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Sample records for hiv intervention trials

  1. Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes.

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    Weiser, Sheri D; Bukusi, Elizabeth A; Steinfeld, Rachel L; Frongillo, Edward A; Weke, Elly; Dworkin, Shari L; Pusateri, Kyle; Shiboski, Stephen; Scow, Kate; Butler, Lisa M; Cohen, Craig R

    2015-09-10

    Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. This is a pilot cluster randomized controlled trial. The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/μl, P security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.

  2. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

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    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  3. Efficacy of a process improvement intervention on delivery of HIV services to offenders: a multisite trial.

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    Pearson, Frank S; Shafer, Michael S; Dembo, Richard; Del Mar Vega-Debién, Graciela; Pankow, Jennifer; Duvall, Jamieson L; Belenko, Steven; Frisman, Linda K; Visher, Christy A; Pich, Michele; Patterson, Yvonne

    2014-12-01

    We tested a modified Network for the Improvement of Addiction Treatment (NIATx) process improvement model to implement improved HIV services (prevention, testing, and linkage to treatment) for offenders under correctional supervision. As part of the Criminal Justice Drug Abuse Treatment Studies, Phase 2, the HIV Services and Treatment Implementation in Corrections study conducted 14 cluster-randomized trials in 2011 to 2013 at 9 US sites, where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training. The outcome measure was the odds of successful delivery of an HIV service. The results were significant at the .05 level, and the point estimate for the odds ratio was 2.14. Although overall the results were heterogeneous, the experiments that focused on implementing HIV prevention interventions had a 95% confidence interval that exceeded the no-difference point. Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments.

  4. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.

    Directory of Open Access Journals (Sweden)

    2005-11-01

    Full Text Available BACKGROUND: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. METHODS AND FINDINGS: A total of 3,274 uncircumcised men, aged 18-24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 - RR. The trial was stopped at the interim analysis, and the mean (interquartile range follow-up was 18.1 mo (13.0-21.0 when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years in the intervention group and 49 (2.1 per 100 person-years in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%-0.68%; p < 0.001. This RR corresponds to a protection of 60% (95% CI: 32%-76%. When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%-77%. CONCLUSION: Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil..

  5. Development of a Multilevel Intervention to Increase HIV Clinical Trial Participation among Rural Minorities

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    Corbie-Smith, Giselle; Odeneye, Ebun; Banks, Bahby; Shandor Miles, Margaret; Roman Isler, Malika

    2013-01-01

    Minorities are disproportionately affected by HIV/AIDS in the rural Southeast; therefore, it is important to develop targeted, culturally appropriate interventions to support rural minority participation in HIV/AIDS research. Using intervention mapping, we developed a comprehensive multilevel intervention for service providers (SPs) and people…

  6. Pilot trial of an expressive writing intervention with HIV-positive methamphetamine-using men who have sex with men.

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    Carrico, Adam W; Nation, Austin; Gómez, Walter; Sundberg, Jeffrey; Dilworth, Samantha E; Johnson, Mallory O; Moskowitz, Judith T; Rose, Carol Dawson

    2015-06-01

    Among men who have sex with men (MSM), the co-occurrence of trauma and stimulant use has negative implications for HIV/AIDS prevention. HIV-positive, methamphetamine-using MSM were recruited to pilot test a 7-session, multicomponent resilient affective processing (RAP) intervention that included expressive writing exercises targeting HIV-related traumatic stress. An open-phase pilot with 10 participants provided support for feasibility of intervention delivery such that 99% of the RAP sessions were completed in a 1-month period. Subsequently, 23 additional participants were enrolled in a pilot randomized controlled trial of the RAP intervention (n = 12) versus an attention-control condition that included writing exercises about neutral topics (n = 11). Acceptability was evidenced by participants randomized to RAP expressing significantly more negative emotions in their writing and reporting greater likelihood of recommending expressive writing exercises to a friend living with HIV. Over the 3-month follow-up period, attention-control participants reported significant decreases in HIV-related traumatic stress while RAP intervention participants reported no significant changes. Compared to attention-control participants, those in the RAP intervention reported significant reductions in the frequency of methamphetamine use immediately following the 1-month RAP intervention period. Thematic analyses of RAP expressive writing exercises revealed that multiple negative life events characterized by social stigma or loss contribute to the complex nature of HIV-related traumatic stress. Findings support the feasibility and acceptability of an exposure-based intervention targeting HIV-related traumatic stress. However, more intensive intervention approaches that simultaneously target trauma and stimulant use will likely be needed to optimize HIV/AIDS prevention efforts with this population. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  7. Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

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    Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

    2016-01-01

    Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

  8. Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

    Science.gov (United States)

    Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

    2015-06-01

    The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

  9. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men.

    Directory of Open Access Journals (Sweden)

    Sabina Hirshfield

    Full Text Available As HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM. Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts.A randomized controlled trial (RCT conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631. No participant incentives were provided.Follow-up was completed by 1,631 (53% of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure ('asked and told' with their last sexual partner (OR 1.32, 95% CI 1.01-1.74. Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54-0.91 and webpage condition (OR 0.43, 95% CI 0.25-0.72 significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20-0.67 and serodiscordant UAI (OR 0.53, 95% CI 0.28-0.96 at follow-up.Findings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing individual knowledge, motivations, and community norms.ClinicalTrials.gov NCT

  10. Efficacy of an adapted HIV and sexually transmitted infection prevention intervention for incarcerated women: a randomized controlled trial.

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    Fogel, Catherine I; Crandell, Jamie L; Neevel, A M; Parker, Sharon D; Carry, Monique; White, Becky L; Fasula, Amy M; Herbst, Jeffrey H; Gelaude, Deborah J

    2015-04-01

    We tested the efficacy of an adapted evidence-based HIV-sexually transmitted infection (STI) behavioral intervention (Providing Opportunities for Women's Empowerment, Risk-Reduction, and Relationships, or POWER) among incarcerated women. We conducted a randomized trial with 521 women aged 18 to 60 years in 2 correctional facilities in North Carolina in 2010 and 2011. Intervention participants attended 8 POWER sessions; control participants received a single standard-of-care STI prevention session. We followed up at 3 and 6 months after release. We examined intervention efficacy with mixed-effects models. POWER participants reported fewer male sexual partners than did control participants at 3 months, although this finding did not reach statistical significance; at 6 months they reported significantly less vaginal intercourse without a condom outside of a monogamous relationship and more condom use with a main male partner. POWER participants also reported significantly fewer condom barriers, and greater HIV knowledge, health-protective communication, and tangible social support. The intervention had no significant effects on incident STIs. POWER is a behavioral intervention with potential to reduce risk of acquiring or transmitting HIV and STIs among incarcerated women returning to their communities.

  11. A profile of U.S.-based trials of behavioral and social interventions for HIV risk reduction.

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    Semaan, Salaam; Kay, Linda; Strouse, Darcy; Sogolow, Ellen; Mullen, Patricia Dolan; Neumann, Mary Spink; Flores, Stephen A; Peersman, Greet; Johnson, Wayne D; Lipman, Paula Darby; Eke, Agatha; Des Jarlais, Don C

    2002-07-01

    We describe 99 (experimental and certain quasi-experimental) U.S.-based trials, reported or published since 1988, of behavioral and social interventions that measured prespecified behavioral and biologic outcomes and aimed to reduce risk for HIV infection. Studies identified through June 1998 by the HIV/AIDS Prevention Research Synthesis project were grouped into 4 risk behavior areas: drug-related (k [number of studies] = 48), heterosexual youth (k = 24), heterosexual adult (k = 17), and same-sex (k = 10). We compared the studies in the 4 areas by variables key to the development, evaluation, and transfer of interventions. Participants comprised injection drug users (43% of studies), drug users out of treatment (29%), African Americans (18%), clinic patients (18%), youth in schools (10%), and drug users in treatment (10%). Most studies were randomized (85%), provided another intervention to the control or comparison groups (71%), and evaluated behavioral interventions (92%). On average, interventions were conducted in 5 sessions (total, 8 hours) during 3 months. The theoretical basis of the intervention was not noted in 57% of the reports. At least one variable from each of the 3 outcome classifications was measured in 8% of the studies: behavioral, biologic, and psychosocial. Distinct profiles exist for the 4 risk areas. Addressing gaps in research and reporting would be helpful for analytical and program activities. This sizable portfolio of evaluated interventions contributes to effectiveness reviews and to considerations of transfer to program practice.

  12. Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial.

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    L'Engle, Kelly L; Green, Kimberly; Succop, Stacey M; Laar, Amos; Wambugu, Samuel

    2015-01-23

    Adherence to prevention, care, and treatment recommendations among people living with HIV (PLHIV) is a critical challenge. Yet good clinical outcomes depend on consistent, high adherence to antiretroviral therapy (ART) regimens. Mobile phones offer a promising means to improve patient adherence and health outcomes. However, limited information exists on the impact that mobile phones for health (mHealth) programs have on ART adherence or the behavior change processes through which such interventions may improve patient health, particularly among ongoing clients enrolled in large public sector HIV service delivery programs and key populations such as men who have sex with men (MSM) and female sex workers (FSW). Our aim is to evaluate an mHealth intervention where text message reminders are used as supportive tools for health providers and as motivators and reminders for ART clients to adhere to treatment and remain linked to care in Ghana. Using an implementation science framework, we seek to: (1) evaluate mHealth intervention effects on patient adherence and health outcomes, (2) examine the delivery of the mHealth intervention for improving HIV care and treatment, and (3) assess the cost-effectiveness of the mHealth intervention. The 36-month study will use a facility cluster randomized controlled design (intervention vs standard of care) for evaluating the impact of mHealth on HIV care and treatment. Specifically, we will look at ART adherence, HIV viral load, retention in care, and condom use at 6 and 12-month follow-up. In addition, participant adoption and satisfaction with the program will be measured. This robust methodology will be complemented by qualitative interviews to obtain feedback on the motivational qualities of the program and benefits and challenges of delivery, especially for key populations. Cost-effectiveness will be assessed using incremental cost-effectiveness ratios, with health effects expressed in terms of viral load suppression and costs

  13. The efficacy of a brief intervention to reduce alcohol misuse in patients with HIV in South Africa: study protocol for a randomized controlled trial

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    Huis in ’t Veld Diana

    2012-10-01

    Full Text Available Abstract Background Alcohol abuse comes with risks for increased morbidity and mortality among patients with HIV. This study aims to determine the prevalence of alcohol use and other risk factors in a sample of primary care patients with HIV in South Africa and to assess a brief intervention to reduce the use of alcohol in this group. Methods/Design A single-blinded randomized controlled trial is designed to determine the efficacy of a brief intervention to reduce hazardous alcohol use in patients with HIV. The study will be carried out on out-patients with HIV in two primary healthcare HIV clinics near Pretoria, South Africa. Alcohol use will be assessed with the Alcohol Use Disorder Identification Test questionnaire. Other data that will be collected relate to health-related quality of life, depression, sexual behavior, internalized AIDS stigma, HIV-related information and adherence to antiretroviral therapy (self-reported 7-day recall of missed doses, Visual Analog Scale and pill count. The intervention consists of a brief counseling session to reduce alcohol risk; the control group receives a health education leaflet. Discussion The findings will be important in the public health setting. If the intervention proves to be efficient, it could potentially be incorporated into the HIV care policy of the Ministry of Health. Trial registration Pan African Clinical trial Registry: PACTR201202000355384

  14. Pilot trial of a parenting and self-care intervention for HIV-positive mothers: the IMAGE program.

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    Murphy, Debra A; Armistead, Lisa; Payne, Diana L; Marelich, William D; Herbeck, Diane M

    2017-01-01

    A pilot study was conducted to assess the effects of the IMAGE pilot intervention (Improving Mothers' parenting Abilities, Growth, and Effectiveness) on mothers living with HIV (MLH). Based on Fisher and Fisher's IMB model [1992. Changing AIDS risk behavior. Psychological Bulletin, 111, 455-474], the intervention focused on self-care and parenting behavior skills of MLH that affect maternal, child, and family outcomes. A randomized pre-test-post-test two-group design with repeated assessments was used. MLH (n = 62) and their children aged 6-14 (n = 62; total N = 124) were recruited for the trial and randomized to the theory-based skills training condition or a standard care control condition. Assessments were conducted at baseline with follow-ups at 3, 6, and 12 months. Maternal, child, and family outcomes were assessed. Results show significant effects of the intervention for improving parenting practices for mothers. The intervention also improved family outcomes, and showed improvements in the parent-child relationship. IMAGE had a positive impact on parenting behaviors, and on maternal, child, and family outcomes. Given MLH can be challenged by their illness and also live in under-resourced environments, IMAGE may be viewed as a viable way to improve quality of life and family outcomes.

  15. Randomized Controlled Trials of Technology-Based HIV/STI and Drug Abuse Preventive Interventions for African American and Hispanic Youth: Systematic Review.

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    Córdova, David; Mendoza Lua, Frania; Ovadje, Lauretta; Hong, Ethan; Castillo, Berenice; Salas-Wright, Christopher P

    2017-12-13

    HIV/sexually transmitted infections (STIs) and drug abuse remain significant public health concerns in the United States, and African American and Hispanic youth are disproportionately affected. Although technology-based interventions are efficacious in preventing and reducing HIV/STI and licit/illicit drug use behaviors, relatively little is known regarding the state of the science of these interventions among African American and Hispanic youth. The aim of this review is to identify and examine randomized controlled trials (RCTs) of technology-based HIV/STI and/or drug abuse preventive interventions for African American and Hispanic youth. We searched electronic databases (ie, PubMed, Proquest, PsycINFO, Ebscohost, Google Scholar) to identify studies between January 2006 and October 2016. RCTs of technology-based interventions targeting African American and Hispanic youth HIV/STI risk behaviors, including sexual risk, licit and illicit drug use, and HIV/STI testing were included. Our search revealed a total of three studies that used an RCT design and included samples comprised of >50% African American and/or Hispanic youth. The follow-up assessments ranged from two weeks to six months and the number of participants in each trial ranged from 72 to 141. The three interventions were theory-driven, interactive, and tailored. The long-term effects of the interventions were mixed, and outcomes included reductions in sex partners, licit drug use, and condomless anal sex acts. Although technology-based interventions seem promising in the prevention of HIV/STI and drug abuse among African American and Hispanic youth, more research is needed. ©David Córdova, Frania Mendoza Lua, Lauretta Ovadje, Ethan Hong, Berenice Castillo, Christopher P Salas-Wright. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 13.12.2017.

  16. An Educational Intervention to Reduce Pain and Improve Pain Management for Malawian People Living With HIV/AIDS and Their Family Carers: A Randomized Controlled Trial.

    Science.gov (United States)

    Nkhoma, Kennedy; Seymour, Jane; Arthur, Antony

    2015-07-01

    Advances being made in improving access to HIV drugs in resource-poor countries mean HIV patients are living longer, and, therefore, experiencing pain over a longer period of time. There is a need to provide effective interventions for alleviating and managing pain. To assess whether a pain educational intervention compared with usual care reduces pain severity and improves pain management in patients with HIV/AIDS and their family carers. This was a randomized, parallel group, superiority trial conducted at HIV and palliative care clinics of two public hospitals in Malawi. A total of 182 adults with HIV/AIDS (Stage III or IV) and their family carers participated; carer participants were those individuals most involved in the patient's unpaid care. The educational intervention comprised a 30 minute face-to-face meeting, a leaflet, and a follow-up telephone call at two weeks. The content of the educational intervention covered definition, causes, and characteristics of pain in HIV/AIDS; beliefs and myths about pain and pain medication; assessment of pain; and pharmacological and nonpharmacological management. The primary outcome was average pain severity measured by the Brief Pain Inventory-Pain Severity subscale. Assessments were recorded at baseline before randomization and at eight weeks after randomization. Of the 182 patient/carer dyads randomly allocated, 157 patient/carer dyads completed the trial. Patients in the intervention group experienced a greater decrease in pain severity (mean difference = 21.09 points, 95% confidence interval = 16.56-25.63; P HIV/AIDS and their family carers. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  17. Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial.

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    Cohen, Craig R; Steinfeld, Rachel L; Weke, Elly; Bukusi, Elizabeth A; Hatcher, Abigail M; Shiboski, Stephen; Rheingans, Richard; Scow, Kate M; Butler, Lisa M; Otieno, Phelgona; Dworkin, Shari L; Weiser, Sheri D

    2015-01-01

    Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women's empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3-5 months after study start and at study end. Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. This trial is registered at ClinicalTrials

  18. A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men

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    Adam W. Carrico

    2016-07-01

    Full Text Available Abstract Background Contingency management (CM is an evidence-based intervention providing tangible rewards as positive reinforcement for abstinence from stimulants such as methamphetamine. Integrative approaches targeting affect regulation could boost the effectiveness of CM in community-based settings and optimize HIV/AIDS prevention efforts. Methods/Design This randomized controlled trial with HIV-positive, methamphetamine-using men who have sex with men (MSM is examining the efficacy of a 5-session, individually delivered positive affect regulation intervention – Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS. ARTEMIS is designed to sensitize individuals to non-drug-related sources of reward as well as assist with managing depression and other symptoms of stimulant withdrawal during CM. HIV-positive, methamphetamine-using MSM who are enrolled in a community-based, 12-week CM program are randomized to receive ARTEMIS or an attention-matched control condition. Follow-up assessments are conducted at 3, 6, 12, and 15 months after enrollment in CM. Four peripheral venous blood samples are collected over the 15-month follow-up with specimen banking for planned biomarker sub-studies. The primary outcome is mean HIV viral load. Secondary outcomes include: sustained HIV viral suppression, T-helper cell count, psychological adjustment, stimulant use, and potentially amplified transmission risk behavior. Discussion Implementation of this randomized controlled trial highlights the importance of delineating boundaries between research activities and community-based service provision. It also provides insights into best practices for integrating the distinct agendas of academic and community partners in clinical research. This trial is currently enrolling and data collection is anticipated to be completed in September of 2018. Trial registration This trial was registered on clinicaltrials.gov ( NCT01926184 on

  19. An Internet-Based Intervention (Condom-Him) to Increase Condom Use Among HIV-Positive Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

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    Miranda, Joyal; Côté, José; Godin, Gaston; Blais, Martin; Otis, Joanne; Guéhéneuc, Yann-Gaël; Fadel, Ghayas; Barton, Luisa; Fowler, Shawn

    2013-10-16

    In the recent years, the Internet has been used as a medium to find sexual partners and engage in risky sexual behavior. This has changed the way in which men having have sex with men (MSM) seek sexual partners and has increased the number of high-risk sexual encounters. Therefore, developers of human immunodeficiency virus (HIV)-prevention interventions have also started using the Internet as a viable medium to promote safe sexual behaviors. However, much of the efforts thus far have been aimed at HIV-negative rather than HIV-positive MSM. HIV-positive individuals continue to engage in risky sexual behaviors and thus constitute an important group in which HIV prevention strategies need to be addressed. Therefore, HIV prevention in HIV-positive MSM is a critical issue. Condom-Him, an Internet-based intervention tailored to increase condom use among HIV-positive MSM, was developed with the aim of improving condom use, self-efficacy, and intentions to use condoms among these individuals. The acceptability and feasibility of this Internet-based intervention will be examined in a pilot study. We will perform a randomized controlled parallel-group superiority trial. HIV-positive MSM who currently engage in unprotected anal sex will be recruited for the study. Participants will be randomly assigned using a one-to-one allocation ratio generated by the computer program. The researchers will be blinded to participant's group assignment. Participants will be assigned either to use the Condom-Him intervention (experimental arm) or to view a list of websites containing HIV/AIDS related information (control arm). Self-administered questionnaires will be provided online before randomization (baseline) and two weeks after intervention (post-test). The study will include a total of 60 participants with 30 in each group. The results from this pilot study will provide further evidence for a larger study to examine the effectiveness of this intervention and will provide a cost

  20. Effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda: results from a non-randomized controlled trial

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    Michielsen Kristien

    2012-09-01

    Full Text Available Abstract Background While the HIV epidemic is levelling off in sub-Saharan Africa, it remains at an unacceptably high level. Young people aged 15-24 years remain particularly vulnerable, resulting in a regional HIV prevalence of 1.4% in young men and 3.3% in young women. This study assesses the effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda on young people’s sexual behavior, HIV knowledge and attitudes. Methods In a non-randomized longitudinal controlled trial, fourteen schools were selected in two neighboring districts in Rwanda Bugesera (intervention and Rwamagana (control. Students (n = 1950 in eight intervention and six control schools participated in three surveys (baseline, six and twelve months in the intervention. Analysis was done using linear and logistic regression using generalized estimation equations adjusted for propensity score. Results The overall retention rate was 72%. Time trends in sexual risk behavior (being sexually active, sex in last six months, condom use at last sex were not significantly different in students from intervention and control schools, nor was the intervention associated with increased knowledge, perceived severity or perceived susceptibility. It did significantly reduce reported stigma. Conclusions Analyzing this and other interventions, we identified several reasons for the observed limited effectiveness of peer education: 1 intervention activities (spreading information are not tuned to objectives (changing behavior; 2 young people prefer receiving HIV information from other sources than peers; 3 outcome indicators are not adequate and the context of the relationship in which sex occurs and the context in which sex occurs is ignored. Effectiveness of peer education may increase through integration in holistic interventions and redefining peer educators’ role as focal points for sensitization and referral to experts and services. Finally, we argue that a

  1. An intervention to reduce HIV risk behavior of substance-using men who have sex with men: a two-group randomized trial with a nonrandomized third group.

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    Gordon Mansergh

    2010-08-01

    Full Text Available Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM, and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group.Participants (n = 1,686 were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p0.05 from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86-1.51, nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons.These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk

  2. A universal testing and treatment intervention to improve HIV control: One-year results from intervention communities in Zambia in the HPTN 071 (PopART cluster-randomised trial.

    Directory of Open Access Journals (Sweden)

    Richard Hayes

    2017-05-01

    Full Text Available The Joint United Nations Programme on HIV/AIDS (UNAIDS 90-90-90 targets require that, by 2020, 90% of those living with HIV know their status, 90% of known HIV-positive individuals receive sustained antiretroviral therapy (ART, and 90% of individuals on ART have durable viral suppression. The HPTN 071 (PopART trial is measuring the impact of a universal testing and treatment intervention on population-level HIV incidence in 21 urban communities in Zambia and South Africa. We report observational data from four communities in Zambia to assess progress towards the UNAIDS targets after 1 y of the PopART intervention.The PopART intervention comprises annual rounds of home-based HIV testing delivered by community HIV-care providers (CHiPs who also support linkage to care, ART retention, and other services. Data from four communities in Zambia receiving the full intervention (including immediate ART for all individuals with HIV were used to determine proportions of participants who knew their HIV status after the CHiP visit; proportions linking to care and initiating ART following referral; and overall proportions of HIV-infected individuals who knew their status (first 90 target and the proportion of these on ART (second 90 target, pre- and post-intervention. We are not able to assess progress towards the third 90 target at this stage of the study. Overall, 121,130 adults (59,283 men and 61,847 women were enumerated in 46,714 households during the first annual round (December 2013 to June 2015. Of the 45,399 (77% men and 55,703 (90% women consenting to the intervention, 80% of men and 85% of women knew their HIV status after the CHiP visit. Of 6,197 HIV-positive adults referred by CHiPs, 42% (95% CI: 40%-43% initiated ART within 6 mo and 53% (95% CI: 52%-55% within 12 mo. In the entire population, the estimated proportion of HIV-positive adults who knew their status increased from 52% to 78% for men and from 56% to 87% for women. The estimated

  3. All4You! A Randomized Trial of an HIV, Other STDs, and Pregnancy Prevention Intervention for Alternative School Students

    Science.gov (United States)

    Coyle, Karin K.; Kirby, Douglas B.; Robin, Leah E.; Banspach, Stephen W.; Baumler, Elizabeth; Glassman, Jill R.

    2006-01-01

    This study evaluated All4You!, a theoretically based curriculum designed to reduce sexual risk behaviors associated with HIV, other STDs, and unintended pregnancy among students in alternative schools. The study featured a randomized controlled trial involving 24 community day schools in northern California. A cohort of 988 students was assessed…

  4. Effects of a Social Network HIV/STD Prevention Intervention for Men Who Have Sex with Men in Russia and Hungary: A Randomized Controlled Trial

    Science.gov (United States)

    Amirkhanian, Yuri A.; Kelly, Jeffrey A.; Takacs, Judit; McAuliffe, Timothy L.; Kuznetsova, Anna V.; Toth, Tamas P.; Mocsonaki, Laszlo; DiFranceisco, Wayne J.; Meylakhs, Anastasia

    2015-01-01

    Objective To test a novel social network HIV risk reduction intervention for MSM in Russia and Hungary, where same-sex behavior is stigmatized and men may best be reached through their social network connections. Design A 2-arm trial with 18 sociocentric networks of MSM randomized to the social network intervention or standard HIV/STD testing/counseling. Setting St. Petersburg, Russia and Budapest, Hungary. Participants 18 “seeds” from community venues invited the participation of their MSM friends who, in turn, invited their own MSM friends into the study, a process that continued outward until eighteen 3-ring sociocentric networks (mean size=35 members, n=626) were recruited. Intervention Empirically-identified network leaders were trained and guided to convey HIV prevention advice to other network members. Main Outcome and Measures Changes in sexual behavior from baseline to 3- and 12-month followup, with composite HIV/STD incidence measured at 12-months to corroborate behavior changes. Results There were significant reductions between baseline, first followup, and second followup in the intervention versus comparison arm for proportion of men engaging in any unprotected anal intercourse (P=.04); UAI with a nonmain partner (P=.04); and UAI with multiple partners (P=.002). The mean percentage of unprotected AI acts significantly declined (P=.001), as well as the mean number of UAI acts among men who initially had multiple partners (P=.05). Biological HIV/STD incidence was 15% in comparison condition networks and 9% in intervention condition networks. Conclusions Even where same-sex behavior is stigmatized, it is possible to reach MSM and deliver HIV prevention through their social networks. PMID:25565495

  5. HIV/AIDS Clinical Trials Fact Sheet

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    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets HIV/ ... 4 p.m. ET) Send us an email HIV/AIDS Clinical Trials Last Reviewed: August 25, 2017 ...

  6. Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Stephenson, Rob; Bonar, Erin E; Carrico, Adam; Hunter, Alexis; Connochie, Daniel; Himmelstein, Rebecca; Bauermeister, Jose

    2018-04-30

    Young men who have sex with men (YMSM) and transgender people in the Detroit Metro Area are the only risk group for whom the incidence of HIV and sexually transmitted infections (STI) has increased since 2000, with HIV incidence nearly doubling among youth. Substance use (including alcohol), which is relatively frequent among YMSM and transgender people, creates barriers to the optimal delivery of HIV prevention and care services. Standard HIV counseling, testing, and referral (CTR) is limited in providing strategies to identify and address substance use. Hence, in its current form, CTR may not be serving the prevention needs of substance-using YMSM and transgender people. Brief counseling interventions, grounded in principles of motivational interviewing, may offer a mechanism to meet the HIV prevention and care needs of substance-using YMSM and transgender people. This prospective, 4-arm, factorial randomized controlled trial aims to examine the efficacy of an motivational interviewing-based substance use brief intervention (SUBI) on participants' substance use and engagement in HIV prevention. The research implements a prospective randomized controlled trial (Project Swerve) of 600 YMSM and transgender people recruited both online and in person. Eligibility criteria include participants who (1) are between the ages of 15 to 29 years, (2) live in the Detroit Metro Area, (3) self-identify as a man or transgender man or woman, (4) have had sexual contact with a man in the 6 months before enrollment, (5) self-report binge drinking or any substance use in the 3 months before enrollment, and (6) self-report an unknown or negative HIV status upon enrollment. Participants are randomized to receive, 3-months apart starting at baseline, 2 individual sessions. Sessions are CTR-only, SUBI-only, CTR followed by SUBI, or SUBI followed by CTR. Project Swerve was launched in April 2017 and enrollment is ongoing. Incorporating a SUBI that utilizes the principles of motivational

  7. Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal.

    Science.gov (United States)

    Orne-Gliemann, Joanna; Larmarange, Joseph; Boyer, Sylvie; Iwuji, Collins; McGrath, Nuala; Bärnighausen, Till; Zuma, Thembelile; Dray-Spira, Rosemary; Spire, Bruno; Rochat, Tamsen; Lert, France; Imrie, John

    2015-03-01

    The Universal HIV Test and Treat (UTT) strategy represents a challenge for science, but is also a challenge for individuals and societies. Are repeated offers of provider-initiated HIV testing and immediate antiretroviral therapy (ART) socially-acceptable and can these become normalized over time? Can UTT be implemented without potentially adding to individual and community stigma, or threatening individual rights? What are the social, cultural and economic implications of UTT for households and communities? And can UTT be implemented within capacity constraints and other threats to the overall provision of HIV services? The answers to these research questions will be critical for routine implementation of UTT strategies. A social science research programme is nested within the ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomised trial in rural South Africa. The programme aims to inform understanding of the (i) social, economic and environmental factors affecting uptake of services at each step of the continuum of HIV prevention, treatment and care and (ii) the causal impacts of the TasP intervention package on social and economic factors at the individual, household, community and health system level. We describe a multidisciplinary, multi-level, mixed-method research protocol that includes individual, household, community and clinic surveys, and combines quantitative and qualitative methods. The UTT strategy is changing the overall approach to HIV prevention, treatment and care, and substantial social consequences may be anticipated, such as changes in social representations of HIV transmission, prevention, HIV testing and ART use, as well as changes in individual perceptions and behaviours in terms of uptake and frequency of HIV testing and ART initiation at high CD4. Triangulation of social science studies within the ANRS 12249 TasP trial will provide comprehensive insights into the acceptability and feasibility of the TasP intervention package at

  8. An Internet-based self-help intervention for people with HIV and depressive symptoms: study protocol for a randomized controlled trial.

    Science.gov (United States)

    van Luenen, Sanne; Kraaij, Vivian; Spinhoven, Philip; Garnefski, Nadia

    2016-03-31

    Many people living with HIV suffer from depressive symptoms. In a previous pilot study, self-help cognitive behavioral therapy (in booklet format) was found to be effective in treating depressive symptoms in people with HIV. We developed an online self-help program in Dutch and English (based on the booklet) for people with HIV and depressive symptoms. Besides the main question regarding the effectiveness of the program aimed at lowering depressive symptoms, sub-questions will focus on the moderators of treatment success (for which patients is the program especially beneficial?) and the mechanisms of change underlying the treatment outcome (which mediators affect the outcome of treatment?). In this paper, the protocol of the study will be described. The effectiveness of the program will be investigated by comparing the intervention group with a waiting list-control group in a randomized controlled design, by including a pretest and three post-tests. The self-help program contains four main components: activation, relaxation, changing maladaptive cognitions, and goal attainment. Participants with mild to moderate depressive symptoms will work on the program for 6 to 10 weeks, during which a coach will provide motivational support by telephone once a week. Participants in the control condition will receive weekly minimal support from a coach for 8 weeks, and after the second post-test, they can gain access to the self-help program. Depressive symptoms and possible mediators (e.g., activation, cognitive coping, self-efficacy, and goal adjustment) will be assessed by self-report three times during the intervention/waiting period and at the pretest and first post-test. The proposed study aims to evaluate the effectiveness of an online self-help intervention for people with HIV and depressive symptoms. If the intervention is shown to be effective, the program will be implemented. Consequently, many patients with HIV could be reached, and their psychological care may be

  9. Randomized controlled trial of a positive affect intervention to reduce stress in people newly diagnosed with HIV; protocol and design for the IRISS study

    Directory of Open Access Journals (Sweden)

    Moskowitz JT

    2014-09-01

    currently few established interventions for people who are newly diagnosed with HIV. We present the design and methods for a randomized trial in which we test the efficacy of one such skills-based intervention that targets positive affect as a novel mechanism of change. The proposed research builds on observational findings of the important unique functions of positive affect. We aim to determine whether a five-session theory- and evidence-based intervention designed to teach skills for increasing the frequency and intensity of daily positive affect does so, and whether this intervention has beneficial effects on subsequent psychological well-being, health behaviors, and physical health up to 15 months after diagnosis with HIV. This is a randomized controlled trial in a sample of adults recruited within 12 weeks of testing positive for HIV. The control group is attention-matched, and follow up assessments will be conducted immediately post intervention (approximately 5 months post diagnosis and at 10 and 15 months post diagnosis. This study is an important next step in research concerning the adaptive functions of positive affect for people coping with HIV or other health-related life stress. Keywords: positive affect, HIV diagnosis, stress, coping, RCT, intervention, physical health

  10. Randomized Clinical Trial of the Effectiveness of a Home-Based Advanced Practice Psychiatric Nurse Intervention: Outcomes for Individuals with Serious Mental Illness and HIV

    Science.gov (United States)

    Hanrahan, Nancy P.; Wu, Evan; Kelly, Deena; Aiken, Linda H.; Blank, Michael B.

    2011-01-01

    Individuals with serious mental illness have greater risk for contracting HIV, multiple morbidities, and die 25 years younger than the general population. This high need and high cost subgroup face unique barriers to accessing required health care in the current health care system. The effectiveness of an advanced practice nurse model of care management was assessed in a four-year random controlled trial. Results are reported in this paper. In a four-year random controlled trial, a total of 238 community-dwelling individuals with HIV and serious mental illness (SMI) were randomly assigned to an intervention group (n=128) or to a control group (n=110). Over 12 months, the intervention group received care management from advanced practice psychiatric nurse, and the control group received usual care. The intervention group showed significant improvement in depression (P=.012) and the physical component of health-related quality of life (P=.03) from baseline to 12 months. The advanced practice psychiatric nurse intervention is a model of care that holds promise for a higher quality of care and outcomes for this vulnerable population. PMID:21935499

  11. A Peer-Educator Network HIV Prevention Intervention Among Injection Drug Users: Results of a Randomized Controlled Trial in St. Petersburg, Russia

    Science.gov (United States)

    Latkin, Carl A.; Kukhareva, Polina V.; Malov, Sergey V.; Batluk, Julia V.; Shaboltas, Alla V.; Skochilov, Roman V.; Sokolov, Nicolay V.; Verevochkin, Sergei V.; Hudgens, Michael G.; Kozlov, Andrei P.

    2014-01-01

    We evaluated the efficacy of a peer-educator network intervention as a strategy to reduce HIV acquisition among injection drug users (IDUs) and their drug and/or sexual networks. A randomized controlled trial was conducted in St. Petersburg, Russia among IDU index participants and their risk network participants. Network units were randomized to the control or experimental intervention. Only the experimental index participants received training sessions to communicate risk reduction techniques to their network members. Analysis includes 76 index and 84 network participants who were HIV uninfected. The main outcome measure was HIV sero-conversion. The incidence rates in the control and experimental groups were 19.57 (95 % CI 10.74–35.65) and 7.76 (95 % CI 3.51–17.19) cases per 100 p/y, respectively. The IRR was 0.41 (95 % CI 0.15–1.08) without a statistically significant difference between the two groups (log rank test statistic X2 = 2.73, permutation p value = 0.16). Retention rate was 67 % with a third of the loss due to incarceration or death. The results show a promising trend that this strategy would be successful in reducing the acquisition of HIV among IDUs. PMID:23881187

  12. Efficacy of a health educator-delivered HIV prevention intervention for Latina women: a randomized controlled trial.

    Science.gov (United States)

    Wingood, Gina M; DiClemente, Ralph J; Villamizar, Kira; Er, Deja L; DeVarona, Martina; Taveras, Janelle; Painter, Thomas M; Lang, Delia L; Hardin, James W; Ullah, Evelyn; Stallworth, JoAna; Purcell, David W; Jean, Reynald

    2011-12-01

    We developed and assessed AMIGAS (Amigas, Mujeres Latinas, Inform andonos, Gui andonos, y Apoy andonos contra el SIDA [friends, Latina women, informing each other, guiding each other, and supporting each other against AIDS]), a culturally congruent HIV prevention intervention for Latina women adapted from SiSTA (Sistas Informing Sistas about Topics on AIDS), an intervention for African American women. We recruited 252 Latina women aged 18 to 35 years in Miami, Florida, in 2008 to 2009 and randomized them to the 4-session AMIGAS intervention or a 1-session health intervention. Participants completed audio computer-assisted self-interviews at baseline and follow-up. Over the 6-month follow-up, AMIGAS participants reported more consistent condom use during the past 90 (adjusted odds ratio [AOR] = 4.81; P < .001) and 30 (AOR = 3.14; P < .001) days and at last sexual encounter (AOR = 2.76; P < .001), and a higher mean percentage condom use during the past 90 (relative change = 55.7%; P < .001) and 30 (relative change = 43.8%; P < .001) days than did comparison participants. AMIGAS participants reported fewer traditional views of gender roles (P = .008), greater self-efficacy for negotiating safer sex (P < .001), greater feelings of power in relationships (P = .02), greater self-efficacy for using condoms (P < .001), and greater HIV knowledge (P = .009) and perceived fewer barriers to using condoms (P < .001). Our results support the efficacy of this linguistically and culturally adapted HIV intervention among ethnically diverse, predominantly foreign-born Latina women.

  13. The SHAZ! Project: Results from a Pilot Randomized Trial of a Structural Intervention to Prevent HIV among Adolescent Women in Zimbabwe

    Science.gov (United States)

    Dunbar, Megan S.; Kang Dufour, Mi-Suk; Lambdin, Barrot; Mudekunye-Mahaka, Imelda; Nhamo, Definate; Padian, Nancy S.

    2014-01-01

    Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and

  14. The Use of Cell Phone Support for Non-adherent HIV-Infected Youth and Young Adults: An Initial Randomized and Controlled Intervention Trial

    Science.gov (United States)

    Belzer, Marvin E.; Naar-King, Sylvie; Olson, Johanna; Sarr, Moussa; Thornton, Sarah; Kahana, Shoshana Y.; Gaur, Aditya H.; Clark, Leslie F.

    2014-01-01

    This randomized behavioral trial examined whether youth living with HIV (YLH) receiving cell-phone support with study funded phone plans, demonstrated improved adherence and viral control during the 24 week intervention and 24 weeks post-intervention compared to controls. Monday through Friday phone calls confirmed medications were taken, provided problem-solving support, and referred to services to address adherence barriers. Of 37 participants (ages 15–24), 62 % were male and 70 % were African American. Self-reported adherence was significantly higher in the intervention group compared to the control at 24 and 48 weeks for the past month (P = 0.007) and log 10 HIV VL was significantly lower at both 24 weeks (2.82 versus 4.52 P = 0.002) and 48 weeks (3.23 versus 4.23 P = 0.043). Adherence and viral load showed medium to large effect sizes across the 48 week study. This is the first study to demonstrate sustained clinically significant reductions in HIV VL using youth friendly technology. PMID:24271347

  15. Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial.

    Science.gov (United States)

    DiClemente, Ralph J; Davis, Teaniese L; Swartzendruber, Andrea; Fasula, Amy M; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M; Brown, Jennifer L; Staples-Horne, Michelle

    2014-01-01

    Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N = 188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment, and counseling. At the 6-month assessment (3-months post-intervention), Imara participants reported higher condom use self-efficacy (p incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains.

  16. The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Megan S Dunbar

    Full Text Available Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ! was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control. The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the

  17. The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe.

    Science.gov (United States)

    Dunbar, Megan S; Kang Dufour, Mi-Suk; Lambdin, Barrot; Mudekunye-Mahaka, Imelda; Nhamo, Definate; Padian, Nancy S

    2014-01-01

    Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and

  18. Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol.

    Science.gov (United States)

    Kuhns, Lisa M; Mimiaga, Matthew J; Reisner, Sari L; Biello, Katie; Garofalo, Robert

    2017-09-16

    Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women. This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits. Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population. ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.

  19. Effects of a Phone Call Intervention to Promote Adherence to Antiretroviral Therapy and Quality of Life of HIV/AIDS Patients in Baoshan, China: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Dongsheng Huang

    2013-01-01

    Full Text Available Background. Suboptimal adherence to antiretroviral therapy (ART is still pervasive. The effect of using a mobile phone call intervention to improve patient adherence is currently not known. Objective. This study aims to investigate the effects of a phone call intervention on adherence to ART and quality of life (QOL of treatment-naive and treatment-experienced patients. Methods. A randomized controlled trial was conducted in the three largest public hospitals. Adherence was measured by self-completed questionnaires. QOL was assessed by the WHOQOL-HIV BREF. Outcomes were assessed at day 15, at 1, 2, and 3 months after start of treatment for treatment-naive patients and at 3 months after study enrollment for treatment-experienced patients. Results. A total of 103 treatment-naive and 93 treatment-experienced HIV/AIDS patients were consecutively recruited. Results show that a phone call intervention could maintain high self-reported adherence among both treatment-naive and treatment-experienced patients. After three months, significant QOL improvements were observed in domains of physical health (P=0.003, level of independence (P=0.018, environment (P=0.002, and spirituality/religion/personal beliefs (P=0.021 among treatment-naive patients. Conclusion. A mobile phone call intervention to patients could maintain high adherence rates although no statistically significant differences were found. A phone call could improve some domains of QOL among treatment-naive patients.

  20. RCT of an integrated CBT-HIV intervention on depressive symptoms and HIV risk.

    Science.gov (United States)

    Tobin, Karin; Davey-Rothwell, Melissa A; Nonyane, Bareng A S; Knowlton, Amy; Wissow, Lawrence; Latkin, Carl A

    2017-01-01

    Depression and depressive symptoms mediate the association between drug use and HIV risk. Yet, there are few interventions that target depressive symptoms and HIV risk for people who use drugs (PWUD). This study was a randomized controlled trial of an integrated cognitive behavioral therapy and HIV prevention intervention to reduce depressive symptoms, injection risk behaviors and increase condom use in a sample of urban people who used heroin or cocaine in the prior 6 months. A total of 315 individuals aged 18-55, who self-reported at least one HIV drug and sex risk behavior and scored ≥16 and symptoms, but weak impact on HIV risk. This trial is registered with ClinicalTrials.gov under the title "Neighborhoods, Networks, Depression, and HIV Risk" number NCT01380613.

  1. Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial.

    Science.gov (United States)

    Go, Vivian F; Frangakis, Constantine; Minh, Nguyen Le; Latkin, Carl; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy W; Zelaya, Carla; Vu, Pham The; Celentano, David D; Quan, Vu Minh

    2015-01-01

    Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed. 455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members. Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms. Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming. ClinicalTrials.gov NCT01689545.

  2. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Côté José

    2012-10-01

    Full Text Available Abstract Background Living with HIV makes considerable demands on a person in terms of self-management, especially as regards adherence to treatment and coping with adverse side-effects. The online HIV Treatment, Virtual Nursing Assistance and Education (Virus de I’immunodéficience Humaine–Traitement Assistance Virtuelle Infirmière et Enseignement; VIH-TAVIE™ intervention was developed to provide persons living with HIV (PLHIV with personalized follow-up and real-time support in managing their medication intake on a daily basis. An online randomized controlled trial (RCT will be conducted to evaluate the efficacy of this intervention primarily in optimizing adherence to combination anti-retroviral therapy (ART among PLHIV. Methods/design A convenience sample of 232 PLHIV will be split evenly and randomly between an experimental group that will use the web application, and a control group that will be handed a list of websites of interest. Participants must be aged 18 years or older, have been on ART for at least 6 months, and have internet access. The intervention is composed of four interactive computer sessions of 20 to 30 minutes hosted by a virtual nurse who engages the PLHIV in a skills-learning process aimed at improving self-management of medication intake. Adherence constitutes the principal outcome, and is defined as the intake of at least 95% of the prescribed tablets. The following intermediary measures will be assessed: self-efficacy and attitude towards antiretroviral medication, symptom-related discomfort, and emotional support. There will be three measurement times: baseline (T0, after 3 months (T3 and 6 months (T6 of baseline measurement. The principal analyses will focus on comparing the two groups in terms of treatment adherence at the end of follow-up at T6. An intention-to-treat (ITT analysis will be carried out to evaluate the true value of the intervention in a real context. Discussion Carrying out this online RCT

  3. A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net HIV Clinic: The Connect4Care (C4C) Trial.

    Science.gov (United States)

    Christopoulos, Katerina A; Riley, Elise D; Carrico, Adam W; Tulsky, Jacqueline; Moskowitz, Judith T; Dilworth, Samantha; Coffin, Lara S; Wilson, Leslie; Peretz, Jason Johnson; Hilton, Joan F

    2018-02-21

    Text messaging is a promising strategy to support HIV care engagement, but little is known about its efficacy in urban safety-net HIV clinic populations. We conducted a randomized controlled trial of a supportive and motivational text messaging intervention, Connect4Care (C4C), among viremic patients who had a history of poor retention or were new to clinic. Participants were randomized (stratified by new HIV diagnosis status) to receive one of the following for 12 months: 1) thrice-weekly intervention messages, plus texted primary care appointment reminders and a monthly text message requesting confirmation of study participation, or; 2) texted reminders and monthly messages alone. Viral load was assessed at 6 and 12 months. The primary outcome was virologic suppression (<200 copies/mL) at 12 months, estimated via repeated measures log-binomial regression, adjusted for new diagnosis status. The secondary outcome was retention in clinic care. Between August 2013-November 2015, 230 participants were randomized. Virologic suppression at 12 months was similar between intervention and control participants (48.8% vs. 45.8%), with negligible change from 6-month estimates, yielding RR 1.07 (95% CI: 0.82, 1.39). Suppression was higher in the newly diagnosed (78.3% vs. 45.3%). There were no intervention effects on the secondary outcome. Exploratory analyses suggested that patients with more responses to study text messages had better outcomes, regardless of arm. The C4C text messaging intervention did not significantly increase virologic suppression or retention in care. Response to text messages may be a useful way for providers to gauge risk for poor HIV outcomes. NCT01917994.

  4. Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Hirshfield, Sabina; Downing, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

    2016-06-17

    Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Sex Positive!([+]) is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Participant recruitment began in June 2015 and ended in December 2015. This protocol describes the underlying theoretical framework and

  5. Community perspectives on the ethical issues surrounding adolescent HIV vaccine trials in South Africa.

    Science.gov (United States)

    Jaspan, Heather B; Soka, Nosiphiwo F; Strode, Ann E; Mathews, Catherine; Mark, Daniella; Flisher, Alan J; Wood, Robin; Bekker, Linda-Gail

    2008-10-23

    Adolescents globally are at high risk for HIV acquisition and are the targets of HIV prevention interventions such as HIV vaccines. In order to understand stakeholders' attitudes towards the ethical issues of adolescent involvement in HIV vaccine trials, we conducted focus group discussions with key members of a semi-urban, informal Cape Town community with high HIV prevalence in which HIV vaccine trials are taking place. Themes were identified from focus group transcripts by four researchers, and included necessity of guardian consent, age of independent consent, and confidentiality of in-trial medical results. In general, ethical adolescent HIV vaccine trials will be feasible in this community.

  6. Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention.

    Science.gov (United States)

    Newcomb, Michael E; Macapagal, Kathryn R; Feinstein, Brian A; Bettin, Emily; Swann, Gregory; Whitton, Sarah W

    2017-08-01

    Young men who have sex with men are at high risk for HIV, and most new HIV infections occur in serious relationships. This pilot study assessed the feasibility, acceptability and preliminary efficacy of the 2GETHER couples-based HIV prevention and relationship education intervention for young same-sex male couples. We enrolled 57 young male couples (N = 114) into a four-session hybrid group and individual intervention. We assessed acceptability via post-session surveys and exit interviews, and we examined preliminary efficacy at a two week posttest. The vast majority of participants (93%) reported exclusively positive impressions of 2GETHER, and all components received high mean ratings. We observed decreases in HIV risk behavior, increases in information, motivation and behavioral skills related to HIV prevention, and improvement in relationship investment between pretest and posttest. Integrating relationship education and sexual health programming may be an effective way to reduce HIV transmissions in young male couples.

  7. A Randomized Controlled Trial of a Resilience-Based Intervention for Children Affected by Parental HIV: Educational Outcomes at 24-, 30-, and 36-Months

    Science.gov (United States)

    Harrison, Sayward E.; Li, Xiaoming; Zhang, JiaJia; Zhao, Junfeng; Zhao, Guoxiang

    2018-01-01

    Children of parents with human immunodeficiency virus (HIV) are at-risk for a variety of negative outcomes, including poor educational achievement. The multi-level, resilience-based "ChildCARE" intervention has been found to yield short-term improvement in a number of school-related variables for children affected by parental HIV.…

  8. Gender-Specific Effects of an Augmented Written Emotional Disclosure Intervention on Posttraumatic, Depressive, and HIV-Disease-Related Outcomes: A Randomized, Controlled Trial

    Science.gov (United States)

    Ironson, Gail; O'Cleirigh, Conall; Leserman, Jane; Stuetzle, Rick; Fordiani, Joanne; Fletcher, MaryAnn; Schneiderman, Neil

    2013-01-01

    Objective: Trauma histories and symptoms of PTSD occur at very high rates in people with HIV and are associated with poor disease management and accelerated disease progression. The authors of this study examined the efficacy of a brief written trauma disclosure intervention on posttraumatic stress, depression, HIV-related physical symptoms, and…

  9. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial.

