartum single-dose nevirapine combined with either 1-week tail of Combivir (zidovudine/lamivudine) or single-dose Truvada (tenofovir/emtricitabine). Methods Maternal plasma and bilateral breast milk samples were collected between April 2008 and April 2011 at 1, 4 and 6 weeks...... postpartum from HIV-infected Tanzanian women. Moreover, plasma samples were collected at delivery from mother and infant. Results HIV-1 RNA was quantified in 1,212 breast milk samples from 273 women. At delivery, 96% of the women and 99% of the infants had detectable nevirapine in plasma with a median...... (interquartile range, IQR) of 1.5 μg/mL (0.75–2.20 μg/mL) and 1.04 μg/mL (0.39–1.71 μg/mL), respectively (P women had detectable nevirapine in plasma and breast milk, with a median (IQR) of 0.13 μg/mL (0.13–0.39 μg/mL) and 0.22 μg/mL (0.13–0.34 μg...

  10. Challenges and emerging opportunities for the HIV prevention, treatment and care cascade in men who have sex with men in Asia Pacific.

    Science.gov (United States)

    van Griensven, Frits; Guadamuz, Thomas E; de Lind van Wijngaarden, Jan Willem; Phanuphak, Nittaya; Solomon, Sunil Suhas; Lo, Ying-Ru

    2017-08-01

    In Asia Pacific, most countries have expanded HIV treatment guidelines to include all those with HIV infection and adopted antiretroviral treatment for prevention (TFP) as a blanket strategy for HIV control. Although the overall epidemic development associated with this focus is positive, the HIV epidemic in men who have sex with men (MSM) is continuing unperturbed without any signs of decline or reversal. This raises doubt about whether TFP as a blanket HIV prevention policy is the right approach. This paper reviews currently available biomedical HIV prevention strategies, national HIV prevention policies and guidelines from selected countries and published data on the HIV cascade in MSM. No evidence for efficacy of TFP in protecting MSM from HIV infection was found. The rationale for this approach is based on assumptions about biological plausibility and external validity of latency-based efficacy found in heterosexual couples. This is different from the route and timing of HIV transmission in MSM. New HIV infections in MSM principally occur in chains of acutely HIV-infected highly sexually active young men, in whom acquisition and transmission are correlated in space and time. By the time TFP renders its effects, most new HIV infections in MSM will have already occurred. On a global level, less than 6% of all reports regarding the HIV care cascade from 1990 to 2016 included MSM, and only 2.3% concerned MSM in low/middle-income countries. Only one report originated from Asia Pacific. Generally, HIV cascade data in MSM show a sobering picture of TFP in engaging and retaining MSM along the continuum. Widening the cascade with a preventive extension, including pre-exposure prophylaxis, the first proven efficacious and only biomedical HIV prevention strategy in MSM, will be instrumental in achieving HIV epidemic control in this group. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No

  11. Effect of cotrimoxazole prophylaxis on malaria occurrence in HIV-infected patients on antiretroviral therapy in sub-Saharan Africa*

    Science.gov (United States)

    Kasirye, R; Baisley, K; Munderi, P; Grosskurth, H

    2015-01-01

    Objective To systematically review the evidence on the effect of cotrimoxazole (CTX) on malaria in HIV-positive individuals on antiretroviral therapy (ART). Methods Web of Science, PubMed and MEDLINE, EMBASE, Global Health and Cochrane Library databases were searched using terms for malaria, HIV and CTX. Studies meeting the inclusion criteria were reviewed and assessed for bias and confounding. Results Six studies (in Uganda, Kenya, Malawi, Zambia and Zimbabwe) had relevant data on the effect of CTX on malaria in patients on ART: four were observational cohort studies (OCS) and two were randomised controlled trials (RCTs); two were in children and one in women only. Samples sizes ranged from 265 to 2200 patients. Four studies compared patients on ART and CTX with patients on ART alone; 2 (RCTs) found a significant increase in smear-positive malaria on ART alone: (IRR 32.5 CI = 8.6–275.0 and HR 2.2 CI = 1.5–3.3) and 2 (OCS) reported fewer parasitaemia episodes on CTX and ART (OR 0.85 CI = 0.65–1.11 and 3.6% vs. 2.4% of samples P = 0.14). One OCS found a 76% (95% CI = 63–84%) vs. 83% (95% CI = 74–89%) reduction in malaria incidence in children on CTX and ART vs. on CTX only, when both were compared with HIV-negative children. The other reported a 64% reduction in malaria incidence after adding ART to CTX (RR = 0.36, 95% CI = 0.18–0.74). The 2 RCTs were unblinded. Only one study reported adherence to CTX and ART, and only two controlled for baseline CD4 count. Conclusion Few studies have investigated the effect of CTX on malaria in patients on ART. Their findings suggest that CTX is protective against malaria even among patients on ART. Objectif Analyser systématiquement les données sur l'effet du cotrimoxazole (CTX) sur le paludisme chez les personnes VIH positives sous traitement antirétroviral (ART). Méthodes Web of Science, PubMed et Medline, Embase, Global Health et les bases de données de Cochrane Library ont été recherchés en