    Science.gov (United States)

    Côté, José; Godin, Gaston; Guéhéneuc, Yann-Gaël; Rouleau, Geneviève; Ramirez-Garcìa, Pilar; Otis, Joanne; Tremblay, Cécile; Fadel, Ghayas

    2012-10-05

    Living with HIV makes considerable demands on a person in terms of self-management, especially as regards adherence to treatment and coping with adverse side-effects. The online HIV Treatment, Virtual Nursing Assistance and Education (Virus de I'immunodéficience Humaine-Traitement Assistance Virtuelle Infirmière et Enseignement; VIH-TAVIE™) intervention was developed to provide persons living with HIV (PLHIV) with personalized follow-up and real-time support in managing their medication intake on a daily basis. An online randomized controlled trial (RCT) will be conducted to evaluate the efficacy of this intervention primarily in optimizing adherence to combination anti-retroviral therapy (ART) among PLHIV. A convenience sample of 232 PLHIV will be split evenly and randomly between an experimental group that will use the web application, and a control group that will be handed a list of websites of interest. Participants must be aged 18 years or older, have been on ART for at least 6 months, and have internet access. The intervention is composed of four interactive computer sessions of 20 to 30 minutes hosted by a virtual nurse who engages the PLHIV in a skills-learning process aimed at improving self-management of medication intake. Adherence constitutes the principal outcome, and is defined as the intake of at least 95% of the prescribed tablets. The following intermediary measures will be assessed: self-efficacy and attitude towards antiretroviral medication, symptom-related discomfort, and emotional support. There will be three measurement times: baseline (T0), after 3 months (T3) and 6 months (T6) of baseline measurement. The principal analyses will focus on comparing the two groups in terms of treatment adherence at the end of follow-up at T6. An intention-to-treat (ITT) analysis will be carried out to evaluate the true value of the intervention in a real context. Carrying out this online RCT poses various challenges in terms of recruitment, ethics, and

  10. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  11. A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data.

    Science.gov (United States)

    Lowther, Keira; Higginson, Irene J; Simms, Victoria; Gikaara, Nancy; Ahmed, Aabid; Ali, Zipporah; Afuande, Gaudencia; Kariuki, Hellen; Sherr, Lorraine; Jenkins, Rachel; Selman, Lucy; Harding, Richard

    2014-09-03

    Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown. A randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-centred care, given by HIV nurses trained in the palliative care approach over a period of 5 months. Rates of recruitment and refusal, the effectiveness of the randomisation procedure, trial follow-up and attrition and extent of missing data are reported.120 patients (60 randomised to control arm, 60 randomised to intervention arm) were recruited over 5.5 months, with a refusal rate of 55.7%. During the study period, three participants died from cancer, three withdrew (two moved away and one withdrew due to time constraints). All of these patients were in the intervention arm: details are reported. There were five additional missing monthly interviews in both the control and intervention study arm, bringing the total of missing data to 26 data points (4.3%). The quality and implications of these data are discussed extensively and openly, including the effect of full and ethical consent procedures, respondent burden, HIV stigma, accurate randomisation, patient safety and the impact of the intervention. Data on recruitment randomisation, attrition and missing data in clinical trials should be routinely reported, in conjunction with the now established practice of publishing study protocols to enhance research integrity, transparency and quality. Transparency is especially important in cross cultural settings, in which the sources of funding and trial design are often not based in the country of data collection. Findings reported can be used to inform future RCTs in this area. Clinicaltrials.gov NCT

  12. Impact of food support on food security and body weight among HIV antiretroviral therapy recipients in Honduras: a pilot intervention trial.

    Science.gov (United States)

    Palar, Kartika; Derose, Kathryn Pitkin; Linnemayr, Sebastian; Smith, Alexandria; Farías, Hugo; Wagner, Glenn; Martinez, Homero

    2015-01-01

    Optimal strategies to improve food security and nutrition for people living with HIV (PLHIV) may differ in settings where overweight and obesity are prevalent and cardiovascular disease risk is a concern. However, no studies among PLHIV have investigated the impact of food support on nutritional outcomes in these settings. We therefore assessed the effect of food support on food insecurity and body weight in a population of PLHIV with high prevalence of overweight and obesity. We implemented a pilot intervention trial in four government-run HIV clinics in Honduras. The trial tested the effect of a monthly household food ration plus nutrition education (n = 203), compared to nutrition education alone (n = 197), over 12 months. Participants were clinic patients receiving antiretroviral therapy (ART). Assessments were obtained at baseline, 6 and 12 months. Primary outcomes for this analysis were food security, using the validated Latin American and Caribbean Food Security Scale and body weight (kg). Thirty-one percent of participants were overweight (22%) or obese (8%) at baseline. At 6 months, the probability of severe food insecurity decreased by 48.3% (p < 0.01) in the food support group, compared to 11.6% in the education-only group (p < 0.01). Among overweight or obese participants, food support led to average weight gain of 1.13 kg (p < 0.01), while nutrition education alone was associated with average weight loss of 0.72 kg (p < 0.10). Nutrition education alone was associated with weight gain among underweight and normal weight participants. Household food support may improve food security but not necessarily nutritional status of ART recipients above and beyond nutrition education. Improving nutritional tailoring of food support and testing the impact of nutrition education should be prioritized for PLHIV in Latin America and similar settings.

  13. Effects of an HIV peer prevention intervention on sexual and injecting risk behaviors among injecting drug users and their risk partners in Thai Nguyen, Vietnam: a randomized controlled trial.

    Science.gov (United States)

    Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Latkin, Carl A; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy; Zelaya, Carla; Vu, Pham The; Chen, Yong; Celentano, David D; Quan, Vu Minh

    2013-11-01

    Globally, 30% of new HIV infections outside sub-Saharan Africa involve injecting drug users (IDU) and in many countries, including Vietnam, HIV epidemics are concentrated among IDU. We conducted a randomized controlled trial in Thai Nguyen, Vietnam, to evaluate whether a peer oriented behavioral intervention could reduce injecting and sexual HIV risk behaviors among IDU and their network members. 419 HIV-negative index IDU aged 18 years or older and 516 injecting and sexual network members were enrolled. Each index participant was randomly assigned to receive a series of six small group peer educator-training sessions and three booster sessions in addition to HIV testing and counseling (HTC) (intervention; n = 210) or HTC only (control; n = 209). Follow-up, including HTC, was conducted at 3, 6, 9 and 12 months post-intervention. The proportion of unprotected sex dropped significantly from 49% to 27% (SE (difference) = 3%, p < 0.01) between baseline and the 3-month visit among all index-network member pairs. However, at 12 months, post-intervention, intervention participants had a 14% greater decline in unprotected sex relative to control participants (Wald test = 10.8, df = 4, p = 0.03). This intervention effect is explained by trial participants assigned to the control arm who missed at least one standardized HTC session during follow-up and subsequently reported increased unprotected sex. The proportion of observed needle/syringe sharing dropped significantly between baseline and the 3-month visit (14% vs. 3%, SE (difference) = 2%, p < 0.01) and persisted until 12 months, but there was no difference across trial arms (Wald test = 3.74, df = 3, p = 0.44). Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand.

    Science.gov (United States)

    Simmons, Nicole; Donnell, Deborah; Ou, San-San; Celentano, David D; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl

    2015-10-01

    Controlled trials of HIV prevention and care interventions are susceptible to contamination. In a randomized controlled trial of a social network peer education intervention among people who inject drugs and their risk partners in Philadelphia, PA and Chiang Mai, Thailand, we tested a contamination measure based on recall of intervention terms. We assessed the recall of test, negative and positive control terms among intervention and control arm participants and compared the relative odds of recall of test versus negative control terms between study arms. The contamination measures showed good discriminant ability among participants in Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was strong evidence of diffusion and contamination. Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in experimental interventions.

  15. Efficacy of a Social Self-Value Empowerment Intervention to Improve Quality of Life of HIV Infected People Receiving Antiretroviral Treatment in Nepal: A Randomized Controlled Trial.

    Science.gov (United States)

    Bhatta, Dharma Nand; Liabsuetrakul, Tippawan

    2017-06-01

    We developed a comprehensive and culturally applicable empowerment intervention social self-value package with an aim to assess its efficacy in order to improve the quality of life (QoL) of HIV infected people receiving antiretroviral treatment. Participants were randomly allocated to receive either six weekly intervention sessions or standard care. Nonlinear mixed-effects models were performed to compare changes in empowerment scores over time. Between September and November 2014, 1447 individuals were screened, of whom 132 were randomly assigned to either the intervention or control group. The mean scores of empowerment, social support and quality of life increased and stigma scores were reduced in the intervention group at 3- and 6-months. An intervention effect on social support, stigma and QoL was significantly increased by time and group with low and high empowerment. No adverse events were reported. The empowerment intervention was efficacious in improving QoL of HIV infected people.

  16. Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

    Science.gov (United States)

    Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L

    2017-08-01

    Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Abramsky Tanya

    2012-06-01

    Full Text Available Abstract Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members; past year experience of physical intimate partner violence and sexual intimate partner violence (among females; community responses to women experiencing violence (among women reporting past year physical/sexual partner violence; and past year concurrency of sexual partners (among males. 1583 women and men (aged 18–49 years were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved

  18. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members); past year experience of physical intimate partner violence and sexual intimate partner violence (among females); community responses to women experiencing violence (among women reporting past year physical/sexual partner violence); and past year concurrency of sexual partners (among males). 1583 women and men (aged 18–49 years) were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved. Discussion This is one of few

  19. A randomized controlled trial of a resilience-based intervention on psychosocial well-being of children affected by HIV/AIDS: Effects at 6- and 12-month follow-up.

    Science.gov (United States)

    Li, Xiaoming; Harrison, Sayward E; Fairchild, Amanda J; Chi, Peilian; Zhao, Junfeng; Zhao, Guoxiang

    2017-10-01

    Global literature suggests that resilience-based interventions may yield improvements in psychosocial well-being for vulnerable children, but limited data are available regarding the efficacy of such interventions among children affected by parental HIV/AIDS. To evaluate initial efficacy of a multi-level resilience-based intervention among children affected by parental HIV/AIDS in China in improving children's psychosocial well-being and resilience-related outcomes. Seven hundred-ninety children, 6-17 years of age, were recruited from rural China. Children were either AIDS orphans or were living with one or two parents infected with HIV/AIDS. Children and primary caregivers were randomly assigned to participate in a 4-arm trial to evaluate the Child-Caregiver-Advocacy Resilience (ChildCARE) intervention. This resilience-based psychosocial intervention provides programming at three levels (child, caregiver, community). Survey data were collected at baseline, 6-months, and 12-months in order to examine efficacy of the child-only and child + caregiver arms in improving children's psychological resilience. Intervention groups displayed improvements in several resilience-related outcomes at 6- and 12-month follow-ups, including self-reported coping, hopefulness, emotional regulation, and self-control. The child-only intervention arm showed some fading of intervention effects by 12-months. Preliminary findings suggest that the ChildCARE intervention is efficacious in promoting psychosocial well-being of children affected by parental HIV/AIDS in rural China. Targeting both children and caregivers for psychosocial intervention may be effective in improving children's resilience. Additional evaluation and modifications, including the inclusion of booster sessions, should be considered to further strengthen the program. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. HIV Interventions to Reduce HIV/AIDS Stigma: A Systematic Review

    Science.gov (United States)

    Banks, Bahby; Jonas, Dan; Miles, Margaret Shandor; Smith, Giselle Corbie

    2011-01-01

    We reviewed the literature to determine the effectiveness of HIV-related interventions in reducing HIV/AIDS stigma. Studies selected had randomized controlled trial (RCT), pretest–posttest with a non-randomized control group, or pretest–posttest one group study designs in which HIV-related interventions were being evaluated, and in which HIV/AIDS stigma was one of the outcomes being measured. A checklist was used to extract data from accepted studies, assess their internal validity, and overall quality. Data were extracted from 19 studies, and 14 of these studies demonstrated effectiveness in reducing HIV/ AIDS stigma. Only 2 of these 14 effective studies were considered good studies, based on quality, the extent to which the intervention focused on reducing HIV/AIDS stigma, and the statistics reported to demonstrate effectiveness. Future studies to reduce HIV/AIDS stigma could improve by designing interventions that pay greater attention to internal validity, use validated HIV/AIDS stigma instruments, and achieve both statistical and public health significance. PMID:21088989

  1. HIV prevention intervention to reduce HIV-related stigma: evidence from China.

    Science.gov (United States)

    Li, Li; Liang, Li-Jung; Lin, Chunqing; Wu, Zunyou; Rotheram-Borus, Mary Jane

    2010-01-02

    The National Institute of Mental Health Collaborative HIV/Sexually Transmitted Disease Prevention Trial provided a unique opportunity to test whether, with the community-based diffusion of HIV/sexually transmitted disease prevention information and an elevated understanding of HIV, the level of stigmatizing attitudes toward people living with HIV/AIDS in the community would be reduced. A total of 4510 market workers in Fuzhou, China, participated in the study, and longitudinal analyses included study samples of 3785 participants in the 12-month follow-up and 3716 participants in the 24-month follow-up. We graphically examined the change in HIV-related stigma indicators over time between control and intervention groups using boxplot and kernel density estimation. A logistic regression analysis with proportional odds model was further used to examine the intervention effect on HIV-related stigmatizing attitudes. Compared with no change over time for the control group, the intervention successfully reduced the level of HIV-related stigmatizing attitudes among the target population at the 12-month follow-up, and the effect increased by two-fold (with respect to odds ratios) at the 24-month follow-up. The intervention demonstrated positive attitude changes associated with HIV-related stigma. Our results show the importance of social norms, rather than simply individual behaviors, in developing and implementing stigma reduction campaigns.

  2. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Francisco, Leilani; Nakuti, Janet; Musuya, Tina; Kyegombe, Nambusi; Starmann, Elizabeth; Kaye, Dan; Michau, Lori; Watts, Charlotte

    2012-06-29

    Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. The SASA! STUDY is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members); past year experience of physical intimate partner violence and sexual intimate partner violence (among females); community responses to women experiencing violence (among women reporting past year physical/sexual partner violence); and past year concurrency of sexual partners (among males). 1583 women and men (aged 18-49 years) were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved. This is one of few cluster randomised trials globally to assess

  3. The Treatment Advocacy Program: A Randomized Controlled Trial of a Peer-Led Safer Sex Intervention for HIV-Infected Men Who Have Sex with Men

    Science.gov (United States)

    McKirnan, David J.; Tolou-Shams, Marina; Courtenay-Quirk, Cari

    2010-01-01

    Objective: Primary care may be an effective venue for delivering behavioral interventions for sexual safety among HIV-positive men who have sex with men (MSM); however, few studies show efficacy for such an approach. We tested the efficacy of the Treatment Advocacy Program (TAP), a 4-session, primary-care-based, individual counseling intervention…

  4. mCME project V.2.0: randomised controlled trial of a revised SMS-based continuing medical education intervention among HIV clinicians in Vietnam.

    Science.gov (United States)

    Gill, Christopher J; Le, Ngoc Bao; Halim, Nafisa; Chi, Cao Thi Hue; Nguyen, Viet Ha; Bonawitz, Rachael; Hoang, Pham Vu; Nguyen, Hoang Long; Huong, Phan Thi Thu; Larson Williams, Anna; Le, Ngoc Anh; Sabin, Lora

    2018-01-01

    Continuing medical education (CME) is indispensable, but costs are a barrier. We tested the effectiveness of a novel mHealth intervention (mCME V.2.0) promoting CME among Vietnamese HIV clinicians. We enrolled HIV clinicians from three provinces near Hanoi. The 6-month intervention consisted of (1) daily short message service multiple-choice quiz questions, (2) daily linked readings, (3) links to online CME courses and (4) feedback messages describing the performance of the participant relative to the group. Control participants had equal access to the online CME courses. Our primary endpoint was utilisation of the online CME courses; secondary endpoints were self-study behaviour, performance on a standardised medical exam and job satisfaction. From 121 total HIV clinicians in the three provinces, 106 (87.6%) enrolled, and 48/53 intervention (90%) and 47/53 control (89%) participants completed the endline evaluations. Compared with controls, intervention participants were more likely to use the CME courses (risk ratio (RR) 2.3, 95% CI 1.4 to 3.8, accounting for 83% of course use (P<0.001)). Intervention participants increased self-study behaviours over controls in terms of use of medical textbooks (P<0.01), consulting with colleagues (P<0.01), searching on the internet (P<0.001), using specialist websites (P=0.02), consulting the Vietnam HIV/AIDS treatment guidelines (P=0.02) and searching the scientific literature (P=0.09). Intervention participants outperformed controls on the exam (+23% vs +12% score gains, P=0.05) and had higher job satisfaction. The mCME V.2.0 intervention improved self-study behaviour, medical knowledge and job satisfaction. This approach has potential for expansion in Vietnam and similar settings. NCT02381743.

  5. A Pilot Randomized Controlled Trial of an Integrated In-person and Mobile Phone Delivered Counseling and Text Messaging Intervention to Reduce HIV Transmission Risk among Male Sex Workers in Chennai, India.

    Science.gov (United States)

    Mimiaga, Matthew J; Thomas, Beena; Biello, Katie; Johnson, Blake E; Swaminathan, Soumya; Navakodi, Pandiyaraja; Balaguru, S; Dhanalakshmi, A; Closson, Elizabeth F; Menon, Sunil; O'Cleirigh, Conall; Mayer, Kenneth H; Safren, Steven A

    2017-11-01

    Men who have sex with men (MSM) are at increased risk for HIV infection in India, particularly those who engage in transactional sex with other men (i.e., male sex workers; MSW). Despite the need, HIV prevention efforts for Indian MSW are lacking. As in other settings, MSW in India increasingly rely on the use of mobile phones for sex work solicitation. Integrating mobile phone technology into an HIV prevention intervention for Indian MSW may mitigate some of the challenges associated with face-to face approaches, such as implementation, lack of anonymity, and time consumption, while at the same time proving to be both feasible and useful. This is a pilot randomized controlled trial to examine participant acceptability, feasibility of study procedures, and preliminary efficacy for reducing sexual risk for HIV. MSW (N = 100) were equally randomized to: (1) a behavioral HIV prevention intervention integrating in-person and mobile phone delivered HIV risk reduction counseling, and daily, personalized text or voice messages as motivating "cognitive restructuring" cues for reducing condomless anal sex (CAS); or (2) a standard of care (SOC) comparison condition. Both groups received HIV counseling and testing at baseline and 6-months, and completed ACASI-based, behavioral and psychosocial assessments at baseline, 3, and 6 months. Mixed-effects regression procedures specifying a Poisson distribution and log link with a random intercept and slope for month of follow-up was estimated to assess the intervention effect on the primary outcomes: (1) CAS acts with male clients who paid them for sex, and (2) CAS acts with male non-paying sexual partners-both outcomes assessed over the past month. The intervention was both feasible (98% retention at 6-months) and acceptable (>96% of all intervention sessions attended); all intervention participants rated the intervention as "acceptable" or "very acceptable." A reduction in the reported number of CAS acts with male clients who

  6. [Enhanced prenatal HIV couple oriented counselling session and couple communication about HIV (ANRS 12127 Prenahtest Trial)].

    Science.gov (United States)

    Plazy, M; Orne-Gliemann, J; Balestre, E; Miric, M; Darak, S; Butsashvili, M; Tchendjou, P; Dabis, F; Desgrées du Loû, A

    2013-08-01

    The Prenahtest study investigated the efficacy of a couple-oriented HIV counselling session (COC) in encouraging couple HIV counselling and testing, and improving intra-couple communication about sexual and reproductive health. We report here on the effect of COC on intra-couple communication about HIV. Within this 4-country trial (India, Georgia, Dominican Republic and Cameroon), 484 to 491 pregnant women per site were recruited and individually randomized to receive either the COC intervention, enhanced counselling with role playing, or standard post-test HIV counselling. Women were interviewed at recruitment, before HIV testing (T0), and 2 to 8 weeks after post-test HIV counselling (T1). Four dichotomous variables documented intra-couple communication about HIV at T1: 1) discussion about HIV, 2) discussion about condom use, 3) suggesting HIV testing and 4) suggesting couple HIV counselling to the partner. An intra-couple HIV communication index was created: low degree of communication ("yes" response to zero or one of the four variables), intermediate degree of communication ("yes" to two or three variables) or high degree of communication ("yes" to the four variables). To estimate the impact of COC on the intra-couple HIV communication index, multivariable logistic regressions were conducted. One thousand six hundred and seven women were included in the analysis of whom 54 (3.4%) were HIV-infected (49 in Cameroon). In the four countries, the counselling group was associated with intra-couple HIV communication (P≤0.03): women allocated to the COC group were significantly more likely to report high or intermediate degrees of intra-couple communication about HIV (versus low degree of communication) than women allocated to standard counselling. COC improved short-term communication about HIV within couples in different sociocultural contexts, a positive finding for a couple approach to HIV prevention. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  7. Development and Open Pilot Trial of an HIV-Prevention Intervention Integrating Mobile-Phone Technology for Male Sex Workers in Chennai, India.

    Science.gov (United States)

    Thomas, Beena; Closson, Elizabeth F; Biello, Katie; Menon, Sunil; Navakodi, Pandiaraja; Dhanalakshmi, A; Mayer, Kenneth H; Safren, Steven A; Mimiaga, Matthew J

    2017-05-01

    In India men who have sex with men and engage in sex work (i.e., male sex workers; MSW) have a high risk of transmitting HIV. Globally, sex workers have become more spatially mobile due to advances in mobile-phone technology. In 2012 in-depth qualitative feedback was garnered from 40 interviews with MSW and four focus groups with 35 key informants (KIs) who had expert knowledge of the local MSW community to inform the design of an HIV-prevention intervention among MSW in Chennai, India. All MSW were recruited during outreach by employees of a Chennai-based organization for MSM (men who have sex with men). The data were analyzed using a descriptive qualitative approach. MSW and KIs discussed the need for intervention content that went beyond basic HIV psychoeducation. They emphasized the importance of addressing psychological distress, alcohol-related risk, and sexual communication skills. Concerns were raised about confidentiality, privacy, and scheduling. Participants endorsed a combination of in-person and mobile-phone-delivered sessions as well as the integration of mobile-phone messaging. These findings served as the basis for the development of a theoretically driven, manual-based intervention incorporating mobile phones. An open pilot assessed the feasibility and acceptability of the intervention with eight MSW. Assessments and HIV testing were administered at baseline, 3, and 6 months post-baseline. Exit interviews were conducted at the conclusion of the intervention. Retention for session attendance and assessment follow-up was 100 %. There was a high level of acceptability for the format, structure, and content. These data show initial promise, feasibility, and acceptability of the intervention.

  8. Viral linkage in HIV-1 seroconverters and their partners in an HIV-1 prevention clinical trial.

    Directory of Open Access Journals (Sweden)

    Mary S Campbell

    2011-03-01

    Full Text Available Characterization of viruses in HIV-1 transmission pairs will help identify biological determinants of infectiousness and evaluate candidate interventions to reduce transmission. Although HIV-1 sequencing is frequently used to substantiate linkage between newly HIV-1 infected individuals and their sexual partners in epidemiologic and forensic studies, viral sequencing is seldom applied in HIV-1 prevention trials. The Partners in Prevention HSV/HIV Transmission Study (ClinicalTrials.gov #NCT00194519 was a prospective randomized placebo-controlled trial that enrolled serodiscordant heterosexual couples to determine the efficacy of genital herpes suppression in reducing HIV-1 transmission; as part of the study analysis, HIV-1 sequences were examined for genetic linkage between seroconverters and their enrolled partners.We obtained partial consensus HIV-1 env and gag sequences from blood plasma for 151 transmission pairs and performed deep sequencing of env in some cases. We analyzed sequences with phylogenetic techniques and developed a Bayesian algorithm to evaluate the probability of linkage. For linkage, we required monophyletic clustering between enrolled partners' sequences and a Bayesian posterior probability of ≥ 50%. Adjudicators classified each seroconversion, finding 108 (71.5% linked, 40 (26.5% unlinked, and 3 (2.0% indeterminate transmissions, with linkage determined by consensus env sequencing in 91 (84%. Male seroconverters had a higher frequency of unlinked transmissions than female seroconverters. The likelihood of transmission from the enrolled partner was related to time on study, with increasing numbers of unlinked transmissions occurring after longer observation periods. Finally, baseline viral load was found to be significantly higher among linked transmitters.In this first use of HIV-1 sequencing to establish endpoints in a large clinical trial, more than one-fourth of transmissions were unlinked to the enrolled partner

  9. Vijana Vijiweni II: a cluster-randomized trial to evaluate the efficacy of a microfinance and peer health leadership intervention for HIV and intimate partner violence prevention among social networks of young men in Dar es Salaam.

    Science.gov (United States)

    Kajula, Lusajo; Balvanz, Peter; Kilonzo, Mrema Noel; Mwikoko, Gema; Yamanis, Thespina; Mulawa, Marta; Kajuna, Deus; Hill, Lauren; Conserve, Donaldson; Reyes, Heathe Luz McNaughton; Leatherman, Sheila; Singh, Basant; Maman, Suzanne

    2016-02-03

    Intimate partner violence (IPV) and sexually transmitted infections (STIs), including HIV, remain important public health problems with devastating health effects for men and women in sub-Saharan Africa. There have been calls to engage men in prevention efforts, however, we lack effective approaches to reach and engage them. Social network approaches have demonstrated effective and sustained outcomes on changing risk behaviors in the U.S. Our team has identified and engaged naturally occurring social networks comprised mostly of young men in Dar es Salaam in an intervention designed to jointly reduce STI incidence and the perpetration of IPV. These stable networks are locally referred to as "camps." In a pilot study we demonstrated the feasibility and acceptability of a combined microfinance and peer health leadership intervention within these camp-based peer networks. We are implementing a cluster-randomized trial to evaluate the efficacy of an intervention combining microfinance with health leadership training in 60 camps in Dar es Salaam, Tanzania. Half of the camps have been randomized to the intervention arm, and half to a control arm. The camps in the intervention arm will receive a combined microfinance and health leadership intervention for a period of two years. The camps in the control arm will receive a delayed intervention. We have enrolled 1,258 men across the 60 study camps. Behavioral surveys will be conducted at baseline, 12-months post intervention launch and 30-month post intervention launch and biological samples will be drawn to test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) at baseline and 30-months. The primary endpoints for assessing intervention impact are IPV perpetration and STI incidence. This is the first cluster-randomized trial targeting social networks of men in sub-Saharan Africa that jointly addresses HIV and IPV perpetration and has both biological and behavioral endpoints. Effective

  10. Effects of biscuit-type feeding supplementation on the neurocognitive outcomes of HIV-affected school-age children: a randomized, double-blind, controlled intervention trial in Kenya

    Directory of Open Access Journals (Sweden)

    Kek Khee Loo

    2017-12-01

    Full Text Available Objective: To determine if meat or soy protein dietary supplementation will enhance the neurocognitive performance of HIV-affected children at-risk of malnutrition and food insecurity. Methods: A randomized, double-blind, controlled intervention trial evaluated the effect of nutritional supplementation on the neurocognitive outcomes of 49 HIV-affected school-age children in western Kenya. The intervention consisted in providing the mother, target child, and siblings with one of three isocaloric biscuit-type supplements – soy, wheat, or beef – on 5 days per week for 18 months. Neurocognitive outcomes of the target children were assessed by a battery of eight measures and followed up longitudinally for up to 24 months. Results: Mixed effects modeling demonstrated significant differences in the rates of increase over time among all three groups (F test degrees of freedom of 2, P<0.05 for Raven’s progressive matrices performance, but not for verbal meaning, arithmetic, digit span backward, forward, and total, embedded figure test, and Beery visual–motor integration scores. Conclusion: HIV-affected school-age children provided with soy protein supplementation showed greater improvement in nonverbal cognitive (fluid intelligence performance compared with peers who received isocaloric beef or wheat biscuits. Soy nutrients may have an enhancing effect on neurocognitive skills in HIV-affected school-age children.

  11. Findings from the SASA! Study: a cluster randomized controlled trial to assess the impact of a community mobilization intervention to prevent violence against women and reduce HIV risk in Kampala, Uganda.

    Science.gov (United States)

    Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Nakuti, Janet; Kyegombe, Nambusi; Starmann, Elizabeth; Cundill, Bonnie; Francisco, Leilani; Kaye, Dan; Musuya, Tina; Michau, Lori; Watts, Charlotte

    2014-07-31

    Intimate partner violence (IPV) and HIV are important and interconnected public health concerns. While it is recognized that they share common social drivers, there is limited evidence surrounding the potential of community interventions to reduce violence and HIV risk at the community level. The SASA! study assessed the community-level impact of SASA!, a community mobilization intervention to prevent violence and reduce HIV-risk behaviors. From 2007 to 2012 a pair-matched cluster randomized controlled trial (CRT) was conducted in eight communities (four intervention and four control) in Kampala, Uganda. Cross-sectional surveys of a random sample of community members, 18- to 49-years old, were undertaken at baseline (n = 1,583) and four years post intervention implementation (n = 2,532). Six violence and HIV-related primary outcomes were defined a priori. An adjusted cluster-level intention-to-treat analysis compared outcomes in intervention and control communities at follow-up. The intervention was associated with significantly lower social acceptance of IPV among women (adjusted risk ratio 0.54, 95% confidence interval (CI) 0.38 to 0.79) and lower acceptance among men (0.13, 95% CI 0.01 to 1.15); significantly greater acceptance that a woman can refuse sex among women (1.28, 95% CI 1.07 to 1.52) and men (1.31, 95% CI 1.00 to 1.70); 52% lower past year experience of physical IPV among women (0.48, 95% CI 0.16 to 1.39); and lower levels of past year experience of sexual IPV (0.76, 95% CI 0.33 to 1.72). Women experiencing violence in intervention communities were more likely to receive supportive community responses. Reported past year sexual concurrency by men was significantly lower in intervention compared to control communities (0.57, 95% CI 0.36 to 0.91). This is the first CRT in sub-Saharan Africa to assess the community impact of a mobilization program on the social acceptability of IPV, the past year prevalence of IPV and levels of sexual concurrency. SASA

  12. Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Woelk, Godfrey B; Kieffer, Mary Pat; Walker, Damilola; Mpofu, Daphne; Machekano, Rhoderick

    2016-02-16

    Efforts to scale up and improve programs for prevention of mother-to-child transmission of HIV (PMTCT) have focused primarily at the health facility level, and limited attention has been paid to defining an effective set of community interventions to improve demand and uptake of services and retention. Many barriers to PMTCT are also barriers to pregnancy, childbirth, and postnatal care faced by mothers regardless of HIV status. Demand for maternal and child health (MCH) and PMTCT services can be limited by critical social, cultural, and structural barriers. Yet, rigorous evaluation has shown limited evidence of effectiveness of multilevel community-wide interventions aimed at improving MCH and HIV outcomes for pregnant women living with HIV. We propose to assess the effect of a package of multilevel community interventions: a social learning and action component, community dialogues, and peer-led discussion groups, on the demand for, uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services. This study will undertake a three-arm randomized trial in Swaziland, Uganda, and Zimbabwe. Districts/regions (n = 9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7,300-27,500) will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEIs) returning to the health facility within 2 months for early infant diagnosis (EID) of HIV. Secondary study outcomes include gestational age of women attending for first antenatal care, male partners tested for HIV, and HEIs receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices, and beliefs on MCH/PMTCT will be assessed through household surveys. Implementation of the protocol necessitated changes in the

  13. Development and implementation of an HIV/AIDS trials management system: a geographical information systems approach

    CSIR Research Space (South Africa)

    Busgeeth, K

    2008-01-01

    Full Text Available of randomised and clinically controlled trials of HIV/AIDS interventions can provide invaluable information to decision-making processes. Using the newly emerging geographical information systems (GIS) technology, researchers have developed a tool which assists...

  14. Community-based implementation and effectiveness in a randomized trial of a risk reduction intervention for HIV-serodiscordant couples: study protocol.

    Science.gov (United States)

    Hamilton, Alison B; Mittman, Brian S; Williams, John K; Liu, Honghu H; Eccles, Alicia M; Hutchinson, Craig S; Wyatt, Gail E

    2014-06-20

    The HIV/AIDS epidemic continues to disproportionately affect African American communities in the US, particularly those located in urban areas. Despite the fact that HIV is often transmitted from one sexual partner to another, most HIV prevention interventions have focused only on individuals, rather than couples. This five-year study investigates community-based implementation, effectiveness, and sustainability of 'Eban II,' an evidence-based risk reduction intervention for African-American heterosexual, serodiscordant couples. This hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model (PCM), a model of phased organizational change from exposure to adoption, implementation, and sustainability. The primary implementation aims are to assist 10 community-based organizations (CBOs) to implement and sustain Eban II; specifically, to partner with CBOs to expose providers to the intervention; facilitate its adoption, implementation and sustainment; and to evaluate processes and determinants of implementation, effectiveness, fidelity, and sustainment. The primary effectiveness aim is to evaluate the effect of Eban II on participant (n = 200 couples) outcomes, specifically incidents of protected sex and proportion of condom use. We will also determine the cost-effectiveness of implementation, as measured by implementation costs and potential cost savings. A mixed methods evaluation will examine implementation at the agency level; staff members from the CBOs will complete baseline measures of organizational context and climate, while key stakeholders will be interviewed periodically throughout implementation. Effectiveness of Eban II will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up. Multi-level hierarchical modeling with a multi

  15. A Systematic Review of Antiretroviral Adherence Interventions for HIV-Infected People Who Use Drugs

    OpenAIRE

    CampBinford, Meredith; Kahana, Shoshana Y.; Altice, Frederick L.

    2012-01-01

    HIV-infected persons who use drugs (PWUDs) are particularly vulnerable for suboptimal combination antiretroviral therapy (cART) adherence. A systematic review of interventions to improve cART adherence and virologic outcomes among HIV-infected PWUDs was conducted. Among the 45 eligible studies, randomized controlled trials suggested directly administered antiretroviral therapy, medication-assisted therapy (MAT), contingency management, and multi-component, nurse-delivered interventions provid...

  16. HIV and AIDS workplace interventions; Gaps between policy and ...

    African Journals Online (AJOL)

    Introduction This study set out to identify gaps between policy and practice of HIV and AIDS workplace interventions in the University of Malawi, in particular College of Medicine in line with the UNIMA HIV and AIDS policy. Objectives The main objective was to establish whether the HIV and AIDS workplace interventions at ...

  17. HIV and dyadic intervention: an interdependence and communal coping analysis.

    Directory of Open Access Journals (Sweden)

    Catherine M Montgomery

    Full Text Available The most common form of HIV transmission in sub-Saharan Africa is heterosexual sex between two partners. While most HIV prevention interventions are aimed at the individual, there is mounting evidence of the feasibility, acceptability, and efficacy of dyadic interventions. However, the mechanisms through which dyadic-level interventions achieve success remain little explored. We address this gap by using Lewis et al's interdependence model of couple communal coping and behaviour change to analyse data from partners participating in an HIV prevention trial in Uganda and Zambia.We conducted a comparative qualitative study using in-depth interviews. Thirty-three interviews were conducted in total; ten with couples and twenty-three with staff members at the two sites. The Ugandan site recruited a sero-discordant couple cohort and the Zambian site recruited women alone. Spouses' transformation of motivation is strong where couples are recruited and both partners stand to gain considerably by participating in the research; it is weaker where this is not the case. As such, coping mechanisms differ in the two sites; among sero-discordant couples in Uganda, communal coping is evidenced through joint consent to participate, regular couple counselling and workshops, sharing of HIV test results, and strong spousal support for adherence and retention. By contrast, coping at the Zambian site is predominantly left to the individual woman and occurs against a backdrop of mutual mistrust and male disenfranchisement. We discuss these findings in light of practical and ethical considerations of recruiting couples to HIV research.We argue for the need to consider the broader context within which behaviour change occurs and propose that future dyadic research be situated within the framework of the 'risk environment'.

  18. Estimating effectiveness in HIV prevention trials with a Bayesian hierarchical compound Poisson frailty model

    Science.gov (United States)

    Coley, Rebecca Yates; Browna, Elizabeth R.

    2016-01-01

    Inconsistent results in recent HIV prevention trials of pre-exposure prophylactic interventions may be due to heterogeneity in risk among study participants. Intervention effectiveness is most commonly estimated with the Cox model, which compares event times between populations. When heterogeneity is present, this population-level measure underestimates intervention effectiveness for individuals who are at risk. We propose a likelihood-based Bayesian hierarchical model that estimates the individual-level effectiveness of candidate interventions by accounting for heterogeneity in risk with a compound Poisson-distributed frailty term. This model reflects the mechanisms of HIV risk and allows that some participants are not exposed to HIV and, therefore, have no risk of seroconversion during the study. We assess model performance via simulation and apply the model to data from an HIV prevention trial. PMID:26869051

  19. Availability of HIV/AIDS community intervention programmes and ...

    African Journals Online (AJOL)

    As a result, mining sites are at great risk of HIV transmission. While a ... Both quantitative and qualitative methods were used to collect data. ... The programmes carried out intervention activities which included HIV/AIDS education campaigns, ...

  20. Social media interventions to prevent HIV: A review of interventions and methodological considerations.

    Science.gov (United States)

    Tso, Lai Sze; Tang, Weiming; Li, Haochu; Yan, H Yanna; Tucker, Joseph D

    2016-06-01

    Persistent new HIV infections and risky behaviors underscore the need for enhanced HIV prevention. Social media interventions may promote safe sexual behaviors, increase HIV testing uptake, and promote safe injection behaviors. This review discusses how social media interventions tap into the wisdom of crowds through crowdsourcing, build peer-mentored communities, and deliver interventions through social networks. Social media HIV prevention interventions are constrained by ethical issues, low social media usage among some key populations, and implementation issues. Comprehensive measurement of social media interventions to prevent HIV is necessary, but requires further development of metrics.

  1. Interventions for preventing mother-to-child HIV transmission: protocol of an overview of systematic reviews.

    Science.gov (United States)

    Wariki, Windy Mariane Virenia; Ota, Erika; Mori, Rintaro; Wiysonge, Charles S; Horvath, Hacsi; Read, Jennifer S

    2017-06-21

    Various interventions to prevent mother-to-child-transmission (MTCT) of HIV have been investigated and implemented. A number of systematic reviews assessing the efficacy of interventions for the prevention of MTCT of HIV reported antiretroviral prophylaxis, caesarean section before labour and before ruptured membranes, and complete avoidance of breastfeeding were efficacious for preventing MTCT of HIV. Recent WHO guidelines recommend lifelong antiretroviral therapy for all pregnant women for treatment of the woman's own HIV infection and for prevention of MTCT of HIV. Therefore, the objective of this overview is to evaluate the currently available systematic reviews of interventions for preventing MTCT of HIV, and to identify the current best evidence-based interventions for reducing the risk of MTCT of HIV. We will include only peer-reviewed systematic reviews of randomised or quasi-randomised controlled trials assessing the effects of interventions for preventing MTCT of HIV that target both HIV-infected women and children aged 2 years and younger born to HIV-infected women. We will search the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effectiveness, Ovid MEDLINE and EMBASE. We will assess review eligibility, the methodological quality of included systematic reviews using A Measurement Tool to Assess The Systematic Reviews and will extract data, comparing our results and resolving discrepancies by consensus. Finally, we will independently assess the certainty of the evidence using Grades of Recommendation, Assessment, Development and Evaluation. Ethics approval is not required. We will publish the results in a peer-reviewed journal and present at conferences, which will inform future research and will be useful for healthcare managers, administrators and policymakers to guide resource allocation decisions and optimisation of interventions to prevent the MTCT of HIV. © Article author(s) (or their employer(s) unless

  2. Betting on the fastest horse: Using computer simulation to design a combination HIV intervention for future projects in Maharashtra, India

    OpenAIRE

    Ruggles, Kelly V.; Patel, Anik R.; Schensul, Stephen; Schensul, Jean; Nucifora, Kimberly; Zhou, Qinlian; Bryant, Kendall; Braithwaite, R. Scott

    2017-01-01

    Objective To inform the design of a combination intervention strategy targeting HIV-infected unhealthy alcohol users in Maharashtra, India, that could be tested in future randomized control trials. Methods Using probabilistic compartmental simulation modeling we compared intervention strategies targeting HIV-infected unhealthy alcohol users on antiretroviral therapy (ART) in Maharashtra, India. We tested interventions targeting four behaviors (unhealthy alcohol consumption, risky sexual behav...

  3. HIV risk and preventive interventions in transgender women sex workers

    Science.gov (United States)

    Poteat, Tonia; Wirtz, Andrea L; Radix, Anita; Borquez, Annick; Silva-Santisteban, Alfonso; Deutsch, Madeline B; Khan, Sharful Islam; Winter, Sam; Operario, Don

    2015-01-01

    Worldwide, transgender women who engage in sex work have a disproportionate risk for HIV compared with natal male and female sex workers. We reviewed recent epidemiological research on HIV in transgender women and show that transgender women sex workers (TSW) face unique structural, interpersonal, and individual vulnerabilities that contribute to risk for HIV. Only six studies of evidence-based prevention interventions were identified, none of which focused exclusively on TSW. We developed a deterministic model based on findings related to HIV risks and interventions. The model examines HIV prevention approaches in TSW in two settings (Lima, Peru and San Francisco, CA, USA) to identify which interventions would probably achieve the UN goal of 50% reduction in HIV incidence in 10 years. A combination of interventions that achieves small changes in behaviour and low coverage of biomedical interventions was promising in both settings, suggesting that the expansion of prevention services in TSW would be highly effective. However, this expansion needs appropriate sustainable interventions to tackle the upstream drivers of HIV risk and successfully reach this population. Case studies of six countries show context-specific issues that should inform development and implementation of key interventions across heterogeneous settings. We summarise the evidence and knowledge gaps that affect the HIV epidemic in TSW, and propose a research agenda to improve HIV services and policies for this population. PMID:25059941

  4. HIV and dyadic intervention: an interdependence and communal coping analysis

    NARCIS (Netherlands)

    Montgomery, C.M.; Watts, C.; Pool, R.

    2012-01-01

    Background The most common form of HIV transmission in sub-Saharan Africa is heterosexual sex between two partners. While most HIV prevention interventions are aimed at the individual, there is mounting evidence of the feasibility, acceptability, and efficacy of dyadic interventions. However, the

  5. 78 FR 78976 - Ryan White HIV/AIDS Program Part C Early Intervention Services Grant Under the Ryan White HIV...

    Science.gov (United States)

    2013-12-27

    ... HIV/AIDS Program Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program AGENCY...: Notice of Ryan White HIV/AIDS Program Part C Early Intervention Services One-Time Noncompetitive Award To... services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White HIV/AIDS...

  6. Intervention outcomes among HIV-affected families over 18 months.

    Science.gov (United States)

    Rotheram-Borus, Mary Jane; Rice, Eric; Comulada, W Scott; Best, Karin; Elia, Carla; Peters, Katherine; Li, Li; Green, Sara; Valladares, Ena

    2012-07-01

    We evaluate the efficacy of a family-based intervention over time among HIV-affected families. Mothers living with HIV (MLH; n = 339) in Los Angeles and their school-aged children were randomized to either an intervention or control condition and followed for 18 months. MLH and their children in the intervention received 16 cognitive-behavioral, small-group sessions designed to help them maintain physical and mental health, parent while ill, address HIV-related stressors, and reduce HIV-transmission behaviors. At recruitment, MLH reported few problem behaviors related to physical health, mental health, or sexual or drug transmission acts. Compared to MLH in the control condition, intervention MLH were significantly more likely to monitor their own CD4 cell counts and their children were more likely to decrease alcohol and drug use. Most MLH and their children had relatively healthy family relationships. Family-based HIV interventions should be limited to MLH who are experiencing substantial problems.

  7. Internet-Based Health Information Consumer Skills Intervention for People Living with HIV/AIDS

    Science.gov (United States)

    Kalichman, Seth C.; Cherry, Charsey; Cain, Demetria; Pope, Howard; Kalichman, Moira; Eaton, Lisa; Weinhardt, Lance; Benotsch, Eric G.

    2006-01-01

    Medical information can improve health, and there is an enormous amount of health information available on the Internet. A randomized clinical trial tested the effectiveness of an intervention based on social-cognitive theory to improve information use among people living with HIV/AIDS. Men and women (N = 448) were placed in either (a) an…

  8. 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.

  9. Cancer clinical trials in persons with HIV infection.

    Science.gov (United States)

    Little, Richard F

    2017-01-01

    The era of modern HIV therapeutics is well underway. The cancer and infectious disease epidemiology of HIV disease has markedly altered as populations are availed to the benefits of antiretroviral therapy (ARV). The types of cancers occurring among those with HIV infection has broadened but the case burden in absolute numbers is very low relative to the background population. There are fewer incident cases of the AIDS-defining cancers (aggressive B-cell lymphomas, Kaposi's sarcoma, and cervical cancer). There is an increased risk for certain non-AIDS-defining cancers, but these occur somewhat sporadically relative to clinical trial enrollment. The changing epidemiology of cancer in HIV poses challenges as well as opportunities for participation of persons with HIV in cancer therapy clinical trials. There are excellent examples of cancer trials that inform cancer therapy for patients with HIV infection. Examples include those from HIV-specific trials and from trials mainly focused on the background population that included patients with HIV infection. Interpretation of clinical trials to guide therapy for those with HIV infection and cancer largely depends on data that does not include HIV-infected patients. The ability to extend clinical trial findings to populations not included in clinical trials remains problematic for a variety of populations, including those with HIV or AIDS. Careful prioritization of studies designed to bridge this gap is needed. However, there are published studies that serve as excellent examples bridging these gaps and the portfolio of cancer therapy trials underway will inform HIV and cancer better than at any time in the past.

  10. What is the benefit of the biomedical and behavioral interventions in preventing HIV transmission?

    Directory of Open Access Journals (Sweden)

    Ricardo Kuchenbecker

    2015-09-01

    Full Text Available ABSTRACTIntroduction:Scientific evidence supports the sinergy between biomedical and behavioral interventions aimed at preventing the transmission of HIV as a strategy to eradicate AIDS.Objective:To characterize comparatively the benefits from biomedical and behavioral interventions to prevent HIV transmission.Methods:Narrative review. We performed a comparative analysis of the benefits of studied interventions by means of estimating the number needed to treat (NNT. Evaluated interventions: counseling activities for behavior change to prevent exposure to HIV; antiretroviral pre-exposure prophylaxis (PrEP and antiretroviral post-exposure prophylasis (PEP for HIV and treatment of serodiscordant couples as a strategy for prevention of HIV transmission (TasP.Results:counseling interventions and TasP have smaller NNTs, equal to, respectively, 11 (95%CI 9 - 18 at 12 months and 34 (95%CI 23 - 54 in 42 months comparatively to PrEP interventions, that resulted in 41 (95%CI 28 - 67 individuals receiving antiretrovirals in order to prevent one case of HIV infection at 36 months for men and serodiscordant couples. PEP interventions are associated with protective effects estimated at 81%. Lack of trials evaluating PEP prevents estimate of NNT.Conclusion:The estimate of the NNT can be a helpful parameter in the comparison between the effectiveness of different behavioral and biomedical HIV prevention strategies. Studies evaluating the benefit and safety of combined behavioral and biomedical interventions are needed, especially considering the attributable fraction of each component. Integration of behavioral and biomedical interventions is required to achieve complete suppression of the virus, and thus reducing viral replication, infectivity and the number of cases.

  11. Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China.

    Science.gov (United States)

    Tang, Weiming; Han, Larry; Best, John; Zhang, Ye; Mollan, Katie; Kim, Julie; Liu, Fengying; Hudgens, Michael; Bayus, Barry; Terris-Prestholt, Fern; Galler, Sam; Yang, Ligang; Peeling, Rosanna; Volberding, Paul; Ma, Baoli; Xu, Huifang; Yang, Bin; Huang, Shujie; Fenton, Kevin; Wei, Chongyi; Tucker, Joseph D

    2016-06-01

    Crowdsourcing, the process of shifting individual tasks to a large group, may enhance human immunodeficiency virus (HIV) testing interventions. We conducted a noninferiority, randomized controlled trial to compare first-time HIV testing rates among men who have sex with men (MSM) and transgender individuals who received a crowdsourced or a health marketing HIV test promotion video. Seven hundred twenty-one MSM and transgender participants (≥16 years old, never before tested for HIV) were recruited through 3 Chinese MSM Web portals and randomly assigned to 1 of 2 videos. The crowdsourced video was developed using an open contest and formal transparent judging while the evidence-based health marketing video was designed by experts. Study objectives were to measure HIV test uptake within 3 weeks of watching either HIV test promotion video and cost per new HIV test and diagnosis. Overall, 624 of 721 (87%) participants from 31 provinces in 217 Chinese cities completed the study. HIV test uptake was similar between the crowdsourced arm (37% [114/307]) and the health marketing arm (35% [111/317]). The estimated difference between the interventions was 2.1% (95% confidence interval, -5.4% to 9.7%). Among those tested, 31% (69/225) reported a new HIV diagnosis. The crowdsourced intervention cost substantially less than the health marketing intervention per first-time HIV test (US$131 vs US$238 per person) and per new HIV diagnosis (US$415 vs US$799 per person). Our nationwide study demonstrates that crowdsourcing may be an effective tool for improving HIV testing messaging campaigns and could increase community engagement in health campaigns. NCT02248558. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  12. On the Efficacy and Mediation of a One-on-One HIV Risk-Reduction Intervention for African American Men Who Have Sex with Men: A Randomized Controlled Trial.

    Science.gov (United States)

    Jemmott, John B; Jemmott, Loretta Sweet; O'Leary, Ann; Icard, Larry D; Rutledge, Scott E; Stevens, Robin; Hsu, Janet; Stephens, Alisa J

    2015-07-01

    We examined the efficacy and mediation of Being Responsible for Ourselves (BRO), an HIV/STI risk-reduction intervention for African American men who have sex with men (MSM), the population with the highest HIV-diagnosis rate in the US. We randomized African American MSM to one of two interventions: BRO HIV/STI risk-reduction, targeting condom use; or attention-matched control, targeting physical activity and healthy diet. The interventions were based on social cognitive theory, the reasoned-action approach, and qualitative research. Men reporting anal intercourse with other men in the past 90 days were eligible and completed pre-intervention, immediately post-intervention, and 6 and 12 months post-intervention surveys. Of 595 participants, 503 (85 %) completed the 12-month follow-up. Generalized-estimating-equations analysis indicated that, compared with the attention-matched control intervention, the BRO intervention did not increase consistent condom use averaged over the 6- and 12-month follow-ups, which was the primary outcome. Although BRO did not affect the proportion of condom-protected intercourse acts, unprotected sexual intercourse, multiple partners, or insertive anal intercourse, it did reduce receptive anal intercourse compared with the control, a behavior linked to incident HIV infection. Mediation analysis using the product-of-coefficients approach revealed that although BRO increased seven of nine theoretical constructs it was designed to affect, it increased only one of three theoretical constructs that predicted consistent condom use: condom-use impulse-control self-efficacy. Thus, BRO indirectly increased consistent condom use through condom-use impulse-control self-efficacy. In conclusion, although BRO increased several theoretical constructs, most of those constructs did not predict consistent condom use; hence, the intervention did not increase it. Theoretical constructs that interventions should target to increase African American MSM

  13. Population-based biomedical sexually transmitted infection control interventions for reducing HIV infection.

    Science.gov (United States)

    Ng, Brian E; Butler, Lisa M; Horvath, Tara; Rutherford, George W

    2011-03-16

    The transmission of sexually transmitted infections (STIs) is closely related to the sexual transmission of human immunodeficiency virus (HIV). Similar risk behaviours, such as frequent unprotected intercourse with different partners, place people at high risk of HIV and STIs, and there is clear evidence that many STIs increase the likelihood of HIV transmission. STI control, especially at the population or community level, may have the potential to contribute substantially to HIV prevention.This is an update of an existing Cochrane review. The review's search methods were updated and its inclusion and exclusion criteria modified so that the focus would be on one well-defined outcome. This review now focuses explicitly on population-based biomedical interventions for STI control, with change in HIV incidence being an outcome necessary for a study's inclusion. To determine the impact of population-based biomedical STI interventions on the incidence of HIV infection. We searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science/Social Science, PsycINFO, and Literatura Latino Americana e do Caribe em Ciências da Saúde (LILACS), for the period of 1 January1980 - 16 August 2010. We initially identified 6003 articles and abstracts. After removing 776 duplicates, one author (TH) removed an additional 3268 citations that were clearly irrelevant. Rigorously applying the inclusion criteria, three authors then independently screened the remaining 1959 citations and abstracts. Forty-six articles were chosen for full-text scrutiny by two authors. Ultimately, four studies were included in the review.We also searched the Aegis database of conference abstracts, which includes the Conference on Retroviruses and Opportunistic Infections (CROI), the International AIDS Conference (IAC), and International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS) meetings from their inception dates (1993, 1985 and

  14. HIV stigma experiences and stigmatisation before and after an intervention

    Directory of Open Access Journals (Sweden)

    H. C. Chidrawi

    2016-10-01

    Full Text Available This study focuses on one aspect of a more extensive SANPAD-funded HIV stigma reduction research project. The study addresses not only the continuous burden of HIV stigma, but more specifically on the low rate of participation in healthcare opportunities and HIV stigma reduction interventions by people living with HIV (PLWH This study tested both change-over-time in HIV stigma experiences of PLWH and change-over-time in the HIV stigmatisation behaviour of people living close to them (PLC in an urban and rural setting in the North-West in South Africa. These aspects were measured before and after the comprehensive community-based HIV stigma reduction intervention. A quantitative single system research design, with a pre-test and four repetitive post-tests, and purposive voluntary and snowball sampling were used. Findings did not indicate significant differences between urban and rural settings, but demonstrated some significance in change-over-time in the HIV stigma experiences of PLWH as well as the HIV stigmatisationbehaviour of PLC after the intervention. Recommendations include the continuation of this intervention, following the same guidelines that were implemented during the study.

  15. HIV stigma experiences and stigmatisation before and after an intervention

    Directory of Open Access Journals (Sweden)

    H. Christa Chidrawi

    2016-12-01

    Full Text Available This study focuses on one aspect of a more extensive SANPAD-funded HIV stigma reduction research project. The study addresses not only the continuous burden of HIV stigma, but more specifically on the low rate of participation in healthcare opportunities and HIV stigma reduction interventions by people living with HIV (PLWH This study tested both change-over-time in HIV stigma experiences of PLWH and change-over-time in the HIV stigmatisation behaviour of people living close to them (PLC in an urban and rural setting in the North-West in South Africa. These aspects were measured before and after the comprehensive community-based HIV stigma reduction intervention. A quantitative single system research design, with a pre-test and four repetitive post-tests, and purposive voluntary and snowball sampling were used. Findings did not indicate significant differences between urban and rural settings, but demonstrated some significance in change-over-time in the HIV stigma experiences of PLWH as well as the HIV stigmatisation behaviour of PLC after the intervention. Recommendations include the continuation of this intervention, following the same guidelines that were implemented during the study.

  16. Increasing Partner Attendance in Antenatal Care and HIV Testing Services: Comparable Outcomes Using Written versus Verbal Invitations in an Urban Facility-Based Controlled Intervention Trial in Mbeya, Tanzania.

    Directory of Open Access Journals (Sweden)

    Stefanie Theuring

    Full Text Available In many Sub-Saharan African settings male partner involvement in antenatal care (ANC remains low, although great benefits for maternal and infant health outcomes have been long recognised, in particular regarding the prevention of HIV transmission. Yet there is paucity on evidence regarding the effectiveness of strategies to increase male partner involvement. This controlled intervention trial in Ruanda Health Centre in Mbeya, Tanzania, assessed the effectiveness of invitation letters for male involvement in ANC. Pregnant women approaching ANC without partners received official letters inviting the partner to attend ANC. A control group was instructed to verbally invite partners. Partner attendance was recorded at two subsequent ANC visits. Rates for male partner return, couple voluntary counselling and testing (CVCT, and influencing factors were analysed. From 199 ANC clients in total, 97 were assigned to the invitation letter group; 30 of these (30.9% returned with their male partners for ANC. In the control group of 102 women, 28 (27.5% returned with their partner. In both groups CVCT rates among jointly returning couples were 100%. Partner return/CVCT rate was not statistically different in intervention and control group (OR 1.2, p = 0.59. Former partner attendance at ANC during a previous pregnancy was the only factor found to be significantly linked with partner return (p = 0.03. Our study demonstrates that rather simple measures to increase male partner attendance in ANC and CVCT can be effective, with written and verbal invitations having comparable outcomes. In terms of practicability in Sub-Saharan African settings, we recommend systematic coaching of ANC clients on how to verbally invite male partners in the first instance, followed by written invitation letters for partners in case of their non-attendance. Further studies covering both urban and rural settings will be more informative for effective translation into policy.

  17. Creating an African HIV clinical research and prevention trials network: HIV prevalence, incidence and transmission.

    Directory of Open Access Journals (Sweden)

    Anatoli Kamali

    Full Text Available HIV epidemiology informs prevention trial design and program planning. Nine clinical research centers (CRC in sub-Saharan Africa conducted HIV observational epidemiology studies in populations at risk for HIV infection as part of an HIV prevention and vaccine trial network. Annual HIV incidence ranged from below 2% to above 10% and varied by CRC and risk group, with rates above 5% observed in Zambian men in an HIV-discordant relationship, Ugandan men from Lake Victoria fishing communities, men who have sex with men, and several cohorts of women. HIV incidence tended to fall after the first three months in the study and over calendar time. Among suspected transmission pairs, 28% of HIV infections were not from the reported partner. Volunteers with high incidence were successfully identified and enrolled into large scale cohort studies. Over a quarter of new cases in couples acquired infection from persons other than the suspected transmitting partner.

  18. Creating an African HIV Clinical Research and Prevention Trials Network: HIV Prevalence, Incidence and Transmission

    Science.gov (United States)

    Kamali, Anatoli; Price, Matt A.; Lakhi, Shabir; Karita, Etienne; Inambao, Mubiana; Sanders, Eduard J.; Anzala, Omu; Latka, Mary H.; Bekker, Linda-Gail; Kaleebu, Pontiano; Asiki, Gershim; Ssetaala, Ali; Ruzagira, Eugene; Allen, Susan; Farmer, Paul; Hunter, Eric; Mutua, Gaudensia; Makkan, Heeran; Tichacek, Amanda; Brill, Ilene K.; Fast, Pat; Stevens, Gwynn; Chetty, Paramesh; Amornkul, Pauli N.; Gilmour, Jill

    2015-01-01

    HIV epidemiology informs prevention trial design and program planning. Nine clinical research centers (CRC) in sub-Saharan Africa conducted HIV observational epidemiology studies in populations at risk for HIV infection as part of an HIV prevention and vaccine trial network. Annual HIV incidence ranged from below 2% to above 10% and varied by CRC and risk group, with rates above 5% observed in Zambian men in an HIV-discordant relationship, Ugandan men from Lake Victoria fishing communities, men who have sex with men, and several cohorts of women. HIV incidence tended to fall after the first three months in the study and over calendar time. Among suspected transmission pairs, 28% of HIV infections were not from the reported partner. Volunteers with high incidence were successfully identified and enrolled into large scale cohort studies. Over a quarter of new cases in couples acquired infection from persons other than the suspected transmitting partner. PMID:25602351

  19. Considerations for a Human Rights Impact Assessment of a Population Wide Treatment for HIV Prevention Intervention.

    Science.gov (United States)

    Hanefeld, Johanna; Bond, Virginia; Seeley, Janet; Lees, Shelley; Desmond, Nicola

    2015-12-01

    Increasing attention is being paid to the potential of anti-retroviral treatment (ART) for HIV prevention. The possibility of eliminating HIV from a population through a universal test and treat intervention, where all people within a population are tested for HIV and all positive people immediately initiated on ART, as part of a wider prevention intervention, was first proposed in 2009. Several clinical trials testing this idea are now in inception phase. An intervention which relies on universally testing the entire population for HIV will pose challenges to human rights, including obtaining genuine consent to testing and treatment. It also requires a context in which people can live free from fear of stigma, discrimination and violence, and can access services they require. These challenges are distinct from the field of medical ethics which has traditionally governed clinical trials and focuses primarily on patient researcher relationship. This paper sets out the potential impact of a population wide treatment as prevention intervention on human rights. It identifies five human right principles of particular relevance: participation, accountability, the right to health, non-discrimination and equality, and consent and confidentiality. The paper proposes that explicit attention to human rights can strengthen a treatment as prevention intervention, contribute to mediating likely health systems challenges and offer insights on how to reach all sections of the population. © 2013 John Wiley & Sons Ltd.

  20. HIV prevention intervention among low-income women in South ...

    African Journals Online (AJOL)

    The aim of the study was to evaluate a motivation-based HIV risk reduction intervention for economically disadvantaged urban women in South Africa. Women were recruited through radio and information pamphlets. At baseline 119 women completed a survey regarding HIV-related knowledge, risk perceptions, ...

  1. A systematic review of income generation interventions, including microfinance and vocational skills training, for HIV prevention.

    Science.gov (United States)

    Kennedy, Caitlin E; Fonner, Virginia A; O'Reilly, Kevin R; Sweat, Michael D

    2014-01-01

    Income generation interventions, such as microfinance or vocational skills training, address structural factors associated with HIV risk. However, the effectiveness of these interventions on HIV-related outcomes in low- and middle-income countries has not been synthesized. The authors conducted a systematic review by searching electronic databases from 1990 to 2012, examining secondary references, and hand-searching key journals. Peer-reviewed studies were included in the analysis if they evaluated income generation interventions in low- or middle-income countries and provided pre-post or multi-arm measures on behavioral, psychological, social, care, or biological outcomes related to HIV prevention. Standardized forms were used to abstract study data in duplicate and study rigor was assessed. Of the 5218 unique citations identified, 12 studies met criteria for inclusion. Studies were geographically diverse, with six conducted in sub-Saharan Africa, three in South or Southeast Asia, and three in Latin America and the Caribbean. Target populations included adult women (N = 6), female sex workers/bar workers (N = 3), and youth/orphans (N = 3). All studies targeted females except two among youth/orphans. Study rigor was moderate, with two group-randomized trials and two individual-randomized trials. All interventions except three included some form of microfinance. Only a minority of studies found significant intervention effects on condom use, number of sexual partners, or other HIV-related behavioral outcomes; most studies showed no significant change, although some may have had inadequate statistical power. One trial showed a 55% reduction in intimate partner violence (adjusted risk ratio 0.45, 95% confidence interval 0.23-0.91). No studies measured incidence/prevalence of HIV or sexually transmitted infections among intervention recipients. The evidence that income generation interventions influence HIV-related behaviors and outcomes is inconclusive. However, these

  2. A systematic review of income generation interventions, including microfinance and vocational skills training, for HIV prevention

    Science.gov (United States)

    Kennedy, Caitlin E.; Fonner, Virginia A.; O'Reilly, Kevin R.; Sweat, Michael D.

    2013-01-01

    Income generation interventions, such as microfinance or vocational skills training, address structural factors associated with HIV risk. However, the effectiveness of these interventions on HIV-related outcomes in low- and middle-income countries has not been synthesized. We conducted a systematic review by searching electronic databases from 1990-2012, examining secondary references, and hand searching key journals. Peer-reviewed studies were included in the analysis if they evaluated income generation interventions in low- or middle-income countries and provided pre-post or multi-arm measures on behavioral, psychological, social, care or biological outcomes related to HIV prevention. Standardized forms were used to abstract study data in duplicate and study rigor was assessed. Of 5,218 unique citations identified, 12 studies met criteria for inclusion. Studies were geographically diverse, with 6 conducted in sub-Saharan Africa, 3 in South or Southeast Asia, and 3 in Latin America and the Caribbean. Target populations included adult women (N=6), female sex workers/bar workers (N=3), and youth/orphans (N=3). All studies targeted females except 2 among youth/orphans. Study rigor was moderate, with 2 group-randomized trials and 2 individual-randomized trials. All interventions except 3 included some form of microfinance. Only a minority of studies found significant intervention effects on condom use, number of sexual partners or other HIV-related behavioral outcomes; most studies showed no significant change, although some may have had inadequate statistical power. One trial showed a 55% reduction in intimate partner violence (adjusted risk ratio 0.45, 95% confidence interval 0.23-0.91). No studies measured incidence/prevalence of HIV or sexually transmitted infections among intervention recipients. The evidence that income generation interventions influence HIV-related behaviors and outcomes is inconclusive. However, these interventions may have important effects

  3. A Livelihood Intervention to Reduce the Stigma of HIV in Rural Kenya: Longitudinal Qualitative Study.

    Science.gov (United States)

    Tsai, Alexander C; Hatcher, Abigail M; Bukusi, Elizabeth A; Weke, Elly; Lemus Hufstedler, Lee; Dworkin, Shari L; Kodish, Stephen; Cohen, Craig R; Weiser, Sheri D

    2017-01-01

    The scale-up of effective treatment has partially reduced the stigma attached to HIV, but HIV still remains highly stigmatized throughout sub-Saharan Africa. Most studies of anti-HIV stigma interventions have employed psycho-educational strategies such as information provision, counseling, and testimonials, but these have had varying degrees of success. Theory suggests that livelihood interventions could potentially reduce stigma by weakening the instrumental and symbolic associations between HIV and premature morbidity, economic incapacity, and death, but this hypothesis has not been directly examined. We conducted a longitudinal qualitative study among 54 persons with HIV participating in a 12-month randomized controlled trial of a livelihood intervention in rural Kenya. Our study design permitted assessment of changes over time in the perspectives of treatment-arm participants (N = 45), as well as an understanding of the experiences of control arm participants (N = 9, interviewed only at follow-up). Initially, participants felt ashamed of their seropositivity and were socially isolated (internalized stigma). They also described how others in the community discriminated against them, labeled them as being "already dead," and deemed them useless and unworthy of social investment (perceived and enacted stigma). At follow-up, participants in the treatment arm described less stigma and voiced positive changes in confidence and self-esteem. Concurrently, they observed that other community members perceived them as active, economically productive, and contributing citizens. None of these changes were noted by participants in the control arm, who described ongoing and continued stigma. In summary, our findings suggest a theory of stigma reduction: livelihood interventions may reduce internalized stigma among persons with HIV and also, by targeting core drivers of negative attitudes toward persons with HIV, positively change attitudes toward persons with HIV held by

  4. 78 FR 25458 - Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV...

    Science.gov (United States)

    2013-05-01

    ... HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice of Ryan White HIV/AIDS... HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White HIV/AIDS Program Part C funds award...

  5. 78 FR 10183 - Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV...

    Science.gov (United States)

    2013-02-13

    ... HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program.... ACTION: Notice of Ryan White HIV/AIDS Program Part C Early Intervention Services One-Time Noncompetitive... care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Ryan White...

  6. 78 FR 18989 - Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV...

    Science.gov (United States)

    2013-03-28

    ... HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program.... ACTION: Notice of Ryan White HIV/AIDS Program Part C Early Intervention Services One-Time Noncompetitive... care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Part C...

  7. 78 FR 31568 - Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV...

    Science.gov (United States)

    2013-05-24

    ... HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program.... ACTION: Notice of Ryan White HIV/AIDS Program Part C Early Intervention Services One-Time Noncompetitive... care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White...

  8. 78 FR 10182 - Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV...

    Science.gov (United States)

    2013-02-13

    ... HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program.... ACTION: Notice of Ryan White HIV/AIDS Program (Part C) Early Intervention Services One-Time... primary care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Part C...

  9. Leveraging microfinance to impact HIV and financial behaviors among adolescents and their mothers in West Bengal: a cluster randomized trial.

    Science.gov (United States)

    Spielberg, Freya; Crookston, Benjamin T; Chanani, Sheila; Kim, Jaewhan; Kline, Sean; Gray, Bobbi L

    2013-01-01

    Microfinance can be used to reach women and adolescent girls with HIV prevention education. We report findings from a cluster-randomized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge, attitudes and behaviors for HIV prevention and savings. Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics. Women and girls who received HIV education showed significant gains in HIV knowledge, awareness that condoms can prevent HIV, self-efficacy for HIV prevention, and confirmed use of clean needles, as compared to the control group. Condom use was rare and did not improve for women. While HIV testing was uncommon, knowledge of HIV-testing resources significantly increased among girls, and trended in the positive direction among women in intervention groups. Conversely, the savings education showed no impact on financial knowledge or behavior change.

  10. Interventions for preventing late postnatal mother-to-child transmission of HIV.

    Science.gov (United States)

    Horvath, Tara; Madi, Banyana C; Iuppa, Irene M; Kennedy, Gail E; Rutherford, George; Read, Jennifer S

    2009-01-21

    Worldwide, mother-to-child transmission (MTCT) of human immunodeficiency virus type 1 (HIV) represents the most common means by which children acquire HIV infection. Efficacious and effective interventions to prevent in utero and intrapartum transmission of HIV infection have been developed and implemented. However, a large proportion of MTCT of HIV occurs postnatally, through breast milk transmission. The objectives of this systematic review were to collate and assess the evidence regarding interventions to decrease late postnatal MTCT of HIV, and to determine the efficacy of such interventions in decreasing late postnatal MTCT of HIV, increasing overall survival, and increasing HIV-free survival. Electronic searches were undertaken using PubMed, EMBASE and other databases for 1980-2008. Hand searches of reference lists of pertinent reviews and studies, as well as abstracts from relevant conferences, were also conducted. Experts in the field were contacted to locate any other studies. The search strategy was iterative. Randomized clinical trials assessing the efficacy of interventions to prevent MTCT of HIV through breast milk were included in the analysis. Other trials and intervention cohort studies with relevant data also were included, but only when randomization was not feasible due to the nature of the intervention (i.e., infant feeding modality). Data regarding HIV infection status and vital status of infants born to HIV-infected women, according to intervention, were extracted from the reports of the studies. Six randomized clinical trials and one intervention cohort study were included in this review. Two trials addressed the issue of shortening the duration of (or eliminating) exposure to breast milk. In a trial of breastfeeding versus formula feeding, formula feeding was efficacious in preventing MTCT of HIV (the cumulative probability of HIV infection at 24 months was 36.7% in the breastfeeding arm and 20.5% in the formula arm [p = 0.001]), but the

  11. Motivators of enrolment in HIV vaccine trials: a review of HIV vaccine preparedness studies.

    Science.gov (United States)

    Dhalla, Shayesta; Poole, Gary

    2011-11-01

    HIV vaccine preparedness studies (VPS) are important precursors to HIV vaccine trials. As well, they contribute to an understanding of motivators and barriers for participation in hypothetical HIV vaccine trials. Motivators can take the form of altruism and a desire for social benefits. Perceived personal benefits, including psychological, personal, and financial well-being, may also motivate participation. The authors performed a systematic review of HIV VPS using the Cochrane Database for Systematic Reviews, Medline, PubMed, Embase, and Google Scholar. The authors independently searched the literature for individual HIV VPS that examined motivators of participation in a hypothetical HIV vaccine trial, using the same search strategy. As the denominators employed in the literature varied across studies, the denominators were standardized to the number of respondents per survey item, regardless of their willingness to participate (WTP) in an HIV vaccine trial. The authors retrieved eight studies on social benefits (i.e., altruism) and 11 studies on personal benefits conducted in the Organization for Economic Co-operation and Development (OECD) countries, as well as 19 studies on social benefits and 20 studies on personal benefits in the non-OECD countries. Various different forms of altruism were found to be the major motivators for participation in an HIV vaccine trial in both the OECD and the non-OECD countries. In a large number of studies, protection from HIV was cited as a personal motivator for participation in a hypothetical HIV vaccine trial in the OECD and the non-OECD countries. Knowledge of motivators can inform and target recruitment for HIV vaccine trials, although it must be remembered that hypothetical motivators may not always translate into motivators in an actual vaccine trial.

  12. Building African Capacity for HIV/AIDS Prevention Trials

    International Development Research Centre (IDRC) Digital Library (Canada)

    Canada-Africa Prevention Trials Network : Building African Capacity for HIV/AIDS Prevention Trials. The Canada-Africa Prevention Trials Network (CAPT Network) was formed through a capacity building grant from the Global Health Research Initiative (GHRI). The Network comprises eight African centres (four in Uganda, ...

  13. A computer-assisted motivational social network intervention to reduce alcohol, drug and HIV risk behaviors among Housing First residents.

    Science.gov (United States)

    Kennedy, David P; Hunter, Sarah B; Chan Osilla, Karen; Maksabedian, Ervant; Golinelli, Daniela; Tucker, Joan S

    2016-03-15

    Individuals transitioning from homelessness to housing face challenges to reducing alcohol, drug and HIV risk behaviors. To aid in this transition, this study developed and will test a computer-assisted intervention that delivers personalized social network feedback by an intervention facilitator trained in motivational interviewing (MI). The intervention goal is to enhance motivation to reduce high risk alcohol and other drug (AOD) use and reduce HIV risk behaviors. In this Stage 1b pilot trial, 60 individuals that are transitioning from homelessness to housing will be randomly assigned to the intervention or control condition. The intervention condition consists of four biweekly social network sessions conducted using MI. AOD use and HIV risk behaviors will be monitored prior to and immediately following the intervention and compared to control participants' behaviors to explore whether the intervention was associated with any systematic changes in AOD use or HIV risk behaviors. Social network health interventions are an innovative approach for reducing future AOD use and HIV risk problems, but little is known about their feasibility, acceptability, and efficacy. The current study develops and pilot-tests a computer-assisted intervention that incorporates social network visualizations and MI techniques to reduce high risk AOD use and HIV behaviors among the formerly homeless. CLINICALTRIALS. NCT02140359.

  14. HIV-1 transmission linkage in an HIV-1 prevention clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Leitner, Thomas [Los Alamos National Laboratory; Campbell, Mary S [UNIV OF WASHINGTON; Mullins, James I [UNIV OF WASHINGTON; Hughes, James P [UNIV OF WASHINGTON; Wong, Kim G [UNIV OF WASHINGTON; Raugi, Dana N [UNIV OF WASHINGTON; Scrensen, Stefanie [UNIV OF WASHINGTON

    2009-01-01

    HIV-1 sequencing has been used extensively in epidemiologic and forensic studies to investigate patterns of HIV-1 transmission. However, the criteria for establishing genetic linkage between HIV-1 strains in HIV-1 prevention trials have not been formalized. The Partners in Prevention HSV/HIV Transmission Study (ClinicaITrials.gov NCT00194519) enrolled 3408 HIV-1 serodiscordant heterosexual African couples to determine the efficacy of genital herpes suppression with acyclovir in reducing HIV-1 transmission. The trial analysis required laboratory confirmation of HIV-1 linkage between enrolled partners in couples in which seroconversion occurred. Here we describe the process and results from HIV-1 sequencing studies used to perform transmission linkage determination in this clinical trial. Consensus Sanger sequencing of env (C2-V3-C3) and gag (p17-p24) genes was performed on plasma HIV-1 RNA from both partners within 3 months of seroconversion; env single molecule or pyrosequencing was also performed in some cases. For linkage, we required monophyletic clustering between HIV-1 sequences in the transmitting and seroconverting partners, and developed a Bayesian algorithm using genetic distances to evaluate the posterior probability of linkage of participants sequences. Adjudicators classified transmissions as linked, unlinked, or indeterminate. Among 151 seroconversion events, we found 108 (71.5%) linked, 40 (26.5%) unlinked, and 3 (2.0%) to have indeterminate transmissions. Nine (8.3%) were linked by consensus gag sequencing only and 8 (7.4%) required deep sequencing of env. In this first use of HIV-1 sequencing to establish endpoints in a large clinical trial, more than one-fourth of transmissions were unlinked to the enrolled partner, illustrating the relevance of these methods in the design of future HIV-1 prevention trials in serodiscordant couples. A hierarchy of sequencing techniques, analysis methods, and expert adjudication contributed to the linkage

  15. A combined microfinance and training intervention can reduce HIV risk behaviour in young female participants.

    Science.gov (United States)

    Pronyk, Paul M; Kim, Julia C; Abramsky, Tanya; Phetla, Godfrey; Hargreaves, James R; Morison, Linda A; Watts, Charlotte; Busza, Joanna; Porter, John Dh

    2008-08-20

    To assess effects of a combined microfinance and training intervention on HIV risk behavior among young female participants in rural South Africa. : Secondary analysis of quantitative and qualitative data from a cluster randomized trial, the Intervention with Microfinance for AIDS and Gender Equity study. Eight villages were pair-matched and randomly allocated to receive the intervention. At baseline and after 2 years, HIV risk behavior was assessed among female participants aged 14-35 years. Their responses were compared with women of the same age and poverty group from control villages. Intervention effects were calculated using adjusted risk ratios employing village level summaries. Qualitative data collected during the study explored participants' responses to the intervention including HIV risk behavior. After 2 years of follow-up, when compared with controls, young participants had higher levels of HIV-related communication (adjusted risk ratio 1.46, 95% confidence interval 1.01-2.12), were more likely to have accessed voluntary counseling and testing (adjusted risk ratio 1.64, 95% confidence interval 1.06-2.56), and less likely to have had unprotected sex at last intercourse with a nonspousal partner (adjusted risk ratio 0.76, 95% confidence interval 0.60-0.96). Qualitative data suggest a greater acceptance of intrahousehold communication about HIV and sexuality. Although women noted challenges associated with acceptance of condoms by men, increased confidence and skills associated with participation in the intervention supported their introduction in sexual relationships. In addition to impacts on economic well being, women's empowerment and intimate partner violence, interventions addressing the economic and social vulnerability of women may contribute to reductions in HIV risk behavior.

  16. Evolving strategies, opportunistic implementation: HIV risk reduction in Tanzania in the context of an incentive-based HIV prevention intervention.

    Directory of Open Access Journals (Sweden)

    Laura Packel

    Full Text Available Behavior change communication (BCC interventions, while still a necessary component of HIV prevention, have not on their own been shown to be sufficient to stem the tide of the epidemic. The shortcomings of BCC interventions are partly due to barriers arising from structural or economic constraints. Arguments are being made for combination prevention packages that include behavior change, biomedical, and structural interventions to address the complex set of risk factors that may lead to HIV infection.In 2009/2010 we conducted 216 in-depth interviews with a subset of study participants enrolled in the RESPECT study - an HIV prevention trial in Tanzania that used cash awards to incentivize safer sexual behaviors. We analyzed community diaries to understand how the study was perceived in the community. We drew on these data to enhance our understanding of how the intervention influenced strategies for risk reduction.We found that certain situations provide increased leverage for sexual negotiation, and these situations facilitated opportunistic implementation of risk reduction strategies. Opportunities enabled by the RESPECT intervention included leveraging conditional cash awards, but participants also emphasized the importance of exploiting new health status knowledge from regular STI testing. Risk reduction strategies included condom use within partnerships and/or with other partners, and an unexpected emphasis on temporary abstinence.Our results highlight the importance of increasing opportunities for implementing risk reduction strategies. We found that an incentive-based intervention could be effective in part by creating such opportunities, particularly among groups such as women with limited sexual agency. The results provide new evidence that expanding regular testing of STIs is another important mechanism for providing opportunities for negotiating behavior change, beyond the direct benefits of testing. Exploiting the latent demand for

  17. Efficacy of computer technology-based HIV prevention interventions: a meta-analysis.

    Science.gov (United States)

    Noar, Seth M; Black, Hulda G; Pierce, Larson B

    2009-01-02

    To conduct a meta-analysis of computer technology-based HIV prevention behavioral interventions aimed at increasing condom use among a variety of at-risk populations. Systematic review and meta-analysis of existing published and unpublished studies testing computer-based interventions. Meta-analytic techniques were used to compute and aggregate effect sizes for 12 randomized controlled trials that met inclusion criteria. Variables that had the potential to moderate intervention efficacy were also tested. The overall mean weighted effect size for condom use was d = 0.259 (95% confidence interval = 0.201, 0.317; Z = 8.74, P partners, and incident sexually transmitted diseases. In addition, interventions were significantly more efficacious when they were directed at men or women (versus mixed sex groups), utilized individualized tailoring, used a Stages of Change model, and had more intervention sessions. Computer technology-based HIV prevention interventions have similar efficacy to more traditional human-delivered interventions. Given their low cost to deliver, ability to customize intervention content, and flexible dissemination channels, they hold much promise for the future of HIV prevention.

  18. development and implementation of an hiv/aids trials management

    African Journals Online (AJOL)

    2008-06-19

    Jun 19, 2008 ... USA's National Library of Medicine, and the metaReg- ister of ... The building of a functioning HIV/AIDS trials management system can provide policymakers, re- .... web browser to view geographical data and access the.

  19. Mediation Analysis of the Efficacy of the Eban HIV/STD Risk-Reduction Intervention for African American HIV Serodiscordant Couples.

    Science.gov (United States)

    El-Bassel, Nabila; Jemmott, John B; Bellamy, Scarlett L; Pequegnat, Willo; Wingood, Gina M; Wyatt, Gail E; Landis, J Richard; Remien, Robert H

    2016-06-01

    Targeting couples is a promising behavioral HIV risk-reduction strategy, but the mechanisms underlying the effects of such interventions are unknown. We report secondary analyses testing whether Social-Cognitive-Theory variables mediated the Eban HIV-risk-reduction intervention's effects on condom-use outcomes. In a multisite randomized controlled trial conducted in four US cities, 535 African American HIV-serodiscordant couples were randomized to the Eban HIV risk-reduction intervention or attention-matched control intervention. Outcomes were proportion condom-protected sex, consistent condom use, and frequency of unprotected sex measured pre-, immediately post-, and 6 and 12 months post-intervention. Potential mediators included Social-Cognitive-Theory variables: outcome expectancies and self-efficacy. Mediation analyses using the product-of-coefficients approach in a generalized-estimating-equations framework revealed that condom-use outcome expectancy, partner-reaction outcome expectancy, intention, self-efficacy, and safer-sex communication improved post-intervention and mediated intervention-induced improvements in condom-use outcomes. These findings underscore the importance of targeting outcome expectancies, self-efficacy, and safer-sex communication in couples-level HIV risk-reduction interventions.

  20. The community-based participatory intervention effect of "HIV-RAAP".

    Science.gov (United States)

    Yancey, Elleen M; Mayberry, Robert; Armstrong-Mensah, Elizabeth; Collins, David; Goodin, Lisa; Cureton, Shava; Trammell, Ella H; Yuan, Keming

    2012-07-01

    To design and test HIV-RAAP (HIV/AIDS Risk Reduction Among Heterosexually Active African American Men and Women: A Risk Reduction Prevention Intervention) a coeducational, culture- and gender-sensitive community-based participatory HIV risk reduction intervention. A community-based participatory research process included intervention development and implementation of a 7-session coeducational curriculum conducted over 7 consecutive weeks. The results indicated a significant intervention effect on reducing sexual behavior risk (P=0.02), improving HIV risk knowledge (P=0.006), and increasing sexual partner conversations about HIV risk reduction (P= 0.001). The HIV-RAAP intervention impacts key domains of heterosexual HIV transmission.

  1. Achievement of interventions on HIV infection prevention among ...

    African Journals Online (AJOL)

    In China, migrants with acquired immunodeficiency syndrome (AIDS) have become a serious problem in the field of AIDS prevention. This study aimed to evaluate the efficacy of interventions for human immunodeficiency virus (HIV) infection prevention for migrants in China and to identify factors associated with intervention ...

  2. A workplace intervention program and the increase in HIV ...

    African Journals Online (AJOL)

    Vulnerability to Human Immunodeficiency Virus (HIV) infection among factory workers is a global problem. This study investigated the effectiveness of an intervention to increase AIDS knowledge, perceived accessibility to condoms and condom use among young factory workers in Thailand. The intervention was a ...

  3. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

  4. A conceptual model exploring the relationship between HIV stigma and implementing HIV clinical trials in rural communities of North Carolina.

    Science.gov (United States)

    Sengupta, Sohini; Strauss, Ronald P; Miles, Margaret S; Roman-Isler, Malika; Banks, Bahby; Corbie-Smith, Giselle

    2010-01-01

    HIV/AIDS disproportionately affects minority groups in the United States, especially in the rural southeastern states. Poverty and lack of access to HIV care, including clinical trials, are prevalent in these areas and contribute to HIV stigma. This is the first study to develop a conceptual model exploring the relationship between HIV stigma and the implementation of HIV clinical trials in rural contexts to help improve participation in those trials. We conducted focus groups with HIV service providers and community leaders, and individual interviews with people living with HIV/AIDS in six counties in rural North Carolina. Themes related to stigma were elicited. We classified the themes into theoretical constructs and developed a conceptual model. HIV stigma themes were classified under the existing theoretical constructs of perceived, experienced, vicarious, and felt normative stigma. Two additional constructs emerged: causes of HIV stigma (e.g., low HIV knowledge and denial in the community) and consequences of HIV stigma (e.g., confidentiality concerns in clinical trials). The conceptual model illustrates that the causes of HIV stigma can give rise to perceived, experienced, and vicarious HIV stigma, and these types of stigma could lead to the consequences of HIV stigma that include felt normative stigma. Understanding HIV stigma in rural counties of North Carolina may not be generalizeable to other rural US southeastern states. The conceptual model emphasizes that HIV stigma--in its many forms--is a critical barrier to HIV clinical trial implementation in rural North Carolina.

  5. Betting on the fastest horse: Using computer simulation to design a combination HIV intervention for future projects in Maharashtra, India.

    Directory of Open Access Journals (Sweden)

    Kelly V Ruggles

    Full Text Available To inform the design of a combination intervention strategy targeting HIV-infected unhealthy alcohol users in Maharashtra, India, that could be tested in future randomized control trials.Using probabilistic compartmental simulation modeling we compared intervention strategies targeting HIV-infected unhealthy alcohol users on antiretroviral therapy (ART in Maharashtra, India. We tested interventions targeting four behaviors (unhealthy alcohol consumption, risky sexual behavior, depression and antiretroviral adherence, in three formats (individual, group based, community and two durations (shorter versus longer. A total of 5,386 possible intervention combinations were tested across the population for a 20-year time horizon and intervention bundles were narrowed down based on incremental cost-effectiveness analysis using a two-step probabilistic uncertainty analysis approach.Taking into account uncertainty in transmission variables and intervention cost and effectiveness values, we were able to reduce the number of possible intervention combinations to be used in a randomized control trial from over 5,000 to less than 5. The most robust intervention bundle identified was a combination of three interventions: long individual alcohol counseling; weekly Short Message Service (SMS adherence counseling; and brief sex risk group counseling.In addition to guiding policy design, simulation modeling of HIV transmission can be used as a preparatory step to trial design, offering a method for intervention pre-selection at a reduced cost.

  6. Betting on the fastest horse: Using computer simulation to design a combination HIV intervention for future projects in Maharashtra, India.

    Science.gov (United States)

    Ruggles, Kelly V; Patel, Anik R; Schensul, Stephen; Schensul, Jean; Nucifora, Kimberly; Zhou, Qinlian; Bryant, Kendall; Braithwaite, R Scott

    2017-01-01

    To inform the design of a combination intervention strategy targeting HIV-infected unhealthy alcohol users in Maharashtra, India, that could be tested in future randomized control trials. Using probabilistic compartmental simulation modeling we compared intervention strategies targeting HIV-infected unhealthy alcohol users on antiretroviral therapy (ART) in Maharashtra, India. We tested interventions targeting four behaviors (unhealthy alcohol consumption, risky sexual behavior, depression and antiretroviral adherence), in three formats (individual, group based, community) and two durations (shorter versus longer). A total of 5,386 possible intervention combinations were tested across the population for a 20-year time horizon and intervention bundles were narrowed down based on incremental cost-effectiveness analysis using a two-step probabilistic uncertainty analysis approach. Taking into account uncertainty in transmission variables and intervention cost and effectiveness values, we were able to reduce the number of possible intervention combinations to be used in a randomized control trial from over 5,000 to less than 5. The most robust intervention bundle identified was a combination of three interventions: long individual alcohol counseling; weekly Short Message Service (SMS) adherence counseling; and brief sex risk group counseling. In addition to guiding policy design, simulation modeling of HIV transmission can be used as a preparatory step to trial design, offering a method for intervention pre-selection at a reduced cost.

  7. Sieve analysis in HIV-1 vaccine efficacy trials.

    Science.gov (United States)

    Edlefsen, Paul T; Gilbert, Peter B; Rolland, Morgane

    2013-09-01

    The genetic characterization of HIV-1 breakthrough infections in vaccine and placebo recipients offers new ways to assess vaccine efficacy trials. Statistical and sequence analysis methods provide opportunities to mine the mechanisms behind the effect of an HIV vaccine. The release of results from two HIV-1 vaccine efficacy trials, Step/HVTN-502 (HIV Vaccine Trials Network-502) and RV144, led to numerous studies in the last 5 years, including efforts to sequence HIV-1 breakthrough infections and compare viral characteristics between the vaccine and placebo groups. Novel genetic and statistical analysis methods uncovered features that distinguished founder viruses isolated from vaccinees from those isolated from placebo recipients, and identified HIV-1 genetic targets of vaccine-induced immune responses. Studies of HIV-1 breakthrough infections in vaccine efficacy trials can provide an independent confirmation to correlates of risk studies, as they take advantage of vaccine/placebo comparisons, whereas correlates of risk analyses are limited to vaccine recipients. Through the identification of viral determinants impacted by vaccine-mediated host immune responses, sieve analyses can shed light on potential mechanisms of vaccine protection.

  8. Immune Interventions to Eliminate the HIV Reservoir.

    Science.gov (United States)

    Hsu, Denise C; Ananworanich, Jintanat

    2017-10-26

    Inducing HIV remission is a monumental challenge. A potential strategy is the "kick and kill" approach where latently infected cells are first activated to express viral proteins and then eliminated through cytopathic effects of HIV or immune-mediated killing. However, pre-existing immune responses to HIV cannot eradicate HIV infection due to the presence of escape variants, inadequate magnitude, and breadth of responses as well as immune exhaustion. The two major approaches to boost immune-mediated elimination of infected cells include enhancing cytotoxic T lymphocyte mediated killing and harnessing antibodies to eliminate HIV. Specific strategies include increasing the magnitude and breadth of T cell responses through therapeutic vaccinations, reversing the effects of T cell exhaustion using immune checkpoint inhibition, employing bispecific T cell targeting immunomodulatory proteins or dual-affinity re-targeting molecules to direct cytotoxic T lymphocytes to virus-expressing cells and broadly neutralizing antibody infusions. Methods to steer immune responses to tissue sites where latently infected cells are located need to be further explored. Ultimately, strategies to induce HIV remission must be tolerable, safe, and scalable in order to make a global impact.

  9. Interventions to reduce risky sexual behaviour for preventing HIV infection in workers in occupational settings.

    Science.gov (United States)

    Ojo, Olumuyiwa; Verbeek, Jos H; Rasanen, Kimmo; Heikkinen, Jarmo; Isotalo, Leena K; Mngoma, Nomusa; Ruotsalainen, Eija

    2011-12-07

    The workplace provides an important avenue to prevent HIV. To evaluate the effect of behavioral interventions for reducing HIV on high risk sexual behavior when delivered in an occupational setting. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and PsycINFO up until March 2011 and CINAHL, LILACS, DARE, OSH Update, and EPPI database up until October 2010. Randomised control trials (RCTs) in occupational settings or among workers at high risk for HIV that measured HIV, sexual transmitted diseases (STD), Voluntary Counseling and Testing (VCT), or risky sexual behaviour. Two reviewers independently selected studies for inclusion, extracted data and assessed risk of bias. We pooled studies that were similar. We found 8 RCTs with 11,164 participants but one study did not provide enough data. Studies compared VCT to no VCT and education to no intervention and to alternative education.VCT uptake increased to 51% when provided at the workplace compared to a voucher for VCT (RR=14.0 (95% CI 11.8 to16.7)). After VCT, self-reported STD decreased (RR = 0.10 (95% CI 0.01 to 0.73)) but HIV incidence (RR=1.4 (95% CI 0.7 to 2.7)) and unprotected sex (RR=0.71 (0.48 to 1.06)) did not decrease significantly. .Education reduced STDs (RR = 0.68 (95%CI 0.48 to 0.96)), unprotected sex (Standardised Mean Difference (SMD)= -0.17 (95% CI -0.29 to -0.05), sex with a commercial sex worker (RR = 0.88 (95% CI 0.81 to 0.96) but not multiple sexual partners (Mean Difference (MD) = -0.22 (95% CI -0.52 to 0.08) nor use of alcohol before sex (MD = -0.01 (95% CI of -0.11 to 0.08). Workplace interventions to prevent HIV are feasible. There is moderate quality evidence that VCT offered at the work site increases the uptake of testing. Even though this did no lower HIV-incidence, there was a decrease in self-reported sexual transmitted diseases and a decrease in risky sexual behaviour. There is low quality evidence that educational interventions decrease sexually

  10. Capacity Building for HIV/AIDS Prevention Trials | IDRC ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    The Canadian International Development Agency (CIDA) is funding the Africa HIV/AIDS Prevention Trials Capacity Building Program under the umbrella of the Global Health Research Initiative (GHRI). The aim of the program is to build the capacity of African researchers and institutions to conduct anticipated clinical trials ...

  11. Cost-Effectiveness of the 'One4All' HIV Linkage Intervention in Guangxi Zhuang Autonomous Region, China.

    Directory of Open Access Journals (Sweden)

    Xiao Zang

    Full Text Available In Guangxi Zhuang Autonomous Region, China, an estimated 80% of newly-identified antiretroviral therapy (ART-eligible patients are not engaged in ART. Delayed ART uptake ultimately translates into high rates of HIV morbidity, mortality, and transmission. To enhance HIV testing receipt and subsequent treatment uptake in Guangxi, the Chinese Center for Disease Control and Prevention (CDC executed a cluster-randomized trial to assess the effectiveness and cost-effectiveness of a streamlined HIV testing algorithm (the One4All intervention in 12 county-level hospitals.To determine the incremental cost-effectiveness of the One4All intervention delivered at county hospitals in Guangxi, China, compared to the current standard of care (SOC.Health System.1-, 5-and 25-years.We adapted a dynamic, compartmental HIV transmission model to simulate HIV transmission and progression in Guangxi, China and identify the economic impact and health benefits of implementing the One4All intervention in all Guangxi hospitals. The One4All intervention algorithm entails rapid point-of-care HIV screening, CD4 and viral load testing of individuals presenting for HIV screening, with same-day results and linkage to counselling. We populated the model with data from the One4All trial (CTN-0056, China CDC HIV registry and published reports. Model outcomes were HIV incidence, mortality, costs, quality-adjusted life years (QALYs, and the incremental cost-effectiveness ratio (ICER of the One4All intervention compared to SOC.The One4All testing intervention was more costly than SOC (CNY 2,182 vs. CNY 846, but facilitated earlier ART access, resulting in delayed disease progression and mortality. Over a 25-year time horizon, we estimated that introducing One4All in Guangxi would result in 802 averted HIV cases and 1629 averted deaths at an ICER of CNY 11,678 per QALY gained. Sensitivity analysis revealed that One4All remained cost-effective at even minimal levels of effectiveness

  12. HIV vaccine trials: critical issues in informed consent.

    Science.gov (United States)

    Lindegger, G; Richter, L M

    2000-06-01

    Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics. It is argued that, though legal indemnity is necessary, vaccine trials should be founded on fully ethical considerations. Various contentious aspects of IC are examined, especially the problem of social desirability and of adequate comprehension. The need for sensitivity to cultural norms in implementing IC procedures is critically reviewed, and some of the potential conflict between ethos and ethics is considered. The transmission of information is examined as a particular aspect of IC in HIV vaccine trials.

  13. Design and Implementation of a Community Health Worker HIV Treatment and Prevention Intervention in an HIV Hot Spot Fishing Community in Rakai, Uganda.

    Science.gov (United States)

    Long, Amanda; Mbabali, Ismail; Hutton, Heidi E; Thomas, Alvin G; Bugos, Eva; Mulamba, Jeremiah; Amico, Kathy Rivet; Nalugoda, Fred; Gray, Ronald H; Wawer, Maria J; Nakigozi, Gertrude; Chang, Larry W

    Innovative approaches are needed to increase engagement in HIV treatment and prevention services, particularly in HIV hot spots. Here, we detail our design, training approach, and early implementation experiences of a community-based HIV intervention called "health scouts." The intervention, utilizing a novel, theory-based approach, trained 10 community residents in an HIV hot spot fishing community to use motivational interviewing strategies and a mobile phone-based counseling application. During the first 3 months, 771 residents (median 82/health scout, range 27-160) were counseled. A directly observed Motivational Interviewing Treatment Integrity scale-based evaluation found adequate performance (median score 20/25, range 11-23). The health scout intervention was feasible to implement in a high HIV-prevalence fishing community, and its impact on HIV care outcomes will be evaluated in an ongoing cluster randomized trial. If found to be effective, it may be an important strategy for responding to HIV in high-burden settings.

  14. Effect of race/ethnicity on participation in HIV vaccine trials and comparison to other trials of biomedical prevention.

    Science.gov (United States)

    Dhalla, Shayesta; Poole, Gary

    2014-01-01

    Racial/ethnic minorities are underrepresented in actual HIV vaccine trials in North America, and willingness to participate (WTP) and retention in an HIV vaccine trial may differ from that in Whites. In this review, the authors identified HIV vaccine preparedness studies (VPS) in North America in high-risk populations that examined the relationship between race/ethnicity and WTP in a preventive phase 3 HIV vaccine trial, and the relationship to retention. Studies were categorized by risk group, and comparison group (Whites vs. non-Whites). Other types of trials of biomedical prevention were also identified, and WTP and retention rates were compared and contrasted to actual HIV vaccine trials. In the studies identified, WTP in a hypothetical trial HIV vaccine trial did not differ by race/ethnicity. In contrast, actual HIV vaccine trials, an HIV acquisition trial, and a phase 2B preexposure prophylaxis (PrEP) trial have enrolled a large percentage of White men. Human papilloma virus (HPV) privately-funded trials have also enrolled a large number of Whites, due to convenience sampling. Retention in the HIV acquisition trial was lower in African-Americans compared with Whites. Strategies to increase WTP and enhanced retention (ER) strategies may help in recruiting and retaining minority participants in actual HIV vaccine trials and other trials of biomedical prevention.

  15. Alkylating HIV-1 Nef - a potential way of HIV intervention

    Directory of Open Access Journals (Sweden)

    Cai Catherine

    2010-07-01

    Full Text Available Abstract Background Nef is a 27 KDa HIV-1 accessory protein. It downregulates CD4 from infected cell surface, a mechanism critical for efficient viral replication and pathogenicity. Agents that antagonize the Nef-mediated CD4 downregulation may offer a new class of drug to combat HIV infection and disease. TPCK (N-α-p-tosyl-L-phenylalanine chloromethyl ketone and TLCK (N-α-p-tosyl-L-lysine chloromethyl ketone are alkylation reagents that chemically modify the side chain of His or Cys residues in a protein. In search of chemicals that inhibit Nef function, we discovered that TPCK and TLCK alkylated HIV Nef. Methods Nef modification by TPCK was demonstrated on reducing SDS-PAGE. The specific cysteine residues modified were determined by site-directed mutagenesis and mass spectrometry (MS. The effect of TPCK modification on Nef-CD4 interaction was studied using fluorescence titration of a synthetic CD4 tail peptide with recombinant Nef-His protein. The conformational change of Nef-His protein upon TPCK-modification was monitored using CD spectrometry Results Incubation of Nef-transfected T cells, or recombinant Nef-His protein, with TPCK resulted in mobility shift of Nef on SDS-PAGE. Mutagenesis analysis indicated that the modification occurred at Cys55 and Cys206 in Nef. Mass spectrometry demonstrated that the modification was a covalent attachment (alkylation of TPCK at Cys55 and Cys206. Cys55 is next to the CD4 binding motif (A56W57L58 in Nef required for Nef-mediated CD4 downregulation and for AIDS development. This implies that the addition of a bulky TPCK molecule to Nef at Cys55 would impair Nef function and reduce HIV pathogenicity. As expected, Cys55 modification reduced the strength of the interaction between Nef-His and CD4 tail peptide by 50%. Conclusions Our data suggest that this Cys55-specific alkylation mechanism may be exploited to develop a new class of anti HIV drugs.