  12. Knowledge and acceptability of alternative HIV prevention bio-medical products among MSM who bareback.

    Science.gov (United States)

    Nodin, N; Carballo-Diéguez, A; Ventuneac, A M; Balan, I C; Remien, R

    2008-01-01

    Condom use is the best available strategy to prevent HIV infection during sexual intercourse. However, since many people choose not to use condoms in circumstances in which HIV risk exists, alternatives to condom use for HIV prevention are needed. Currently there are several alternative bio-medical HIV-prevention products in different stages of development: microbicides, vaccines, post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP). Seventy-two men who have sex with men (MSM) who took part in a study on Internet use and intentional condomless anal intercourse were asked about these four products during a semi-structured interview. The questions explored knowledge and acceptability of all the products and willingness to participate in microbicide and vaccine trials. Qualitative analysis of the data suggests that these men had virtually no knowledge of PrEP, very limited knowledge of microbicides, some information about PEP and considerably more knowledge about vaccines. Reactions towards the products were generally positive except for PrEP, for which reactions were polarized as either enthusiastic or negative. With the exception of PrEP, many men expressed willingness to use the products in the future. Most men would be willing to participate in trials for microbicides and vaccines if given basic reassurances. Concerns over negative side effects and preoccupation with possible infection were some of the motives given for non-willingness to participate in a vaccine trial. These results should inform the development of future trials of biomedical prevention products.

  13. Strategies to prevent HIV transmission to serodiscordant couples.

    Science.gov (United States)

    Hallal, Ronaldo Campos; Raxach, Juan Carlos; Barcellos, Nêmora Tregnago; Maksud, Ivia

    2015-09-01

    The use antiretroviral reduces the sexual transmission of HIV, expanding interventions for serodiscordant couples. This article aims to review the use of antiretroviral and other prevention interventions among serodiscordant couples and to analyze its use in Brazil. A retrospective review was performed through the MEDLINE database and bases included in the Biblioteca Virtual em Saúde. The articles recovered exhibit four main strategies: (1) condom; (2) reduction of risks in sexual practices; (3) use of antiretrovirals, particularly early initiation of antiretroviral therapy (TASP) and pre-exposure prophylaxis (PrEP); (4) risk reduction in reproduction. TASP is highly effective in reducing sexual transmission, PrEP was tested in serodiscordant couples and both reduce the sexual transmission risk in different sexual practices, enabling individualized prevention strategies. When used in combination, antiretrovirals and sexual practices with condoms offer greater efficacy than any single strategy. The combined use of new and old strategies allows us to build a prevention policy for all.

  14. Why HIV positive patients on antiretroviral treatment and/or cotrimoxazole prophylaxis use traditional medicine: perceptions of health workers, traditional healers and patients: a study in two provinces of South Africa.

    Science.gov (United States)

    Puoane, T R; Hughes, G D; Uwimana, J; Johnson, Q; Folk, W R

    2012-01-01

    The study explored the perceptions, knowledge and attitudes of patients, health workers and traditional healers about the use of traditional medicine and Anti Retroviral Therapy (ART). The study explored the perceptions, knowledge and attitudes of patients, health workers and traditional healers about the use of traditional medicine and Anti Retroviral Therapy (ART), using an exploratory qualitative design in two provinces of South Africa: an urban township health facility in the Western Cape, and a rural district hospital in KwaZulu-Natal (KZN) with antennal HIV rate of 32% and 28%'respectively. In-depth interviews were conducted with 14 participants: six HIV patients on ART and using Traditional Medicine(TM), two doctors, two nurses and four traditional healers. Two focus group discussions -one at each site - were held with community health workers who work with HIV-positive patients (Western Cape [5] and in KZN [4]). Patient said to have used Traditional Healing Practices (THP) before they were diagnosed with HIV, and some who have been diagnosed with HIV continue using TM in conjunction with ART and/or Cotrimoxazole prophylaxis. Patients preferred not to disclose THP to health professionals because of lack of support and understanding. Patients utilize THP because of family expectations, privacy and confidentiality, especially when they have not disclosed their HIV status. Healthcare professionals had strong negative opinions about THP, especially for HIV-positive patients. Traditional healers supported the patient's rationale for THP use. This study revealed a need to better understand factors involved in patients' choosing to use THP concurrently with ART.