  16. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol

    Science.gov (United States)

    Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S. Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-01-01

    Background The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. Objective We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. Methods This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with

  17. Practice brief: adolescents and HIV clinical trials: ethics, culture, and context.

    Science.gov (United States)

    MacQueen, Kathleen M; Karim, Quarraisha Abdool

    2007-01-01

    One quarter of HIV infections globally occur among young people 15 to 24 years of age, and more than half of all new infections are in people younger than 25 years. Clearly, there is a need to identify and implement effective HIV prevention strategies among at-risk teens. Some of the most effective options for slowing the epidemic are biomedical, and several promising methods are in development, including microbicides, vaccines, and preexposure prophylaxis (PREP, or the daily use of antiretrovirals to prevent the acquisition of HIV). There is widespread reluctance to enroll minors in such biomedical prevention trials because of concerns about vulnerability related to physical maturity, experiential maturity, and diminished autonomy as well as legal and social challenges that vary across and within nations. However, excluding minors from trials misses an important opportunity to evaluate the effectiveness, acceptability, and safety of innovative interventions under the best conditions for identifying and resolving potential problems. The challenges of including minors in HIV prevention trials are highlighted through the example of one rural South African community that has been particularly devastated by the HIV epidemic.

  18. HIV/STI interventions targeting women who experience forced sex: A systematic review of global literature.

    Science.gov (United States)

    Deming, Michelle E; Bhochhibhoya, Amir; Ingram, LaDrea; Stafford, Crystal; Li, Xiaoming

    2018-04-12

    Women are disproportionately affected by HIV in many regions of the world and they represent the fastest growing demographic in the HIV epidemic. In addition, sexual violence against women is a global public health issue which increases women's vulnerability of HIV/STI acquisition. However, the relationship between sexual violence and HIV/STI risk are complex and contribute to the growing epidemic of women infected with HIV/STIs. Our purpose for this review is to examine existing HIV/STI interventions that target women who experience forced sex. Interventions designed to address women's unique needs in HIV/STI prevention are critical in reducing women's vulnerability to HIV/STIs.

  19. "Straight Talk" for African-American heterosexual men: results of a single-arm behavioral intervention trial.

    Science.gov (United States)

    Frye, Victoria; Henny, Kirk; Bonner, Sebastian; Williams, Kim; Bond, Keosha T; Hoover, Donald R; Lucy, Debbie; Greene, Emily; Koblin, Beryl A

    2013-01-01

    In the United States, heterosexual transmission is the second leading cause of HIV/AIDS, and two-thirds of all heterosexually acquired cases diagnosed between 2005 and 2008 occurred among African-Americans. Few HIV prevention interventions have been designed specifically for African-American heterosexual men not seeking clinical treatment. Here we report results of a single-arm intervention trial of a theory-based HIV prevention intervention designed to increase condom use, reduce concurrent partnering and increase HIV testing among heterosexually active African-American men living in high HIV prevalence areas of New York City. We tested our hypothesis using McNemar discordant pairs exact test for binary variables and paired t-tests for continuous variables. We observed statistically significant declines in mean number of total and new female partners, unprotected sex partners, and partner concurrency in both primary and nonprimary sex partnerships between baseline and 3 months postintervention.

  20. Restorative interventions for HIV facial lipoatrophy.

    Science.gov (United States)

    Carey, Dianne; Liew, Steven; Emery, Sean

    2008-01-01

    Facial lipoatrophy is a common and distressing manifestation of HIV lipodystrophy. The changes in facial appearance can reduce quality of life, self esteem and antiretroviral adherence. Apart from the modest benefits of thymidine-based nucleoside analog cessation, there are no proven therapies for lipoatrophy. Management of established fat loss can be challenging as restoration of lost fat mass is extremely gradual. Plastic surgery and cosmetic procedures can restore lost facial volume. Both biodegradable and permanent filling agents have been investigated for HIV facial lipoatrophy. Biodegradable products offer a good safety profile, but maintenance of aesthetic benefits necessitates reinjection over time. Although permanent products offer longevity and lower treatment costs, adverse events should they occur can be serious and of long duration. Despite the substantial increase in options for soft-tissue augmentation in recent years, well-performed clinical studies in HIV-infected adults with facial lipoatrophy are scarce, and long-term clinical safety data are lacking. This review will summarize available efficacy and safety data of the biodegradable and permanent agents utilized for soft-tissue augmentation in this population. Difficulties associated with comparing treatment efficacy data, assessment of facial lipoatrophy presence and severity, and measurement of facial fat will be discussed. Available data indicate that in HIV-infected adults, most filling agents have short-term clinically safety, and can provide aesthetic improvement and improve well-being, social functioning and quality of life. However, well-designed studies with objectively assessed endpoints are needed to elucidate optimal treatments for this distressing condition.

  1. HIV Infection: Transmission, Effects on Early Development, and Interventions.

    Science.gov (United States)

    Lowenthal, Barbara

    1997-01-01

    Describes the modes of transmission of HIV and the course of the disease in infants and toddlers. Information is provided on its effects on early development, medical screening and treatments, therapies, psychosocial assistance, and interventions, including nutritional therapy, occupational and physical therapies, and speech and language therapy.…

  2. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  3. Redemption of the "spoiled identity:" the role of HIV-positive individuals in HIV care cascade interventions.

    Science.gov (United States)

    Camlin, Carol S; Charlebois, Edwin D; Geng, Elvin; Semitala, Fred; Wallenta, Jeanna; Getahun, Monica; Kampiire, Leatitia; Bukusi, Elizabeth A; Sang, Norton; Kwarisiima, Dalsone; Clark, Tamara D; Petersen, Maya L; Kamya, Moses R; Havlir, Diane V

    2017-12-01

    The concept of "therapeutic citizenship" has drawn attention to ways in which public testimony, the "story-telling in the public sphere" undertaken by people living with HIV (PLHIV), has shaped the global response to the epidemic. This paper presents qualitative findings from two large studies in eastern Africa that reveal how the advent of population-based HIV testing campaigns and efforts to accelerate antiretroviral "treatment for all" has precipitated a rapidly expanding therapeutic citizenship "project," or social movement. The title of this paper refers to Goffman's original conceptualization of stigma as a social process through which a person's identity is rendered "spoiled." Data were derived from qualitative studies embedded within two clinical trials, Sustainable East African Research in Community Health (SEARCH) (NCT# 01864603) in Kenya and Uganda, and START-ART (NCT# 01810289) in Uganda, which aimed to offer insights into the pathways through which outcomes across the HIV care continuum can be achieved by interventions deployed in the studies, any unanticipated consequences, and factors that influenced implementation. Qualitative in-depth semi-structured interviews were conducted among cohorts of adults in 2014 through 2015; across both studies and time periods, 217 interviews were conducted with 166 individuals. Theoretically informed, team-based analytic approaches were used for the analyses. Narratives from PLHIV, who have not always been conceptualized as actors but rather usually as targets of HIV interventions, revealed strongly emergent themes related to these individuals' use of HIV biomedical resources and discourses to fashion a new, empowered subjecthood. Experiencing the benefits of antiretroviral therapy (ART) emboldens many individuals to transform their "spoiled" identities to attain new, valorized identities as "advocates for ART" in their communities. We propose that the personal revelation of what some refer to as the "gospel of ARVs

  4. Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial.

    Science.gov (United States)

    Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San; Hart, Stephen; Wallis, Carole; Morgado, Mariza G; Saravanan, Shanmugam; Tripathy, Srikanth; Hovind, Laura; Piwowar-Manning, Estelle; Sabin, Devin; McCauley, Marybeth; Gamble, Theresa; Zhang, Xinyi C; Eron, Joseph J; Gallant, Joel E; Kumwenda, Johnstone; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James; Badal-Faesen, Sharlaa; Akelo, Victor; Hosseinipour, Mina C; Santos, Breno R; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H

    2016-07-01

    Early initiation of antiretroviral treatment (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HIV Prevention Trials Network 052 trial who started ART at CD4 counts of 350-550 cells per cubic millimeter and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7 of 8 (87.5%) participants who started ART at lower CD4 cell counts.

  5. Masculinity and HIV disclosure among heterosexual South African men: implications for HIV/AIDS intervention.

    Science.gov (United States)

    Dageid, Wenche; Govender, Kaymarlin; Gordon, Sarah F

    2012-01-01

    Relationships and constructions of masculinity are central to understanding the process of male HIV disclosure, which is an important step towards accessing HIV-related services. Data from in-depth interviews and focus-group discussions with 23 HIV-positive, self-identified heterosexual, Black South African men were used to explore the disclosure process and how this process was negotiated in the context of constructions of masculinity. Of these men, 20 had disclosed to one or more persons, with partners and siblings being the preferred confidants. Disclosure was dependent on the acceptance of HIV status, perceived support and healthy relationships with others, HIV counselling and participation in educational and training activities. Non-disclosure was explained as a result of stigma, fear of rejection, discrimination, a lack of healthy relationships with others and lack of access to suitable disclosure strategies. Negative perceptions of HIV and hegemonic conceptions of masculinity hindered men from disclosing and seeking health services. Many men, however, managed to renegotiate their masculine identities to become responsible, knowledgeable HIV-positive individuals, protecting their families and becoming community educators. Findings suggest the need to consider gendered, contextual, skills-building/income-generating and guided interventions to promote male HIV disclosure and service uptake.

  6. Qualitative exploration of a smoking cessation trial for people living with HIV in South Africa.

    Science.gov (United States)

    Krishnan, Nandita; Gittelsohn, Joel; Ross, Alexandra; Elf, Jessica; Chon, Sandy; Niaura, Raymond; Martinson, Neil; Golub, Jonathan E

    2017-06-16

    In South Africa, people living with HIV (PLWH) have a high prevalence of smoking, which undermines the beneficial effects of antiretroviral therapy (ART). However, little is known about barriers to smoking cessation and what interventions work for PLWH in this setting. A randomized trial comparing intensive anti-smoking counseling versus counseling and nicotine replacement therapy (NRT) was recently concluded in Klerksdorp, South Africa. In a post-trial follow-up, 23 in-depth interviews with patients and one focus group discussion with counselors from the trial were conducted. A codebook was developed and codes were applied to the transcripts, which were analyzed using a thematic analysis. Barriers at the economic, social/interpersonal, and individual levels induced stress, which hindered smoking cessation. Economic stressors included unemployment and poverty. Social or interpersonal stressors were lack of social support for quitting smoking and lack of social support due to having HIV. Individual stressors were traumatic life events. Alcohol was used to cope with stress and frequently co-occurred with smoking. Managing cravings was a barrier unrelated to stress. Participants proposed income and employment opportunities, group counseling and more frequent counseling as solutions to address stressors at different levels. NRT was helpful to mitigate cravings. Future smoking cessation interventions need to target barriers at multiple levels. Increasing the supply and duration of NRT may increase its effectiveness. Other behavioral approaches such as group counseling or peer counseling could hold promise in this setting but need to be tested for efficacy through randomized controlled trials. To our knowledge, this is the first qualitative study examining barriers to smoking cessation for people living with HIV in South Africa. Smoking is highly prevalent among people with HIV in South Africa and cessation interventions are urgently needed. A better understanding of

  7. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol.

    Science.gov (United States)

    Lukhele, Bhekumusa Wellington; Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-11-22

    The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with the mean change in the wait

  8. Interventions to modify sexual risk behaviours for preventing HIV in homeless youth.

    Science.gov (United States)

    Naranbhai, Vivek; Abdool Karim, Quarraisha; Meyer-Weitz, Anna

    2011-01-19

    Homeless youth are at high risk for HIV infection as a consequence of risky sexual behaviour. Interventions for homeless youth are challenging. Assessment of the effectiveness of interventions to modify sexual risk behaviours for preventing HIV in homeless youth is needed. To evaluate and summarize the effectiveness of interventions for modifying sexual risk behaviours and preventing transmission of HIV among homeless youth. We searched electronic databases (CENTRAL, MEDLINE, EMBASE, AIDSearch, Gateway, PsycInfo, LILACS), reference lists of eligible articles, international health agency publication lists, and clinical trial registries. The search was updated January 2010. We contacted authors of published reports and other key role players. Randomised studies of interventions to modify sexual risk behaviour (biological, self-reporting of sexual-risk behaviour or health-seeking behaviour) in homeless youth (12-24 years). Data from eligible studies were extracted by two reviewers. We assessed risk of bias per the Cochrane Collaborations tool. None of the eligible studies reported any primary biological outcomes for this review. Reports of self-reporting sexual risk behaviour outcomes varied across studies precluding calculation of summary measures of effect; we present the outcomes descriptively for each study. We contacted authors for missing or ambiguous data. We identified three eligible studies after screening a total of 255 unique records. All three were performed in the United States of America and recruited substance-abusing male and female adolescents (total N=615) through homeless shelters into randomised controlled trials of independent and non-overlapping behavioural interventions. The three trials differed in theoretical background, delivery method, dosage (number of sessions,) content and outcome assessments. Overall, the variability in delivery and outcomes precluded estimation of summary of effect measures. We assessed the risk of bias to be high for

  9. Social Media Interventions to Promote HIV Testing, Linkage, Adherence, and Retention: Systematic Review and Meta-Analysis

    Science.gov (United States)

    Gupta, Somya; Wang, Jiangtao; Hightow-Weidman, Lisa B; Muessig, Kathryn E; Tang, Weiming; Pan, Stephen; Pendse, Razia; Tucker, Joseph D

    2017-01-01

    Background Social media is increasingly used to deliver HIV interventions for key populations worldwide. However, little is known about the specific uses and effects of social media on human immunodeficiency virus (HIV) interventions. Objective This systematic review examines the effectiveness of social media interventions to promote HIV testing, linkage, adherence, and retention among key populations. Methods We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and Cochrane guidelines for this review and registered it on the International Prospective Register of Systematic Reviews, PROSPERO. We systematically searched six databases and three conference websites using search terms related to HIV, social media, and key populations. We included studies where (1) the intervention was created or implemented on social media platforms, (2) study population included men who have sex with men (MSM), transgender individuals, people who inject drugs (PWID), and/or sex workers, and (3) outcomes included promoting HIV testing, linkage, adherence, and/or retention. Meta-analyses were conducted by Review Manager, version 5.3. Pooled relative risk (RR) and 95% confidence intervals were calculated by random-effects models. Results Among 981 manuscripts identified, 26 studies met the inclusion criteria. We found 18 studies from high-income countries, 8 in middle-income countries, and 0 in low-income countries. Eight were randomized controlled trials, and 18 were observational studies. All studies (n=26) included MSM; five studies also included transgender individuals. The focus of 21 studies was HIV testing, four on HIV testing and linkage to care, and one on antiretroviral therapy adherence. Social media interventions were used to do the following: build online interactive communities to encourage HIV testing/adherence (10 studies), provide HIV testing services (9 studies), disseminate HIV information (9 studies), and develop

  10. The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment among TB/HIV patients in Lesotho: rationale and design of a mixed-methods, cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    Andrea A. Howard

    2016-06-01

    Full Text Available Background: Initiating antiretroviral therapy (ART early during tuberculosis (TB treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective: The Start TB Patients on ART and Retain on Treatment (START Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package (CIP to improve early ART initiation, retention, and TB treatment success among TB/HIV patients in Berea District, Lesotho. Design: Twelve health facilities were randomized to receive the CIP or standard of care after stratification by facility type (hospital or health center. The CIP includes nurse training and mentorship, using a clinical algorithm; transport reimbursement and health education by village health workers (VHW for patients and treatment supporters; and adherence support using text messaging and VHW. Routine data were abstracted for all newly registered TB/HIV patients; anticipated sample size was 1,200 individuals. A measurement cohort of TB/HIV patients initiating ART was recruited; the target enrollment was 384 individuals, each to be followed for the duration of TB treatment (6–9 months. Inclusion criteria were HIV-infected; on TB treatment; initiated ART within 2 months of TB treatment initiation; age ≥18; English- or Sesotho-speaking; and capable of informed consent. The exclusion criterion was multidrug-resistant TB. Three groups of key informants were recruited from intervention clinics: early ART initiators; non/late ART initiators; and health care workers. Primary outcomes include ART initiation, retention, and TB treatment success. Secondary outcomes include time to ART initiation, adherence, change in CD4+ count, sputum smear conversion, cost-effectiveness, and acceptability. Follow-up and data abstraction are complete

  11. A human immunodeficiency virus risk reduction intervention for incarcerated youth: a randomized controlled trial.

    Science.gov (United States)

    Goldberg, Eudice; Millson, Peggy; Rivers, Stephen; Manning, Stephanie Jeanneret; Leslie, Karen; Read, Stanley; Shipley, Caitlin; Victor, J Charles

    2009-02-01

    To evaluate, by gender, the impact of a structured, comprehensive risk reduction intervention with and without boosters on human immunodeficiency virus (HIV) knowledge, attitudes and behaviors in incarcerated youth; and to determine predictors of increasing HIV knowledge and reducing high-risk attitudes and behaviors. This randomized controlled trial involved participants completing structured interviews at 1, 3, and 6 months. Repeated measures analysis of variance was used to analyze changes over time. The study was conducted in secure custody facilities and in the community. The study sample comprising 391 incarcerated youth, 102 female and 289 male aged 12-18, formed the voluntary sample. Participants were randomly assigned to one of three conditions: education intervention; education intervention with booster; or no systematic intervention. The outcome and predictor measures included the Rosenberg Self-Esteem Scale, Youth Self Report, Drug Use Inventory, and HIV Knowledge, Attitudes and Behavior Scale. The 6-month retention rate was 59.6%. At 6 months, males in the education and booster groups sustained increases in knowledge scores (p variations by gender underline the importance of gender issues in prevention interventions. Predictors of success were identified to inform future HIV education interventions.

  12. Preliminary findings of an adapted evidence-based woman-focused HIV intervention on condom use and negotiation among at-risk women in Pretoria, South Africa.

    Science.gov (United States)

    Wechsberg, Wendee M; Luseno, Winnie K; Kline, Tracy L; Browne, Felicia A; Zule, William A

    2010-01-01

    This article presents the results of a randomized trial in South Africa of an adapted evidence-based Woman-Focused intervention on condom use with primary sex partners. The preliminary findings show that regardless of HIV status, condom negotiation was significantly associated with condom use at the 3- and 6-month follow-ups. By intervention group, significant intervention effects were found at 6-month follow-up for HIV-positive and HIV-unknown status women in the Woman-Focused intervention who were more likely than women in the Standard intervention to report condom use with a primary male partner. Among HIV-positive women, those in the Woman-Focused group and those with greater sexual control were more likely to report condom use at the 6-month follow-up. The findings indicate that gender-based interventions for women may result in increased condom negotiation skills.

  13. Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Stephenson, Rob; Metheny, Nicholas; Sharma, Akshay; Sullivan, Stephen; Riley, Erin

    2017-11-28

    Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible

  14. Telephone delivered interventions for reducing morbidity and mortality in people with HIV infection.

    Science.gov (United States)

    Gentry, Sarah; van-Velthoven, Michelle H M M T; Tudor Car, Lorainne; Car, Josip

    2013-05-31

    This is one of three Cochrane reviews examining the role of the telephone in HIV/AIDS services. Telephone interventions, delivered either by landline or mobile phone, may be useful in the management of people living with HIV (PLHIV) in many situations. Telephone delivered interventions have the potential to reduce costs, save time and facilitate more support for PLHIV. To assess the effectiveness of voice landline and mobile telephone delivered interventions for reducing morbidity and mortality in people with HIV infection. We searched The Cochrane Central Register of Controlled Trials, MEDLINE, PubMed Central, EMBASE, PsycINFO, ISI Web of Science, Cumulative Index to Nursing & Allied Health, World Health Organisation's The Global Health Library and Current Controlled Trials from 1980 to June 2011. We searched the following grey literature sources: Dissertation Abstracts International, Centre for Agriculture Bioscience International Direct Global Health database, The System for Information on Grey Literature Europe, The Healthcare Management Information Consortium database, Google Scholar, Conference on Retroviruses and Opportunistic Infections, International AIDS Society, AIDS Educational Global Information System and reference lists of articles. Randomised controlled trials (RCTs), quasi-randomised controlled trials, controlled before and after studies, and interrupted time series studies comparing the effectiveness of telephone delivered interventions for reducing morbidity and mortality in persons with HIV infection versus in-person interventions or usual care, regardless of demographic characteristics and in all settings. Both mobile and landline telephone interventions were included, but mobile phone messaging interventions were excluded. Two reviewers independently searched, screened, assessed study quality and extracted data. Primary outcomes were change in behaviour, healthcare uptake or clinical outcomes. Secondary outcomes were appropriateness of the

  15. 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.

  16. School-based interventions for preventing Hiv, sexually transmitted infections, and pregnancy in adolescents

    Science.gov (United States)

    Mason-Jones, Amanda J; Sinclair, David; Mathews, Catherine; Kagee, Ashraf; Hillman, Alex; Lombard, Carl

    2016-01-01

    sub-Saharan Africa (Malawi, South Africa, Tanzania, Zimbabwe, and Kenya), one in Latin America (Chile), and two in Europe (England and Scotland). Sexual and reproductive health educational programmes Six trials evaluated school-based educational interventions. In these trials, the educational programmes evaluated had no demonstrable effect on the prevalence of HIV (RR 1.03, 95% CI 0.80 to 1.32, three trials; 14,163 participants; low certainty evidence), or other STIs (herpes simplex virus prevalence: RR 1.04, 95% CI 0.94 to 1.15; three trials, 17,445 participants; moderate certainty evidence; syphilis prevalence: RR 0.81, 95% CI 0.47 to 1.39; one trial, 6977 participants; low certainty evidence). There was also no apparent effect on the number of young women who were pregnant at the end of the trial (RR 0.99, 95% CI 0.84 to 1.16; three trials, 8280 participants; moderate certainty evidence). Material or monetary incentive-based programmes to promote school attendance Two trials evaluated incentive-based programmes to promote school attendance. In these two trials, the incentives used had no demonstrable effect on HIV prevalence (RR 1.23, 95% CI 0.51 to 2.96; two trials, 3805 participants; low certainty evidence). Compared to controls, the prevalence of herpes simplex virus infection was lower in young women receiving a monthly cash incentive to stay in school (RR 0.30, 95% CI 0.11 to 0.85), but not in young people given free school uniforms (Data not pooled, two trials, 7229 participants; very low certainty evidence). One trial evaluated the effects on syphilis and the prevalence was too low to detect or exclude effects confidently (RR 0.41, 95% CI 0.05 to 3.27; one trial, 1291 participants; very low certainty evidence). However, the number of young women who were pregnant at the end of the trial was lower among those who received incentives (RR 0.76, 95% CI 0.58 to 0.99; two trials, 4200 participants; low certainty evidence). Combined educational and incentive

  17. Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa.

    Science.gov (United States)

    Slack, Catherine; Strode, Ann; Fleischer, Theodore; Gray, Glenda; Ranchod, Chitra

    2007-05-13

    South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research. This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics committees; and lobbying the National Regulatory Authority for guidance.

  18. Efficacy of theory-based HIV behavioral prevention among rural-to-urban migrants in China: a randomized controlled trial.

    Science.gov (United States)

    Li, Xiaoming; Lin, Danhua; Wang, Bo; Du, Hongfei; Tam, Cheuk Chi; Stanton, Bonita

    2014-08-01

    Our objective was to evaluate the efficacy of a cultural adaptation of a social cognitive theory-based HIV behavioral prevention program among young rural-to-urban migrants in China. The intervention design and assessment were guided by the Protection Motivation Theory (PMT). The intervention was evaluated through a randomized controlled trial with 6-month and 12-month follow-ups. The primary behavioral outcome was the use of condoms. Other outcome measures include HIV knowledge, condom use knowledge, HIV-related perceptions (PMT constructs), and intention to use condom. The mixed-effects regression models for condom use with regular partners indicated that overall frequency of condom use, condom use in last three sexual acts and proper condom use increased over time for the participants but the increases were significantly greater among the intervention group than the control group at 6-month and 12-month follow-ups. The mixed-effects models for HIV-related perceptions indicated that extrinsic rewards, intrinsic rewards, and response costs decreased while vulnerability, severity, response efficacy, and self-efficacy increased over time for the intervention group. The increases in HIV knowledge, condom use knowledge, and intention to use condom were also significantly greater among the intervention group than the control group. The data in the current study suggested efficacy of a social cognitive theory-based behavioral intervention in increasing condom use among young migrants in China. The intervention also increased protective perceptions and decreased risk perception posited by the theory (i.e., PMT).

  19. Randomized controlled trials of HIV/AIDS prevention and treatment in Africa: results from the Cochrane HIV/AIDS Specialized Register.

    Directory of Open Access Journals (Sweden)

    Babalwa Zani

    Full Text Available INTRODUCTION: To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs. Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. OBJECTIVES: To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. METHODS: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. RESULTS: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20, Zambia (12 and Zimbabwe (9. The median sample size was 628 (range 33-9645. Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. CONCLUSION: Prevention trials dominate the trial

  20. Building Capacity for HIV/AIDS Prevention Trials Research and ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    A relatively small number of African sites have the clinical and laboratory capacity to design, manage and carry out HIV/AIDS prevention trials. This project is based on the premise that many of the required skills are already present at additional locations, but need further development. The grant will facilitate interaction ...

  1. Development and implementation of an HIV/AIDS trials ...

    African Journals Online (AJOL)

    To demonstrate how the tool provides consistent, quantitative information in an accessible format, making it a key tool in evidence-based decision-making. Methods. We identified all HIV/AIDS trials in relation to publications for the period 1980 - 2007, using both electronic and manual search methods. To facilitate searching ...

  2. Social Media Interventions to Promote HIV Testing, Linkage, Adherence, and Retention: Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Cao, Bolin; Gupta, Somya; Wang, Jiangtao; Hightow-Weidman, Lisa B; Muessig, Kathryn E; Tang, Weiming; Pan, Stephen; Pendse, Razia; Tucker, Joseph D

    2017-11-24

    Social media is increasingly used to deliver HIV interventions for key populations worldwide. However, little is known about the specific uses and effects of social media on human immunodeficiency virus (HIV) interventions. This systematic review examines the effectiveness of social media interventions to promote HIV testing, linkage, adherence, and retention among key populations. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and Cochrane guidelines for this review and registered it on the International Prospective Register of Systematic Reviews, PROSPERO. We systematically searched six databases and three conference websites using search terms related to HIV, social media, and key populations. We included studies where (1) the intervention was created or implemented on social media platforms, (2) study population included men who have sex with men (MSM), transgender individuals, people who inject drugs (PWID), and/or sex workers, and (3) outcomes included promoting HIV testing, linkage, adherence, and/or retention. Meta-analyses were conducted by Review Manager, version 5.3. Pooled relative risk (RR) and 95% confidence intervals were calculated by random-effects models. Among 981 manuscripts identified, 26 studies met the inclusion criteria. We found 18 studies from high-income countries, 8 in middle-income countries, and 0 in low-income countries. Eight were randomized controlled trials, and 18 were observational studies. All studies (n=26) included MSM; five studies also included transgender individuals. The focus of 21 studies was HIV testing, four on HIV testing and linkage to care, and one on antiretroviral therapy adherence. Social media interventions were used to do the following: build online interactive communities to encourage HIV testing/adherence (10 studies), provide HIV testing services (9 studies), disseminate HIV information (9 studies), and develop intervention materials (1 study). Of the

  3. Internet use among Ugandan adolescents: implications for HIV intervention.

    Directory of Open Access Journals (Sweden)

    Michele L Ybarra

    2006-11-01

    Full Text Available The Internet is fast gaining recognition as a powerful, low-cost method to deliver health intervention and prevention programs to large numbers of young people across diverse geographic regions. The feasibility and accessibility of Internet-based health interventions in resource-limited settings, where cost-effective interventions are most needed, is unknown. To determine the utility of developing technology-based interventions in resource-limited settings, availability and patterns of usage of the Internet first need to be assessed.The Uganda Media and You Survey was a cross-sectional survey of Internet use among adolescents (ages 12-18 years in Mbarara, Uganda, a municipality mainly serving a rural population in sub-Saharan Africa. Participants were randomly selected among eligible students attending one of five participating secondary day and boarding schools in Mbarara, Uganda. Of a total of 538 students selected, 93% (500 participated. Of the total respondents, 45% (223 reported ever having used the Internet, 78% (175 of whom reported going online in the previous week. As maternal education increased, so too did the odds of adolescent Internet use. Almost two in five respondents (38% [189] reported already having used a computer or the Internet to search for health information. Over one-third (35% [173] had used the computer or Internet to find information about HIV/AIDS, and 20% (102 had looked for sexual health information. Among Internet users, searching for HIV/AIDS information on a computer or online was significantly related to using the Internet weekly, emailing, visiting chat rooms, and playing online games. In contrast, going online at school was inversely related to looking for HIV/AIDS information via technology. If Internet access were free, 66% (330 reported that they would search for information about HIV/AIDS prevention online.Both the desire to use, and the actual use of, the Internet to seek sexual health and HIV

  4. Internet use among Ugandan adolescents: implications for HIV intervention.

    Science.gov (United States)

    Ybarra, Michele L; Kiwanuka, Julius; Emenyonu, Nneka; Bangsberg, David R

    2006-11-01

    The Internet is fast gaining recognition as a powerful, low-cost method to deliver health intervention and prevention programs to large numbers of young people across diverse geographic regions. The feasibility and accessibility of Internet-based health interventions in resource-limited settings, where cost-effective interventions are most needed, is unknown. To determine the utility of developing technology-based interventions in resource-limited settings, availability and patterns of usage of the Internet first need to be assessed. The Uganda Media and You Survey was a cross-sectional survey of Internet use among adolescents (ages 12-18 years) in Mbarara, Uganda, a municipality mainly serving a rural population in sub-Saharan Africa. Participants were randomly selected among eligible students attending one of five participating secondary day and boarding schools in Mbarara, Uganda. Of a total of 538 students selected, 93% (500) participated. Of the total respondents, 45% (223) reported ever having used the Internet, 78% (175) of whom reported going online in the previous week. As maternal education increased, so too did the odds of adolescent Internet use. Almost two in five respondents (38% [189]) reported already having used a computer or the Internet to search for health information. Over one-third (35% [173]) had used the computer or Internet to find information about HIV/AIDS, and 20% (102) had looked for sexual health information. Among Internet users, searching for HIV/AIDS information on a computer or online was significantly related to using the Internet weekly, emailing, visiting chat rooms, and playing online games. In contrast, going online at school was inversely related to looking for HIV/AIDS information via technology. If Internet access were free, 66% (330) reported that they would search for information about HIV/AIDS prevention online. Both the desire to use, and the actual use of, the Internet to seek sexual health and HIV/AIDS information is

  5. Internet Use among Ugandan Adolescents: Implications for HIV Intervention

    Science.gov (United States)

    Ybarra, Michele L; Kiwanuka, Julius; Emenyonu, Nneka; Bangsberg, David R

    2006-01-01

    Background The Internet is fast gaining recognition as a powerful, low-cost method to deliver health intervention and prevention programs to large numbers of young people across diverse geographic regions. The feasibility and accessibility of Internet-based health interventions in resource-limited settings, where cost-effective interventions are most needed, is unknown. To determine the utility of developing technology-based interventions in resource-limited settings, availability and patterns of usage of the Internet first need to be assessed. Methods and Findings The Uganda Media and You Survey was a cross-sectional survey of Internet use among adolescents (ages 12–18 years) in Mbarara, Uganda, a municipality mainly serving a rural population in sub-Saharan Africa. Participants were randomly selected among eligible students attending one of five participating secondary day and boarding schools in Mbarara, Uganda. Of a total of 538 students selected, 93% (500) participated. Of the total respondents, 45% (223) reported ever having used the Internet, 78% (175) of whom reported going online in the previous week. As maternal education increased, so too did the odds of adolescent Internet use. Almost two in five respondents (38% [189]) reported already having used a computer or the Internet to search for health information. Over one-third (35% [173]) had used the computer or Internet to find information about HIV/AIDS, and 20% (102) had looked for sexual health information. Among Internet users, searching for HIV/AIDS information on a computer or online was significantly related to using the Internet weekly, emailing, visiting chat rooms, and playing online games. In contrast, going online at school was inversely related to looking for HIV/AIDS information via technology. If Internet access were free, 66% (330) reported that they would search for information about HIV/AIDS prevention online. Conclusions Both the desire to use, and the actual use of, the Internet to

  6. The Role of Critical Self-Reflection of Assumptions in an Online HIV Intervention for Men Who Have Sex with Men

    Science.gov (United States)

    Wilkerson, J. Michael; Danilenko, Gene P.; Smolenski, Derek J.; Myer, Bryn B.; Rosser, B. R. Simon

    2011-01-01

    The Men's INTernet Study II included a randomized controlled trial to develop and test an Internet-based HIV prevention intervention for U.S men who use the Internet to seek sex with men. In 2008, participants (n = 560) were randomized to an online, interactive, sexual risk-reduction intervention or to a wait list null control. After 3 months,…

  7. Establishing HIV treatment as prevention in the HIV Prevention Trials Network 052 randomized trial: an ethical odyssey.

    Science.gov (United States)

    Cohen, Myron S; McCauley, Marybeth; Sugarman, Jeremy

    2012-06-01

    Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HIV Prevention Trials Network (HPTN) 052, the multinational clinical trial addressing this issue that has profound public health implications. To describe and analyze the major ethical challenges faced in HPTN 052. The ethical issues and modifications of HPTN 052 in response to these issues were cataloged by the principal investigator, the lead coordinator, and the ethicist working on the trial. The major ethical issues that were unique to the trial were then described and analyzed in light of the published literature as well as guidances and policies. The ethical challenges that must be addressed in many clinical trials, such as those related to obtaining informed consent and making provisions for ancillary care, are not described. When HPTN 052 was being designed, ethical questions emerged related to the relevance of the research question itself given data from observational research and a range of beliefs about the appropriate means of preventing and treating HIV infection and AIDS. Furthermore, ethical challenges were faced regarding site selection since there was a scientific need to conduct the research in settings where HIV incidence was high, but alternatives to study participation should be available. As in most HIV-prevention research, ethical questions surrounded the determination of the appropriate prevention package for all of those enrolled. During the course of the trial, guidance documents and policies emerged that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity. When the study results were made public, there was a need to ensure access to the treatment shown to be effective that in some cases differed from the

  8. West African Platform for HIV Intervention Research (WAPHIR ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    West African Platform for HIV Intervention Research (WAPHIR) : plateforme de recherche interventionnelle en matière de VIH en Afrique de l'Ouest. Grâce à cette subvention, on appuiera l'établissement d'un partenariat dirigé par des Africains de l'Ouest, en collaboration avec des partenaires canadiens et européens, afin ...

  9. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  10. Community health worker interventions to promote psychosocial outcomes among people living with HIV-A systematic review.

    Directory of Open Access Journals (Sweden)

    Hae-Ra Han

    Full Text Available Community health worker (CHW interventions are a successful strategy to promote health among HIV-negative and persons living with HIV (PLWH. Psychosocial factors are critical dimensions of HIV/AIDS care contributing to prognosis of the disease, yet it is unclear how CHW interventions improve psychosocial outcomes in PLWH. The purpose of this study was to critically appraise the types, scope, and nature of CHW interventions designed to address psychosocial outcomes in PLWH.We performed database searches-PubMed, EMBASE, CINAHL, and Cochrane-to identify randomized controlled trials published in English before April 2017. Fourteen articles met the eligibility criteria.Half of the studies were conducted in the United States. Social cognitive theory was used more than once in nine theory-guided studies. CHW interventions were largely focused on reducing depression (n = 6 or stigma related to HIV (n = 4, or promoting quality of life (n = 4, social support (n = 4, and self-efficacy (n = 4. Didactic methods and role-playing were used to train CHWs. CHWs played multiple roles in delivering intervention, including a counselor and a supporter (n = 10, educator (n = 5, or a navigator (n = 3. CHW intervention fidelity was assessed in 4 studies. Five studies found positive changes in six psychosocial outcomes including quality of life (2 of 4 and self-efficacy (2 of 4. CHW interventions had no effect on social support in 2 of 4 studies, and stigma in 3 of 4 studies. None of the CHW interventions were successful in reducing depressive symptoms among PLWH.Evidence partially supported the use of CHWs in promoting psychosocial outcomes in PLWH. Future CHW intervention should be expanded in scope to address key psychosocial determinants of HIV/AIDS outcomes such as health literacy. Further, fidelity measures should be incorporated into intervention delivery.

  11. Status of ANC-linked HIV counseling and testing as an intervention ...

    African Journals Online (AJOL)

    Status of ANC-linked HIV counseling and testing as an intervention for PMTCT in public health facilities in Addis Ababa: quality of HIV counseling given to pregnant women for PMTCT. ... AJOL African Journals Online. HOW TO USE AJOL.

  12. Psychological interventions for post-traumatic stress disorder in people living with HIV in Resource poor settings: a systematic review.

    Science.gov (United States)

    Verhey, Ruth; Chibanda, Dixon; Brakarsh, Jonathan; Seedat, Soraya

    2016-10-01

    Post-traumatic stress disorder is pervasive in low- and middle-income countries. There is evidence to suggest that post-traumatic stress disorder is more common among people living with HIV than non-infected matched controls. We carried out a systematic review of interventions for adult post-traumatic stress disorder from resource poor settings with a focus on people living with HIV. We included all studies that investigated interventions for adult post-traumatic stress disorder from resource poor settings with a focus on interventions that were either randomised controlled trials or observational cohort studies carried out from 1980 to May 2015. Of the 25 articles that were identified for full review, two independent reviewers identified seven studies that met our study inclusion criteria. All randomised controlled trials (RCT) (n = 6) used cognitive behavioural therapy-based interventions and focused on people living with HIV in resource poor settings. There was only one study focusing on the use of lay counsellors to address post-traumatic stress disorder but core competencies were not described. There were no intervention studies from Africa, only an observational cohort study from Rwanda. Rigorously evaluated interventions for adult post-traumatic stress disorder in people living with HIV are rare. Most were undertaken in resource poor settings located in high-income countries. There is a need for research on the development and implementation of appropriate interventions for post-traumatic stress disorder in people living with HIV in low- and middle-income countries. © 2016 John Wiley & Sons Ltd.

  13. "It is better to die": experiences of traditional health practitioners within the HIV treatment as prevention trial communities in rural South Africa (ANRS 12249 TasP trial).

    Science.gov (United States)

    Moshabela, Mosa; Zuma, Thembelihle; Orne-Gliemann, Joanna; Iwuji, Collins; Larmarange, Joseph; McGrath, Nuala

    2016-01-01

    The ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomized trial in rural South Africa uses a "test and treat" approach. Home-based testing services and antiretroviral treatment initiation satellite clinics were implemented in every cluster as part of the trial. A social science research agenda was nested within TasP with the aim of understanding the social, economic and contextual factors that affect individuals, households, communities and health systems with respect to TasP. Considering the rural nature of the trial setting, we sought to understand community perceptions and experiences of the TasP Trial interventions as seen through the eyes of traditional health practitioners (THPs). A qualitative study design was adopted using four repeat focus group discussions conducted with nine THPs, combined with community walks and photo-voice techniques, over a period of 18 months. A descriptive, interpretive and explanatory approach to analysis was adopted. Findings indicate that THPs engaged with the home-based testing services and HIV clinics established for TasP. Specifically, home-based testing services were perceived as relatively successful in increasing access to HIV testing. A major gap observed by THPs was linkage to HIV clinics. Most of their clients, and some of the THPs themselves, found it difficult to use HIV clinics due to fear of labelling, stigma and discrimination, and the ensuing personal implications of unsolicited disclosure. On the one hand, a growing number of patients diagnosed with HIV have found sanctuary with THPs as alternatives to clinics. On the other hand, THPs in turn have been struggling to channel patients suspected of HIV into clinics through referrals. Therefore, acceptability of the TasP test and treat approach by THPs is a major boost to the intervention, but further success can be achieved through strengthened ties with communities to combat stigma and effectively link patients into HIV care, including partnerships with THPs

  14. The Community-based Participatory Intervention Effect of “HIV-RAAP”

    Science.gov (United States)

    Yancey, Elleen M.; Mayberry, Robert; Armstrong-Mensah, Elizabeth; Collins, David; Goodin, Lisa; Cureton, Shava; Trammell, Ella H.; Yuan, Keming

    2012-01-01

    Objectives To design and test HIV-RAAP (HIV/AIDS Risk Reduction Among Heterosexually Active African American Men and Women: A Risk Reduction Prevention Intervention) a coeducational, culture- and gender-sensitive community-based participatory HIV risk reduction intervention. Methods A community-based participatory research process included intervention development and implementation of a 7-session coeducational curriculum conducted over 7 consecutive weeks. Results The results indicated a significant intervention effect on reducing sexual behavior risk (P=0.02), improving HIV risk knowledge (P=0.006), and increasing sexual partner conversations about HIV risk reduction (P= 0.001). Conclusions The HIV-RAAP intervention impacts key domains of heterosexual HIV transmission. PMID:22488405

  15. European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

    Gale, E A M; Bingley, P J; Emmett, C L

    2004-01-01

    with a pseudorandom number generator and we used size balanced blocks of four and stratified by age and national group. Primary outcome was development of diabetes, as defined by WHO criteria. Analysis was done on an intention-to-treat basis. FINDINGS: There was no difference in the development of diabetes between...... secretion. INTERPRETATION: Large-scale controlled trials of interventions designed to prevent the onset of type 1 diabetes are feasible, but nicotinamide was ineffective at the dose we used.......BACKGROUND: Results of studies in animals and human beings suggest that type 1 diabetes is preventable. Nicotinamide prevents autoimmune diabetes in animal models, possibly through inhibition of the DNA repair enzyme poly-ADP-ribose polymerase and prevention of beta-cell NAD depletion. We aimed...

  16. A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

    Science.gov (United States)

    Burns, Kara; Keating, Patrick; Free, Caroline

    2016-08-12

    Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom

  17. Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.

    Science.gov (United States)

    Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

    2016-06-01

    The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities. In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional

  18. Efficacy of enhanced HIV counseling for risk reduction during pregnancy and in the postpartum period: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Suzanne Maman

    Full Text Available Pregnancy and the postpartum period present important intervention opportunities. Counseling can leverage the motivation women have during this time to change behaviors that may negatively affect their health and the heath of their infants.Pregnant women attending an antenatal clinic in South Africa were randomly allocated to treatment (n=733 and control arms (n=747. Treatment arm participants received enhanced HIV pre- and post-test counseling, legal support and access to support groups at baseline, which occurred at the first antenatal visit, and then six and ten weeks postpartum. Control arm participants received standard HIV testing and counseling (HTC and two postpartum attention control sessions. Outcomes were incidence of sexually transmitted infection (STI by 14 weeks postpartum and past 30-day inconsistent condom use at 14 weeks and 9 months postpartum.There were no intervention effects on incident STIs for either HIV-negative (adjusted risk ratio (aRR 1.01, 95% CI 0.71-1.44 or HIV-positive participants (aRR 0.86, 95% CI 0.61-1.23. The intervention was associated with a 28% decrease in risk of past 30-day inconsistent condom use at nine-months among HIV-negative women (aRR 0.72,95% CI 0.59-0.88, but did not affect inconsistent condom use among HIV-positive women (aRR1.08; 95% CI 0.67-1.75.An enhanced counseling intervention during pregnancy and the postpartum period can lead to reductions in inconsistent condom use among HIV-negative women. Results underscore the importance of the counseling that accompanies HIV HTC. More work is needed to understand how to promote and sustain risk reduction among HIV-positive women.ClinicalTrials.gov NCT01683461.

  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. A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

    Science.gov (United States)

    Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

    2008-01-01

    Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

  1. Pregnancy, contraceptive use, and HIV acquisition in HPTN 039: relevance for HIV prevention trials among African women.

    Science.gov (United States)

    Reid, Stewart E; Dai, James Y; Wang, Jing; Sichalwe, Bupe N; Akpomiemie, Godspower; Cowan, Frances M; Delany-Moretlwe, Sinead; Baeten, Jared M; Hughes, James P; Wald, Anna; Celum, Connie

    2010-04-01

    Biomedical HIV prevention trials enroll sexually active women at risk of HIV and often discontinue study product during pregnancy. We assessed risk factors for pregnancy and HIV acquisition, and the effect of pregnancy on time off study drug in HIV Prevention Trials Network 039. A total of 1358 HIV negative, herpes simplex virus type 2-seropositive women from South Africa, Zambia, and Zimbabwe were enrolled and followed for up to 18 months. A total of 228 pregnancies occurred; time off study drug due to pregnancy accounted for 4% of woman-years of follow-up among women. Being pregnant was not associated with increased HIV risk (hazard ratio 0.64, 95% confidence interval 0.23-1.80, P = 0.40). However, younger age was associated with increased risk for both pregnancy and HIV. There was no association between condom use as a sole contraceptive and reduced pregnancy incidence; hormonal contraception was not associated with increased HIV risk. Bacterial vaginosis at study entry was associated with increased HIV risk (hazard ratio 2.03, P = 0.02). Pregnancy resulted in only a small amount of woman-time off study drug. Young women are at high risk for HIV and are an appropriate population for HIV prevention trials but also have higher risk of pregnancy. Condom use was not associated with reduced incidence of pregnancy.

  2. Research findings are catalyst to nationwide HIV prevention trial in ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    2017-12-20

    Dec 20, 2017 ... ... who are less able to make the right choices to protect themselves — has ... A related project, also supported by IDRC, provided training to boost ... The trial interventions had the most impact among young women in Botswana. ... of the young women in communities who received the intervention package.

  3. Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa

    Directory of Open Access Journals (Sweden)

    Moodley Jothi

    2010-04-01

    Full Text Available Abstract Background South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging from 4.5-9.1% per year. Unfortunately none of the interventions tested had any impact on reducing the risk of HIV acquisition; however, extremely valuable experience was gained, lessons learned and capacity built, while the communities gained associated benefits. Experience Our experience in conducting these trials ranged from setting up community partnerships to developing clinical research sites and dissemination of trial results. Community engagement included setting up community-based research sites with approval from both political and traditional leaders, and developing community advisory groups to assist with the research process. Community-wide education on HIV/sexually transmitted infection prevention, treatment and care was provided to over 90 000 individuals. Myths and misconceptions were addressed through methods such as anonymous suggestion boxes in clinic waiting areas and intensive education and counselling. Attempts were made to involve male partners to foster support and facilitate recruitment of women. Peer educator programmes were initiated to provide ongoing education and also to facilitate recruitment of women to the trials. Recruitment strategies such as door-to-door recruitment and community group meetings were initiated. Over 90% of women enrolled were retained. Community benefits from the trial included education on HIV prevention, treatment and care and provision of ancillary care (such as Pap smears, reproductive health care and

  4. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial

    OpenAIRE

    Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Francisco, Leilani; Nakuti, Janet; Musuya, Tina; Kyegombe, Nambusi; Starmann, Elizabeth; Kaye, Dan; Michau, Lori; Watts, Charlotte

    2012-01-01

    Abstract Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact ...

  5. Motivators to participation in actual HIV vaccine trials.

    Science.gov (United States)

    Dhalla, Shayesta; Poole, Gary

    2014-02-01

    An examination of actual HIV vaccine trials can contribute to an understanding of motivators for participation in these studies. Analysis of these motivators reveals that they can be categorized as social and personal benefits. Social benefits are generally altruistic, whereas personal benefits are psychological, physical, and financial. In this systematic review, the authors performed a literature search for actual preventive HIV vaccine trials reporting motivators to participation. Of studies conducted in the Organization for Economic Co-operation and Development (OECD) countries, the authors retrieved 12 studies reporting on social benefits and seven reporting on personal benefits. From the non-OECD countries, nine studies reported on social benefits and eight studies on personal benefits. Social benefits were most frequently described on macroscopic, altruistic levels. Personal benefits were most frequently psychological in nature. Rates of participation were compared between the OECD and the non-OECD countries. Knowledge of actual motivators in specific countries and regions can help target recruitment in various types of actual HIV vaccine trials.

  6. A HIV stigma reduction intervention for people living with HIV and their families

    Directory of Open Access Journals (Sweden)

    Johanna B. Pretorius

    2016-10-01

    Aim: To explore and describe the experiences of PLWH and CFM during and after a community-based HIV stigma reduction intervention in both an urban and rural setting in the North-West. Method: A qualitative description approach through in-depth interviews was used in both settings. Purposive sampling was used for the PLWH and snowball sampling for the CFM. Data was analysed using open coding. Results: Both urban and rural groups gained a richer understanding of HIV stigma and how to cope with it. The relationships were enriched by PLWH feeling more supported and CFM realising how they stigmatised PLWH and that they should be more supportive. Leadership was activated in PLWH and CFM through the stigma reduction project that they participated in. Conclusion: No significant differences were found between rural and urban communities, thus the intervention can be implemented with similar results in both settings. The intervention showed positive outcomes for both PLWH and CFM. Bringing PLWH and CFM together during an intervention in an equalised relationship proved to be useful as PLWH felt more supported and CFM showed much more compassion towards PLWH after the intervention.

  7. Evaluating HIV/STD interventions in developing countries: do current indicators do justice to advances in intervention approaches?

    CSIR Research Space (South Africa)

    MacPhail, C

    1999-12-01

    Full Text Available -prevention interventions. * To whom correspondence should be addressed Introduction While the development of an effective vaccine and cure for HIV remain elusive, interventions aimed at HIV-prevention continue to be the best hope for limiting transmission of the virus... regarding similar issues in developed countries had been eliminated, 41 articles remained. These were accessed and carefully read by the first author, in order to develop an interpretative thematic analysis focusing on the types of interventions described...

  8. Willingness to participate in HIV vaccine trials among men who have sex with men in Chennai and Mumbai, India: a social ecological approach.

    Science.gov (United States)

    Chakrapani, Venkatesan; Newman, Peter A; Singhal, Neeti; Jerajani, Jhalak; Shunmugam, Murali

    2012-01-01

    Recruitment of low- and middle-income country volunteers from most-at-risk populations in HIV vaccine trials is essential to vaccine development. In India, men who have sex with men (MSM) are at disproportionately high risk for HIV infection and an important population for trial recruitment. Investigations of willingness to participate (WTP) in HIV vaccine trials have focused predominantly on individual-level determinants. We explored multi-level factors associated with WTP among MSM in India. We conducted 12 focus groups (n = 68) with low socioeconomic MSM in Chennai and Mumbai, and 14 key informant interviews with MSM community leaders and service providers. Focus groups/interviews were recorded, transcribed and translated into English. Two bilingual investigators conducted thematic analysis using line-by-line coding and a constant comparative method, with member-checking by community representatives. Factors associated with WTP were evidenced across the social ecology of MSM-social-structural: poverty, HIV-, sexual- and gender non-conformity stigma, institutionalized discrimination and government sponsorship of trials; community-level: endorsement by MSM community leaders and organizations, and fear of within-group discrimination; interpersonal: anticipated family discord, partner rejection, having financially-dependent family members and disclosure of same-sex sexuality; and individual-level: HIV vaccine trial knowledge and misconceptions, safety concerns, altruism and preventive misconception. Pervasive familial, community and social-structural factors characteristic of the Indian sociocultural context may complicate individual-focused approaches to WTP and thereby constrain the effectiveness of interventions to support recruitment and retention in HIV vaccine trials. Interventions to reduce stigma and discrimination against MSM and people living with HIV, capacity-building of MSM community organizations and transparent communications tailored to the knowledge

  9. HIV/AIDS Interventions in an Aging U.S. Population

    Science.gov (United States)

    Jacobson, Stephanie A.

    2011-01-01

    According to the Centers for Disease Control and Prevention (CDC), 25 percent of people living with HIV in the United States in 2006 were age 50 and older. HIV prevention for people over 50 is an important health concern, especially as the U.S. population grows older. Scholarly research has identified the need for HIV/AIDS interventions in the…

  10. 75 FR 3746 - Ryan White HIV/AIDS Part C Early Intervention Services (EIS) Program

    Science.gov (United States)

    2010-01-22

    ... HIV/AIDS Part C Early Intervention Services (EIS) Program AGENCY: Health Resources and Services...: Critical funding for HIV/AIDS care and treatment to the target populations in Orange County, Orlando..., 2010). The Orange County Health Department is known Statewide as an exceptional site for HIV/AIDS care...

  11. A Controlled Study of an HIV/AIDS/STI/TB Intervention with Faith ...

    African Journals Online (AJOL)

    The aim of the study was to develop an HIV and AIDS training manual, and to evaluate the knowledge, attitudes and management of faith healers of Apostolic churches regarding HIV and AIDS, before and after they attended an HIV and AIDS training programme. A quasi-experimental intervention design was used with faith ...

  12. Developing a mHealth intervention to promote uptake of HIV testing among African communities in the UK: a qualitative study.

    Science.gov (United States)

    Evans, C; Turner, K; Suggs, L S; Occa, A; Juma, A; Blake, H

    2016-07-28

    HIV-related mHealth interventions have demonstrable efficacy in supporting treatment adherence, although the evidence base for promoting HIV testing is inconclusive. Progress is constrained by a limited understanding of processes used to develop interventions and weak theoretical underpinnings. This paper describes a research project that informed the development of a theory-based mHealth intervention to promote HIV testing amongst city-dwelling African communities in the conditions. A community-based participatory social marketing design was adopted. Six focus groups (48 participants in total) were undertaken and analysed using a thematic framework approach, guided by constructs from the Health Belief Model. Key themes were incorporated into a set of text messages, which were pre-tested and refined. The focus groups identified a relatively low perception of HIV risk, especially amongst men, and a range of social and structural barriers to HIV testing. In terms of self-efficacy around HIV testing, respondents highlighted a need for communities and professionals to work together to build a context of trust through co-location in, and co-involvement of, local communities which would in turn enhance confidence in, and support for, HIV testing activities of health professionals. Findings suggested that messages should: avoid an exclusive focus on HIV, be tailored and personalised, come from a trusted source, allay fears and focus on support and health benefits. HIV remains a stigmatized and de-prioritized issue within African migrant communities in the UK, posing barriers to HIV testing initiatives. A community-based participatory social marketing design can be successfully used to develop a culturally appropriate text messaging HIV intervention. Key challenges involved turning community research recommendations into brief text messages of only 160 characters. The intervention needs to be evaluated in a randomized control trial. Future research should explore the

  13. Changes in sexual behavior of HIV-infected older adults enrolled in a clinical trial of standalone group psychotherapies targeting depression

    Science.gov (United States)

    Lovejoy, Travis I.; Heckman, Timothy G.; Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene

    2014-01-01

    By 2015, one-half of all HIV-positive persons in the U.S. will be 50-plus years of age, and as many as 30% of older adults living with HIV/AIDS continue to engage in unprotected sexual intercourse. Contemporary positive prevention models often include mental health treatment as a key component of HIV prevention interventions. This secondary data analysis characterized longitudinal patterns of sexual behavior in HIV-positive older adults enrolled in a randomized controlled trial of group mental health interventions and assessed the efficacy of psychosocial treatments that targeted depression to reduce sexual risk behavior. Participants were 295 HIV-positive adults ≥ 50 years of age experiencing mild to severe depressive symptoms, randomized to one of three study conditions: a 12-session coping improvement group intervention, a 12-session interpersonal support group intervention, or individual therapy upon request. Approximately one-fifth of participants reported one or more occasions of unprotected anal or vaginal intercourse with HIV-negative sexual partners or persons of unknown HIV serostatus over the study period. Changes in sexual behavior did not vary by intervention condition, indicating that standalone treatments that target and reduce depression may be insufficient to reduce sexual risk behavior in depressed HIV-positive older adults. PMID:24668254

  14. School-based interventions for preventing HIV, sexually transmitted infections, and pregnancy in adolescents.

    Science.gov (United States)

    Mason-Jones, Amanda J; Sinclair, David; Mathews, Catherine; Kagee, Ashraf; Hillman, Alex; Lombard, Carl

    2016-11-08

    (Chile), and two in Europe (England and Scotland). Sexual and reproductive health educational programmesSix trials evaluated school-based educational interventions.In these trials, the educational programmes evaluated had no demonstrable effect on the prevalence of HIV (RR 1.03, 95% CI 0.80 to 1.32, three trials; 14,163 participants; low certainty evidence), or other STIs (herpes simplex virus prevalence: RR 1.04, 95% CI 0.94 to 1.15; three trials, 17,445 participants; moderate certainty evidence; syphilis prevalence: RR 0.81, 95% CI 0.47 to 1.39; one trial, 6977 participants; low certainty evidence). There was also no apparent effect on the number of young women who were pregnant at the end of the trial (RR 0.99, 95% CI 0.84 to 1.16; three trials, 8280 participants; moderate certainty evidence). Material or monetary incentive-based programmes to promote school attendanceTwo trials evaluated incentive-based programmes to promote school attendance.In these two trials, the incentives used had no demonstrable effect on HIV prevalence (RR 1.23, 95% CI 0.51 to 2.96; two trials, 3805 participants; low certainty evidence). Compared to controls, the prevalence of herpes simplex virus infection was lower in young women receiving a monthly cash incentive to stay in school (RR 0.30, 95% CI 0.11 to 0.85), but not in young people given free school uniforms (Data not pooled, two trials, 7229 participants; very low certainty evidence). One trial evaluated the effects on syphilis and the prevalence was too low to detect or exclude effects confidently (RR 0.41, 95% CI 0.05 to 3.27; one trial, 1291 participants; very low certainty evidence). However, the number of young women who were pregnant at the end of the trial was lower among those who received incentives (RR 0.76, 95% CI 0.58 to 0.99; two trials, 4200 participants; low certainty evidence). Combined educational and incentive-based programmesThe single trial that evaluated free school uniforms also included a trial arm in which

  15. HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Michael M Chanda

    2017-11-01

    Full Text Available HIV self-testing (HIVST may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs in Zambia.Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1 delivery (direct distribution of an oral HIVST from the peer educator, (2 coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy, or (3 standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320; 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005. Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40. At 1 month, the majority of HIV tests were self-tests (88.4%. HIV self

  16. HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

    Science.gov (United States)

    Chanda, Michael M; Ortblad, Katrina F; Mwale, Magdalene; Chongo, Steven; Kanchele, Catherine; Kamungoma, Nyambe; Fullem, Andrew; Dunn, Caitlin; Barresi, Leah G; Harling, Guy; Bärnighausen, Till; Oldenburg, Catherine E

    2017-11-01

    HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use

  17. Using the multiphase optimization strategy (MOST to optimize an HIV care continuum intervention for vulnerable populations: a study protocol

    Directory of Open Access Journals (Sweden)

    Marya Viorst Gwadz

    2017-05-01

    Full Text Available Abstract Background More than half of persons living with HIV (PLWH in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART, mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST, will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear, social- (e.g., stigma, and structural-level barriers (e.g., difficulties accessing ancillary services. Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation, each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to

  18. A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

    Science.gov (United States)

    Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

    2008-06-01

    To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

  19. Maternal and child psychological outcomes of HIV disclosure to young children in rural South Africa: the Amagugu intervention.

    Science.gov (United States)

    Rochat, Tamsen J; Arteche, Adriane X; Stein, Alan; Mitchell, Joanie; Bland, Ruth M

    2015-06-01

    Increasingly, HIV-infected parents are surviving to nurture their children. Parental HIV disclosure is beneficial, but disclosure rates to younger children remain low. Previously, we demonstrated that the 'Amagugu' intervention increased disclosure to young children; however, effects on psychological outcomes have not been examined in detail. This study investigates the impact of the intervention on the maternal and child psychological outcomes. This pre-post evaluation design enrolled 281 HIV-infected women and their HIV-uninfected children (6-10 years) at the Africa Centre for Health and Population Studies, in rural South Africa. The intervention included six home-based counselling sessions delivered by lay-counsellors. Psychological outcomes included maternal psychological functioning (General Health Questionnaire, GHQ12 using 0,1,2,3 scoring); parenting stress (Parenting Stress Index, PSI36); and child emotional and behavioural functioning (Child Behaviour Checklist, CBCL). The proportions of mothers with psychological distress reduced after intervention: GHQ threshold at least 12 (from 41.3 to 24.9%, P distress and parent-child relationship, showed significant improvement, while mothers' perception of 'child as difficult' was not significantly improved. Reductions in scores were not moderated by disclosure level (full/partial). There was a significant reduction in child emotional and behavioural problems (CBCL Pre M = 56.1; Post M = 48.9, P disclosure level, suggesting general nonspecific positive effects on family relationships. Findings require validation in a randomized control trial.

  20. Controlling HIV Epidemics among Injection Drug Users: Eight Years of Cross-Border HIV Prevention Interventions in Vietnam and China

    Science.gov (United States)

    Hammett, Theodore M.; Des Jarlais, Don C.; Kling, Ryan; Kieu, Binh Thanh; McNicholl, Janet M.; Wasinrapee, Punneeporn; McDougal, J. Stephen; Liu, Wei; Chen, Yi; Meng, Donghua; Huu Nguyen, Tho; Ngoc Hoang, Quyen; Van Hoang, Tren

    2012-01-01

    Introduction HIV in Vietnam and Southern China is driven by injection drug use. We have implemented HIV prevention interventions for IDUs since 2002–2003 in Lang Son and Ha Giang Provinces, Vietnam and Ning Ming County (Guangxi), China. Methods Interventions provide peer education and needle/syringe distribution. Evaluation employed serial cross-sectional surveys of IDUs 26 waves from 2002 to 2011, including interviews and HIV testing. Outcomes were HIV risk behaviors, HIV prevalence and incidence. HIV incidence estimation used two methods: 1) among new injectors from prevalence data; and 2) a capture enzyme immunoassay (BED testing) on all HIV+ samples. Results We found significant declines in drug-related risk behaviors and sharp reductions in HIV prevalence among IDUs (Lang Son from 46% to 23% [pHIV incidence to low levels among new injectors through 36–48 months, then some rebound, particularly in Ning Ming, but BED-based estimates revealed significant reductions in incidence through 96 months. Discussion This is one of the longest studies of HIV prevention among IDUs in Asia. The rebound in incidence among new injectors may reflect sexual transmission. BED-based estimates may overstate incidence (because of false-recent results in patients with long-term infection or on ARV treatment) but adjustment for false-recent results and survey responses on duration of infection generally confirm BED-based incidence trends. Combined trends from the two estimation methods show sharp declines in incidence to low levels. The significant downward trends in all primary outcome measures indicate that the Cross-Border interventions played an important role in bringing HIV epidemics among IDUs under control. The Cross-Border project offers a model of HIV prevention for IDUs that should be considered for large-scale replication. PMID:22952640

  1. Structural Network Position and Performance of Health Leaders Within an HIV Prevention Trial.

    Science.gov (United States)

    Mulawa, Marta I; Yamanis, Thespina J; Kajula, Lusajo J; Balvanz, Peter; Maman, Suzanne

    2018-04-28

    The effectiveness of peer leaders in promoting health may depend on the position they occupy within their social networks. Using sociocentric (whole network) and behavioral data from the intervention arm of a cluster-randomized HIV prevention trial in Dar es Salaam, Tanzania, we used generalized linear models with standardized predictors to examine the association between heath leaders' baseline structural network position (i.e., in-degree and betweenness centrality) and their 12-month self-reported (1) confidence in educating network members about HIV and gender-based violence (GBV) and (2) number of past-week conversations about HIV and GBV. As in-degree centrality increased, leaders reported fewer HIV-related conversations. As betweenness centrality increased, leaders reported greater number of conversations about GBV. Network position was not significantly associated with confidence in discussing either topic. Our results suggest that peer leaders who occupy spaces between sub-groups of network members may be more effective in engaging their peers in sensitive or controversial topics like GBV than more popular peer leaders.

  2. Pentoxifylline, inflammation, and endothelial function in HIV-infected persons: a randomized, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Samir K Gupta

    Full Text Available Untreated HIV may increase the risk of cardiovascular events. Our preliminary in vitro and in vivo research suggests that pentoxifylline (PTX reduces vascular inflammation and improves endothelial function in HIV-infected persons not requiring antiretroviral therapy.We performed a randomized, placebo-controlled trial of PTX 400 mg orally thrice daily for 8 weeks in 26 participants. The primary endpoint was change in flow-mediated dilation (FMD of the brachial artery after 8 weeks. Nitroglycerin-mediated dilation (NTGMD and circulating markers of inflammation, cellular immune activation, coagulation, and metabolism were also assessed.The difference in mean absolute change (SD in FMD after 8 weeks between the placebo [-1.06 (1.45%] and PTX [-1.93 (3.03%] groups was not significant (P = 0.44. No differences in NTGMD were observed. The only significant between-group difference in the changes in biomarkers from baseline to week 8 was in soluble tumor necrosis factor receptor-1 (sTNFRI [-83.2 pg/mL in the placebo group vs. +65.9 pg/mL in the PTX group; P = 0.03]. PTX was generally well-tolerated.PTX did not improve endothelial function and unexpectedly increased the inflammatory biomarker sTNFRI in HIV-infected participants not requiring antiretroviral therapy. Additional interventional research is needed to reduce inflammation and cardiovascular risk in this population.ClinicalTrials.gov NCT00796822.

  3. Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial (SPRINT)

    Science.gov (United States)

    Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

    2016-01-01

    Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those age ≥ 75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates

  4. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  5. Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol

    Directory of Open Access Journals (Sweden)

    Jin Yan

    2017-04-01

    Full Text Available Abstract Background Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM. Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. Methods This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs, personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers’ development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject’s participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis

  6. Ethical issues in a stage 1 cognitive-behavioral therapy feasibility study and trial to reduce alcohol use among HIV-infected outpatients in western Kenya.

    Science.gov (United States)

    Papas, Rebecca K; Gakinya, Benson N; Baliddawa, Joyce B; Martino, Steve; Bryant, Kendall J; Meslin, Eric M; Sidle, John E

    2012-07-01

    Epidemics of both HIV/AIDS and alcohol abuse in sub-Saharan Africa have spurred the conduct of local behavioral therapy trials for these problems, but the ethical issues involved in these trials have not been fully examined. In this paper, we discuss ethical issues that emerged during the conduct of a behavioral intervention adaptation and trial using cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. The study was performed within our multinational collaboration, the USAID-Academic Model Providing Access to Healthcare Partnership. We discuss relevant ethical considerations and how we addressed them.

  7. Explaining high and low performers in complex intervention trials: a new model based on diffusion of innovations theory.

    Science.gov (United States)

    McMullen, Heather; Griffiths, Chris; Leber, Werner; Greenhalgh, Trisha

    2015-05-31

    Complex intervention trials may require health care organisations to implement new service models. In a recent cluster randomised controlled trial, some participating organisations achieved high recruitment, whereas others found it difficult to assimilate the intervention and were low recruiters. We sought to explain this variation and develop a model to inform organisational participation in future complex intervention trials. The trial included 40 general practices in a London borough with high HIV prevalence. The intervention was offering a rapid HIV test as part of the New Patient Health Check. The primary outcome was mean CD4 cell count at diagnosis. The process evaluation consisted of several hundred hours of ethnographic observation, 21 semi-structured interviews and analysis of routine documents (e.g., patient leaflets, clinical protocols) and trial documents (e.g., inclusion criteria, recruitment statistics). Qualitative data were analysed thematically using--and, where necessary, extending--Greenhalgh et al.'s model of diffusion of innovations. Narrative synthesis was used to prepare case studies of four practices representing maximum variety in clinicians' interest in HIV (assessed by level of serological testing prior to the trial) and performance in the trial (high vs. low recruiters). High-recruiting practices were, in general though not invariably, also innovative practices. They were characterised by strong leadership, good managerial relations, readiness for change, a culture of staff training and available staff time ('slack resources'). Their front-line staff believed that patients might benefit from the rapid HIV test ('relative advantage'), were emotionally comfortable administering it ('compatibility'), skilled in performing it ('task issues') and made creative adaptations to embed the test in local working practices ('reinvention'). Early experience of a positive HIV test ('observability') appeared to reinforce staff commitment to recruiting

  8. The challenge of defining standards of prevention in HIV prevention trials

    NARCIS (Netherlands)

    Philpott, Sean; Heise, Lori; McGrory, Elizabeth; Paxton, Lynn; Hankins, Catherine; Alexander, Lorraine; Apuuli, David Kihumuro; Baeten, Jared; Birx, Deborah; de Bruyn, Guy; Bukusi, Elizabeth; Burns, David; Calazans, Gabriela; Campbell, James; Caswell, Georgina; Coutinho, Alex; Dawson, Liza; Dhai, Amaboo; Dube, Samukeliso; Ecuru, Julius; Essack, Zaynab; Farley, Timothy; Gafos, Mitzy; Irungu, Pauline; Kaleebu, Pontiano; Kamali, Anatoli; Kestelyn, Evelyne; Kublin, James; Lohse, Nicolai; Lutalo, Tom; Macklin, Ruth; Mâsse, Benôıt; Mauney, Chris; McCormack, Sheena; Miller, Lori; Mfutso-Bengo, Joseph; Misra, Rajender; Muganwa, Margaret; Ndase, Patrick; Nel, Annalene; Nielsen, Leslie; Nkala, Busisiwe; O'Reilly, Kevin; Okware, Sam; Paicheler, Geneviève; Rees, Helen; Rerks-Ngarm, Supachai; Ridzon, Renee; Rosenberg, Zeda; Singh, Jerome

    2011-01-01

    As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on

  9. 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 ...

  10. HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial.

    Directory of Open Access Journals (Sweden)

    Sharon A Riddler

    Full Text Available Little is known regarding HIV disease outcomes among individuals who become infected with HIV while receiving antiretroviral medications for prevention. We compared HIV disease parameters among women who seroconverted while receiving tenofovir-containing oral or vaginal pre-exposure prophylaxis (PrEP to placebo.Participants with HIV seroconversion in a randomized placebo-controlled trial of oral tenofovir, oral tenofovir/emtricitabine, and vaginal tenofovir gel (MTN-003 were followed in a longitudinal cohort study (MTN-015. The effect of oral and vaginal tenofovir-containing PrEP on HIV disease progression was compared to placebo using linear mixed effects and Cox proportional hazard models, as appropriate. Additional analyses were performed to compare the outcomes among participants with detectable tenofovir or emtricitabine in plasma at the first quarterly visit in MTN-003.A total of 224 participants were included in the analysis; 93% from South Africa and 94% clade C virus. No differences in HIV RNA at steady state or the trajectory over 12 months were observed for each active arm compared to placebo; tenofovir gel recipients had higher CD4+ T cell counts (722 vs 596 cells/mm3; p = 0.02 at 90 days after estimated HIV seroconversion and higher average rates of change over 12 months compared to placebo (-181 vs -92 cells/mm3 per year; p = 0.08. With a median follow-up of 31 months, no significant differences were observed for time to CD4+ T cell count ≤350 cells/mm3, or the composite endpoint of CD4+ T cells ≤350 cells/mm3, initiation of antiretroviral therapy or death for each active arm compared to placebo. Additionally, there were no significant differences in the HIV RNA or CD4+ T cell counts at baseline, the change to month 12, or any disease progression outcomes among participants with oral drug detected and no oral drug detected compared to placebo.No clinically significant differences in HIV seroconversion outcomes were observed

  11. Review of randomized controlled trials of nutritional supplementation in people living with HIV

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    Sneij A

    2016-04-01

    Full Text Available Alicia Sneij, Adriana Campa, Marianna K Baum Stempel College of Public Health and Social Work, Florida International University, Modesto Maidique Campus, Miami, FL, USA Background: Nutritional deficiencies are widespread in people living with HIV (PLWH, prior to the antiretroviral treatment (ART. Nutrient deficiencies and other nutrition-related conditions, however, have been identified in patients receiving ART. Trials of nutritional supplementation have been conducted to alleviate these nutritional conditions and improve or reverse nutrition-related outcomes. This review aims to evaluate the benefits of supplementation, its unintended adverse effects, and the difference in approach and focus, research design, formulations, and outcomes between those randomized clinical trials (RCTs conducted before and after the initiation of ART. Methods: An evidence-based systematic review of the literature was conducted using electronic databases and the resources of the Florida International University Research Library. Forty-two RCTs were selected for review, and their design and outcomes were compared and contrasted conceptually and in the form of tables. Results: Most of the RCTs (n=31 were conducted before the advent of ART, and their aims were delaying disease progression, reversing malnutrition, and improving pregnancy outcomes in women and infants infected with HIV. The RCTs conducted with coadministration of ART were fewer (n=11, with relative smaller sample size, of shorter duration, and mainly focused on preventing or ameliorating the nutrition-related conditions generated by the chronic infection, its treatment, and the aging of PLWH. Conclusion: As ART is becoming more accessible worldwide, and people are living longer with the disease, more longitudinal trials of nutritional interventions with larger sample sizes are needed to study the nutritional consequences and potential treatments for PLWH. Keywords: HIV, antiretroviral therapy

  12. Addressing challenges in scaling up TB and HIV treatment integration in rural primary healthcare clinics in South Africa (SUTHI): a cluster randomized controlled trial protocol.

    Science.gov (United States)

    Naidoo, Kogieleum; Gengiah, Santhanalakshmi; Yende-Zuma, Nonhlanhla; Padayatchi, Nesri; Barker, Pierre; Nunn, Andrew; Subrayen, Priashni; Abdool Karim, Salim S

    2017-11-13

    A large and compelling clinical evidence base has shown that integrated TB and HIV services leads to reduction in human immunodeficiency virus (HIV)- and tuberculosis (TB)-associated mortality and morbidity. Despite official policies and guidelines recommending TB and HIV care integration, its poor implementation has resulted in TB and HIV remaining the commonest causes of death in several countries in sub-Saharan Africa, including South Africa. This study aims to reduce mortality due to TB-HIV co-infection through a quality improvement strategy for scaling up of TB and HIV treatment integration in rural primary healthcare clinics in South Africa. The study is designed as an open-label cluster randomized controlled trial. Sixteen clinic supervisors who oversee 40 primary health care (PHC) clinics in two rural districts of KwaZulu-Natal, South Africa will be randomized to either the control group (provision of standard government guidance for TB-HIV integration) or the intervention group (provision of standard government guidance with active enhancement of TB-HIV care integration through a quality improvement approach). The primary outcome is all-cause mortality among TB-HIV patients. Secondary outcomes include time to antiretroviral therapy (ART) initiation among TB-HIV co-infected patients, as well as TB and HIV treatment outcomes at 12 months. In addition, factors that may affect the intervention, such as conditions in the clinic and staff availability, will be closely monitored and documented. This study has the potential to address the gap between the establishment of TB-HIV care integration policies and guidelines and their implementation in the provision of integrated care in PHC clinics. If successful, an evidence-based intervention comprising change ideas, tools, and approaches for quality improvement could inform the future rapid scale up, implementation, and sustainability of improved TB-HIV integration across sub-Sahara Africa and other resource

  13. Individuals motivated to participate in adherence, care and treatment (imPACT): development of a multi-component intervention to help HIV-infected recently incarcerated individuals link and adhere to HIV care.

    Science.gov (United States)

    Golin, Carol E; Knight, Kevin; Carda-Auten, Jessica; Gould, Michele; Groves, Jennifer; L White, Becky; Bradley-Bull, Steve; Amola, Kemi; Fray, Niasha; Rosen, David L; Mugavaro, Michael J; Pence, Brian W; Flynn, Patrick M; Wohl, David

    2016-09-06

    Policy-makers promote a seek, test, treat and retain (STTR) strategy to expand HIV testing, support linkage and engagement in care, and enhance the continuous use of antiretroviral therapy for those HIV-infected. This HIV prevention strategy is particularly appropriate in correctional settings where HIV screening and treatment are routinely available yet many HIV-infected individuals have difficulty sustaining sufficient linkage and engagement in care, disease management, and viral suppression after prison release. Our research team developed Project imPACT (individuals motivated to Participate in Adherence, Care and Treatment), a multi-component approach for HIV-Infected recently incarcerated individuals that specifically targets their care linkage, retention, and medication adherence by addressing multiple barriers to care engagement after release. The ultimate goals of this intervention are to improve the health of HIV-infected individuals recently released from prison and reduce HIV transmission to their communities by maintaining viral suppression. This paper describes the intervention and technology development processes, based on best practices for intervention development and process evaluation. These processes included: 1) identifying the target population; 2) clarifying the theoretical basis for intervention design; 3) describing features of its foundational interventions; 4) conducting formative qualitative research; 5) integrating and adapting foundational interventions to create and refine intervention content based on target audience feedback. These stages along with the final intervention product are described in detail. The intervention is currently being evaluation and a two arm randomized, controlled trial in two US state prison systems. Based on a literature review, qualitative research, integration of proven interventions and behavioral theory, the final imPACT intervention focused on the transition period two to three months before and three

  14. Cost-effectiveness of HIV prevention interventions in Andhra Pradesh state of India

    Directory of Open Access Journals (Sweden)

    Kumar G Anil

    2010-05-01

    Full Text Available Abstract Background Information on cost-effectiveness of the range of HIV prevention interventions is a useful contributor to decisions on the best use of resources to prevent HIV. We conducted this assessment for the state of Andhra Pradesh that has the highest HIV burden in India. Methods Based on data from a representative sample of 128 public-funded HIV prevention programs of 14 types in Andhra Pradesh, we have recently reported the number of HIV infections averted by each type of HIV prevention intervention and their cost. Using estimates of the age of onset of HIV infection, we used standard methods to calculate the cost per Disability Adjusted Life Year (DALY saved as a measure of cost-effectiveness of each type of HIV prevention intervention. Results The point estimates of the cost per DALY saved were less than US $50 for blood banks, men who have sex with men programmes, voluntary counselling and testing centres, prevention of parent to child transmission clinics, sexually transmitted infection clinics, and women sex worker programmes; between US $50 and 100 for truckers and migrant labourer programmes; more than US $100 and up to US $410 for composite, street children, condom promotion, prisoners and workplace programmes and mass media campaign for the general public. The uncertainty range around these estimates was very wide for several interventions, with the ratio of the high to the low estimates infinite for five interventions. Conclusions The point estimates for the cost per DALY saved from the averted HIV infections for all interventions was much lower than the per capita gross domestic product in this Indian state. While these indicative cost-effectiveness estimates can inform HIV control planning currently, the wide uncertainty range around estimates for several interventions suggest the need for more firm data for estimating cost-effectiveness of HIV prevention interventions in India.

  15. Socio-behaviour challenges to phase III HIV vaccine trials in Sub ...

    African Journals Online (AJOL)

    Abstract. Background: A number of countries in sub-Saharan Africa are preparing for HIV vaccine efficacy trials. Social and behavioural factors related to HIV transmission require examination in each setting where these trials are considered. As part of this, several countries have also recently begun preparatory research ...

  16. Priority interventions to reduce HIV transmission in sex work settings in sub-Saharan Africa and delivery of these services.

    Science.gov (United States)

    Chersich, Matthew F; Luchters, Stanley; Ntaganira, Innocent; Gerbase, Antonio; Lo, Ying-Ru; Scorgie, Fiona; Steen, Richard

    2013-03-04

    Virtually no African country provides HIV prevention services in sex work settings with an adequate scale and intensity. Uncertainty remains about the optimal set of interventions and mode of delivery. We systematically reviewed studies reporting interventions for reducing HIV transmission among female sex workers in sub-Saharan Africa between January 2000 and July 2011. Medline (PubMed) and non-indexed journals were searched for studies with quantitative study outcomes. We located 26 studies, including seven randomized trials. Evidence supports implementation of the following interventions to reduce unprotected sex among female sex workers: peer-mediated condom promotion, risk-reduction counselling and skills-building for safer sex. One study found that interventions to counter hazardous alcohol-use lowered unprotected sex. Data also show effectiveness of screening for sexually transmitted infections (STIs) and syndromic STI treatment, but experience with periodic presumptive treatment is limited. HIV testing and counselling is essential for facilitating sex workers' access to care and antiretroviral treatment (ART), but testing models for sex workers and indeed for ART access are little studied, as are structural interventions, which create conditions conducive for risk reduction. With the exception of Senegal, persistent criminalization of sex work across Africa reduces sex workers' control over working conditions and impedes their access to health services. It also obstructs health-service provision and legal protection. There is sufficient evidence of effectiveness of targeted interventions with female sex workers in Africa to inform delivery of services for this population. With improved planning and political will, services - including peer interventions, condom promotion and STI screening - would act at multiple levels to reduce HIV exposure and transmission efficiency among sex workers. Initiatives are required to enhance access to HIV testing and ART for

  17. Priority interventions to reduce HIV transmission in sex work settings in sub-Saharan Africa and delivery of these services

    Science.gov (United States)

    Chersich, Matthew F; Luchters, Stanley; Ntaganira, Innocent; Gerbase, Antonio; Lo, Ying-Ru; Scorgie, Fiona; Steen, Richard

    2013-01-01

    Introduction Virtually no African country provides HIV prevention services in sex work settings with an adequate scale and intensity. Uncertainty remains about the optimal set of interventions and mode of delivery. Methods We systematically reviewed studies reporting interventions for reducing HIV transmission among female sex workers in sub-Saharan Africa between January 2000 and July 2011. Medline (PubMed) and non-indexed journals were searched for studies with quantitative study outcomes. Results We located 26 studies, including seven randomized trials. Evidence supports implementation of the following interventions to reduce unprotected sex among female sex workers: peer-mediated condom promotion, risk-reduction counselling and skills-building for safer sex. One study found that interventions to counter hazardous alcohol-use lowered unprotected sex. Data also show effectiveness of screening for sexually transmitted infections (STIs) and syndromic STI treatment, but experience with periodic presumptive treatment is limited. HIV testing and counselling is essential for facilitating sex workers’ access to care and antiretroviral treatment (ART), but testing models for sex workers and indeed for ART access are little studied, as are structural interventions, which create conditions conducive for risk reduction. With the exception of Senegal, persistent criminalization of sex work across Africa reduces sex workers’ control over working conditions and impedes their access to health services. It also obstructs health-service provision and legal protection. Conclusions There is sufficient evidence of effectiveness of targeted interventions with female sex workers in Africa to inform delivery of services for this population. With improved planning and political will, services – including peer interventions, condom promotion and STI screening – would act at multiple levels to reduce HIV exposure and transmission efficiency among sex workers. Initiatives are

  18. Enhanced Personal Contact With HIV Patients Improves Retention in Primary Care: A Randomized Trial in 6 US HIV Clinics

    Science.gov (United States)

    Gardner, Lytt I.; Giordano, Thomas P.; Marks, Gary; Wilson, Tracey E.; Craw, Jason A.; Drainoni, Mari-Lynn; Keruly, Jeanne C.; Rodriguez, Allan E.; Malitz, Faye; Moore, Richard D.; Bradley-Springer, Lucy A.; Holman, Susan; Rose, Charles E.; Girde, Sonali; Sullivan, Meg; Metsch, Lisa R.; Saag, Michael; Mugavero, Michael J.; Drainoni, Mari-Lynn; Ferreira, Cintia; Koppelman, Lisa; McDoom, Maya; Naisteter, Michal; Osella, Karina; Ruiz, Glory; Skolnik, Paul; Sullivan, Meg; Gibbs-Cohen, Sophia; Desrivieres, Elana; Frederick, Mayange; Gravesande, Kevin; Holman, Susan; Johnson, Harry; Taylor, Tonya; Wilson, Tracey; Cheever, Laura; Malitz, Faye; Mills, Robert; Craw, Jason; Gardner, Lytt; Girde, Sonali; Marks, Gary; Batey, Scott; Gaskin, Stephanie; Mugavero, Michael; Murphree, Jill; Raper, Jim; Saag, Michael; Thogaripally, Suneetha; Willig, James; Zinski, Anne; Arya, Monisha; Bartholomew, David; Biggs, Tawanna; Budhwani, Hina; Davila, Jessica; Giordano, Tom; Miertschin, Nancy; Payne, Shapelle; Slaughter, William; Jenckes, Mollie; Keruly, Jeanne; McCray, Angie; McGann, Mary; Moore, Richard; Otterbein, Melissa; Zhou, Liming; Garzon, Carolyn; Jean-Simon, Jesline; Mercogliano, Kathy; Metsch, Lisa; Rodriguez, Allan; Saint-Jean, Gilbert; Shika, Marvin; Bradley-Springer, Lucy; Corwin, Marla

    2014-01-01

    Background. The aim of the study was to determine whether enhanced personal contact with human immunodeficiency virus (HIV)–infected patients across time improves retention in care compared with existing standard of care (SOC) practices, and whether brief skills training improves retention beyond enhanced contact. Methods. The study, conducted at 6 HIV clinics in the United States, included 1838 patients with a recent history of inconsistent clinic attendance, and new patients. Each clinic randomized participants to 1 of 3 arms and continued to provide SOC practices to all enrollees: enhanced contact with interventionist (EC) (brief face-to-face meeting upon returning for care visit, interim visit call, appointment reminder calls, missed visit call); EC + skills (organization, problem solving, and communication skills); or SOC only. The intervention was delivered by project staff for 12 months following randomization. The outcomes during that 12-month period were (1) percentage of participants attending at least 1 primary care visit in 3 consecutive 4-month intervals (visit constancy), and (2) proportion of kept/scheduled primary care visits (visit adherence). Results. Log-binomial risk ratios comparing intervention arms against the SOC arm demonstrated better outcomes in both the EC and EC + skills arms (visit constancy: risk ratio [RR], 1.22 [95% confidence interval {CI}, 1.09–1.36] and 1.22 [95% CI, 1.09–1.36], respectively; visit adherence: RR, 1.08 [95% CI, 1.05–1.11] and 1.06 [95% CI, 1.02–1.09], respectively; all Ps < .01). Intervention effects were observed in numerous patient subgroups, although they were lower in patients reporting unmet needs or illicit drug use. Conclusions. Enhanced contact with patients improved retention in HIV primary care compared with existing SOC practices. A brief patient skill-building component did not improve retention further. Additional intervention elements may be needed for patients reporting illicit

  19. Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol.

    Science.gov (United States)

    Yan, Jin; Zhang, Aidi; Zhou, Liang; Huang, Zhulin; Zhang, Pan; Yang, Guoli

    2017-04-24

    Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM). Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app) aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs), personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers' development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject's participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis. This will be the first study of its kind in China to

  20. Interim data monitoring to enroll higher-risk participants in HIV prevention trials

    Directory of Open Access Journals (Sweden)

    Umo-Otong John

    2009-06-01

    Full Text Available Abstract Background Lower-than-expected incidence of HIV undermines sample size calculations and compromises the power of a HIV prevention trial. We evaluated the effectiveness of interim monitoring of HIV infection rates and on-going modification of recruitment strategies to enroll women at higher risk of HIV in the Cellulose Sulfate Phase III study in Nigeria. Methods We analyzed prevalence and incidence of HIV and other sexually transmitted infections, demographic and sexual behavior characteristics aggregated over the treatment groups on a quarterly basis. The site investigators were advised on their recruitment strategies based on the findings of the interim analyses. Results A total of 3619 women were screened and 1644 enrolled at the Ikeja and Apapa clinics in Lagos, and at the Central and Peripheral clinics in Port Harcourt. Twelve months after study initiation, the overall incidence of HIV was less than one-third of the pre-study assumption, with rates of HIV that varied substantially between clinics. Due to the low prevalence and incidence rates of HIV, it was decided to close the Ikeja clinic in Lagos and to find new catchment areas in Port Harcourt. This strategy was associated with an almost two-fold increase in observed HIV incidence during the second year of the study. Conclusion Given the difficulties in estimating HIV incidence, a close monitoring of HIV prevalence and incidence rates during a trial is warranted. The on-going modification of recruitment strategies based on the regular analysis of HIV rates appeared to be an efficient method for targeting populations at greatest risk of HIV infection and increasing study power in the Nigeria trial. Trial Registration The trial was registered with the ClinicalTrials.gov registry under #NCT00120770 http://clinicaltrials.gov/ct2/show/NCT00120770

  1. Mediators of a smoking cessation intervention for persons living with HIV/AIDS

    Science.gov (United States)

    Vidrine, Damon J.; Kypriotakis, George; Li, Liang; Arduino, Roberto C.; Fletcher, Faith E.; Tamí-Maury, Irene; Gritz, Ellen R.

    2015-01-01

    Background Cigarette smoking among persons living with HIV (PLWH) is a pressing public health concern, and efforts to evaluate cessation treatments are needed. The purpose of the present study was to assess potential mechanisms of a cell phone-delivered intervention for HIV-positive smokers. Methods Data from 350 PLWH enrolled in a randomized smoking cessation treatment trial were utilized. Participants were randomized to either usual care (UC) or a cell phone intervention (CPI) group. The independent variable of interest was treatment group membership, while the dependent variable of interest was smoking abstinence at a 3-month follow-up. The hypothesized treatment mechanisms were depression, anxiety, social support, quit motivation and self-efficacy change scores. Results Abstinence rates in the UC and CPI groups were 4.7% (8 of 172) and 15.7% (28 of 178), respectively. The CPI group (vs. UC) experienced a larger decline in depression between baseline and the 3-month follow-up, and a decline in anxiety. Self-efficacy increased for the CPI group and declined for the UC group. Quit motivation and social support change scores did not differ by treatment group. Only self-efficacy met the predefined criteria for mediation. The effect of the cell phone intervention on smoking abstinence through change in self-efficacy was statistically significant (p<.001) and accounted for 17% of the total effect of the intervention on abstinence. Conclusions The findings further emphasize the important mechanistic function of self-efficacy in promoting smoking cessation for PLWH. Additional efforts are required to disentangle the relationships between emotional, distress motivation, and efficacious smoking cessation treatment. PMID:25542824

  2. The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Andrea A. Howard

    2017-06-01

    Discussion: The ENRICH Study evaluates a CIP targeting barriers to IPT implementation. If the CIP is found effective and acceptable, this study has the potential to inform TB prevention strategies for HIV patients in resource-limited countries in sub-Saharan Africa.

  3. The Amagugu Intervention: A conceptual framework for increasing HIV disclosure and parent-led communication about health and HIV prevention among HIV-infected parents with HIV-uninfected primary school-aged children

    Directory of Open Access Journals (Sweden)

    Tamsen Jean Rochat

    2016-08-01

    Full Text Available Advances in access to HIV prevention and treatment have reduced vertical transmission of HIV, with most children born to HIV-infected parents being HIV-uninfected themselves. A major challenge that HIV-infected parents face is disclosure of their HIV status to their predominantly HIV-uninfected children. Their children enter middle childhood and early adolescence facing many challenges associated with parental illness and hospitalisation, often exacerbated by stigma and a lack of access to health education and support. Increasingly, evidence suggests that primary school-aged children have the developmental capacity to grasp concepts of health and illness, including HIV, and that in the absence of parent-led communication and education about these issues, HIV-exposed children may be at increased risk of psychological and social problems. The Amagugu intervention is a six-session home-based intervention, delivered by lay counsellors, which aims to increase parenting capacity to disclose their HIV status and offer health education to their primary school-aged children. The intervention includes information and activities on disclosure, health care engagement and custody planning. An uncontrolled pre-post evaluation study with 281 families showed the intervention was feasible, acceptable and effective in increasing maternal disclosure. The aim of this manuscript is to describe the conceptual model of the Amagugu intervention, as developed post-evaluation, showing the proposed pathways of risk that Amagugu aims to disrupt through its intervention targets, mechanisms and activities; and to present a summary of results from the large scale evaluation study of Amagugu to demonstrate the acceptability and feasibility of the intervention model. This relatively low-intensity home-based intervention led to: increased HIV disclosure to children, improvements in mental health for mother and child, and improved health care engagement and custody planning for

  4. Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial.

    Directory of Open Access Journals (Sweden)

    Katrina Ortblad

    2017-11-01

    Full Text Available HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs, who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities.We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants were randomized to either (1 direct provision of HIV self-tests, (2 provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3 standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants' median age was 28 years (IQR 24-32. Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing-to understand the intervention effects on frequent testing-and self-reported facility-based testing-to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17-1.51, p < 0.001 and at 4 months (RR 1.14, 95% CI 1.07-1.22, p < 0.001. Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07-1.31, p = 0.001 and at 4 months (RR 1.03, 95% CI 1.01-1.05, p = 0.02. At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm

  5. Cost-effectiveness of a brief video-based HIV intervention for African American and Latino sexually transmitted disease clinic clients.

    Science.gov (United States)

    Sweat, M; O'Donnell, C; O'Donnell, L

    2001-04-13

    Decisions about the dissemination of HIV interventions need to be informed by evidence of their cost-effectiveness in reducing negative health outcomes. Having previously shown the effectiveness of a single-session video-based group intervention (VOICES/VOCES) in reducing incidence of sexually transmitted diseases (STD) among male African American and Latino clients attending an urban STD clinic, this study estimates its cost-effectiveness in terms of disease averted. Cost-effectiveness was calculated using data on effectiveness from a randomized clinical trial of the VOICES/VOCES intervention along with updated data on the costs of intervention from four replication sites. STD incidence and self-reported behavioral data were used to make estimates of reduction in HIV incidence among study participants. The average annual cost to provide the intervention to 10 000 STD clinic clients was estimated to be US$447 005, with a cost per client of US$43.30. This expenditure would result in an average of 27.69 HIV infections averted, with an average savings from averted medical costs of US$5 544 408. The number of quality adjusted life years saved averaged 387.61, with a cost per HIV infection averted of US$21 486. This brief behavioral intervention was found to be feasible and cost-saving when targeted to male STD clinic clients at high risk of contracting and transmitting infections, indicating that this strategy should be considered for inclusion in HIV prevention programming.

  6. Development of a Personalized Bidirectional Text Messaging Tool for HIV Adherence Assessment and Intervention among Substance Abusers

    Science.gov (United States)

    Ingersoll, Karen; Dillingham, Rebecca; Reynolds, George; Hettema, Jennifer; Freeman, Jason; Hosseinbor, Sharzad; Winstead-Derlega, Chris

    2013-01-01

    We describe the development of a two-way text messaging intervention tool for substance users who are non-adherent with HIV medications, and examine message flow data for feasibility and acceptability. The assessment and intervention tool, TxText, is fully automated, sending participants mood, substance use, and medication adherence queries by text message. Participants respond, the tool recognizes the category of response, and sends the personalized intervention message that participants designed in return. In 10 months, the tool sent 16,547 messages (half initial, half follow-up) to 31 participants assigned to the TxText condition, who sent 6711 messages in response to the initial messages. Response rates to substance use (n=2370), medication (n=2918) and mood (n=4639) queries were 67%, 69%, and 64%, respectively. Responses indicating medication adherence, abstinence from substances, and good moods were more common than negative responses. The TxText tool can send messages daily over a 3 month period, receive responses, and decode them to deliver personalized affirming or intervention messages. While we await the outcomes of a pilot randomized trial, the process analysis shows that TxText is acceptable and feasible for substance abusers with HIV, and may serve as a complement to HIV medical care. PMID:24029625

  7. Adolescent decision making about participation in a hypothetical HIV vaccine trial.

    Science.gov (United States)

    Alexander, Andreia B; Ott, Mary A; Lally, Michelle A; Sniecinski, Kevin; Baker, Alyne; Zimet, Gregory D

    2015-03-10

    The purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences. As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16-19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized. Twelve concepts related to adolescents' decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate. The results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation. Published by Elsevier Ltd.

  8. Development of a coping intervention to improve traumatic stress and HIV care engagement among South African women with sexual trauma histories.

    Science.gov (United States)

    Sikkema, Kathleen J; Choi, Karmel W; Robertson, Corne; Knettel, Brandon A; Ciya, Nonceba; Knippler, Elizabeth T; Watt, Melissa H; Joska, John A

    2018-06-01

    This paper describes the development and preliminary trial run of ImpACT (Improving AIDS Care after Trauma), a brief coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We engaged in an iterative process to culturally adapt a cognitive-behavioral intervention for delivery within a South African primary care clinic. This process involved three phases: (a) preliminary intervention development, drawing on content from a prior evidence-based intervention; (b) contextual adaptation of the curriculum through formative data collection using a multi-method qualitative approach; and (c) pre-testing of trauma screening procedures and a subsequent trial run of the intervention. Feedback from key informant interviews and patient in-depth interviews guided the refinement of session content and adaptation of key intervention elements, including culturally relevant visuals, metaphors, and interactive exercises. The trial run curriculum consisted of four individual sessions and two group sessions. Strong session attendance during the trial run supported the feasibility of ImpACT. Participants responded positively to the logistics of the intervention delivery and the majority of session content. Trial run feedback helped to further refine intervention content and delivery towards a pilot randomized clinical trial to assess the feasibility and potential efficacy of this intervention. Copyright © 2018 Elsevier Ltd. All rights reserved.

  9. HIV/STI prevention interventions: A systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Globerman Jason

    2017-12-01

    Full Text Available Behavioral interventions can prevent the transmission of HIV and sexually transmitted infections. This systematic review and meta-analysis assesses the effectiveness and quality of available evidence of HIV prevention interventions for people living with HIV in high-income settings. Searches were conducted in MEDLINE, EMBASE, PsycINFO, and CDC Compendium of Effective Interventions. Interventions published between January, 1998 and September, 2015 were included. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE. Forty-six articles and 63 datasets involving 14,096 individuals met inclusion criteria. Included articles were grouped by intervention type, comparison group and outcome. Few of these had high or moderate quality of evidence and statistically significant effects. One intervention type, group-level health education interventions, were effective in reducing HIV/STI incidence when compared to attention controls. A second intervention type, comprehensive risk counseling and services, was effective in reducing sexual risk behaviors when compared to both active and attention controls. All other intervention types showed no statistically significant effect or had low or very low quality of evidence. Given that the majority of interventions produced low or very low quality of evidence, researchers should commit to rigorous evaluation and high quality reporting of HIV intervention studies.

  10. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  11. Pharmacological treatment of painful HIV-associated sensory neuropathy: a systematic review and meta-analysis of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Tudor J C Phillips

    Full Text Available BACKGROUND: Significant pain from HIV-associated sensory neuropathy (HIV-SN affects ∼40% of HIV infected individuals treated with antiretroviral therapy (ART. The prevalence of HIV-SN has increased despite the more widespread use of ART. With the global HIV prevalence estimated at 33 million, and with infected individuals gaining increased access to ART, painful HIV-SN represents a large and expanding world health problem. There is an urgent need to develop effective pain management strategies for this condition. METHOD AND FINDINGS: OBJECTIVE: To evaluate the clinical effectiveness of analgesics in treating painful HIV-SN. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Cochrane central register of controlled trials, www.clinicaltrials.gov, www.controlled-trials.com and the reference lists of retrieved articles. SELECTION CRITERIA: Prospective, double-blinded, randomised controlled trials (RCTs investigating the pharmacological treatment of painful HIV-SN with sufficient quality assessed using a modified Jadad scoring method. REVIEW METHODS: Four authors assessed the eligibility of articles for inclusion. Agreement of inclusion was reached by consensus and arbitration. Two authors conducted data extraction and analysis. Dichotomous outcome measures (≥ 30% and ≥ 50% pain reduction were sought from RCTs reporting interventions with statistically significant efficacies greater than placebo. These data were used to calculate RR and NNT values. RESULTS: Of 44 studies identified, 19 were RCTs. Of these, 14 fulfilled the inclusion criteria. Interventions demonstrating greater efficacy than placebo were smoked cannabis NNT 3.38 95%CI(1.38 to 4.10, topical capsaicin 8%, and recombinant human nerve growth factor (rhNGF. No superiority over placebo was reported in RCTs that examined amitriptyline (100mg/day, gabapentin (2.4 g/day, pregabalin (1200 mg/day, prosaptide (16 mg/day, peptide-T (6 mg/day, acetyl-L-carnitine (1g

  12. Pharmacological Treatment of Painful HIV-Associated Sensory Neuropathy: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

    Science.gov (United States)

    Phillips, Tudor J. C.; Cherry, Catherine L.; Cox, Sarah; Marshall, Sarah J.; Rice, Andrew S. C.