  15. Treatment and prevention of HIV infection with long-acting antiretrovirals.

    Science.gov (United States)

    Benítez-Gutiérrez, Laura; Soriano, Vicente; Requena, Silvia; Arias, Ana; Barreiro, Pablo; de Mendoza, Carmen

    2018-05-01

    Current antiretroviral therapy allows to achieve and sustain maximal suppression of HIV replication in most treated patients. As result, the life expectancy of HIV-infected persons has improved dramatically and is nowadays similar to that of the HIV-negative population. However, oral antiretrovirals have to be taken daily and indefinitely to avoid resumption of HIV replication and selection of drug resistance. Unfortunately, drug adherence is often suboptimal and tends to decline over time. Areas covered: New drugs, formulations and delivery systems are being developed for extended-release of antiretrovirals. At this time, intramuscular cabotegravir and rilpivirine, dapivirine vaginal rings and tenofovir alafenamide subdermal implants are the products in more advanced stages of clinical development. Their pharmacokinetics/dynamics and safety/efficacy are reviewed. Expert commentary: In the absence of eradicative therapy for individuals with HIV infection and protective vaccines for persons at risk, long-term antiretroviral therapy is the best approach for preventing disease progression in patients and halting transmissions, either as result of 'treatment as prevention' for HIV carriers or 'pre-exposure prophylaxis' for uninfected individuals at risk. In all these scenarios, the advent of long-acting antiretrovirals will expand options for overcoming the challenge of suboptimal drug adherence and reduce the burden of HIV infection.

  16. Factors affecting adherence to short-course ARV prophylaxis for preventing mother-to-child transmission of HIV in sub-Saharan Africa: a review and lessons for future elimination.

    Science.gov (United States)

    Colombini, Manuela; Stöckl, Heidi; Watts, Charlotte; Zimmerman, Cathy; Agamasu, Enyonam; Mayhew, Susannah H

    2014-01-01

    Despite the biomedical potential to eliminate vertical HIV transmission, drug adherence to short regimens is often sub-optimal. To inform future programmes, we reviewed evidence on the factors influencing maternal and infant drug adherence to preventing MTCT drug regimens at delivery in sub-Saharan Africa. A literature review yielding 14 studies on adherence to drug regimes among HIV-positive pregnant women and mothers in sub-Saharan Africa was conducted. Rates of maternal adherence to preventive drug regimens at time of delivery varied widely across sites between 35 and 93.5%. Factors most commonly associated with low adherence to antiretroviral therapy (ARV) prophylaxis for preventing MTCT at the health system level include giving birth at home, quality and timing of HIV testing and counselling, and late distribution of nevirapine (NVP). Socio-demographic and demand-side factors include fear of stigma, lack of male involvement, fear of partner's reaction to disclosure, few antenatal (ANC) visits, young age and lack of education. With the implementation of the newly published WHO guidelines recommending triple-drug ARV regimen during pregnancy and breastfeeding for all women with HIV, it is important that women are able to adhere to recommended drug regimens. Service improvements should include clear and timely communication with women about the benefits of combined regimens and greater emphasis on patient confidentiality. Efforts must be made to help women overcome barriers that reduce adherence, such as financial logistical challenges, social stigma and women's fear of violence.

  17. Post exposure prophylaxis against human immunodeficiency virus ...

    African Journals Online (AJOL)

    Objective: To determine the level of awareness, knowledge and practice of human immunodeficiency virus post exposure prophylaxis (HIV PEP) among paediatricians in Nigeria. Methodology: The study was a cross sectional questionnairebased survey conducted among paediatrcians that attended the Paediatric ...

  18. Post exposure prophylaxis against human immunodeficiency virus ...

    African Journals Online (AJOL)

    2015-11-23

    Nov 23, 2015 ... Abstract: Objective: To deter- mine the level of awareness, knowledge and practice of human immunodeficiency virus post ex- posure prophylaxis (HIV PEP) among paediatricians in Nigeria. Methodology: The study was a cross sectional questionnaire- based survey conducted among paediatrcians that ...