    2010-01-01

    Background Significant pain from HIV-associated sensory neuropathy (HIV-SN) affects ∼40% of HIV infected individuals treated with antiretroviral therapy (ART). The prevalence of HIV-SN has increased despite the more widespread use of ART. With the global HIV prevalence estimated at 33 million, and with infected individuals gaining increased access to ART, painful HIV-SN represents a large and expanding world health problem. There is an urgent need to develop effective pain management strategies for this condition. Method and Findings Objective: To evaluate the clinical effectiveness of analgesics in treating painful HIV-SN. Design: Systematic review and meta-analysis. Data sources: Medline, Cochrane central register of controlled trials, www.clinicaltrials.gov, www.controlled-trials.com and the reference lists of retrieved articles. Selection criteria: Prospective, double-blinded, randomised controlled trials (RCTs) investigating the pharmacological treatment of painful HIV-SN with sufficient quality assessed using a modified Jadad scoring method. Review methods: Four authors assessed the eligibility of articles for inclusion. Agreement of inclusion was reached by consensus and arbitration. Two authors conducted data extraction and analysis. Dichotomous outcome measures (≥30% and ≥50% pain reduction) were sought from RCTs reporting interventions with statistically significant efficacies greater than placebo. These data were used to calculate RR and NNT values. Results Of 44 studies identified, 19 were RCTs. Of these, 14 fulfilled the inclusion criteria. Interventions demonstrating greater efficacy than placebo were smoked cannabis NNT 3.38 95%CI(1.38 to 4.10), topical capsaicin 8%, and recombinant human nerve growth factor (rhNGF). No superiority over placebo was reported in RCTs that examined amitriptyline (100mg/day), gabapentin (2.4g/day), pregabalin (1200mg/day), prosaptide (16mg/day), peptide-T (6mg/day), acetyl-L-carnitine (1g/day), mexilitine (600mg

  13. Integrating technology into complex intervention trial processes: a case study.

    Science.gov (United States)

    Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

    2016-11-17

    Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. A combination of commercially available hardware and a bespoke online database

  14. Text-Messaging-Enhanced HIV Intervention for African American Adolescents: A Feasibility Study

    Science.gov (United States)

    Cornelius, Judith B.; Dmochowski, Jacek; Boyer, Cherrie; St Lawrence, Janet; Lightfoot, Marguerita; Moore, Michael

    2013-01-01

    We examined the feasibility and acceptability of an HIV prevention intervention for African American adolescents delivered via mobile cell phones and looked at intervention-related changes in beliefs and sexual behaviors. We used a longitudinal one-group comparison design with data collected at three points. Forty adolescents, 13–18 years old, participated in the Becoming a Responsible Teen intervention followed by the delivery of daily multimedia messages for 3 months. The mobile-cell-phone enhanced intervention was feasible and acceptable to the participants. Greater HIV knowledge, improved attitudes toward condoms, and increased perceived HIV risk scores were observed with older adolescents (16–18 years old). Behavior trends showed a decrease in the number of times participants reported engaging in unprotected sexual intercourse over the previous 2 months. Mobile-cell-phone multimedia-text-messaging boosters tested in this study provided preliminary evidence of efficacy of the enhanced HIV prevention intervention for African American youth. PMID:23122907

  15. Qualitative analysis of an educational intervention with HIV-discordant heterosexual Latino couples.

    Science.gov (United States)

    Pérez-Jiménez, David; Orengo-Aguayo, Rosaura E

    2011-12-01

    This qualitative analysis elucidates the potential elements of the intervention that may be effective in terms of a) increasing knowledge about HIV/ AIDS in the members of this population; b) increasing the use of male condoms and the practice of mutual masturbation; and c) changing opinions toward male condom use and mutual masturbation. Five heterosexual HIV-discordant couples participated in the adapted intervention, which consisted of four three-hour-long sessions. One month after the intervention, we conducted a qualitative semi-structured interview with every participant to evaluate issues related to the process and content of the activities comprising the intervention, the impact of the intervention, logistics, and recruitment and retention as well as to make a more general evaluation. The information was submitted to qualitative content analysis. After the intervention, participants reported having better attitudes regarding safer sex, particularly in terms of condom use. A reason given by the participants to feel more positive toward condom use and mutual masturbation was that these practices could prevent the infection of the HIV-negative partner. This study provides important evidence of an intervention that promises to be efficacious in preventing some high-risk sexual behaviors among Latino HIV-discordant heterosexual couples. The evidence presented seems to suggest that an intervention that includes basic relevant information about HIV/AIDS, that explains the benefits of condom use and other safer sex options, and that provides effective negotiation and communication strategies could significantly reduce HIV transmission among these couples.

  16. Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.

    Science.gov (United States)

    Nyaoke, Borna A; Mutua, Gaudensia N; Sajabi, Rose; Nyasani, Delvin; Mureithi, Marianne W; Anzala, Omu A

    2017-01-01

    1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as 'advancing research' and collaboration with science, and personal benefits such as health benefits and financial interests. A thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site. Of the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research. The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation) to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine clinical trials.

  17. Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.

    Directory of Open Access Journals (Sweden)

    Borna A Nyaoke

    Full Text Available 1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as 'advancing research' and collaboration with science, and personal benefits such as health benefits and financial interests.A thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site.Of the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research.The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine

  18. Disparities in HIV knowledge and attitudes toward biomedical interventions among the non-medical HIV workforce in the United States.

    Science.gov (United States)

    Copeland, Raniyah M; Wilson, Phill; Betancourt, Gabriela; Garcia, David; Penner, Murray; Abravanel, Rebecca; Wong, Eric Y; Parisi, Lori D

    2017-12-01

    Non-medical, community-based workers play a critical role in supporting people living with (or at risk of acquiring) HIV along the care continuum. The biomedical nature of promising advances in HIV prevention, such as pre-exposure prophylaxis and treatment-as-prevention, requires frontline workers to be knowledgeable about HIV science and treatment. This study was developed to: measure knowledge of HIV science and treatment within the HIV non-medical workforce, evaluate workers' familiarity with and attitudes toward recent biomedical interventions, and identify factors that may affect HIV knowledge and attitudes. A 62-question, web-based survey was completed in English or Spanish between 2012 and 2014 by 3663 US-based employees, contractors, and volunteers working in AIDS service organizations, state/local health departments, and other community-based organizations in a non-medical capacity. Survey items captured the following: respondent demographics, HIV science and treatment knowledge, and familiarity with and attitudes toward biomedical interventions. An average of 61% of HIV knowledge questions were answered correctly. Higher knowledge scores were associated with higher education levels, work at organizations that serve people living with HIV/AIDS or who are at a high risk of acquiring HIV, and longer tenure in the field. Lower knowledge scores were associated with non-Hispanic Black or Black race/ethnicity and taking the survey in Spanish. Similarly, subgroup analyses showed that respondents who were non-Hispanic Black or Hispanic (versus non-Hispanic white), as well as those located in the South (versus other regions) scored significantly lower. These subpopulations were also less familiar with and had less positive attitudes toward newer biomedical prevention interventions. Respondents who took the survey in Spanish (versus English) had lower knowledge scores and higher familiarity with, but generally less positive attitudes toward, biomedical interventions

  19. The 'third wave' of HIV prevention: Filling gaps in integrated interventions, knowledge, and funding

    OpenAIRE

    Sepúlveda, J

    2012-01-01

    There is growing optimism in the global health community that the HIV epidemic can be halted. After decades of relying primarily on behavior change to prevent HIV transmission, a second generation of prevention efforts based on medical or biological interventions such as male circumcision and preexposure prophylaxis-the use of antiretroviral drugs to protect uninfected, at-risk individuals-has shown promising results. This article calls for a third generation of HIV prevention efforts that wo...

  20. 77 FR 57096 - Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program

    Science.gov (United States)

    2012-09-17

    ... Intervention Services Grant Under the Ryan White HIV/AIDS Program AGENCY: Health Resources and Services... primary care services for persons living with HIV/AIDS, including primary adult HIV medical care, adult... Medical Center managed the Ryan White HIV/AIDS Program through a contractual agreement with the...

  1. Pharmacists' Intervention to Reduce Drug Related Problems in HIV ...

    African Journals Online (AJOL)

    Despite advances in the use of highly active antiretroviral therapy (HAART) in the management of HIV/AIDS, drug-related problems (DRPs) still remain an issue, particularly in developing countries. This study evaluated the incidence of DRPs among HIV/AIDS patients in a HIV/AIDS care centre in southern Nigeria and the ...

  2. Behavioral interventions to reduce risk for sexual transmission of HIV among men who have sex with men.

    Science.gov (United States)

    Johnson, Wayne D; Diaz, Rafael M; Flanders, William D; Goodman, Michael; Hill, Andrew N; Holtgrave, David; Malow, Robert; McClellan, William M

    2008-07-16

    Men who have sex with men (MSM) remain at great risk for HIV infection. Program planners and policy makers need descriptions of interventions and quantitative estimates of intervention effects to make informed decisions concerning prevention funding and research. The number of intervention strategies for MSM that have been examined with strong research designs has increased substantially in the past few years. 1. To locate and describe outcome studies evaluating the effects of behavioral HIV prevention interventions for MSM.2. To summarize the effectiveness of these interventions in reducing unprotected anal sex.3. To identify study characteristics associated with effectiveness.4. To identify gaps and indicate future research, policy, and practice needs. We searched electronic databases, current journals, manuscripts submitted by researchers, bibliographies of relevant articles, conference proceedings, and other reviews for published and unpublished reports from 1988 through December 2007. We also asked researchers working in HIV prevention about new and ongoing studies. Studies were considered in scope if they examined the effects of behavioral interventions aimed at reducing risk for HIV or STD transmission among MSM. We reviewed studies in scope for criteria of outcome relevance (measurement of at least one of a list of behavioral or biologic outcomes, e.g., unprotected sex or incidence of HIV infections) and methodologic rigor (randomized controlled trials or certain strong quasi-experimental designs with comparison groups). We used fixed and random effects models to summarize rate ratios (RR) comparing intervention and control groups with respect to count outcomes (number of occasions of or partners for unprotected anal sex), and corresponding prevalence ratios (PR) for dichotomous outcomes (any unprotected anal sex vs. none). We used published formulas to convert effect sizes and their variances for count and dichotomous outcomes where necessary. We accounted

  3. Advantages and Disadvantages for Receiving Internet-Based HIV/AIDS Interventions at Home or at Community Based Organization

    Science.gov (United States)

    Green, Shana M.; Lockhart, Elizabeth; Marhefka, Stephanie L.

    2015-01-01

    Within recent years public health interventions have become technologically based to reflect the digital age we currently live in and appeal to the public in innovative and novel ways. The Internet breaks down boundaries distance imposes and increases our ability to reach and connect with people. Internet-based interventions have the potential to expand access to effective behavioral interventions. The US National HIV/AIDS Strategy states that people living with HIV should have access to effective behavioral interventions like Healthy Relationships (HR) to help them develop safe sex and disclosure skills. However, access to HR is limited across the country, especially for people in remote or rural areas. Internet-based Healthy Relationships Video Groups (HR-VG) delivered at home or community based organizations (CBOs) can possibly expand access. This study assesses the preferences of women living with HIV (WLH) for participation in HR-VG among 21 WLH who participated in a randomized control trial (RCT) testing HR-VG and completed open-ended semi-structured telephone interviews. Transcripts were thematically analyzed to determine advantages, disadvantages and overall preference for home or agency delivery of HR-VG. Themes relating to convenience, technology access, privacy, distractions, HIV serostatus disclosure and social opportunities were identified as advantages or disadvantages to participating in HR-VG at each location. Overall privacy was the most salient concern of accessing HR-VG at home or at a CBO. Considering the concerns expressed by WLH, further studies are needed to assess how an Internet-based intervention delivered at home for WLH can maintain privacy while being cost effective. PMID:26357907

  4. Straight talk: HIV prevention for African-American heterosexual men: theoretical bases and intervention design.

    Science.gov (United States)

    Frye, Victoria; Bonner, Sebastian; Williams, Kim; Henny, Kirk; Bond, Keosha; Lucy, Debbie; Cupid, Malik; Smith, Stephen; Koblin, Beryl A

    2012-10-01

    In the United States, racial disparities in HIV/AIDS are stark. Although African Americans comprise an estimated 14% of the U.S. population, they made up 52% of new HIV cases among adults and adolescents diagnosed in 2009. Heterosexual transmission is now the second leading cause of HIV in the United States. African Americans made up a full two-thirds of all heterosexually acquired HIV/AIDS cases between 2005 and 2008. Few demonstrated efficacious HIV prevention interventions designed specifically for adult, African-American heterosexual men exist. Here, we describe the process used to design a theory-based HIV prevention intervention to increase condom use, reduce concurrent partnering, and increase HIV testing among heterosexually active African-American men living in high HIV prevalence areas of New York City. The intervention integrated empowerment, social identity, and rational choices theories and focused on four major content areas: HIV/AIDS testing and education; condom skills training; key relational and behavioral turning points; and masculinity and fatherhood.

  5. 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.

  6. A Comprehensive HIV Stigma-reduction and Wellness-enhancement Community Intervention: A Case Study.

    NARCIS (Netherlands)

    French, H.; Greeff, M.; Watson, M.J.; Doak, C.M.

    2014-01-01

    We describe the implementation of a comprehensive HIV stigma-reduction and wellness-enhancement community intervention that focused on people living with HIV (PLWH), as well as people living close to them (PLC) from six designated groups. A holistic multiple case study design was used in urban and

  7. Carletonville-Mothusimpilo project: limiting transmission of HIV through community-based interventions

    CSIR Research Space (South Africa)

    Williams, BG

    2000-06-01

    Full Text Available at the start of the epidemic, contributed to the spread of HIV in Carletonville, the largest gold-mining complex in the world. We first consider the political and economic context within which earlier attempts to develop HIV intervention programmes were made...

  8. A Comparative Evaluation of Two Interventions for Educator Training in HIV/AIDS in South Africa

    Science.gov (United States)

    Chao, Li-Wei; Gow, Jeff; Akintola, Olagoke; Pauly, Mark

    2010-01-01

    The purpose of this study was to compare two different methods to teach educators about HIV/AIDS. Sixty educators were selected from eight schools in KwaZulu-Natal Province, South Africa, to undergo HIV/AIDS training using an interactive CD-ROM intervention. Another sixty educators from other schools were selected to undergo a two-day Life Skills…

  9. The state of HIV awareness after three decades of intervention in ...

    African Journals Online (AJOL)

    admin

    about sex with their partners (AOR=0.6; 95% CI=0.4-0.9) had significantly low knowledge about the modes of HIV ... place of residence and discussion about sex with partners. ..... Focus group discussion participant stressed .... success of prevention interventions (16, 17). ... Ame I. HIV/AIDS, gender and Reproductive Health.

  10. 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.

  11. The Study of HIV and Antenatal Care Integration in Pregnancy in Kenya: Design, Methods, and Baseline Results of a Cluster-Randomized Controlled Trial

    Science.gov (United States)

    Turan, Janet M.; Steinfeld, Rachel L.; Onono, Maricianah; Bukusi, Elizabeth A.; Woods, Meghan; Shade, Starley B.; Washington, Sierra; Marima, Reson; Penner, Jeremy; Ackers, Marta L.; Mbori-Ngacha, Dorothy; Cohen, Craig R.

    2012-01-01

    Background Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma. Methodology/Principal Findings A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009– March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines. Conclusions/Significance This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery

  12. A randomized controlled trial of soap opera videos streamed to smartphones to reduce risk of sexually transmitted human immunodeficiency virus (HIV) in young urban African American women.

    Science.gov (United States)

    Jones, Rachel; Hoover, Donald R; Lacroix, Lorraine J

    2013-01-01

    Love, Sex, and Choices (LSC) is a soap opera video series created to reduce HIV sex risk in women. LSC was compared to text messages in a randomized trial in 238 high-risk mostly Black young urban women. 117 received 12-weekly LSC videos, 121 received 12-weekly HIV prevention messages on smartphones. Changes in unprotected sex with high risk partners were compared by mixed models. Unprotected sex with high risk men significantly declined over 6 months post-intervention for both arms, from 21-22 acts to 5-6 (p video over the text arm, though this difference was not statistically significant. However, the LSC was highly popular and viewers wanted the series to continue. This is the first study to report streaming soap opera video episodes to reduce HIV risk on smartphones. LSC holds promise as an Internet intervention that could be scaled-up and combined with HIV testing. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Motives for (not) participating in a lifestyle intervention trial

    DEFF Research Database (Denmark)

    Lakerveld, J.; IJzelenberg, W.; van Tulder, M.

    2008-01-01

    : the perception of being unhealthy and willingness to change their lifestyle. The main barriers reported by non-participants were financial arguments and time investment. Conclusion. The differences between participants and non-participants in a lifestyle intervention trial are in mainly demographic factors......Background. Non-participants can have a considerable influence on the external validity of a study. Therefore, we assessed the socio-demographic, health-related, and lifestyle behavioral differences between participants and non-participants in a comprehensive CVD lifestyle intervention trial......, and explored the motives and barriers underlying the decision to participate or not. Methods. We collected data on participants (n = 50) and non-participants (n = 50) who were eligible for inclusion in a comprehensive CVD lifestyle interventional trial. Questionnaires and a hospital patient records database...

  14. Adapting an Evidence-Based HIV-Prevention Intervention for Women in Domestic Violence Shelters

    Science.gov (United States)

    Cavanaugh, Courtenay E.; Campbell, Jacquelyn; Braxton, Nikia; Harvey, Jenna; Wingood, Gina

    2016-01-01

    Objective Despite the documented intersection of intimate partner violence and HIV, there is a paucity of evidence-based HIV prevention interventions for female survivors of intimate partner violence in the United States. This paper describes the adaptation of an effective HIV prevention intervention, Sisters Informing Sisters about Topics on AIDS (SISTA), for women in domestic violence shelters and the steps taken to improve the adapted intervention’s implementation. Method The adaptation process was guided by the ADAPT-ITT framework and data collected from directors, direct client service providers, and residents of two domestic violence shelters located in urban areas, as well as topical experts. Results Eleven of 12 shelter staff (92%) reported that HIV interventions had never been implemented at their shelter and 64% reported they had not provided residents with educational brochures about HIV prevention. Changes made to adapt SISTA for this population and enhance the implementation of the intervention included reducing the intervention’s duration; adding education about the intersection of intimate partner violence, substance use, and HIV; and adding an HIV risk assessment and safety plan. Conclusions Next steps will include implementing the adapted intervention and evaluating its perceived acceptability and efficacy, and assessing whether contextual factors influence the intervention’s implementation. PMID:27398257

  15. A group-based counselling intervention for depression comorbid with HIV/AIDS using a task shifting approach in South Africa: a randomized controlled pilot study.

    Science.gov (United States)

    Petersen, I; Hanass Hancock, J; Bhana, A; Govender, K

    2014-04-01

    Co-morbid depression in HIV-positive patients on anti-retroviral (ART) treatment poses a public health threat. It compromises treatment adherence and accelerates disease progression. This study aimed to assess the feasibility of a group-based counselling intervention for depressed HIV-positive patients in primary health care (PHC) in South Africa using a task shifting approach. Using a randomized control design, 76 HIV-positive patients with co-morbid depression were initially recruited. This reduced to 34 in the final cohort. Participants were assessed using the Patient Health Questionnaire (PHQ9), Hopkins Symptom Checklist (HSCL-25) and Multidimensional Scale of Perceived Social Support (MSPSS) at baseline and 3-month follow-up. The intervention was adapted from a local group-based Interpersonal Therapy (IPT) intervention. Process evaluation interviews were held with the HIV counsellors who delivered the intervention and a sub-sample of participants. Repeated measures ANOVA analysis showed significantly greater improvement on depression scores on the PHQ9 in the intervention group compared to the control group. A significant decline in the mean scores on the HSCL-25 was found for both groups although this was more pronounced for the intervention group. There was no significant improvement in the MSPSS scores. The small sample size of the final cohort affected the power of the study to detect significant differences between the intervention and control groups on the MSPSS. Longer term impact of the intervention is unknown. These preliminary findings suggest that group-based counselling for depression in HIV-positive patients can potentially be effectively delivered by appropriately trained and supported lay HIV counsellors. The need for a larger trial is indicated. Copyright © 2014 Elsevier B.V. All rights reserved.

  16. Acceptability of HIV cure-related trials: the challenges for physicians and people living with HIV (ANRS-APSEC).

    Science.gov (United States)

    Preau, Marie; Doumergue, Marjolaine; Protiere, Christel; Goujard, Cécile; Mora, Marion; Meyer, Laurence; Lelievre, Jean-Daniel; Raffi, François; Spire, Bruno; Lambotte, Olivier; Suzan-Monti, Marie

    2018-01-18

    Essential HIV cure-related clinical trials (HCRCT) have a potentially high-risk profile in terms of participants' health, which could hinder enrollment by people living with HIV (PLWH) and healthcare professionals (HP). The ANRS-APSEC survey is part of the IAS "Towards an HIV cure" initiative, which promotes multidisciplinary research for a safe, affordable and scalable cure. The study objectives were to understand the psychosocial mechanisms underlying PLWH and HP viewpoints about future HCRCT. Six focus group discussions (three with PLWH (n = 21) and three with HP (n = 30)) were held in three French infectious disease units. From these, three perspectives on HCRCT were identified. The first involved beliefs and knowledge associating HCRCT with poorer health and quality of life for PLWH. The second concerned perceptions of HCRCT as a biological and epidemiological flashback to a situation when HIV infection was left uncontrolled. The third was characterized by aspects of historical HIV culture that embrace innovation.

  17. Long-term dietary intervention trials: critical issues and challenges

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-07-01

    Full Text Available Abstract Background There are many challenges involved in running randomised controlled dietary intervention trials that investigate health outcomes. The aim of this paper was to evaluate the recruitment process, retention of participants and challenges faced in our dairy intervention trial, and to provide strategies to combat the difficulties of running long-term dietary intervention trials. Methods A 12-month, randomised, two-way crossover study was conducted in overweight adults with habitually low dairy food consumption to assess the effects of a high dairy intake (4 servings of reduced-fat dairy per day compared with a low dairy intake (1 serving of reduced-fat dairy per day on measures of cardiometabolic and cognitive health. On completion of the high dairy intake phase, each participant was interviewed about their experience in the trial and responses were used to evaluate the key issues for study participants. Results Although the recruitment target was achieved, high rates of attrition (49.3% and difficulties maintaining participant compliance (reported by 37.8% of participants were major threats to the viability of the study. Factors that contributed to the high attrition included inability to comply with the dietary requirements of the study protocol (27.0%, health problems or medication changes (24.3% and time commitment (10.8%. Conclusion Attrition and adherence to study requirements present challenges to trials requiring longer-term dietary change. Including a run-in period to further assess the motivation, commitment and availability of participants, maintaining regular contact with participants during control phases, minimising time commitment, providing flexibility with dietary requirements, facilitating positive experiences, and stringent monitoring of diet are some key recommendations for future dietary intervention trials. Trial registration Australia and New Zealand Clinical Trials Registry (ACTRN 12608000538347

  18. Pilot Testing an Internet-Based STI and HIV Prevention Intervention With Chilean Women

    Science.gov (United States)

    Villegas, Natalia; Santisteban, Daniel; Cianelli, Rosina; Ferrer, Lilian; Ambrosia, Todd; Peragallo, Nilda; Lara, Loreto

    2015-01-01

    Purpose The incidence of sexually transmitted infections (STIs) and human immunodeficiency virus (HIV) is high among young Chilean women, and there are no STI or HIV prevention interventions available to them that incorporate technology. The purpose of this study was to investigate the preliminary efficacy of an Internet-based STI and HIV prevention intervention (I-STIPI) for Chilean young women on measures of STI- and HIV-related information, motivation, behavioral skills, and preventive behaviors. Design This is a pretest-posttest study. Forty young Chilean women between 18 and 24 years of age participated in an investigation of the I-STIPI’s preliminary efficacy on STI and HIV prevention-related outcomes between baseline and a postintervention assessment. The intervention consisted of four online modules. Data collection was conducted in Santiago, Chile. Paired-samples t test analysis was used to determine whether there were significant differences in each of the outcome variables. Findings After receiving I-STIPI, women reported a significant increase in levels of STI- and HIV-related knowledge, attitudes toward the use of condoms and perceived self-efficacy, and a reduction of risky sexual behaviors with uncommitted partners. Conclusions The I-STIPI showed promise as an Internet-based intervention that can reduce barriers to accessing preventive interventions and increase STI and HIV preventive behaviors in young Chilean women. Clinical Relevance The study provided important information about the ability of an Internet-based intervention to reduce young women’s risk factors and to provide positive preliminary efficacy on STI- and HIV-related outcomes. Internet-based interventions can eliminate many barriers to receiving prevention interventions and may prove to be cost effective. PMID:25410132

  19. Effectiveness of peer-led education on knowledge, attitude and risk behavior practices related to HIV among students at a Malaysian public university--a randomized controlled trial.

    Science.gov (United States)

    Ibrahim, Normala; Rampal, Lekhraj; Jamil, Zubaidah; Zain, Azhar Mohd

    2012-11-01

    Develop, implement and evaluate the effectiveness of a peer-led education program related to HIV/AIDS among university students. randomized controlled trial with 276 university students at Faculty of Medicine and Health Sciences University Putra Malaysia (UPM), Serdang in 2011. A peer-led education program on HIV prevention by university students. differences in knowledge, attitude and risk behavior practices related to HIV between baselines, immediate follow-up after intervention and after three months. Significant improvement in sound knowledge in the intervention group as compared to the control group (Odds ratio, 1.75; 95% CI 1.01, 3.00; p=0.04) and improvement in good attitude related to HIV (Odds ratio 2.22; 95% CI 1.37, 3.61; p=0.01). The odds of high substance risk behavior was significantly reduced in the intervention group as compared to the control group (Odds ratio 0.07; 95% CI 0.02, 0.34; p=0.01). The association between good knowledge and intervention was modified by the different time points (baseline, immediately after intervention and 3 months after intervention), ethnicity and gender. Peer-led education program in HIV prevention improves knowledge, attitude and substance risk behavior. Changes in sexual risk behavior may require a longer follow-up. Copyright © 2012 Elsevier Inc. All rights reserved.

  20. Simulations for designing and interpreting intervention trials in infectious diseases.

    Science.gov (United States)

    Halloran, M Elizabeth; Auranen, Kari; Baird, Sarah; Basta, Nicole E; Bellan, Steven E; Brookmeyer, Ron; Cooper, Ben S; DeGruttola, Victor; Hughes, James P; Lessler, Justin; Lofgren, Eric T; Longini, Ira M; Onnela, Jukka-Pekka; Özler, Berk; Seage, George R; Smith, Thomas A; Vespignani, Alessandro; Vynnycky, Emilia; Lipsitch, Marc

    2017-12-29

    Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods. Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics, which are critical for proper trial design and interpretation. Certain ethical aspects of a trial can also be quantified using simulations. Further, after a trial has been conducted, simulations can be used to explore the possible explanations for the observed effects. Much is to be gained through a multidisciplinary approach that builds collaborations among experts in infectious disease dynamics, epidemiology, statistical science, economics, simulation methods, and the conduct of clinical trials.

  1. Intervention Mapping to develop a Social Cognitive Theory-based intervention for chronic pain tailored to individuals with HIV.

    Science.gov (United States)

    Merlin, Jessica S; Young, Sarah R; Johnson, Mallory O; Saag, Michael; Demonte, William; Kerns, Robert; Bair, Matthew J; Kertesz, Stefan; Turan, Janet M; Kilgore, Meredith; Clay, Olivio J; Pekmezi, Dorothy; Davies, Susan

    2018-06-01

    Chronic pain is an important comorbidity among individuals with HIV. Behavioral interventions are widely regarded as evidence-based, efficacious non-pharmacologic interventions for chronic pain in the general population. An accepted principle in behavioral science is that theory-based, systematically-developed behavioral interventions tailored to the unique needs of a target population are most likely to be efficacious. Our aim was to use Intervention Mapping to systematically develop a Social Cognitive Theory (SCT)-based intervention for chronic pain tailored to individuals with HIV that will improve pain intensity and pain-related functional impairment. Our Intervention Mapping process was informed by qualitative inquiry of 24 patients and seven providers in an HIV primary care clinic. The resulting intervention includes group and one-on-one sessions and peer and staff interventionists. We also developed a conceptual framework that integrates our qualitative findings with SCT-based theoretical constructs. Using this conceptual framework as a guide, our future work will investigate the intervention's impact on chronic pain outcomes, as well as our hypothesized proximal mediators of the intervention's effect.

  2. Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial.

    Science.gov (United States)

    Kurth, Ann E; Spielberg, Freya; Cleland, Charles M; Lambdin, Barrot; Bangsberg, David R; Frick, Pamela A; Severynen, Anneleen O; Clausen, Marc; Norman, Robert G; Lockhart, David; Simoni, Jane M; Holmes, King K

    2014-04-15

    Evaluate a computerized intervention supporting antiretroviral therapy (ART) adherence and HIV transmission prevention. Longitudinal randomized controlled trial. An academic HIV clinic and a community-based organization in Seattle. In a total of 240 HIV-positive adults on ART, 209 completed 9-month follow-up (87% retention). Randomization to computerized counseling or assessment only, 4 sessions over 9 months. HIV-1 viral suppression, and self-reported ART adherence and transmission risks, compared using generalized estimating equations. Overall, intervention participants had reduced viral load: mean 0.17 log10 decline, versus 0.13 increase in controls, P = 0.053, and significant difference in ART adherence baseline to 9 months (P = 0.046). Their sexual transmission risk behaviors decreased (odds ratio = 0.55, P = 0.020), a reduction not seen among controls (odds ratio = 1.1, P = 0.664), and a significant difference in change (P = 0.040). Intervention effect was driven by those most in need; among those with detectable virus at baseline (>30 copies/mL, n = 89), intervention effect was mean 0.60 log10 viral load decline versus 0.15 increase in controls, P = 0.034. ART adherence at the final follow-up was 13 points higher among intervention participants versus controls, P = 0.038. Computerized counseling is promising for integrated ART adherence and safer sex, especially for individuals with problems in these areas. This is the first intervention to report improved ART adherence, viral suppression, and reduced secondary sexual transmission risk behavior.

  3. Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

    DEFF Research Database (Denmark)

    Lifson, A; Rhame, F; Bellosa, W

    2006-01-01

    adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...

  4. HIV/AIDS Prevention Trials Capacity Building Grants - Phase II ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Canada's international response to the HIV/AIDS epidemic is largely built around the work of the Canadian HIV Vaccine Initiative (CHVI). CHVI proposes to increase the capacity of Canada and low- and middle-income countries to respond to the HIV/AIDS pandemic by developing new HIV vaccines and other preventive ...

  5. Advancing Behavioral HIV Prevention: Adapting an Evidence-Based Intervention for People Living with HIV and Alcohol Use Disorders

    Directory of Open Access Journals (Sweden)

    M. L. Armstrong

    2015-01-01

    Full Text Available Alcohol use disorders (AUDs are highly prevalent among people living with HIV/AIDS (PLWHA and are associated with increased HIV risk behaviors, suboptimal treatment adherence, and greater risk for disease progression. We used the ADAPT-ITT strategy to adapt an evidence-based intervention (EBI, the Holistic Health Recovery Program (HHRP+, that focuses on secondary HIV prevention and antiretroviral therapy (ART adherence and apply it to PLWHA with problematic drinking. Focus groups (FGs were conducted with PLWHA who consume alcohol and with treatment providers at the largest HIV primary care clinic in New Orleans, LA. Overall themes that emerged from the FGs included the following: (1 negative mood states contribute to heavy alcohol consumption in PLWHA; (2 high levels of psychosocial stress, paired with few adaptive coping strategies, perpetuate the use of harmful alcohol consumption in PLWHA; (3 local cultural norms are related to the permissiveness and pervasiveness of drinking and contribute to heavy alcohol use; (4 healthcare providers unanimously stated that outpatient options for AUD intervention are scarce, (5 misperceptions about the relationships between alcohol and HIV are common; (6 PLWHA are interested in learning about alcohol’s impact on ART and HIV disease progression. These data were used to design the adapted EBI.

  6. Life skills: evaluation of a theory-driven behavioral HIV prevention intervention for young transgender women.

    Science.gov (United States)

    Garofalo, Robert; Johnson, Amy K; Kuhns, Lisa M; Cotten, Christopher; Joseph, Heather; Margolis, Andrew

    2012-06-01

    Young transgender women are at increased risk for HIV infection due to factors related to stigma/marginalization and participation in risky sexual behaviors. To date, no HIV prevention interventions have been developed or proven successful with young transgender women. To address this gap, we developed and pilot tested a homegrown intervention "Life Skills," addressing the unique HIV prevention needs of young transgender women aged 16-24 years. Study aims included assessing the feasibility of a small group-based intervention with the study population and examining participant's engagement in HIV-related risk behaviors pre- and 3-months-post-intervention. Fifty-one (N = 51) young transgender women enrolled in the study. Our overall attendance and retention rates demonstrate that small group-based HIV prevention programs for young transgender women are both feasible and acceptable. Trends in outcome measures suggest that participation in the intervention may reduce HIV-related risk behaviors. Further testing of the intervention with a control group is warranted.

  7. Comparative Cost Analysis of Four Interventions to Prevent HIV Transmission in Bandung, Indonesia

    Directory of Open Access Journals (Sweden)

    Eveline J.M. Verstraaten

    2017-11-01

    Full Text Available Background: the costs of HIV/AIDS interventions in Indonesia are largely unknown. Knowing these costs is an important input for policy makers in the decision-making of setting priorities among HIV/AIDS interventions. The aim of this analysis is to determine the costs of four HIV/AIDS interventions in Bandung, Indonesia in 2015, to inform the local AIDS commission. Methods: data on utilization and costs of the different interventions were collected in a sexual transmitted infections (STI-clinic and the KPA, the local HIV/AIDS commission, for the period of January 2015-December 2015. The costs were estimated from a societal perspective, using a micro-costing approach. Results: the total annualized costs for condom distribution, mobile voluntary counselling and testing (VCT, religious based information, communication, and education (IEC and STI services equalled US$56,926, US$2,985, US$1,963 and US$5,865, respectively. Conclusion: this analysis has provided cost estimates of four different HIV/AIDS interventions in Bandung, Indonesia. Additionally, it has estimated the costs of scaling up these interventions. Together, this provides important information for policy makers vis-à-vis the implementation of these interventions. However, an evaluation of the effectiveness of these interventions is needed to estimate the cost-effectiveness.

  8. Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

    Science.gov (United States)

    Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.

    2014-01-01

    Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects

  9. Improving ethical and participatory practice for marginalized populations in biomedical HIV prevention trials: lessons from Thailand.

    Directory of Open Access Journals (Sweden)

    Dan Allman

    Full Text Available BACKGROUND: This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired. METHODS: In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP guided this work. RESULTS: Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs. Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will. DISCUSSION: Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical

  10. Improving ethical and participatory practice for marginalized populations in biomedical HIV prevention trials: lessons from Thailand.

    Science.gov (United States)

    Allman, Dan; Ditmore, Melissa Hope; Kaplan, Karyn

    2014-01-01

    This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired. In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP) guided this work. Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs). Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will. Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical and participatory practice in other parts of the world where

  11. 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.

  12. A randomized controlled trial of an HIV/AIDS Symptom Management Manual for depressive symptoms.

    Science.gov (United States)

    Eller, Lucille S; Kirksey, Kenn M; Nicholas, Patrice K; Corless, Inge B; Holzemer, William L; Wantland, Dean J; Willard, Suzanne S; Robinson, Linda; Hamilton, Mary Jane; Sefcik, Elizabeth F; Moezzi, Shahnaz; Mendez, Marta Rivero; Rosa, Maria; Human, Sarie

    2013-01-01

    Abstract Depressive symptoms are highly prevalent, underdiagnosed, and undertreated in people living with HIV/AIDS (PLWH), and are associated with poorer health outcomes. This randomized controlled trial examined the effects of the HIV/AIDS Symptom Management Manual self-care symptom management strategies compared with a nutrition manual on depressive symptoms in an international sample of PLWH. The sample consisted of a sub-group (N=222) of participants in a larger study symptom management study who reported depressive symptoms. Depressive symptoms of the intervention (n=124) and control (n=98) groups were compared over three months: baseline, one-month, and two-months. Use and effectiveness of specific strategies were examined. Depressive symptom frequency at baseline varied significantly by country (χ (2) 12.9; p=0.04). Within the intervention group there were significant differences across time in depressive symptom frequency [F(2, 207) = 3.27, p=0.05], intensity [F(2, 91) = 4.6, p=0.01], and impact [F(2, 252) = 2.92, p= 0.05), and these were significantly lower at one month but not at two months, suggesting that self-care strategies are effective in reducing depressive symptoms, however effects may be short term. Most used and most effective self-care strategies were distraction techniques and prayer. This study suggests that people living with HIV can be taught and will employ self-care strategies for management of depressive symptoms and that these strategies are effective in reducing these symptoms. Self-care strategies are noninvasive, have no side-effects, and can be readily taught as an adjunct to other forms of treatment. Studies are needed to identify the most effective self-care strategies and quantify optimum dose and frequency of use as a basis for evidence-based practice.

  13. Randomized controlled trial of caregiver training for HIV-infected child neurodevelopment and caregiver well being.

    Science.gov (United States)

    Bass, Judith K; Opoka, Robert; Familiar, Itziar; Nakasujja, Noeline; Sikorskii, Alla; Awadu, Jorem; Givon, Deborah; Shohet, Cilly; Murray, Sarah M; Augustinavicius, Jura; Mendelson, Tamar; Boivin, Michael

    2017-08-24

    HIV infection places children at neurodevelopmental risk; for young children in poverty, risk is compounded by compromised caregiving quality. The mediational intervention for sensitizing caregivers (MISC) program trained caregivers on fostering daily interactions with young children. We hypothesized that MISC could enhance neurodevelopment of rural Ugandan HIV-infected children and improve mental health outcomes of their caregivers, which might mediate improved caregiving quality. A randomized trial of HIV-infected young children (ages 2-5 years) and their female caregivers; cluster randomization was to MISC or a nutrition curriculum. A total of 18 geographic clusters in rural Uganda. Children and caregivers were evaluated at baseline, 6 months, 1 year, and 1-year post-training. Mullen Scales of Early Learning, the Color-Object Association Test for memory, the Early Childhood Vigilance Test of attention, and the Behavior Rating Inventory of Executive Function for the children. Caregivers completed measures of depression and anxiety symptoms and daily functioning. MISC had a significant impact on postintervention receptive language (adjusted mean difference = 3.13, 95% confidence interval 0.08, 6.18) that persisted at 1-year follow-up. MISC caregivers reported significantly less functional impairment postprogram (adjusted mean difference = -0.15, 95% confidence interval -0.28, -0.01). Other outcomes were NS. Both intervention conditions resulted in improvements in the study children over time. MISC showed additional impacts on child language and caregiver well-being. Future directions that include assessing the extent enhanced language development resulting from improved caregiving may better prepare impoverished children for school.

  14. Advantages and disadvantages for receiving Internet-based HIV/AIDS interventions at home or at community-based organizations.

    Science.gov (United States)

    Green, Shana M; Lockhart, Elizabeth; Marhefka, Stephanie L

    2015-01-01

    Within recent years, public health interventions have become technology based to reflect the digital age we currently live in and appeal to the public in innovative and novel ways. The Internet breaks down boundaries distance imposes and increases our ability to reach and connect with people. Internet-based interventions have the potential to expand access to effective behavioral interventions (EBIs). The US National HIV/AIDS Strategy states that people living with HIV should have access to EBIs such as healthy relationships (HR) to help them develop safe sex and disclosure skills. However, access to HR is limited across the country, especially for people in remote or rural areas. Internet-based healthy relationships video groups (HR-VG) delivered at home or community-based organizations (CBOs) can possibly expand access. This study assesses the preferences of women living with HIV (WLH) for participation in HR-VG among 21 WLH who participated in a randomized control trial (RCT) testing HR-VG and completed open-ended semi-structured telephone interviews. Transcripts were thematically analyzed to determine advantages and disadvantages of home or CBO delivery of HR-VG. Themes relating to convenience, technology access, privacy, distractions, HIV serostatus disclosure, and social opportunities were identified as advantages or disadvantages to participating in HR-VG at each location. Overall, privacy was the most salient concern of accessing HR-VG at home or at a CBO. Considering the concerns expressed by WLH, further studies are needed to assess how an Internet-based intervention delivered at home for WLH can maintain privacy while being cost effective.

  15. A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation.

    Science.gov (United States)

    Lifson, Alan R; Workneh, Sale; Hailemichael, Abera; MacLehose, Richard F; Horvath, Keith J; Hilk, Rose; Fabian, Lindsey; Sites, Anne; Shenie, Tibebe

    2018-06-01

    Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites. From each site, we enrolled adults newly entering HIV care. Participants at intervention sites were assigned a CHW who provided: HIV and health education; counseling and social support; and facilitated communication with HIV clinics. All participants are followed through three years with annual health surveys, plus HIV clinic record abstraction including clinic visit dates. CHWs record operational data about their client contacts. 1799 HIV patients meeting inclusion criteria were enrolled and randomized: 59% were female, median age = 32 years, median CD4 + count = 263 cells/mm 3 , and 41% were WHO Stage III or IV. A major enrollment challenge was fewer new HIV patients initiating care at participating sites due to shortage of HIV test kits. At intervention sites, 71 CHWs were hired, trained and assigned to clients. In meeting with clients, CHWs needed to accommodate to various challenges, including HIV stigma, distance, and clients lacking cell phones. This randomized community HIV trial using CHWs in a resource-limited setting was successfully launched, but required flexibility to adapt to unforeseen challenges.

  16. Maternal HIV disclosure to HIV-uninfected children in rural South Africa: a pilot study of a family-based intervention.

    Science.gov (United States)

    Rochat, Tamsen J; Mkwanazi, Ntombizodumo; Bland, Ruth

    2013-02-18

    As access to treatment increases, large numbers of HIV-positive parents are raising HIV-negative children. Maternal HIV disclosure has been shown to have benefits for mothers and children, however, disclosure rates remain low with between 30-45% of mothers reporting HIV disclosure to their children in both observational and intervention studies. Disclosure of HIV status by parent to an HIV-uninfected child is a complex and challenging psychological and social process. No intervention studies have been designed and tested in Southern Africa to support HIV-positive parents to disclose their status, despite this region being one of the most heavily affected by the HIV epidemic. This paper describes the development of a family-centred, structured intervention to support mothers to disclose their HIV status to their HIV-negative school-aged children in rural South Africa, an area with high HIV prevalence. The intervention package includes printed materials, therapeutic tools and child-friendly activities and games to support age-appropriate maternal HIV disclosure, and has three main aims: (1) to benefit family relationships by increasing maternal HIV disclosure; (2) to increase children's knowledge about HIV and health; (3) to improve the quality of custody planning for children with HIV-positive mothers. We provide the theoretical framework for the intervention design and report the results of a small pilot study undertaken to test its acceptability in the local context. The intervention was piloted with 24 Zulu families, all mothers were HIV-positive and had an HIV-negative child aged 6-9 years. Lay counsellors delivered the six session intervention over a six to eight week period. Qualitative data were collected on the acceptability, feasibility and the effectiveness of the intervention in increasing disclosure, health promotion and custody planning. All mothers disclosed something to their children: 11/24 disclosed fully using the words "HIV" while 13/24 disclosed

  17. Financing structural interventions: going beyond HIV-only value for money assessments.

    Science.gov (United States)

    Remme, Michelle; Vassall, Anna; Lutz, Brian; Luna, Jorge; Watts, Charlotte

    2014-01-28

    Structural interventions can reduce HIV vulnerability. However, HIV-specific budgeting, based on HIV-specific outcomes alone, could lead to the undervaluation of investments in such interventions and suboptimal resource allocation. We investigate this hypothesis by examining the consequences of alternative financing approaches. We compare three approaches for deciding whether to finance a structural intervention to keep adolescent girls in school in Malawi. In the first, HIV and non-HIV budget holders participate in a cross-sectoral cost-benefit analysis and fund the intervention if the benefits outweigh the costs. In the second silo approach, each budget holder considers the cost-effectiveness of the intervention in terms of their own objectives and funds the intervention on the basis of their sector-specific thresholds of what is cost-effective or not. In the third cofinancing approach, budget holders use cost-effectiveness analysis to determine how much they would be willing to contribute towards the intervention, provided that other sectors are willing to pay for the remaining costs. In addition, we explore approaches for determining the HIV share in the cofinancing scenario. We find that efficient structural interventions may be less likely to be prioritized, financed and taken to scale where sectors evaluate their options in isolation. A cofinancing approach minimizes welfare loss and could be incorporated in a sector budgeting perspective. Structural interventions may be underimplemented and their cross-sectoral benefits foregone. Cofinancing provides an opportunity for multiple HIV, health and development objectives to be achieved simultaneously, but will require effective cross-sectoral coordination mechanisms for planning, implementation and financing.

  18. Implementation of a "County-Township-Village" Allied HIV Prevention and Control Intervention in Rural China.

    Science.gov (United States)

    Yu, Jun; Zhang, Yi; Jiang, Junjun; Lu, Qinglin; Liang, Bingyu; Liu, Deping; Fang, Keyong; Huang, Jiegang; He, Yang; Ning, Chuanyi; Liao, Yanyan; Lai, Jingzhen; Wei, Wudi; Qin, Fengxiang; Ye, Li; Geng, Wenkui; Liang, Hao

    2017-09-01

    In China, rural areas are a weak link of HIV/AIDS prevention and control. From September 2011, an innovative "county-township-village" allied intervention was implemented in Longzhou County, Guangxi, which assigned the tasks of HIV/AIDS prevention and control to the county Centers for Disease Control and Prevention (CDC), township hospitals, and village clinics, respectively, instead of traditional intervention in which the county CDC undertook the entire work. A 6-year consecutive cross-sectional survey, including 3-year traditional intervention (2009-2011) and 3-year innovative intervention (2012-2014), was conducted to evaluate the effects of the new intervention. Compared to traditional intervention, the innovative intervention achieved positive effects in decreasing risky behaviors. Among female sex workers, condom use rate in the last month increased from 72.06% to 96.82% (p ratio of HIV infection during innovative intervention was 0.631 (95% confidence interval 0.549-0.726) compared with traditional one. Cost-effectiveness analysis indicates that innovative intervention restores each disability-adjusted life year costing an average of $124.26. Taken together, Longzhou's innovative intervention has achieved good effects on HIV/AIDS prevention and control and provides a good reference for rural China.

  19. A Group Intervention for HIV/STI Risk Reduction among Indian Couples

    Directory of Open Access Journals (Sweden)

    Ritu Nehra

    2013-12-01

    Full Text Available Background: HIV in India is transmitted primarily by heterosexual contact. The present study sought to test the feasibility of a group HIV/STI risk reduction intervention among heterosexual couples in India. Methods: Focus groups and key informant interviews were used in 2008 to culturally tailor the intervention. Thirty sexually active and HIV/STI negative couples were enrolled and assessed regarding risk behavior and sexual barrier acceptability. Gender-concordant group sessions used cognitive behavioral strategies for HIV/STI prevention. Results: At baseline, male condom use was low (36%; no participants reported use of female condoms or vaginal gels. HIV knowledge was low; women had more HIV knowledge and more positive attitudes towards condom use than men. Post-intervention, willingness to use all barrier products (t = 10.0, P< .001 and intentions to avoid risk behavior increased (t = 5.62, P< .001. Conclusion: This study illustrates the feasibility of utilizing a group intervention to enhance HIV/STI risk reduction among Indian couples.

  20. Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

    Science.gov (United States)

    Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

    2015-12-01

    The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools

  1. HIV-infected People in Sudan Moving Toward Chronic Poverty: Possible Interventions.

    Science.gov (United States)

    Ismail, Salwa Muddthir; Eisa, Ammar Abobakre; Ibrahim, Faisal

    2016-01-01

    We sought to identify the socioeconomic impact on people living with HIV (PLWH) in Sudan. Focus group discussions were used to collect data and identify the most outstanding domains of HIV impact on PLWH and the survival mechanisms that may be common to a group of diverse HIV-infected persons (n = 30). The findings indicated that the most striking financial and social impacts were due to stigma associated with HIV in the conservative Sudanese society, which led to loss of work with all its consequences (e.g., children's education and health care expenses were affected). The socioeconomic impacts of HIV on infected populations are discussed, and suggestions for possible interventions to mitigate harmful impacts and stigma within the society, the workplace, and health care settings are highlighted. We concluded that HIV has intensified the existing problems of infected people, contributing to their vulnerability to poverty. Copyright © 2016 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

  2. 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.