  19. Implications of HIV PrEP Trials Results

    Science.gov (United States)

    Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

    2011-01-01

    Abstract Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of HIV Pre-Exposure Prophylaxis (PrEP) Trials Results sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Bill and Melinda Gates Foundation (BMGF) was held on January 29, 2010, at the Natcher Conference Center, NIH, Bethesda, MD. Participants included basic scientists, clinical researchers (including investigators performing the current PrEP trials), and representatives from the U.S. Food and Drug Administration (FDA) and the agencies sponsoring the trials: the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), the BMGF, and the U.S. NIH. We report here a summary of the presentations and highlights of salient discussion topics from this workshop. PMID:20969483

  20. Clinical use of vaginal or rectally applied microbicides in patients suffering from HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Gupta SK

    2013-10-01

    Full Text Available Satish Kumar Gupta, Nutan Reproductive Cell Biology Laboratory, National Institute of Immunology, New Delhi, India Abstract: Microbicides, primarily used as topical pre-exposure prophylaxis, have been proposed to prevent sexual transmission of HIV. This review covers the trends and challenges in the development of safe and effective microbicides to prevent sexual transmission of HIV. Initial phases of microbicide development used such surfactants as nonoxynol-9 (N-9, C13G, and sodium lauryl sulfate, aiming to inactivate the virus. Clinical trials of microbicides based on N-9 and C31G failed to inhibit sexual transmission of HIV. On the contrary, N-9 enhanced susceptibility to sexual transmission of HIV-1. Subsequently, microbicides based on polyanions and a variety of other compounds that inhibit the binding, fusion, or entry of virus to the host cells were evaluated for their efficacy in different clinical setups. Most of these trials failed to show either safety or efficacy for prevention of HIV transmission. The next phase of microbicide development involved antiretroviral drugs. Microbicide in the form of 1% tenofovir vaginal gel when tested in a Phase IIb trial (CAPRISA 004 in a coitally dependent manner revealed that tenofovir gel users were 39% less likely to become HIV-infected compared to placebo control. However, in another trial (VOICE MTN 003, tenofovir gel used once daily in a coitally independent mode failed to show any efficacy to prevent HIV infection. Tenofovir gel is currently in a Phase III safety and efficacy trial in South Africa (FACTS 001 employing a coitally dependent dosing regimen. Further, long-acting microbicide-delivery systems (vaginal ring for slow release of such antiretroviral drugs as dapivirine are also undergoing clinical trials. Discovering new markers as correlates of protective efficacy, novel long-acting delivery systems with improved adherence in the use of microbicides, discovering new compounds

  1. Comparing Provider and Client Preferences for HIV Prevention Services in South Africa among Men Who Have Sex with Men.

    Science.gov (United States)

    Shaver, John; Sullivan, Patrick; Siegler, Aaron; de Voux, Alex; Phaswana-Mafuya, Nancy; Bekker, Linda-Gail; Baral, Stefan D; Wirtz, Andrea L; Beyrer, Chris; Brown, Ben; Stephenson, Rob

    Combination prevention efforts are now recommended toward reducing HIV incidence among men who have sex with men (MSM). Understanding the perceptions of both MSM and service providers is critical to informing the development of prevention packages and ultimately improving intervention effectiveness. This study assessed the preferences of MSM and health service providers in the administration of HIV-prevention efforts. Qualitative data were gathered from a series of separate MSM and health care provider focus groups in 2 South African cities. Participants discussed HIV-prevention services and MSM client experiences within South Africa and identified the 3 most important clinic characteristics and 3 most important HIV-prevention services for MSM clients. Priorities indicated by both MSM and health care providers were confidentiality of visit, friendly staff, and condoms, while discrepancies existed between MSM and providers regarding provider consistency and the provision of pre-exposure prophylaxis/post-exposure prophylaxis (PrEP/PEP) and lubricant as prevention methods. Effective interventions must address these discrepancies through the design of intervention and provider training to optimally accommodate MSM.

  2. Creating effective partnerships for HIV prevention trials: report of a UNAIDS Consultation, Geneva 20-21 June 2005.

    Science.gov (United States)

    2006-04-04

    With an estimated 5 million adults and children newly infected worldwide in 2005, research into new HIV prevention technologies and approaches is urgently needed. Prompted by the heated debate in 2004 about trials of tenofovir for HIV pre-exposure prophylaxis, UNAIDS initiated a year-long process to promote effective partnerships between researchers and civil society in HIV prevention trials, culminating in the 'Creating effective partnerships for HIV prevention trials' consultation in June 2005. Key stakeholders, including researchers, activists, ethicists, government officials, international agencies, civil society, trial participants, sponsors and funders addressed a wide range of issues concerning the rapidly evolving and sometimes tense dynamics of HIV prevention research partnerships. Implementation of the technical and procedural recommendations from this consultation requires collaboration, commitment and a willingness to experiment with new approaches and work with new partners. Researchers, donors, governments, community groups and activists must all be willing to define responsibilities and be held accountable for their contributions to HIV prevention research partnerships, weighing and balancing gains against the costs of time, money, and capacity as the HIV epidemic progresses.