  3. Stigma Reduction in Adolescents and Young Adults Newly Diagnosed with HIV: Findings from the Project ACCEPT Intervention

    OpenAIRE

    Harper, Gary W.; Lemos, Diana; Hosek, Sybil G.

    2014-01-01

    This article describes the influence of a group-based behavioral intervention for adolescents and young adults newly diagnosed with HIV (Project ACCEPT) on four dimensions of HIV-related stigma—personalized stigma, disclosure concerns, negative self-image, and concern with public attitudes about people with HIV—as measured by the Berger HIV Stigma Scale. Stigma was addressed in a holistic manner during the intervention by providing HIV/AIDS-related information, facilitating the acquisition of...

  4. The study of HIV and antenatal care integration in pregnancy in Kenya: design, methods, and baseline results of a cluster-randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Janet M Turan

    Full Text Available Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT, HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma.A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment. During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines.This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving

  5. HIV Rapid Testing in Substance Abuse Treatment: Implementation Following a Clinical Trial

    Science.gov (United States)

    Haynes, L. F.; Korte, J. E.; Holmes, B. E.; Gooden, L.; Matheson, T.; Feaster, D. J.; Leff, J. A.; Wilson, L.; Metsch, L. R.; Schackman, B. R.

    2011-01-01

    The Substance Abuse Mental Health Services Administration has promoted HIV testing and counseling as an evidence-based practice. Nevertheless, adoption of HIV testing in substance abuse treatment programs has been slow. This article describes the experience of a substance abuse treatment agency where, following participation in a clinical trial,…

  6. Core journals that publish clinical trials of physical therapy interventions.

    Science.gov (United States)

    Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R

    2010-11-01

    The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best

  7. Intervention induced changes on parenting practices, youth self-pride and sexual norms to reduce HIV-related behaviors among rural African American youths.

    Science.gov (United States)

    Murry, Velma McBride; Berkel, Cady; Chen, Yi-Fu; Brody, Gene H; Gibbons, Frederick X; Gerrard, Meg

    2011-09-01

    AIDS is the leading killer of African Americans between the ages of 25 and 44, many of whom became infected when they were teenagers or young adults. The disparity in HIV infection rate among African Americans youth residing in rural Southern regions of the United States suggests that there is an urgent need to identify ways to promote early preventive intervention to reduce HIV-related risk behavior. The Strong African American Families (SAAF) program, a preventive intervention for rural African American parents and their 11-year-olds, was specially designed to deter early sexual onset and the initiation and escalation of alcohol and drug use among rural African American preadolescents. A clustered-randomized prevention trial was conducted, contrasting families who took part in SAAF with control families. The trial, which included 332 families, indicated that intervention-induced changes occurred in intervention-targeted parenting, which in turn facilitated changes in youths' internal protective processes and positive sexual norms. Long-term follow up assessments when youth were 17 years old revealed that intervention-induced changes in parenting practices mediated the effect of intervention-group influences on changes in the onset and escalation of risky sexual behaviors over 65 months through its positive influence on adolescents' self-pride and their sexual norms. The findings underscore the powerful effects of parenting practices among rural African American families that over time serve a protective role in reducing youth's risk behavior, including HIV vulnerable behaviors.

  8. Streaming weekly soap opera video episodes to smartphones in a randomized controlled trial to reduce HIV risk in young urban African American/black women.

    Science.gov (United States)

    Jones, Rachel; Lacroix, Lorraine J

    2012-07-01

    Love, Sex, and Choices is a 12-episode soap opera video series created as an intervention to reduce HIV sex risk. The effect on women's HIV risk behavior was evaluated in a randomized controlled trial in 238 high risk, predominately African American young adult women in the urban Northeast. To facilitate on-demand access and privacy, the episodes were streamed to study-provided smartphones. Here, we discuss the development of a mobile platform to deliver the 12-weekly video episodes or weekly HIV risk reduction written messages to smartphones, including; the technical requirements, development, and evaluation. Popularity of the smartphone and use of the Internet for multimedia offer a new channel to address health disparities in traditionally underserved populations. This is the first study to report on streaming a serialized video-based intervention to a smartphone. The approach described here may provide useful insights in assessing advantages and disadvantages of smartphones to implement a video-based intervention.

  9. Meta-analyses on behavioral interventions to reduce the risk of transmission of HIV.

    Science.gov (United States)

    Vergidis, Paschalis I; Falagas, Matthew E

    2009-06-01

    Different behavioral interventions have found to be efficacious in reducing high-risk sexual activity. Interventions have been evaluated in both original research and meta-analytic reviews. Most of the studies have shown that interventions are efficacious among different study populations. In adolescents, both in- and out-of-the classroom interventions showed a decrease in the risk of unprotected sex. In African Americans, greater efficacy was found for interventions including peer education. For Latinos, effect was larger in interventions with segmentation in the same gender. Geographic and social isolation are barriers in approaching MSM. For IDUs, interventions provided within a treatment program have an impact on risk reduction above that produced by drug treatment alone. Finally, people diagnosed with HIV tend to reduce their sexual risk behavior. However, adherence to safe sex practices for life can be challenging. Relentless efforts for implementation of behavioral interventions to decrease high-risk behavior are necessary to decrease HIV transmission.

  10. Piloting a Savings-Led Microfinance Intervention with Women Engaging in Sex Work in Mongolia: Further Innovation for HIV Risk Reduction.

    Science.gov (United States)

    Tsai, Laura Cordisco; Witte, Susan S; Aira, Toivgoo; Altantsetseg, Batsukh; Riedel, Marion

    2011-12-30

    This paper describes a pilot study testing the feasibility of an innovative savings-led microfinance intervention in increasing the economic empowerment and reducing the sexual risk behavior of women engaging in sex work in Mongolia. Women's economic vulnerability may increase their risk for HIV by compromising their ability to negotiate safer sex with partners and heightening the likelihood they will exchange sex for survival. Microfinance has been considered a potentially powerful structural HIV prevention strategy with women conducting sex work, as diversification of income sources may increase women's capacity to negotiate safer transactional sex. With 50% of all reported female HIV cases in Mongolia detected among women engaging in sex work, direct prevention intervention with women conducting sex work represents an opportunity to prevent a potentially rapid increase in HIV infection in urban Mongolia. The piloted intervention consisted of a matched savings program in which matched savings could be used for business development or vocational education, combined with financial literacy and business development training for women engaging in sex work. Results of the pilot demonstrate participants' increased confidence in their ability to manage finances, greater hope for pursuing vocational goals, moderate knowledge gains regarding financial literacy, and an initial transition from sex work to alternative income generation for five out of nine participants. The pilot findings highlight the potential for such an intervention and the need for a clinical trial testing the efficacy of savings-led microfinance programs in reducing HIV risk for women engaging in sex work in Mongolia.

  11. Pregnancy in HIV clinical trials in Sub Saharan Africa: failure of consent or contraception?

    Directory of Open Access Journals (Sweden)

    Agnes Ssali

    Full Text Available Higher than expected pregnancy rates have been observed in HIV related clinical trials in Sub-Saharan Africa. We designed a qualitative study to explore the factors contributing to high pregnancy rates among participants in two HIV clinical trials in Sub-Saharan Africa.Female and male participants enrolled in one of two clinical HIV trials in south-west Uganda were approached. The trials were a phase III microbicide efficacy trial among HIV negative women using vaginal gel (MDP; and a trial of primary prevention prophylaxis for invasive cryptococcal disease using fluconazole among HIV infected men and women in Uganda (CRYPTOPRO. 14 focus group discussions and 8 in-depth interviews were conducted with HIV positive and negative women and their male partners over a six month period. Areas explored were their experiences about why and when one should get pregnant, factors affecting use of contraceptives, HIV status disclosure and trial product use.All respondents acknowledged being advised of the importance of avoiding pregnancy during the trial. Factors reported to contribute to pregnancy included; trust that the investigational product (oral capsules/vaginal gel would not harm the baby, need for children, side effects that led to inconsistent contraceptive use, low acceptance of condom use among male partners. Attitudes towards getting pregnant are fluid within couples over time and the trials often last for more than a year. Researchers need to account for high pregnancy rates in their sample size calculations, and consider lesser used female initiated contraceptive options e.g. diaphragm or female condoms. In long clinical trials where there is a high fetal or maternal risk due to investigational product, researchers and ethics committees should consider a review of participants contraceptive needs/pregnancy desire review after a fixed period, as need for children, partners and health status of participants may alter over time.

  12. A HIV stigma reduction intervention for people living with HIV and ...

    African Journals Online (AJOL)

    Johanna Beatrix Pretorius

    stigma as conceptualised by Alonzo and Reynolds (1995) is used for this ... to access healthcare as it inhibits HIV testing and disclosure of. HIV status ... 2007; Rao et al., 2012) indicates that few effective pro- ..... stress-related mental illness.

  13. The Fire is Coming: An HIV Prevention Intervention Contextualized to the Maasai People of Tanzania

    Directory of Open Access Journals (Sweden)

    Holly Freitas

    2014-01-01

    Full Text Available “The Fire is Coming” film is an innovative HIV-prevention intervention contextualized to the Maasai people of Tanzania through use of a traditional Maasai story. The intervention was developed and implemented in partnership with Maasai Pastoralists for Education and Development (MAPED. Although there have been numerous Knowledge-Attitude-Practice (KAP surveys conducted among the Maasai, this is the first control-group comparison study designed to measure the effectiveness of an HIV-prevention intervention contextualized specifically to the Maasai people of Tanzania. We will first discuss the background and context in which the intervention was developed and methods used to develop the intervention. We will then discuss the evaluation methods, results, and implications of a retrospective Knowledge, Attitudes, Practices (KAP two-village comparison survey (n=200 for “The Fire is Coming” HIV-prevention intervention among Maasai people. There was a significant effect for HIV-related attitudes, t(16 = 2.77, p 0.05. Implications: Belief in one’s ability to do something is often the pivotal point for behavior change. The results of the survey denote a highly effective intervention in changing HIV-related attitudes and behaviors. It is promising for replication among other Maasai communities and for adaptation with indigenous people groups in other regions.

  14. Behavioral HIV Prevention Interventions Among Latinas in the US: A Systematic Review of the Evidence.

    Science.gov (United States)

    Daniel-Ulloa, Jason; Ulibarri, M; Baquero, B; Sleeth, C; Harig, H; Rhodes, S D

    2016-12-01

    Compared to White women, Latinas are 4 times more likely to contract HIV. In an effort to determine the overall state of the science meant to address this disparity, we reviewed the current HIV prevention intervention literature for U.S. Latinas. We searched 5 online electronic databases from their inception through July, 2014, for HIV prevention interventions including a majority sample of Latinas. Of 1041 articles identified, 20 studies met inclusion criteria. We documented study designs, participant characteristics, outcomes, theories used, and other intervention characteristics. Overall, HIV knowledge and attitudes were the predominant outcome; a small minority of studies included self-reported condom use or STD incidence. Strategies used to address cultural factors specific to Latinas and HIV included; lay health advisors, using ethnographic narratives, or using the Theory of Gender and Power, however few of the interventions adopted these strategies. This study identified several gaps in the intervention literature that need to be addressed. In addition to including more direct measures of decreased HIV risk (ex. condom use), more systematic use of strategies meant to address gender and cultural factors that may place Latinas at increased risk (e.g., gender inequity, traditional gender role norms such as machismo and marianismo, and relationship power dynamics).

  15. Sexual risk reduction for HIV-infected persons: a meta-analytic review of "positive prevention" randomized clinical trials.

    Science.gov (United States)

    Yin, Lu; Wang, Na; Vermund, Sten H; Shepherd, Bryan E; Ruan, Yuhua; Shao, Yiming; Qian, Han-Zhu

    2014-01-01

    Prevention intervention trials have been conducted to reduce risk of sexual transmission among people living with HIV/AIDS (PLWHA), but the findings were inconsistent. We performed a systematic review and meta-analysis to evaluate overall efficacy of prevention interventions on unprotected vaginal or anal intercourse (UVAI) among PLWHA from randomized clinical trials (RCTs). RCTs of prevention interventions among PLWHA published as of February 2012 were identified by systematically searching thirteen electronic databases. The primary outcome was UVAI. The difference of standardized mean difference (SMD) of UVAI between study arms, defined as effect size (ES), was calculated for each study and then pooled across studies using standard meta-analysis with a random effects model. Lower likelihood of UVAI was observed in the intervention arms compared with the control arms either with any sexual partners (mean ES: -0.22; 95% confidence interval [CI]: -0.32, -0.11) or with HIV-negative or unknown-status sexual partners (mean ES and 95% CI: -0.13 [-0.22, -0.04]). Short-term efficacy of interventions with ≤ 10 months of follow up was significant in reducing UVAI (1-5 months: -0.27 [-0.45, -0.10]; 6-10 months: -0.18 [-0.30, -0.07]), while long-term efficacy of interventions was weaker and might have been due to chance (11-15 months: -0.13 [-0.34, 0.08]; >15 months: -0.05 [-0.43, 0.32]). Our meta-analyses confirmed the short-term impact of prevention interventions on reducing self-reported UVAI among PLWHA irrespective of the type of sexual partner, but did not support a definite conclusion on long-term effect. It is suggested that booster intervention sessions are needed to maintain a sustainable reduction of unprotected sex among PLWHA in future risk reduction programs.

  16. Effect of an online video-based intervention to increase HIV testing in men who have sex with men in Peru.

    Directory of Open Access Journals (Sweden)

    Magaly M Blas

    2010-05-01

    Full Text Available Although many men who have sex with men (MSM in Peru are unaware of their HIV status, they are frequent users of the Internet, and can be approached by that medium for promotion of HIV testing.We conducted an online randomized controlled trial to compare the effect of HIV-testing motivational videos versus standard public health text, both offered through a gay website. The videos were customized for two audiences based on self-identification: either gay or non-gay men. The outcomes evaluated were 'intention to get tested' and 'HIV testing at the clinic.'In the non-gay identified group, 97 men were randomly assigned to the video-based intervention and 90 to the text-based intervention. Non-gay identified participants randomized to the video-based intervention were more likely to report their intention of getting tested for HIV within the next 30 days (62.5% vs. 15.4%, Relative Risk (RR: 2.77, 95% Confidence Interval (CI: 1.42-5.39. After a mean of 125.5 days of observation (range 42-209 days, 11 participants randomized to the video and none of the participants randomized to text attended our clinic requesting HIV testing (p = 0.001. In the gay-identified group, 142 men were randomized to the video-based intervention and 130 to the text-based intervention. Gay-identified participants randomized to the video were more likely to report intentions of getting an HIV test within 30 days, although not significantly (50% vs. 21.6%, RR: 1.54, 95% CI: 0.74-3.20. At the end of follow up, 8 participants who watched the video and 10 who read the text visited our clinic for HIV testing (Hazard Ratio: 1.07, 95% CI: 0.40-2.85.This study provides some evidence of the efficacy of a video-based online intervention in improving HIV testing among non-gay-identified MSM in Peru. This intervention may be adopted by institutions with websites oriented to motivate HIV testing among similar MSM populations.Clinicaltrials.gov NCT00751192.

  17. Mobile technology use and desired technology-based intervention characteristics among HIV+ Black men who have sex with men.

    Science.gov (United States)

    Senn, Theresa E; Braksmajer, Amy; Coury-Doniger, Patricia; Urban, Marguerite A; Carey, Michael P

    2017-04-01

    HIV positive Black men who have sex with men (MSM) are retained in HIV medical care at suboptimal rates. Interventions targeted to Black MSM are needed to help to improve their retention in care. The purposes of this study were to investigate the use of mobile technology among HIV+ Black MSM and to explore participants' thoughts about the use of mobile technology for HIV retention in care interventions. Twenty-two HIV+ Black MSM completed a technology use survey and participated in a qualitative interview regarding technology-based interventions. The majority of participants (95%) had access to a cell phone, and used their phones frequently (median 3 hours/day). Men preferred interventions that would allow for anonymous participation and that would provide individually tailored support. Mobile technology is a promising approach to intervention delivery for both younger and older HIV+ Black MSM. These interventions should incorporate features that are desirable to men (i.e., anonymous participation and individual tailoring).

  18. Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH.

    Science.gov (United States)

    El-Bassel, Nabila; Gilbert, Louisa; Goddard-Eckrich, Dawn; Chang, Mingway; Wu, Elwin; Hunt, Tim; Epperson, Matt; Shaw, Stacey A; Rowe, Jessica; Almonte, Maria; Witte, Susan

    2014-01-01

    This study is designed to address the need for evidence-based HIV/STI prevention approaches for drug-involved women under criminal justice community supervision. We tested the efficacy of a group-based traditional and multimedia HIV/STI prevention intervention (Project WORTH: Women on the Road to Health) among drug-involved women under community supervision. We randomized 306 women recruited from community supervision settings to receive either: (1) a four-session traditional group-based HIV/STI prevention intervention (traditional WORTH); (2) a four-session multimedia group-based HIV/STI prevention intervention that covered the same content as traditional WORTH but was delivered in a computerized format; or (3) a four-session group-based Wellness Promotion intervention that served as an attention control condition. The study examined whether the traditional or multimedia WORTH intervention was more efficacious in reducing risks when compared to Wellness Promotion; and whether multimedia WORTH was more efficacious in reducing risks when compared to traditional WORTH. Primary outcomes were assessed over the 12-month post-intervention period and included the number of unprotected sex acts, the proportion of protected sex acts, and consistent condom use. At baseline, 77% of participants reported unprotected vaginal or anal sex (n = 237) and 63% (n = 194) had multiple sex partners. Women assigned to traditional or multimedia WORTH were significantly more likely than women assigned to the control condition to report an increase in the proportion of protected sex acts (β = 0.10; 95% CI = 0.02-0.18) and a decrease in the number of unprotected sex acts (IRR = 0.72; 95% CI = 0.57-0.90). The promising effects of traditional and multimedia WORTH on increasing condom use and high participation rates suggest that WORTH may be scaled up to redress the concentrated epidemics of HIV/STIs among drug-involved women in the criminal justice system. ClinicalTrials

  19. Evaluations of Structural Interventions for HIV Prevention: A Review of Approaches and Methods.

    Science.gov (United States)

    Iskarpatyoti, Brittany S; Lebov, Jill; Hart, Lauren; Thomas, Jim; Mandal, Mahua

    2018-04-01

    Structural interventions alter the social, economic, legal, political, and built environments that underlie processes affecting population health. We conducted a systematic review of evaluations of structural interventions for HIV prevention in low- and middle-income countries (LMICs) to better understand methodological and other challenges and identify effective evaluation strategies. We included 27 peer-reviewed articles on interventions related to economic empowerment, education, and substance abuse in LMICs. Twenty-one evaluations included clearly articulated theories of change (TOCs); 14 of these assessed the TOC by measuring intermediary variables in the causal pathway between the intervention and HIV outcomes. Although structural interventions address complex interactions, no evaluation included methods designed to evaluate complex systems. To strengthen evaluations of structural interventions, we recommend clearly articulating a TOC and measuring intermediate variables between the predictor and outcome. We additionally recommend adapting study designs and analytic methods outside traditional epidemiology to better capture complex results, influences external to the intervention, and unintended consequences.

  20. A Randomized Controlled Trial Evaluating Efficacy of Promoting a Home-Based HIV Self-Testing with Online Counseling on Increasing HIV Testing Among Men Who Have Sex with Men.

    Science.gov (United States)

    Wang, Zixin; Lau, Joseph T F; Ip, Mary; Ho, Shara P Y; Mo, Phoenix K H; Latkin, Carl; Ma, Yee Ling; Kim, Yoona

    2018-01-01

    We developed an innovative home-based HIV self-testing (HIVST) service that included mailing of a free HIVST kit, and providing online real-time instructions and pre-test/post-test counseling (HIVST-OIC). The present parallel-group and non-blinded randomized controlled trial was conducted to evaluate the efficacy of promoting HIVST-OIC in increasing HIV testing rate among 430 men who have sex with men (MSM), with access to online live-chat applications in Hong Kong. At month 6, as compared to the control group, the intervention group reported significantly higher prevalence of HIV testing of any type (89.8 vs. 50.7%; relative risk (RR): 1.77; p strong potential in increasing prevalence of HIV testing and reducing sexual risk behaviors. Implementation research is warranted.

  1. Therapeutic DNA vaccination of vertically HIV-infected children: report of the first pediatric randomised trial (PEDVAC.

    Directory of Open Access Journals (Sweden)

    Paolo Palma

    Full Text Available SUBJECTS: Twenty vertically HIV-infected children, 6-16 years of age, with stable viral load control and CD4+ values above 400 cells/mm(3. INTERVENTION: Ten subjects continued their ongoing antiretroviral treatment (ART, Group A and 10 were immunized with a HIV-DNA vaccine in addition to their previous therapy (ART and vaccine, Group B. The genetic vaccine represented HIV-1 subtypes A, B and C, encoded Env, Rev, Gag and RT and had no additional adjuvant. Immunizations took place at weeks 0, 4 and 12, with a boosting dose at week 36. Monitoring was performed until week 60 and extended to week 96. RESULTS: Safety data showed good tolerance of the vaccine. Adherence to ART remained high and persistent during the study and did not differ significantly between controls and vaccinees. Neither group experienced either virological failure or a decline of CD4+ counts from baseline. Higher HIV-specific cellular immune responses were noted transiently to Gag but not to other components of the vaccine. Lymphoproliferative responses to a virion antigen HIV-1 MN were higher in the vaccinees than in the controls (p = 0.047, whereas differences in reactivity to clade-specific Gag p24, RT or Env did not reach significance. Compared to baseline, the percentage of HIV-specific CD8+ lymphocytes releasing perforin in the Group B was higher after the vaccination schedule had been completed (p = 0.031. No increased CD8+ perforin levels were observed in control Group A. CONCLUSIONS: The present study demonstrates the feasibility, safety and moderate immunogenicity of genetic vaccination in vertically HIV-infected children, paving the way for amplified immunotherapeutic approaches in the pediatric population. TRIAL REGISTRATION: clinicaltrialsregister.eu _2007-002359-18IT.

  2. Implementation of evidence-based HIV interventions for young adult African American women in church settings.

    Science.gov (United States)

    Stewart, Jennifer M

    2014-01-01

    To assess the barriers and facilitators to using African American churches as sites for implementation of evidence-based HIV interventions among young African American women. Mixed methods cross-sectional design. African American churches in Philadelphia, PA. 142 African American pastors, church leaders, and young adult women ages 18 to 25. Mixed methods convergent parallel design. The majority of young adult women reported engaging in high-risk HIV-related behaviors. Although church leaders reported willingness to implement HIV risk-reduction interventions, they were unsure of how to initiate this process. Key facilitators to the implementation of evidence-based interventions included the perception of the leadership and church members that HIV interventions were needed and that the church was a promising venue for them. A primary barrier to implementation in this setting is the perception that discussions of sexuality should be private. Implementation of evidence-based HIV interventions for young adult African American women in church settings is feasible and needed. Building a level of comfort in discussing matters of sexuality and adapting existing evidence-based interventions to meet the needs of young women in church settings is a viable approach for successful implementation. © 2014 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

  3. Epidemic impacts of a community empowerment intervention for HIV prevention among female sex workers in generalized and concentrated epidemics.

    Science.gov (United States)

    Wirtz, Andrea L; Pretorius, Carel; Beyrer, Chris; Baral, Stefan; Decker, Michele R; Sherman, Susan G; Sweat, Michael; Poteat, Tonia; Butler, Jennifer; Oelrichs, Robert; Semini, Iris; Kerrigan, Deanna

    2014-01-01

    Sex workers have endured a high burden of HIV infection in and across HIV epidemics. A comprehensive, community empowerment-based HIV prevention intervention emphasizes sex worker organization and mobilization to address HIV risk and often includes community-led peer education, condom distribution, and other activities. Meta-analysis of such interventions suggests a potential 51% reduction in inconsistent condom use. Mathematical modeling exercises provide theoretical insight into potential impacts of the intervention on HIV incidence and burden in settings where interventions have not yet been implemented. We used a deterministic model, Goals, to project the impact on HIV infections when the community empowerment interventions were scaled up among female sex workers in Kenya, Thailand, Brazil, and Ukraine. Modeling scenarios included expansion of the comprehensive community empowerment-based HIV prevention intervention from baseline coverage over a 5-year period (5-65% in Kenya and Ukraine; 10-70% in Thailand and Brazil), while other interventions were held at baseline levels. A second exercise increased the intervention coverage simultaneously with equitable access to ART for sex workers. Impacts on HIV outcomes among sex workers and adults are observed from 2012-2016 and, compared to status quo when all interventions are held constant. Optimistic but feasible coverage (65%-70%) of the intervention demonstrated a range of impacts on HIV: 220 infections averted over 5 yrs. among sex workers in Thailand, 1,830 in Brazil, 2,220 in Ukraine, and 10,800 infections in Kenya. Impacts of the intervention for female sex workers extend to the adult population, cumulatively averting 730 infections in Thailand to 20,700 adult infections in Kenya. Impacts vary by country, influenced by HIV prevalence in risk groups, risk behaviors, intervention use, and population size. A community empowerment approach to HIV prevention and access to universal ART for female sex workers is a

  4. Recent progress in immune-based interventions to prevent HIV-1 transmission to children.

    Science.gov (United States)

    Voronin, Yegor; Jani, Ilesh; Graham, Barney S; Cunningham, Coleen K; Mofenson, Lynne M; Musoke, Philippa M; Permar, Sallie R; Scarlatti, Gabriella

    2017-12-01

    Globally, 150,000 new paediatric human immunodeficiency virus type 1 (HIV-1) infections occurred in 2015. There remain complex challenges to the global elimination of paediatric HIV-1 infection. Thus, for the global community to achieve elimination of new paediatric HIV-1 infections, innovative approaches need to be explored. Immune-based approaches to prevention of mother-to-child transmission (MTCT) may help fill some of the remaining gaps and provide new opportunities to achieve an AIDS-free generation. Immune-based interventions to prevent MTCT of HIV-1 may include paediatric HIV vaccines and passive immunization approaches. Recent discoveries providing evidence of robust immune responses to HIV in infants open new and exciting prospects for paediatric HIV vaccines. Moreover, successful vaccination of infants has a different set of requirements than vaccination of adults and may be easier to achieve. Proof-of-concept has been established over the last two decades that passively administered HIV-1 Env-specific monoclonal antibody (mAbs) can prevent chimeric simian human immunodeficiency virus (SHIV) transmission to newborn nonhuman primates. There has been tremendous progress in isolating and characterizing broadly neutralizing antibodies to HIV, and clinical testing of these antibodies for treatment and prevention in both infants and adults is a major effort in the field. Immune-based interventions need to be actively explored as they can provide critically important tools to address persistent challenges in MTCT prevention. It is a pivotal time for the field with active discussions on the best strategy to further reduce HIV infection of infants and accomplish the World Health Organization Fast-Track 2030 goals to eliminate new paediatric HIV infections. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

  5. Willingness to Participate in HIV Vaccine Trials among Men Who Have Sex with Men in Chennai and Mumbai, India: A Social Ecological Approach

    Science.gov (United States)

    Chakrapani, Venkatesan; Newman, Peter A.; Singhal, Neeti; Jerajani, Jhalak; Shunmugam, Murali

    2012-01-01

    Background Recruitment of low- and middle-income country volunteers from most-at-risk populations in HIV vaccine trials is essential to vaccine development. In India, men who have sex with men (MSM) are at disproportionately high risk for HIV infection and an important population for trial recruitment. Investigations of willingness to participate (WTP) in HIV vaccine trials have focused predominantly on individual-level determinants. We explored multi-level factors associated with WTP among MSM in India. Methods We conducted 12 focus groups (n = 68) with low socioeconomic MSM in Chennai and Mumbai, and 14 key informant interviews with MSM community leaders and service providers. Focus groups/interviews were recorded, transcribed and translated into English. Two bilingual investigators conducted thematic analysis using line-by-line coding and a constant comparative method, with member-checking by community representatives. Results Factors associated with WTP were evidenced across the social ecology of MSM–social-structural: poverty, HIV-, sexual- and gender non-conformity stigma, institutionalized discrimination and government sponsorship of trials; community-level: endorsement by MSM community leaders and organizations, and fear of within-group discrimination; interpersonal: anticipated family discord, partner rejection, having financially-dependent family members and disclosure of same-sex sexuality; and individual-level: HIV vaccine trial knowledge and misconceptions, safety concerns, altruism and preventive misconception. Conclusion Pervasive familial, community and social-structural factors characteristic of the Indian sociocultural context may complicate individual-focused approaches to WTP and thereby constrain the effectiveness of interventions to support recruitment and retention in HIV vaccine trials. Interventions to reduce stigma and discrimination against MSM and people living with HIV, capacity-building of MSM community organizations and

  6. Willingness to participate in HIV vaccine trials among men who have sex with men in Chennai and Mumbai, India: a social ecological approach.

    Directory of Open Access Journals (Sweden)

    Venkatesan Chakrapani

    Full Text Available Recruitment of low- and middle-income country volunteers from most-at-risk populations in HIV vaccine trials is essential to vaccine development. In India, men who have sex with men (MSM are at disproportionately high risk for HIV infection and an important population for trial recruitment. Investigations of willingness to participate (WTP in HIV vaccine trials have focused predominantly on individual-level determinants. We explored multi-level factors associated with WTP among MSM in India.We conducted 12 focus groups (n = 68 with low socioeconomic MSM in Chennai and Mumbai, and 14 key informant interviews with MSM community leaders and service providers. Focus groups/interviews were recorded, transcribed and translated into English. Two bilingual investigators conducted thematic analysis using line-by-line coding and a constant comparative method, with member-checking by community representatives.Factors associated with WTP were evidenced across the social ecology of MSM-social-structural: poverty, HIV-, sexual- and gender non-conformity stigma, institutionalized discrimination and government sponsorship of trials; community-level: endorsement by MSM community leaders and organizations, and fear of within-group discrimination; interpersonal: anticipated family discord, partner rejection, having financially-dependent family members and disclosure of same-sex sexuality; and individual-level: HIV vaccine trial knowledge and misconceptions, safety concerns, altruism and preventive misconception.Pervasive familial, community and social-structural factors characteristic of the Indian sociocultural context may complicate individual-focused approaches to WTP and thereby constrain the effectiveness of interventions to support recruitment and retention in HIV vaccine trials. Interventions to reduce stigma and discrimination against MSM and people living with HIV, capacity-building of MSM community organizations and transparent communications tailored to

  7. Psychosocial Interventions for Women with HIV/AIDS: A Critical Review

    Science.gov (United States)

    Hernandez, Julieta P.; Macgowan, Mark J.

    2015-01-01

    Objective: Recent research on psychosocial interventions addressing the well-being of women with HIV/AIDS has brought new options for practitioners. This study critically reviews the treatment features, methodological quality, and efficacy of these interventions. Methods: A comprehensive search between 2000 and 2011 identified 19 studies employing…

  8. South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

    Science.gov (United States)

    Essack, Zaynab; Wassenaar, Douglas R

    2018-04-01

    HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

  9. Improved HIV and TB Knowledge and Competence Among Mid-level Providers in a Cluster-Randomized Trial of One-on-One Mentorship for Task Shifting.

    Science.gov (United States)

    Naikoba, Sarah; Senjovu, Kaggwa D; Mugabe, Pallen; McCarthy, Carey F; Riley, Patricia L; Kadengye, Damazo T; Dalal, Shona

    2017-08-15

    Health worker shortages pose a challenge to the scale up of HIV care and treatment in Uganda. Training mid-level providers (MLPs) in the provision of HIV and tuberculosis (TB) treatment can expand existing health workforce capacity and access to HIV services. We conducted a cluster-randomized trial of on-site clinical mentorship for HIV and TB care at 10 health facilities in rural Uganda. Twenty MLPs at 5 randomly assigned to an intervention facilities received 8 hours a week of one-on-one mentorship, every 6 weeks over a 9-month period; and another 20 at 5 control facilities received no clinical mentorship. Enrolled MLPs' clinical knowledge and competence in management of HIV and TB was assessed using case scenarios and clinical observation at baseline and immediately after the 9-month intervention. The performance of the study health facilities on 8 TB and HIV care indicators was tracked over the 9-month period using facility patient records. Thirty-nine out 40 enrolled MLPs had case scenario and clinical observation scores for both the baseline and end of intervention assessments. Mentorship was associated with a mean score increase of 16.7% (95% confidence interval: 9.8 to 23.6, P shifting.

  10. Venues for Meeting Sex Partners and Partner HIV Risk Characteristics: HIV Prevention Trials Network (HPTN064) Women's HIV Seroincidence Study (ISIS).

    Science.gov (United States)

    Roman Isler, M; Golin, C; Wang, J; Hughes, J; Justman, J; Haley, D; Kuo, I; Adimora, A; Chege, W; Hodder, S

    2016-06-01

    Identifying venues where women meet sexual partners, particular partners who increase women's risk of acquiring HIV, could inform prevention efforts. We categorized venues where women enrolled in HPTN 064 reported meeting their last three sex partners as: (1) Formal, (2) Public, (3) Private, and (4) Virtual spaces. We used multinomial logistic regression to assess the association between these venues and women's individual characteristics and reports of their partners' HIV risk characteristics. The 2099 women reported meeting 3991 partners, 51 % at Public, 30 % Private, 17 % Formal and 3 % at Virtual venues. Women meeting partners at Formal venues reported more education and condom use than women meeting partners at other venues. Fewer partners met through Formal venues had "high" risk characteristics for HIV than through other venues and hence may pose less risk of HIV transmission. HIV prevention interventions can help women choose partners with fewer risk characteristics across all venue types.

  11. IMPORTANCE OF MULTIPLE CRITERIA FOR PRIORITY SETTING OF HIV/AIDS INTERVENTIONS.

    Science.gov (United States)

    Tromp, Noor; Prawiranegara, Rozar; Siregar, Adiatma; Sunjaya, Deni; Baltussen, Rob

    2015-01-01

    This study describes the views of various stakeholders on the importance of different criteria for priority setting of HIV/AIDS interventions in Indonesia. Based on a general list of criteria and a focus group discussion with stakeholders (n = 6), a list was developed of thirty-two criteria that play a role in priority setting in HIV/AIDS control in West-Java province. Criteria were categorized according to the World Health Organization's health system goals and building block frameworks. People living with HIV/AIDS (n = 49), healthcare workers (HCW) (n = 41), the general population (n = 43), and policy makers (n = 22) rated the importance of thirty-two criteria on a 5-point Likert-scale. Thereafter, respondents ranked the highest rated criteria to express more detailed preferences. Stakeholders valued the following criteria as most important for the priority setting of HIV/AIDS interventions: an intervention's impact on the HIV/AIDS epidemic, reduction of stigma, quality of care, effectiveness on individual level, and feasibility in terms of current capacity of the health system (i.e., HCW, product, information, and service requirements), financial sustainability, and acceptance by donors. Overall, stakeholders' preferences for the importance of criteria are similar. Our study design outlines an approach for other settings to identify which criteria are important for priority setting of health interventions. For Indonesia, these study results may be used in priority setting processes for HIV/AIDS control and may contribute to more transparent and systematic allocation of resources.

  12. Systematic review of HIV prevention interventions in China: a health communication perspective.

    Science.gov (United States)

    Xiao, Zhiwen; Noar, Seth M; Zeng, Lily

    2014-02-01

    To examine whether communication strategies and principles have been utilized in the HIV prevention intervention programs conducted in China. Comprehensive literature searches were conducted using PsycINFO, Medline, and Academic Search Complete with combinations of a number of keywords. Studies were included if they (1) were conducted in China and published prior to October 2011; (2) tested interventions promoting HIV/sexual risk reduction; and (3) reported empirical outcome evaluations on HIV knowledge, condom use and other condom-related variables. Data on 11 dimensions were extracted and analyzed, including formative research, theory, message targeting, messenger and channels, process evaluation, evaluation design, outcome measures. The majority of the 45 intervention studies were not theory-based, did not report conducting formative research or process evaluation, used pretest-posttest control group designs, combined nonmedia channels, printed and visual materials, and employed HIV knowledge and condom use as outcome measures. Many HIV prevention interventions in China have been successful in reducing HIV risk-related outcomes. This literature has its weaknesses; however, the current review illuminates gaps in the literature and points to important future directions for research.

  13. Computer-enhanced interventions for drug use and HIV risk in the emergency room: preliminary results on psychological precursors of behavior change.

    Science.gov (United States)

    Bonar, Erin E; Walton, Maureen A; Cunningham, Rebecca M; Chermack, Stephen T; Bohnert, Amy S B; Barry, Kristen L; Booth, Brenda M; Blow, Frederic C

    2014-01-01

    This article describes process data from a randomized controlled trial among 781 adults recruited in the emergency department who reported recent drug use and were randomized to: intervener-delivered brief intervention (IBI) assisted by computer, computerized BI (CBI), or enhanced usual care (EUC). Analyses examined differences between baseline and post-intervention on psychological constructs theoretically related to changes in drug use and HIV risk: importance, readiness, intention, help-seeking, and confidence. Compared to EUC, participants receiving the IBI significantly increased in confidence and intentions; CBI patients increased importance, readiness, confidence, and help-seeking. Both groups increased relative to the EUC in likelihood of condom use with regular partners. Examining BI components suggested that benefits of change and tools for change were associated with changes in psychological constructs. Delivering BIs targeting drug use and HIV risk using computers appears promising for implementation in healthcare settings. This trial is ongoing and future work will report behavioral outcomes. © 2013.

  14. Identifying Key Drivers of the Impact of an HIV Cure Intervention in Sub-Saharan Africa

    DEFF Research Database (Denmark)

    Phillips, Andrew N; Cambiano, Valentina; Revill, Paul

    2016-01-01

    BACKGROUND: It is unknown what properties would be required to make an intervention in low income countries that can eradicate or control human immunodeficiency virus (HIV) without antiretroviral therapy (ART) cost-effective. METHODS: We used a model of HIV and ART to investigate the effect...... of introducing an ART-free viral suppression intervention in 2022 using Zimbabwe as an example country. We assumed that the intervention (cost: $500) would be accessible for 90% of the population, be given to those receiving effective ART, have sufficient efficacy to allow ART interruption in 95%, with a rate...... of viral rebound of 5% per year in the first 3 months, and a 50% decline in rate with each successive year. RESULTS: An ART-free viral suppression intervention with these properties would result in >0.53 million disability-adjusted-life-years averted over 2022-2042, with a reduction in HIV program costs...

  15. A randomized controlled trial to enhance coping and posttraumatic growth and decrease posttraumatic stress disorder in HIV-Infected men who have sex with men in Beijing, China.

    Science.gov (United States)

    Ye, Zhi; Yu, Nancy Xiaonan; Zhu, Wanling; Chen, Lihua; Lin, Danhua

    2018-06-01

    Although HIV-infected men who have sex with men (MSM) constitute a newly emerged high-risk group in China, little research outside Western countries is available on effective intervention programs to enhance their well-being. The purpose of this randomized controlled trial was to evaluate the efficacy of a group intervention program designed to improve the well-being and adaptive coping strategies of 60 HIV-infected MSM in Beijing, China, randomly assigned either to the intervention group for participation in four weekly sessions or to the control group for placement on a waiting list. They all completed measurements at pre- and postintervention. Compared with the control group, the intervention group reported significantly increased problem-focused coping strategies and levels of posttraumatic growth (PTG) as well as decreased symptoms of posttraumatic stress disorder (PTSD) at the completion of the intervention. In addition, mediation analysis showed that changes in problem-focused coping strategies mediated the intervention effect on increases in PTG; however, the mediating effect of coping strategies on the association of intervention and PTSD was not significant. This study provides empirical evidence for conducting psychological intervention to promote the well-being of HIV-infected MSM. The findings also elucidate the mechanism through which intervention improved PTG.

  16. High HIV, HPV, and STI Prevalence Among Young Western Cape, South African Women: EVRI HIV Prevention Preparedness Trial

    NARCIS (Netherlands)

    Giuliano, Anna R.; Botha, Matthys H.; Zeier, Michele; Abrahamsen, Martha E.; Glashoff, Richard H.; van der Laan, Louvina E.; Papenfuss, Mary; Engelbrecht, Susan; Schim van der Loeff, Maarten F.; Sudenga, Staci L.; Torres, Benji N.; Kipping, Siegfried; Taylor, Douglas

    2015-01-01

    Background:This study sought to assess the feasibility of conducting a phase III HIV prevention trial using a multivalent human papillomavirus (HPV) vaccine (Gardasil; Merck, Whitehouse Station, NJ).Methods:A total of 479 sexually active women aged 16-24 years in the Western Cape, South Africa, were

  17. Qualitative Analysis of an Educational Intervention with HIV-Discordant Heterosexual Latino Couples

    Science.gov (United States)

    Pérez-Jiménez, David; Orengo-Aguayo, Rosaura E.

    2012-01-01

    Objective This qualitative analysis elucidates the potential elements of the intervention that may be effective in terms of a) increasing knowledge about HIV/AIDS in the members of this population; b) increasing the use of male condoms and the practice of mutual masturbation; and c) changing opinions toward male condom use and mutual masturbation. Methods Five heterosexual HIV-discordant couples participated in the adapted intervention, which consisted of four three-hour-long sessions. One month after the intervention, we conducted a qualitative semi-structured interview with every participant to evaluate issues related to the process and content of the activities comprising the intervention, the impact of the intervention, logistics, and recruitment and retention as well as to make a more general evaluation. The information was submitted to qualitative content analysis. Results After the intervention, participants reported having better attitudes regarding safer sex, particularly in terms of condom use. A reason given by the participants to feel more positive toward condom use and mutual masturbation was that these practices could prevent the infection of the HIV-negative partner. Conclusion This study provides important evidence of an intervention that promises to be efficacious in preventing some high-risk sexual behaviors among Latino HIV-discordant heterosexual couples. The evidence presented seems to suggest that an intervention that includes basic relevant information about HIV/AIDS, that explains the benefits of condom use and other safer sex options, and that provides effective negotiation and communication strategies could significantly reduce HIV transmission among these couples. PMID:22263299

  18. Impact of community-based interventions on HIV knowledge, attitudes, and transmission.

    Science.gov (United States)

    Salam, Rehana A; Haroon, Sarah; Ahmed, Hashim H; Das, Jai K; Bhutta, Zulfiqar A

    2014-01-01

    In 2012, an estimated 35.3 million people lived with HIV, while approximately two million new HIV infections were reported. Community-based interventions (CBIs) for the prevention and control of HIV allow increased access and ease availability of medical care to population at risk, or already infected with, HIV. This paper evaluates the impact of CBIs on HIV knowledge, attitudes, and transmission. We included 39 studies on educational activities, counseling sessions, home visits, mentoring, women's groups, peer leadership, and street outreach activities in community settings that aimed to increase awareness on HIV/AIDS risk factors and ensure treatment adherence. Our review findings suggest that CBIs to increase HIV awareness and risk reduction are effective in improving knowledge, attitudes, and practice outcomes as evidenced by the increased knowledge scores for HIV/AIDS (SMD: 0.66, 95% CI: 0.25, 1.07), protected sexual encounters (RR: 1.19, 95% CI: 1.13, 1.25), condom use (SMD: 0.96, 95% CI: 0.03, 1.58), and decreased frequency of sexual intercourse (RR: 0.76, 95% CI: 0.61, 0.96). Analysis shows that CBIs did not have any significant impact on scores for self-efficacy and communication. We found very limited evidence on community-based management for HIV infected population and prevention of mother- to-child transmission (MTCT) for HIV-infected pregnant women. Qualitative synthesis suggests that establishment of community support at the onset of HIV prevention programs leads to community acceptance and engagement. School-based delivery of HIV prevention education and contraceptive distribution have also been advocated as potential strategies to target high-risk youth group. Future studies should focus on evaluating the effectiveness of community delivery platforms for prevention of MTCT, and various emerging models of care to improve morbidity and mortality outcomes.

  19. Salk's HIV immunogen: an immune-based therapy in human trials since 1988.

    Science.gov (United States)

    Jonas Salk, the developer of the first polio vaccine, has created a therapeutic vaccine for HIV which helps the immune system fight disease progression. Salk uses inactivated HIV-1 virus combined with Incomplete Freund's Adjuvant (IFA) in the vaccine preparation. The resulting HIV-1 immunogen was first studied in 1987, and since then, 235 seropositive individuals have received inoculations without serious adverse effects. Data from the first 25 subjects indicate that immunization with the HIV-1 immunogen results in improvement of cell-mediated response against the virus, a slower increase in the amount of virus present, and a reduced rate of clinical progression. Subsequent studies also show that higher doses of immunogen may produce stronger cell-mediated responses and high HIV-DTH (delayed-type hypersensitivity responsiveness immunogen) is associated with better outcome. Additional trials of HIV-1 immunogen are awaiting Food and Drug Administration approval.

  20. A pilot RCT of an intervention to reduce HIV condomless sex and increase self-acceptance among MSM in Chennai, India

    OpenAIRE

    Safren, Steven A.; Thomas, Beena E.; Mayer, Kenneth H.; Biello, Katie B.; Mani, Jamuna; Rajagandhi, Vijaylakshmi; Periyasamy, Murugesan; Swaminathan, Soumya; Mimiaga, Matthew J.

    2014-01-01

    This is a 2-arm pilot randomized controlled trial (N=96) of a behavioral intervention (4 group and 4 individual sessions) integrating risk reduction counseling with counseling to foster self-acceptance in MSM in India compared to Enhanced Standard of Care (ESOC). Both conditions involved HIV and STI testing and counseling at baseline and 6-months, and assessments of condomless sex at baseline, 3-, and 6-months. A significant condition by time interaction suggested a difference in the rate of ...

  1. Comparison of Self-report to Biomarkers of Recent HIV Infection: Findings from the START Trial.

    Science.gov (United States)

    Schlusser, Katherine E; Sharma, Shweta; de la Torre, Pola; Tambussi, Giuseppe; Draenert, Rika; Pinto, Angie N; Metcalf, Julia A; German, Danielle; Neaton, James D; Laeyendecker, Oliver

    2018-02-09

    Identifying individuals with recent HIV infection is critical to research related to viral reservoirs, outbreak investigations and intervention applications. A multi-assay algorithm (MAA) for recency of infection was used in conjunction with self-reported date of infection and documented date of diagnosis to estimate the number of participants recently infected in the Strategic Timing of AntiRetroviral Treatment (START) trial. We tested samples for three groups of participants from START using a MAA: (1) 167 individuals who reported being infected ≤ 6 months before randomization; (2) 771 individuals who did not know their date of infection but were diagnosed within 6 months before randomization; and (3) as controls for the MAA, 199 individuals diagnosed with HIV ≥ 2 years before randomization. Participants with low titer and avidity and a baseline viral load > 400 copies/mL were classified as recently infected. A significantly higher percentage of participants who self-reported being infected ≤ 6 months were classified as recently infected compared to participants diagnosed ≥ 2 years (65% [109/167] vs. 2.5% [5/199], p START were infected within 6 months of randomization. Compared to those not recently infected, these participants were younger, had higher HIV RNA levels and were more likely to come from high income countries and from populations such as MSM with more regular HIV testing.

  2. Exploring the potential of a family-based prevention intervention to reduce alcohol use and violence within HIV-affected families in Rwanda.

    Science.gov (United States)

    Chaudhury, Sumona; Brown, Felicity L; Kirk, Catherine M; Mukunzi, Sylvere; Nyirandagijimana, Beatha; Mukandanga, Josee; Ukundineza, Christian; Godfrey, Kalisa; Ng, Lauren C; Brennan, Robert T; Betancourt, Theresa S

    2016-03-01

    HIV-affected families report higher rates of harmful alcohol use, intimate partner violence (IPV) and family conflict, which can have detrimental effects on children. Few evidence-based interventions exist to address these complex issues in Sub-Saharan Africa. This mixed methods study explores the potential of a family-based intervention to reduce IPV, family conflict and problems related to alcohol use to promote child mental health and family functioning within HIV-affected families in post-genocide Rwanda. A family home-visiting, evidence-based intervention designed to identify and enhance resilience and communication in families to promote mental health in children was adapted and developed for use in this context for families affected by caregiver HIV in Rwanda. The intervention was adapted and developed through a series of pilot study phases prior to being tested in open and randomized controlled trials (RCTs) in Rwanda for families affected by caregiver HIV. Quantitative and qualitative data from the RCT are explored here using a mixed methods approach to integrate findings. Reductions in alcohol use and IPV among caregivers are supported by qualitative reports of improved family functioning, lower levels of violence and problem drinking as well as improved child mental health, among the intervention group. This mixed methods analysis supports the potential of family-based interventions to reduce adverse caregiver behaviors as a major mechanism for improving child well-being. Further studies to examine these mechanisms in well-powered trials are needed to extend the evidence-base on the promise of family-based intervention for use in low- and middle-income countries.

  3. Effectiveness of Psycho-Educational Intervention in HIV Patients? Treatment

    OpenAIRE

    Ribeiro, Clarisse; Sarmento e Castro, Rui; Dinis-Ribeiro, M?rio; Fernandes, Lia

    2015-01-01

    Adherence to Highly Active Antiretroviral Therapy (HAART) is the main prognostic factor associated with HIV disease progression and death. The aim was to evaluate the effectiveness of a psycho-educational program to promote adherence to HAART in HIV patients. A longitudinal study (n=102) over 9 months in an Infectious Diseases Hospital was carried out. Adherence to HAART was measured with standardized scales and values of viral load. Two groups were defined: adherents and non-adherents. In th...