  3. Will "Combined Prevention" Eliminate Racial/Ethnic Disparities in HIV Infection among Persons Who Inject Drugs in New York City?

    Directory of Open Access Journals (Sweden)

    Don Des Jarlais

    Full Text Available It has not been determined whether implementation of combined prevention programming for persons who inject drugs reduce racial/ethnic disparities in HIV infection. We examine racial/ethnic disparities in New York City among persons who inject drugs after implementation of the New York City Condom Social Marketing Program in 2007. Quantitative interviews and HIV testing were conducted among persons who inject drugs entering Mount Sinai Beth Israel drug treatment (2007-2014. 703 persons who inject drugs who began injecting after implementation of large-scale syringe exchange were included in the analyses. Factors independently associated with being HIV seropositive were identified and a published model was used to estimate HIV infections due to sexual transmission. Overall HIV prevalence was 4%; Whites 1%, African-Americans 17%, and Hispanics 4%. Adjusted odds ratios were 21.0 (95% CI 5.7, 77.5 for African-Americans to Whites and 4.5 (95% CI 1.3, 16.3 for Hispanics to Whites. There was an overall significant trend towards reduced HIV prevalence over time (adjusted odd ratio = 0.7 per year, 95% confidence interval (0.6-0.8. An estimated 75% or more of the HIV infections were due to sexual transmission. Racial/ethnic disparities among persons who inject drugs were not significantly different from previous disparities. Reducing these persistent disparities may require new interventions (treatment as prevention, pre-exposure prophylaxis for all racial/ethnic groups.

  4. Combination HIV prevention for female sex workers: what is the evidence?

    Science.gov (United States)

    Bekker, Linda-Gail; Johnson, Leigh; Cowan, Frances; Overs, Cheryl; Besada, Donela; Hillier, Sharon; Cates, Willard

    2015-01-03

    Sex work occurs in many forms and sex workers of all genders have been affected by HIV epidemics worldwide. The determinants of HIV risk associated with sex work occur at several levels, including individual biological and behavioural, dyadic and network, and community and social environmental levels. Evidence indicates that effective HIV prevention packages for sex workers should include combinations of biomedical, behavioural, and structural interventions tailored to local contexts, and be led and implemented by sex worker communities. A model simulation based on the South African heterosexual epidemic suggests that condom promotion and distribution programmes in South Africa have already reduced HIV incidence in sex workers and their clients by more than 70%. Under optimistic model assumptions, oral pre-exposure prophylaxis together with test and treat programmes could further reduce HIV incidence in South African sex workers and their clients by up to 40% over a 10-year period. Combining these biomedical approaches with a prevention package, including behavioural and structural components as part of a community-driven approach, will help to reduce HIV infection in sex workers in different settings worldwide. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Additional gonorrhea and Chlamydia infections found with rapid follow-up screening in men who have sex with men with an indication for HIV postexposure prophylaxis

    NARCIS (Netherlands)

    de Vrieze, Nynke H. N.; van Rooijen, Martijn S.; van de Loeff, Maarten Schim; de Vries, Henry J. C.

    2014-01-01

    Sexually transmitted infection was found in 16.5% of the men who have sex with men with a postexposure prophylaxis indication. Chlamydia and gonorrhea screening was repeated after 14 days. Among those who were initially sexually transmitted infection negative, 4.1% had chlamydia or gonorrhea. In

  6. Indigenous HIV Prevention Beliefs and Practices Among Low-Earning Chinese Sex Workers as Context for Introducing Female Condoms and Other Novel Prevention Options.

    Science.gov (United States)

    Dunn, Jennifer; Zhang, Qingning; Weeks, Margaret R; Li, Jianghong; Liao, Susu; Li, Fei

    2017-07-01

    New interventions to reduce HIV and sexually transmitted infections (STI) among female sex workers are introduced into the context of women's existing prevention beliefs and practices. These indigenous practices affected implementation of our program to introduce female condoms to women in sex-work establishments in southern China. We used ethnographic field observations and in-depth interviews to document common prevention methods women reported using to protect themselves before and during intervention implementation. Individual, sex-work establishment, and other contextual factors, including sources of information and social and economic pressures to use or reject prevention options, shaped their perceptions and selection of these methods and affected adoption of female condoms as an additional tool. Efforts to improve uptake of effective prevention methods among low-income sex workers require attention to the context and spectrum of women's HIV/STI prevention practices when introducing innovations such as female condoms, microbicides, pre-exposure prophylaxis pills, and others, as they become available.

  7. Nanomedicine in the development of anti-HIV microbicides.

    Science.gov