  4. An HIV/AIDS intervention programme with Buddhist aid in Yunnan Province.

    Science.gov (United States)

    Wu, Feng; Zhang, Kong-lai; Shan, Guang-liang

    2010-04-20

    The prevalence of HIV/AIDS in Chinese ethnic minorities is an important component of China's AIDS issues. In this study, we launched an intervention programme in Yunnan Province of China, where the Dai people live, to carry out the community-based HIV/AIDS health education and behavioral interventions on ordinary Dai farmers. The Dai people believe in Theravada Buddhism. Four rural communities were randomly divided into two groups. In one group (Buddhist group), HIV/AIDS health education and behavioral intervention were carried out by monks. The other group (women group) was instructed by women volunteers. The intervention continued for one year and the data were collected before and after the intervention project. In the Buddhist group, the villagers' AIDS related knowledge score was boosted from 3.11 to 3.65 (P Buddhist group, the villager's attitude score towards the people living with HIV and AIDS (PLWHA) also increased significantly from 1.51 to 2.16 (P Buddhist organization has limited success in promoting the use of condoms, but plays an important role in eliminating HIV/AIDS related discrimination.

  5. Association of Implementation of a Universal Testing and Treatment Intervention With HIV Diagnosis, Receipt of Antiretroviral Therapy, and Viral Suppression in East Africa.

    Science.gov (United States)

    Petersen, Maya; Balzer, Laura; Kwarsiima, Dalsone; Sang, Norton; Chamie, Gabriel; Ayieko, James; Kabami, Jane; Owaraganise, Asiphas; Liegler, Teri; Mwangwa, Florence; Kadede, Kevin; Jain, Vivek; Plenty, Albert; Brown, Lillian; Lavoy, Geoff; Schwab, Joshua; Black, Douglas; van der Laan, Mark; Bukusi, Elizabeth A; Cohen, Craig R; Clark, Tamara D; Charlebois, Edwin; Kamya, Moses; Havlir, Diane

    2017-06-06

    Antiretroviral treatment (ART) is now recommended for all HIV-positive persons. UNAIDS has set global targets to diagnose 90% of HIV-positive individuals, treat 90% of diagnosed individuals with ART, and suppress viral replication among 90% of treated individuals, for a population-level target of 73% of all HIV-positive persons with HIV viral suppression. To describe changes in the proportions of HIV-positive individuals with HIV viral suppression, HIV-positive individuals who had received a diagnosis, diagnosed individuals treated with ART, and treated individuals with HIV viral suppression, following implementation of a community-based testing and treatment program in rural East Africa. Observational analysis based on interim data from 16 rural Kenyan (n = 6) and Ugandan (n = 10) intervention communities in the SEARCH Study, an ongoing cluster randomized trial. Community residents who were 15 years or older (N = 77 774) were followed up for 2 years (2013-2014 to 2015-2016). HIV serostatus and plasma HIV RNA level were measured annually at multidisease health campaigns followed by home-based testing for nonattendees. All HIV-positive individuals were offered ART using a streamlined delivery model designed to reduce structural barriers, improve patient-clinician relationships, and enhance patient knowledge and attitudes about HIV. Primary outcome was viral suppression (plasma HIV RNAHIV-positive individuals, assessed at baseline and after 1 and 2 years. Secondary outcomes included HIV diagnosis, ART among previously diagnosed individuals, and viral suppression among those who had initiated ART. Among 77 774 residents (male, 45.3%; age 15-24 years, 35.1%), baseline HIV prevalence was 10.3% (7108 of 69 283 residents). The proportion of HIV-positive individuals with HIV viral suppression at baseline was 44.7% (95% CI, 43.5%-45.9%; 3464 of 7745 residents) and after 2 years of intervention was 80.2% (95% CI, 79.1%-81.2%; 5666 of 7068 residents), an

  6. Social marketing interventions to increase HIV/STI testing uptake among men who have sex with men and male-to-female transgender women.

    Science.gov (United States)

    Wei, Chongyi; Herrick, Amy; Raymond, H Fisher; Anglemyer, Andrew; Gerbase, Antonio; Noar, Seth M

    2011-09-07

    Social marketing interventions have been shown to both promote and change many health-related behaviours and issues. As the HIV epidemic continues to disproportionately affect MSM and transgender women around the world, social marketing interventions have the potential to increase HIV/STI testing uptake among these populations. To assess the impact of social marketing interventions on HIV/STI testing uptake among men who have sex with men and transgender women compared to pre-intervention or control group testing uptake in the same population. We searched the following electronic databasesfor results from 01 January 1980 to the search date, 14 July 2010: Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, LILACS (Latin America and Brazil), PsycINFO, PubMed, Web of Science/Web of Social Science, Chinese National Knowledge Infrastructure (CNKI), and CQ VIP (China). We also searched for conference abstracts in the Aegis archive of HIV/AIDS conference abstracts and the CROI and International AIDS Society websites. In addition to searching electronic databases, we searched the following sources of grey literature: Australasian Digital Theses Program, Canadian Evaluation Society,  Eastview: China Conference Proceedings, ProQuest Dissertations and Theses, and World Health Organization Library Information System  (WHOLIS). We contacted individual researchers, experts working in the field, and authors of major trials for suggestions of any relevant manuscripts that were in preparation or in press. References of published articles from the databases above were searched for additional, pertinent materials. All languages were included in this search. Randomized controlled trials and controlled clinical trials that compared social marketing interventions with a control were included. Interrupted time series and pretest-posttest design studies (controlled or uncontrolled) that compared social marketing interventions with no intervention or a control were also

  7. Workplace interventions to reduce HIV and TB stigma among health care workers - Where do we go from here?

    Science.gov (United States)

    Siegel, Jacob; Yassi, Annalee; Rau, Asta; Buxton, Jane A; Wouters, Edwin; Engelbrecht, Michelle C; Uebel, Kerry E; Nophale, Letshego E

    2015-01-01

    Fear of stigma and discrimination among health care workers (HCWs) in South African hospitals is thought to be a major factor in the high rates of HIV and tuberculosis infection experienced in the health care workforce. The aim of the current study is to inform the development of a stigma reduction intervention in the context of a large multicomponent trial. We analysed relevant results of four feasibility studies conducted in the lead up to the trial. Our findings suggest that a stigma reduction campaign must address community and structural level drivers of stigma, in addition to individual level concerns, through a participatory and iterative approach. Importantly, stigma reduction must not only be embedded in the institutional management of HCWs but also be attentive to the localised needs of HCWs themselves.

  8. HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial

    OpenAIRE

    Andersson, Neil; Cockcroft, Anne; Thabane, Lehana; Marokoane, Nobantu; Laetsang, Ditiro; Masisi, Mokgweetsi

    2013-01-01

    Background Most HIV prevention strategies assume beneficiaries can act on their prevention decisions. But some people are unable to do so. They are ?choice-disabled?. Economic and educational interventions can reduce sexual violence, but there is less evidence that they can reduce HIV. There is little research on complex interventions in HIV prevention, yet all countries in southern Africa implement combination prevention programmes. Methods/Design The primary objective is to reduce HIV infec...

  9. 75 FR 54898 - Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program

    Science.gov (United States)

    2010-09-09

    ... Intervention Services Grant Under the Ryan White HIV/AIDS Program AGENCY: Health Resources and Services... Part C funds under The Ryan White HIV/AIDS Program to support comprehensive primary care services for persons living with HIV/AIDS, including primary medical care, laboratory testing, oral health care...

  10. 76 FR 30951 - Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program

    Science.gov (United States)

    2011-05-27

    ... Intervention Services Grant Under the Ryan White HIV/AIDS Program AGENCY: Health Resources and Services... White HIV/AIDS Program, Part C Funds for the Tutwiler Clinic. SUMMARY: HRSA will award non-competitively Ryan White HIV/AIDS Program, Part C funds to the Tutwiler Clinic, Tutwiler, Mississippi, to support...

  11. 75 FR 28263 - Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program

    Science.gov (United States)

    2010-05-20

    ... Intervention Services Grant Under the Ryan White HIV/AIDS Program AGENCY: Health Resources and Services... services for persons living with HIV/AIDS, including primary medical care, laboratory testing, oral health... continue providing services after March 31, 2010. HRSA's HIV/AIDS Bureau identified the Rural Health Group...

  12. Implementing a Randomized Controlled Trial through a Community-Academia Partnered Participatory Research: Arte con Salud Research-Informed Intervention.

    Science.gov (United States)

    Noboa-Ortega, Patricia; Figueroa-Cosme, Wanda I; Feldman-Soler, Alana; Miranda-Díaz, Christine

    2017-06-01

    "Arte con Salud" is an HIV/AIDS prevention intervention tailored for Puerto Rican women who have sex with men. The intervention curriculum was refined through a community-academic collaboration between Taller Salud, the UPRCayey Campus, and the UCC-School of Medicine, subsided in 2012-13 by PRCTRC. The collaboration has been crucial to validate the impact of using art as a tool to facilitate sexual negotiation skills and safer sexual practices among adult women have sex with men participating in HIV prevention education. This article describes the vision, valley, victory phases endured to establish a community-academia partnership based on the CPPR framework as an effective mean to implement a randomized controlled trial intervention (RCT). We also discuss the barriers, outcomes, and lessons learned from this partnership. Some of the identified solutions include: setting goals to secure funding, regular meetings, and the inclusion of undergraduate level students to assist in the implementation of the intervention. These solutions helped to build trust among the community and academic partners. As a result of this collaboration, a total of 86 participants were enrolled and 5 competitive research grants have been submitted. The community-academic collaboration was essential in order to build a solid research infrastructure that addresses the complexities of HIV prevention education among groups of Puerto Rican women.

  13. Evaluating social outcomes of HIV/AIDS interventions: a critical assessment of contemporary indicator frameworks.

    Science.gov (United States)

    Mannell, Jenevieve; Cornish, Flora; Russell, Jill

    2014-01-01

    Contemporary HIV-related theory and policy emphasize the importance of addressing the social drivers of HIV risk and vulnerability for a long-term response. Consequently, increasing attention is being given to social and structural interventions, and to social outcomes of HIV interventions. Appropriate indicators for social outcomes are needed in order to institutionalize the commitment to addressing social outcomes. This paper critically assesses the current state of social indicators within international HIV/AIDS monitoring and evaluation frameworks. We analyzed the indicator frameworks of six international organizations involved in efforts to improve and synchronize the monitoring and evaluation of the HIV/AIDS response. Our analysis classifies the 328 unique indicators according to what they measure and assesses the degree to which they offer comprehensive measurement across three dimensions: domains of the social context, levels of change and organizational capacity. The majority of indicators focus on individual-level (clinical and behavioural) interventions and outcomes, neglecting structural interventions, community interventions and social outcomes (e.g. stigma reduction; community capacity building; policy-maker sensitization). The main tool used to address social aspects of HIV/AIDS is the disaggregation of data by social group. This raises three main limitations. Indicator frameworks do not provide comprehensive coverage of the diverse social drivers of the epidemic, particularly neglecting criminalization, stigma, discrimination and gender norms. There is a dearth of indicators for evaluating the social impacts of HIV interventions. Indicators of organizational capacity focus on capacity to effectively deliver and manage clinical services, neglecting capacity to respond appropriately and sustainably to complex social contexts. Current indicator frameworks cannot adequately assess the social outcomes of HIV interventions. This limits knowledge about

  14. Technology-Mediated Interventions and Quality of Life for Persons Living with HIV/AIDS. A Systematic Review.

    Science.gov (United States)

    Cho, Hwayoung; Iribarren, Sarah; Schnall, Rebecca

    2017-04-12

    As HIV/AIDS is considered a chronic disease; quality of life (QoL) has become an important focus for researchers and healthcare providers. Technology-mediated interventions have demonstrated improved clinical effectiveness in outcomes, such as viral suppression, for persons living with HIV/AIDS (PLWH). However, the evidence to support the impact of these interventions on QoL is lacking. The aim of this paper was to assess the impact of technology-mediated interventions on QoL and to identify the instruments used to measure the QoL of PLWH. For this review we followed the PRISMA guidelines. A literature search was conducted in PubMed, CINAHL, Cochrane, and EMBASE databases in April 2016. Inclusion criteria limited articles to those with technology-mediated interventions as compared to usual care; articles with the population defined as HIV-infected patients; and articles with QoL measured as a health outcome in randomized controlled trials. The Cochrane Collaboration Risk of Bias Tool was used to assess study quality. Of the 1,554 peer-reviewed articles returned in the searches, 10 met the inclusion criteria. This systematic review identified four types of technology-mediated interventions and two types of QoL instruments used to examine the impact of technology-mediated interventions on PLWH. Four studies of technology-mediated interventions resulted in improvement in QoL. Four studies considered QoL as a secondary outcome and resulted in a negative or neutral impact on QoL. Overall, four studies had a low risk of bias, one study had a moderate risk of bias, and the other five studies had a high risk of bias. The evidence to support the improvement of QoL using technology-mediated interventions is insufficient. This lack of research highlights the need for increased study of QoL as an outcome measure and the need for consistent measures to better understand the role of technology-mediated interventions in improving QoL for PLWH.

  15. The 'third wave' of HIV prevention: filling gaps in integrated interventions, knowledge, and funding.

    Science.gov (United States)

    Sepúlveda, Jaime

    2012-07-01

    There is growing optimism in the global health community that the HIV epidemic can be halted. After decades of relying primarily on behavior change to prevent HIV transmission, a second generation of prevention efforts based on medical or biological interventions such as male circumcision and preexposure prophylaxis--the use of antiretroviral drugs to protect uninfected, at-risk individuals--has shown promising results. This article calls for a third generation of HIV prevention efforts that would integrate behavioral, biological, and structural interventions focused on the social, political, and environmental underpinnings of the epidemic, making use of local epidemiological evidence to target affected populations. In this third wave, global programs should deliver HIV prevention services together with cost-effective interventions for reproductive health and for tuberculosis, malaria, and other diseases. Additionally, new efforts are needed to address gaps in HIV prevention research, evaluation, and implementation. Increased and sustained funding, along with evidence-based allocation of funds, will be necessary to accelerate the decline in new HIV infections.

  16. The Mediating Role of Partner Communication Frequency on Condom Use Among African-American Adolescent Females Participating in an HIV Prevention Intervention

    Science.gov (United States)

    Sales, Jessica M.; Lang, Delia L.; DiClemente, Ralph J.; Latham, Teaniese P; Wingood, Gina M.; Hardin, James W.; Rose, Eve S.

    2011-01-01

    Objective Although effective HIV prevention interventions have been developed for adolescents, few interventions have explored whether components of the intervention are responsible for the observed changes in behaviors post-intervention. This study examined the mediating role of partner communication frequency on African-American adolescent females’ condom use post-participation in a demonstrated efficacious HIV risk-reduction intervention. Main Outcome Measures Percent condom use in the past 60 days and consistent condom use in the past 6o days across the 12-month follow-up period. Design As part of a randomized controlled trial of African-American adolescent females (N=715), 15-21 years, seeking sexual health services, completed a computerized interview at baseline (prior to intervention) and again 6- and 12-month follow-up post-intervention participation. The interview assessed adolescents’ sexual behavior and partner communication skills, among other variables, at each time point. Using generalized estimating equation (GEE) techniques, both logistic and linear regression models were employed to test mediation over the 12-month follow-up period. Additional tests were conducted to assess the significance of the mediated models. Results Mediation analyses observed that partner communication frequency was a significant partial mediator of both proportion condom-protected sex acts (p =.001) and consistent condom use (p = .001). Conclusion Partner communication frequency, an integral component of this HIV intervention, significantly increased as a function of participating in the intervention partially explaining the change in condom use observed 12-months post-intervention. Understanding what intervention components are associated with behavior change is important for future intervention development. PMID:21843001

  17. Challenges in detecting HIV persistence during potentially curative interventions: a study of the Berlin patient.

    Directory of Open Access Journals (Sweden)

    Steven A Yukl

    Full Text Available There is intense interest in developing curative interventions for HIV. How such a cure will be quantified and defined is not known. We applied a series of measurements of HIV persistence to the study of an HIV-infected adult who has exhibited evidence of cure after allogeneic hematopoietic stem cell transplant from a homozygous CCR5Δ32 donor. Samples from blood, spinal fluid, lymph node, and gut were analyzed in multiple laboratories using different approaches. No HIV DNA or RNA was detected in peripheral blood mononuclear cells (PBMC, spinal fluid, lymph node, or terminal ileum, and no replication-competent virus could be cultured from PBMCs. However, HIV RNA was detected in plasma (2 laboratories and HIV DNA was detected in the rectum (1 laboratory at levels considerably lower than those expected in ART-suppressed patients. It was not possible to obtain sequence data from plasma or gut, while an X4 sequence from PBMC did not match the pre-transplant sequence. HIV antibody levels were readily detectable but declined over time; T cell responses were largely absent. The occasional, low-level PCR signals raise the possibility that some HIV nucleic acid might persist, although they could also be false positives. Since HIV levels in well-treated individuals are near the limits of detection of current assays, more sensitive assays need to be developed and validated. The absence of recrudescent HIV replication and waning HIV-specific immune responses five years after withdrawal of treatment provide proof of a clinical cure.

  18. Integration of family planning services into HIV care and treatment in Kenya: a cluster-randomized trial.

    Science.gov (United States)

    Grossman, Daniel; Onono, Maricianah; Newmann, Sara J; Blat, Cinthia; Bukusi, Elizabeth A; Shade, Starley B; Steinfeld, Rachel L; Cohen, Craig R

    2013-10-01

    To determine whether integrating family planning services into HIV care is associated with increased use of more effective contraceptive methods (sterilization, intrauterine device, implant, injectable or oral contraceptives). Cluster-randomized trial. Eighteen public HIV clinics in Nyanza Province, Kenya. Women aged 18-45 years receiving care at participating HIV clinics; 5682 clinical encounters from baseline period (December 2009-February 2010) and 12,531 encounters from end-line period (July 2011-September 2011, 1 year after site training). Twelve sites were randomized to integrate family planning services into the HIV clinic, whereas six clinics were controls where clients desiring contraception were referred to family planning clinics at the same facility. Increase in use of more effective contraceptive methods between baseline and end-line periods. Pregnancy rates during the follow-up year (October 2010-September 2011) were also compared. Women seen at integrated sites were significantly more likely to use more effective contraceptive methods at the end of the study [increased from 16.7 to 36.6% at integrated sites, compared to increase from 21.1 to 29.8% at controls; odds ratio (OR) 1.81, 95% confidence interval (CI) 1.24-2.63]. Condom use decreased non-significantly at intervention sites compared to controls (OR 0.64, 95% CI 0.35-1.19). No difference was observed in incident pregnancy in the first year after integration comparing intervention to control sites (incidence rate ratio 0.90; 95% CI 0.68-1.20). Integration of family planning services into HIV care clinics increased use of more effective contraceptive methods with a non-significant reduction in condom use. Although no significant reduction in pregnancy incidence was observed during the study, 1 year may be too short a period of observation for this outcome.

  19. A reanalysis of a behavioral intervention to prevent incident HIV infections: Including indirect effects in modeling outcomes of Project EXPLORE

    Science.gov (United States)

    Eaton, Lisa A.; Kalichman, Seth C.; Kenny, David A.; Harel, Ofer

    2013-01-01

    Background Project EXPLORE -- a large-scale, behavioral intervention tested among men who have sex with men (MSM) at-risk for HIV infection --was generally deemed as ineffective in reducing HIV incidence. Using novel and more precise data analytic techniques we reanalyzed Project EXPLORE by including both direct and indirect paths of intervention effects. Methods Data from 4,296 HIV negative MSM who participated in Project EXPLORE, which included ten sessions of behavioral risk reduction counseling completed from 1999-2005, were included in the analysis. We reanalyzed the data to include parameters that estimate the overtime effects of the intervention on unprotected anal sex and the over-time effects of the intervention on HIV status mediated by unprotected anal sex simultaneously in a single model. Results We found the indirect effect of intervention on HIV infection through unprotected anal sex to be statistically significant up through 12 months post-intervention, OR=.83, 95% CI=.72-.95. Furthermore, the intervention significantly reduced unprotected anal sex up through 18 months post-intervention, OR=.79, 95% CI=.63-.99. Discussion Our results reveal effects not tested in the original model that offer new insight into the effectiveness of a behavioral intervention for reducing HIV incidence. Project EXPLORE demonstrated that when tested against an evidence-based, effective control condition can result in reductions in rates of HIV acquisition at one year follow-up. Findings highlight the critical role of addressing behavioral risk reduction counseling in HIV prevention. PMID:23245226

  20. Leveraging strong social ties among young men in Dar es Salaam: A pilot intervention of microfinance and peer leadership for HIV and gender-based violence prevention.

    Science.gov (United States)

    Maman, Suzanne; Kajula, Lusajo; Balvanz, Peter; Kilonzo, Mrema; Mulawa, Marta; Yamanis, Thespina

    2016-12-01

    Gender inequality is at the core of the HIV patterns that are evident in sub-Saharan Africa. Gender-based violence (GBV) and lack of economic opportunity are important structural determinants of HIV risk. We piloted a microfinance and health promotion intervention among social networks of primarily young men in Dar es Salaam. Twenty-two individuals participated in the microfinance component and 30 peer leaders were recruited and trained in the peer health leadership component. We collected and analysed observational data from trainings, monitoring data on loan repayment, and reports of peer conversations to assess the feasibility and acceptability of the intervention. Eighteen of the loan recipients (82%) paid back their loans, and of these 15 (83%) received a second, larger loan. Among the loan defaulters, one died, one had chronic health problems, and two disappeared, one of whom was imprisoned for theft. The majority of conversations reported by peer health leaders focused on condoms, sexual partner selection, and HIV testing. Few peer leaders reported conversations about GBV. We demonstrated the feasibility and acceptability of this innovative HIV and GBV prevention intervention. The lessons learned from this pilot have informed the implementation of a cluster-randomised trial of the microfinance and peer health leadership intervention.

  1. Developing a Culturally Appropriate HIV and Hepatitis C Prevention Intervention for Latino Criminal Justice Clients.

    Science.gov (United States)

    Ibañez, Gladys E; Whitt, Elaine; Rosa, Mario de la; Martin, Steve; O'Connell, Daniel; Castro, Jose

    2016-07-01

    The population within the criminal justice system suffers from various health disparities including HIV and hepatitis C virus (HCV). African American and Latino offenders represent the majority of the offender population. Evidence-based interventions to prevent HIV and HCV among criminal justice clients are scant and usually do not take cultural differences into account. Toward this end, this study describes the process of culturally adapting an HIV/HCV prevention intervention for Latino criminal justice clients in Miami, Florida, by using the ecological validity model. Recommendations for culturally adapting an intervention for Latinos include an emphasis on language and integrating cultural themes such as familism and machismo. © The Author(s) 2016.

  2. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

    Directory of Open Access Journals (Sweden)

    Huisjes Anjoke JM

    2007-07-01

    Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN

  3. Are Cultural Values and Beliefs Included in U.S. Based HIV Interventions?

    Science.gov (United States)

    Wyatt, Gail E.; Williams, John K.; Gupta, Arpana; Malebranche, Dominique

    2013-01-01

    Objective To determine the extent to which current U.S. based HIV/AIDS prevention and risk reduction interventions address and include aspects of cultural beliefs in definitions, curricula, measures and related theories that may contradict current safer sex messages. Method A comprehensive literature review was conducted to determine which published HIV/AIDS prevention and risk reduction interventions incorporated aspects of cultural beliefs. Results This review of 166 HIV prevention and risk reduction interventions, published between 1988 and 2010, identified 34 interventions that varied in cultural definitions and the integration of cultural concepts. Conclusion HIV interventions need to move beyond targeting specific populations based upon race/ethnicity, gender, sexual, drug and/or risk behaviors and incorporate cultural beliefs and experiences pertinent to an individual’s risk. Theory based interventions that incorporate cultural beliefs within a contextual framework are needed if prevention and risk reduction messages are to reach targeted at risk populations. Implications for the lack of uniformity of cultural definitions, measures and related theories are discussed and recommendations are made to ensure that cultural beliefs are acknowledged for their potential conflict with safer sex skills and practices. PMID:21884721

  4. Are cultural values and beliefs included in U.S. based HIV interventions?

    Science.gov (United States)

    Wyatt, Gail E; Williams, John K; Gupta, Arpana; Malebranche, Dominique

    2012-11-01

    To determine the extent to which current United States based human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) prevention and risk reduction interventions address and include aspects of cultural beliefs in definitions, curricula, measures and related theories that may contradict current safer sex messages. A comprehensive literature review was conducted to determine which published human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) prevention and risk reduction interventions incorporated aspects of cultural beliefs. This review of 166 human immunodeficiency virus (HIV) prevention and risk reduction interventions, published between 1988 and 2010, identified 34 interventions that varied in cultural definitions and the integration of cultural concepts. human immunodeficiency virus (HIV) interventions need to move beyond targeting specific populations based upon race/ethnicity, gender, sexual, drug and/or risk behaviors and incorporate cultural beliefs and experiences pertinent to an individual's risk. Theory based interventions that incorporate cultural beliefs within a contextual framework are needed if prevention and risk reduction messages are to reach targeted at risk populations. Implications for the lack of uniformity of cultural definitions, measures and related theories are discussed and recommendations are made to ensure that cultural beliefs are acknowledged for their potential conflict with safer sex skills and practices. Copyright © 2011. Published by Elsevier Inc.

  5. Power and the association with relationship quality in South African couples: Implications for HIV/AIDS interventions.

    Science.gov (United States)

    Conroy, Amy A; McGrath, Nuala; van Rooyen, Heidi; Hosegood, Victoria; Johnson, Mallory O; Fritz, Katherine; Marr, Alexander; Ngubane, Thulani; Darbes, Lynae A

    2016-03-01

    Power imbalances within sexual relationships have significant implications for HIV prevention in sub-Saharan Africa. Little is known about how power influences the quality of a relationship, which could be an important pathway leading to healthy behavior around HIV/AIDS. This paper uses data from 448 heterosexual couples (896 individuals) in rural KwaZulu-Natal, South Africa who completed baseline surveys from 2012 to 2014 as part of a couples-based HIV intervention trial. Using an actor-partner interdependence perspective, we assessed: (1) how both partners' perceptions of power influences their own (i.e., actor effect) and their partner's reports of relationship quality (i.e., partner effect); and (2) whether these associations differed by gender. We examined three constructs related to power (female power, male equitable gender norms, and shared power) and four domains of relationship quality (intimacy, trust, mutually constructive communication, and conflict). For actor effects, shared power was strongly and consistently associated with higher relationship quality across all four domains. The effect of shared power on trust, mutually constructive communication, and conflict were stronger for men than women. The findings for female power and male equitable gender norms were more mixed. Female power was positively associated with women's reports of trust and mutually constructive communication, but negatively associated with intimacy. Male equitable gender norms were positively associated with men's reports of mutually constructive communication. For partner effects, male equitable gender norms were positively associated with women's reports of intimacy and negatively associated with women's reports of conflict. Research and health interventions aiming to improving HIV-related behaviors should consider sources of shared power within couples and potential leverage points for empowerment at the couple level. Efforts solely focused on empowering women should also

  6. Power and the Association with Relationship Quality in South African Couples: Implications for HIV/AIDS Interventions

    Science.gov (United States)

    Conroy, Amy A.; McGrath, Nuala; van Rooyen, Heidi; Hosegood, Victoria; Johnson, Mallory O.; Fritz, Katherine; Marr, Alexander; Ngubane, Thulani; Darbes, Lynae A.

    2016-01-01

    Introduction Power imbalances within sexual relationships have significant implications for HIV prevention in sub-Saharan Africa. Little is known about how power influences the quality of a relationship, which could be an important pathway leading to healthy behavior around HIV/AIDS. Methods This paper uses data from 448 heterosexual couples (896 individuals) in rural KwaZulu-Natal, South Africa who completed baseline surveys from 2012–2014 as part of a couples-based HIV intervention trial. Using an actor-partner interdependence perspective, we assessed: (1) how both partners’ perceptions of power influences their own (i.e., actor effect) and their partner’s reports of relationship quality (i.e., partner effect); and (2) whether these associations differed by gender. We examined three constructs related to power (female power, male equitable gender norms, and shared power) and four domains of relationship quality (intimacy, trust, mutually constructive communication, and conflict). Results For actor effects, shared power was strongly and consistently associated with higher relationship quality across all four domains. The effect of shared power on trust, mutually constructive communication, and conflict were stronger for men than women. The findings for female power and male equitable gender norms were more mixed. Female power was positively associated with women’s reports of trust and mutually constructive communication, but negatively associated with intimacy. Male equitable gender norms were positively associated with men’s reports of mutually constructive communication. For partner effects, male equitable gender norms were positively associated with women’s reports of intimacy and negatively associated with women’s reports of conflict. Conclusions Research and health interventions aiming to improving HIV-related behaviors should consider sources of shared power within couples and potential leverage points for empowerment at the couple level

  7. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: A small randomized controlled trial

    Science.gov (United States)

    Creswell, J. David; Myers, Hector F.; Cole, Steven W.; Irwin, Michael R.

    2009-01-01

    Mindfulness meditation training has stress reduction benefits in various patient populations, but its effects on biological markers of HIV-1 progression are unknown. The present study tested the efficacy of an 8-week Mindfulness-based stress reduction (MBSR) meditation program compared to a 1-day control seminar on CD4+ T lymphocyte counts in stressed HIV infected adults. A single-blind randomized controlled trial was conducted with enrollment and follow-up occurring between November 2005 and December 2007. A diverse community sample of 48 HIV-1 infected adults was randomized and entered treatment in either an 8-week MBSR or a 1-day control stress reduction education seminar. The primary outcome was circulating counts of CD4+ T lymphocytes. Participants in the 1-day control seminar showed declines in CD4+ T lymphocyte counts whereas counts among participants in the 8-week MBSR program were unchanged from baseline to post-intervention (time × treatment condition interaction, p = .02). This effect was independent of antiretroviral (ARV) medication use. Additional analyses indicated that treatment adherence to the mindfulness meditation program, as measured by class attendance, mediated the effects of mindfulness meditation training on buffering CD4+ T lymphocyte declines. These findings provide an initial indication that mindfulness meditation training can buffer CD4+ T lymphocyte declines in HIV-1 infected adults. PMID:18678242

  8. An Integrated Intervention for Increasing Clinical Nurses’ Knowledge of HIV/AIDS-Related Occupational Safety

    Directory of Open Access Journals (Sweden)

    Liping He

    2016-11-01

    Full Text Available Background: Approximately 35 new HIV (Human Immunodeficiency Virus, HIV cases and at least 1000 serious infections are transmitted annually to health care workers. In China, HIV prevalence is increasing and nursing personnel are encountering these individuals more than in the past. Contaminated needle-stick injuries represent a significant occupational burden for nurses. Evidence suggests that nurses in China may not fully understand HIV/AIDS (Acquired immunodeficiency syndrome, AIDS and HIV-related occupational safety. At this time, universal protection precautions are not strictly implemented in Chinese hospitals. Lack of training may place nurses at risk for occupational exposure to blood-borne pathogens. Objectives: To assess the effectiveness of integrated interventions on nurses’ knowledge improvement about reducing the risk of occupationally acquired HIV infection. Methods: We audited integrated interventions using 300 questionnaires collected from nurses at the Affiliated Hospital of Xiangnan University, a public polyclinic in Hunan Province. The intervention studied was multifaceted and included appropriate and targeted training content for hospital, department and individual levels. After three months of occupational safety integrated interventions, 234 participants who completed the program were assessed. Results: Of the subjects studied, 94.3% (283/300 were injured one or more times by medical sharp instruments or splashed by body fluids in the last year and 95.3% considered their risk of occupational exposure high or very high. After the intervention, awareness of HIV/AIDS-related knowledge improved significantly (χ2 = 86.34, p = 0.00, and correct answers increased from 67.9% to 82.34%. Correct answers regarding risk perception were significantly different between pre-test (54.4% and post-test (66.6% (χ2 = 73.2, p = 0.00. When coming into contact with patient body fluids and blood only 24.0% of subjects used gloves regularly

  9. Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

    Directory of Open Access Journals (Sweden)

    Paul P Christopher

    Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

  10. Web and Mobile Based HIV Prevention and Intervention Programs Pros and Cons - A Review.

    Science.gov (United States)

    Niakan, Sharareh; Mehraeen, Esmaeil; Noori, Tayebeh; Gozali, Elahe

    2017-01-01

    With the increasing growth of HIV positive people the use of information and communication technologies (ICT) can play an important role in controlling the spread of the AIDS. Web and Mobile are the new technologies that young people take advantage from them. In this study a review to investigate the web and mobile based HIV prevention and intervention programs was carried out. A scoping review was conducted including PubMed, Science direct, Web of Science and Proquest to find relevant sources that published in 2009 to 2016. To identify published, original research that reported the web and mobile-based HIV prevention and intervention programs, an organized search was conducted with the following search keywords in combination: HIV, AIDS, m-Health, Mobile phone, Cell phone, Smartphone, Mobile health, internet, and web. Using the employed strategies, 173 references retrieved. Searched articles were compared based on their titles and abstracts. To identify duplicated articles, the title and abstracts were considered and 101 duplicated references were excluded. By going through the full text of related papers, 35 articles were found to be more related to the questions of this paper from which 72 final included. The advantages of web and mobile-based interventions include the possibility to provide constancy in the delivery of an intervention, impending low cost, and the ability to spread the intervention to an extensive community. Online programs such as Chat room-based Education program, Web-based therapeutic education system, and Online seek information can use for HIV/AIDS prevention. To use of mobile for HIV/AIDS prevention and intervention, programs including in: Health system focused applications, Population health focused applications, and Health messaging can be used.

  11. Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

    Science.gov (United States)

    Malmivaara, Antti

    2016-09-01

    Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

  12. Copenhagen comorbidity in HIV infection (COCOMO study: a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark

    Directory of Open Access Journals (Sweden)

    Andreas Ronit

    2016-11-01

    Full Text Available Abstract Background Modern combination antiretroviral therapy (cART has improved survival for people living with HIV (PLWHIV. Non-AIDS comorbidities have replaced opportunistic infections as leading causes of mortality and morbidity, and are becoming a key health concern as this population continues to age. The aim of this study is to estimate the prevalence and incidence of non-AIDS comorbidity among PLWHIV in Denmark in the cART era and to determine risk factors contributing to the pathogenesis. The study primarily targets cardiovascular, respiratory, and hepatic non-AIDS comorbidity. Methods/design The Copenhagen comorbidity in HIV-infection (COCOMO study is an observational, longitudinal cohort study. The study was initiated in 2015 and recruitment is ongoing with the aim of including 1500 PLWHIV from the Copenhagen area. Follow-up examinations after 2 and 10 years are planned. Uninfected controls are derived from the Copenhagen General Population Study (CGPS, a cohort study including 100,000 uninfected participants from the same geographical region. Physiological and biological measures including blood pressure, ankle-brachial index, electrocardiogram, spirometry, exhaled nitric oxide, transient elastography of the liver, computed tomography (CT angiography of the heart, unenhanced CT of the chest and upper abdomen, and a number of routine biochemical analysis are uniformly collected in participants from the COCOMO study and the CGPS. Plasma, serum, buffy coat, peripheral blood mononuclear cells (PBMC, urine, and stool samples are collected in a biobank for future studies. Data will be updated through periodical linking to national databases. Discussion As life expectancy for PLWHIV improves, it is essential to study long-term impact of HIV and cART. We anticipate that findings from this cohort study will increase knowledge on non-AIDS comorbidity in PLWHIV and identify targets for future interventional trials. Recognizing the demographic

  13. Adaptive Intervention Design in Mobile Health: Intervention Design and Development in the Cell Phone Intervention for You (CITY) Trial

    Science.gov (United States)

    Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

    2015-01-01

    Background/Aims The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this manuscript is to describe the design and development of the intervention tested in the Cell Phone Intervention for You (CITY) study and to highlight the importance of adaptive intervention design (AID) that made it possible. The CITY study was an NHLBI-sponsored, controlled 24-month randomized clinical trial (RCT) comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (BMI ≥ 25 kg/m2) young adults. Methods Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, AID, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The AID strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. AID was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. Results The cellphone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive – providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over two years to

  14. Effects Of HIV stigma reduction interventions in diasporic communities: insights from the CHAMP study.

    Science.gov (United States)

    Li, Alan Tai-Wai; Fung, Kenneth Po-Lun; Maticka-Tyndale, Eleanor; Wong, Josephine Pui-Hing

    2018-06-01

    Racialized diasporic communities in Canada experience disproportionate burden of HIV infection. Their increased vulnerabilities are associated with interlocking challenges, including barriers in accessing resources, migration and settlement stress, and systemic exclusion. Further, people living with HIV (PLHIV) in these diasporic communities face stigma and discrimination in both mainstream Canadian society as well as their own ethno-racial communities. HIV stigma negatively impacts all aspects of HIV care, from testing to disclosure to treatment and ongoing care. In response to these challenges, a Toronto based community organization developed and implemented the CHAMP project to engage people living with HIV/AIDS (PLHIV) and leaders from different service sectors from the African/Caribbean, Asian and Latino communities to explore challenges and strategies to reduce HIV stigma and build community resilience. The study engaged 66 PLHIV and ethno-racial leaders from faith, media and social justice sectors in two stigma-reduction training programs: Acceptance Commitment Therapy Training (ACT) and Social Justice Capacity Building (SJCB). Data collection included pre-and post- intervention surveys, focus groups and monthly activity logs. Participants were followed for a year and data on changes in the participants' attitudes and behaviors as well as their actual engagement in HIV prevention, PLHIV support and stigma reduction activities were collected. CHAMP results showed that the interventions were effective in reducing HIV stigma and increasing participants' readiness to take action towards positive social change. Participants' activity logs over a period of 9 months after completing the training showed they had engaged in 1090 championship activities to advocate for HIV related health equity and social justice issues affecting racialized and newcomer PLHIV and communities.

  15. Dropout from physical activity interventions in people living with HIV: a systematic review and meta-analysis.

    Science.gov (United States)

    Vancampfort, D; Mugisha, J; Richards, J; De Hert, M; Lazzarotto, A R; Schuch, F B; Probst, M; Stubbs, B

    2017-05-01

    Physical activity (PA) interventions have been shown to improve the health of people living with HIV (PLWH), yet treatment dropout poses an important challenge. We conducted a meta-analysis to investigate the prevalence and predictors of treatment dropout in PA interventions in PLWH. Electronic databases were searched for records up to September 2016. Randomized control trials of PA interventions in PLWH reporting dropout rates were included. Random effects meta-analysis and meta-regression analyses were employed. In 36 studies involving 49 PA intervention arms, 1128 PLWH were included (mean age = 41.6 years; 79.3% male; 39% White). The trim and fill adjusted treatment dropout rate was 29.3% (95% CI = 24.5-34.7%). There was a significant lower dropout rate in resistance training interventions compared with aerobic (p = 0.003) PA interventions, in studies utilizing supervised interventions throughout the study period (p dropout rates were a lower percentage of male participants (β = 1.15, standard error (SE) = 0.49, z = 2.0, p = 0.048), a lower body mass index(BMI) (β = 0.14, SE = 0.06, z = 2.16, p = 0.03), and a lower cardiorespiratory fitness (β = 0.10, SE = 0.04, z = 2.7, p = 0.006). The dropout from PA interventions is much higher in PLWH than in many other populations with chronic morbidities. Qualified professionals (i.e., exercise physiologists, physical educators, or physical therapists) should be incorporated as key care providers in the multidisciplinary care of HIV/AIDS and should prescribe supervised PA for PLWH in order to enhance adherence and reduce the burden of HIV/AIDS. Special attention should be given men, those with a higher BMI, and those with a lower cardiorespiratory fitness.

  16. Training needs assessment of service providers: targeted intervention for HIV/AIDS in Jharkhand, India.

    Science.gov (United States)

    Kumar, Anant; Kumar, Prakash

    2013-01-01

    Training needs assessments are pivotal for any capacity building program. Building capacity of service providers and staff involved in HIV/AIDS intervention programs is crucial because of the distinct nature of such programs. It requires specific knowledge, skills, and attitudes that are of utmost importance, influencing the reach of the program and its impact in halting and reversing the epidemic. This study was conducted to identify the training needs assessment of personnel involved in targeted intervention for high risk populations vulnerable to HIV infection in Jharkhand, India. Through the study the authors critically examine the existing training needs and gaps and suggest strategies to address them.

  17. Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

    1999-01-01

    intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

  18. Continuous quality improvement intervention for adolescent and young adult HIV testing services in Kenya improves HIV knowledge.

    Science.gov (United States)

    Wagner, Anjuli D; Mugo, Cyrus; Bluemer-Miroite, Shay; Mutiti, Peter M; Wamalwa, Dalton C; Bukusi, David; Neary, Jillian; Njuguna, Irene N; O'Malley, Gabrielle; John-Stewart, Grace C; Slyker, Jennifer A; Kohler, Pamela K

    2017-07-01

    To determine whether continuous quality improvement (CQI) improves quality of HIV testing services for adolescents and young adults (AYA). CQI was introduced at two HIV testing settings: Youth Centre and Voluntary Counseling and Testing (VCT) Center, at a national referral hospital in Nairobi, Kenya. Primary outcomes were AYA satisfaction with HIV testing services, intent to return, and accurate HIV prevention and transmission knowledge. Healthcare worker (HCW) satisfaction assessed staff morale. T tests and interrupted time series analysis using Prais-Winsten regression and generalized estimating equations accounting for temporal trends and autocorrelation were conducted. There were 172 AYA (Youth Centre = 109, VCT = 63) during 6 baseline weeks and 702 (Youth Centre = 454, VCT = 248) during 24 intervention weeks. CQI was associated with an immediate increase in the proportion of AYA with accurate knowledge of HIV transmission at Youth Centre: 18 vs. 63% [adjusted risk difference (aRD) 0.42,95% confidence interval (CI) 0.21 to 0.63], and a trend at VCT: 38 vs. 72% (aRD 0.30, 95% CI -0.04 to 0.63). CQI was associated with an increase in the proportion of AYA with accurate HIV prevention knowledge in VCT: 46 vs. 61% (aRD 0.39, 95% CI 0.02-0.76), but not Youth Centre (P = 0.759). In VCT, CQI showed a trend towards increased intent to retest (4.0 vs. 4.3; aRD 0.78, 95% CI -0.11 to 1.67), but not at Youth Centre (P = 0.19). CQI was not associated with changes in AYA satisfaction, which was high during baseline and intervention at both clinics (P = 0.384, P = 0.755). HCW satisfaction remained high during intervention and baseline (P = 0.746). CQI improved AYA knowledge and did not negatively impact HCW satisfaction. Quality improvement interventions may be useful to improve adolescent-friendly service delivery.

  19. What do You Need to Get Male Partners of Pregnant Women Tested for HIV in Resource Limited Settings? The Baby Shower Cluster Randomized Trial.

    Science.gov (United States)

    Ezeanolue, Echezona E; Obiefune, Michael C; Yang, Wei; Ezeanolue, Chinenye O; Pharr, Jennifer; Osuji, Alice; Ogidi, Amaka G; Hunt, Aaron T; Patel, Dina; Ogedegbe, Gbenga; Ehiri, John E

    2017-02-01

    Male partner involvement has the potential to increase uptake of interventions to prevent mother-to-child transmission of HIV (PMTCT). Finding cultural appropriate strategies to promote male partner involvement in PMTCT programs remains an abiding public health challenge. We assessed whether a congregation-based intervention, the Healthy Beginning Initiative (HBI), would lead to increased uptake of HIV testing among male partners of pregnant women during pregnancy. A cluster-randomized controlled trial of forty churches in Southeastern Nigeria randomly assigned to either the HBI (intervention group; IG) or standard of care referral to a health facility (control group; CG) was conducted. Participants in the IG received education and were offered onsite HIV testing. Overall, 2498 male partners enrolled and participated, a participation rate of 88.9%. Results showed that male partners in the IG were 12 times more likely to have had an HIV test compared to male partners of pregnant women in the CG (CG = 37.71% vs. IG = 84.00%; adjusted odds ratio = 11.9; p HIV testing and counseling among male partners of pregnant women.

  20. Determining a cost effective intervention response to HIV/AIDS in Peru

    Science.gov (United States)

    Aldridge, Robert W; Iglesias, David; Cáceres, Carlos F; Miranda, J Jaime

    2009-01-01

    Background The HIV epidemic in Peru is still regarded as concentrated - sentinel surveillance data shows greatest rates of infection in men who have sex with men, while much lower rates are found in female sex workers and still lower in the general population. Without an appropriate set of preventive interventions, continuing infections could present a challenge to the sustainability of the present programme of universal access to treatment. Determining how specific prevention and care strategies would impact on the health of Peruvians should be key in reshaping the national response. Methods HIV/AIDS prevalence levels for risk groups with sufficient sentinel survey data were estimated. Unit costs were calculated for a series of interventions against HIV/AIDS which were subsequently inputted into a model to assess their ability to reduce infection transmission rates. Interventions included: mass media, voluntary counselling and testing; peer counselling for female sex workers; peer counselling for men who have sex with men; peer education of youth in-school; condom provision; STI treatment; prevention of mother to child transmission; and highly active antiretroviral therapy. Impact was assessed by the ability to reduce rates of transmission and quantified in terms of cost per DALY averted. Results Results of the analysis show that in Peru, the highest levels of HIV prevalence are found in men who have sex with men. Cost effectiveness varied greatly between interventions ranging from peer education of female commercial sex workers at $US 55 up to $US 5,928 (per DALY averted) for prevention of mother to child transmission. Conclusion The results of this work add evidence-based clarity as to which interventions warrant greatest consideration when planning an intervention response to HIV in Peru. Cost effectiveness analysis provides a necessary element of transparency when facing choices about priority setting, particularly when the country plans to amplify its

  1. Determining a cost effective intervention response to HIV/AIDS in Peru

    Directory of Open Access Journals (Sweden)

    Cáceres Carlos F

    2009-09-01

    Full Text Available Abstract Background The HIV epidemic in Peru is still regarded as concentrated - sentinel surveillance data shows greatest rates of infection in men who have sex with men, while much lower rates are found in female sex workers and still lower in the general population. Without an appropriate set of preventive interventions, continuing infections could present a challenge to the sustainability of the present programme of universal access to treatment. Determining how specific prevention and care strategies would impact on the health of Peruvians should be key in reshaping the national response. Methods HIV/AIDS prevalence levels for risk groups with sufficient sentinel survey data were estimated. Unit costs were calculated for a series of interventions against HIV/AIDS which were subsequently inputted into a model to assess their ability to reduce infection transmission rates. Interventions included: mass media, voluntary counselling and testing; peer counselling for female sex workers; peer counselling for men who have sex with men; peer education of youth in-school; condom provision; STI treatment; prevention of mother to child transmission; and highly active antiretroviral therapy. Impact was assessed by the ability to reduce rates of transmission and quantified in terms of cost per DALY averted. Results Results of the analysis show that in Peru, the highest levels of HIV prevalence are found in men who have sex with men. Cost effectiveness varied greatly between interventions ranging from peer education of female commercial sex workers at $US 55 up to $US 5,928 (per DALY averted for prevention of mother to child transmission. Conclusion The results of this work add evidence-based clarity as to which interventions warrant greatest consideration when planning an intervention response to HIV in Peru. Cost effectiveness analysis provides a necessary element of transparency when facing choices about priority setting, particularly when the country

  2. Achievement of interventions on HIV infection prevention among ...

    African Journals Online (AJOL)

    2018-03-22

    Mar 22, 2018 ... were more likely to work in small factories and engaged in man- ..... The reason for this discrepancy is that eastern cities are more liberal, AIDS .... For the developed eastern region, convenient network ... medium-sized cities. .... the integration of HIV and sexual and reproductive health services for young.

  3. A workplace intervention program and the increase in HIV ...

    African Journals Online (AJOL)

    SAHARA-J: Journal of Social Aspects of HIV/AIDS. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 14, No 1 (2017) >. Log in or Register to get access to full text downloads.

  4. Factors related to sexual practices and successful sexually transmitted infection/HIV intervention programs for Latino adolescents.

    Science.gov (United States)

    Lee, Young-Me; Dancy, Barbara; Florez, Elizabeth; Holm, Karyn

    2013-01-01

    The purpose of this integrative literature review was to explore factors that are related to sexual practices among Latino adolescents and identify which of those factors are common across successful sexually transmitted infection (STI)/HIV intervention programs for Latino adolescents. An integrative literature review was conducted. Search terms included Latino, Hispanic, education, intervention/prevention programs, sex, sexuality, reproductive health, health risk behaviors, multiple sex partners, contraception, STI/HIV/AIDS, sexually transmitted diseases, delay in initiation of sexual intercourse, consistent use of birth control, avoidance of STI/HIV infections, unintended pregnancy, cultural factors, and gender roles. Findings revealed from the review of 17 articles addressing factors related to sexual practices among Latino adolescents included familialism, religion, gender roles, level of knowledge/information, and privacy/confidentiality. Five successful STI/HIV intervention programs, that incorporated those factors to effectively reduce risky sexual behaviors were identified. STI/HIV knowledge and gender roles were recognized as common factors integrated into and across successful intervention programs for this population. Only STI/HIV knowledge and gender roles were found as common factors across the five successful STI/HIV intervention programs and should be incorporated into future intervention programs that are culturally and gender specific. Therefore, health care providers need to understand culturally related gender roles and their impact on sexual practices to provide culturally sensitive and appropriate sex education about STIs and HIV for Latino adolescents to increase the program potential for reducing STI/HIV. © 2013 Wiley Periodicals, Inc.

  5. HIV/AIDS Prevention Trials Capacity Building Grants

    International Development Research Centre (IDRC) Digital Library (Canada)

    The Canadian HIV Vaccine Initiative (CHVI), Canada's contribution to the Global HIV. Vaccine Enterprise, is a five-year collaborative initiative between the Government of Canada and the Bill & Melinda Gates Foundation, and represents a significant. Canadian contribution to global efforts to develop a safe, effective, ...

  6. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. The role of technical assistance in the replication of effective HIV interventions.

    Science.gov (United States)

    O'Donnell, L; Scattergood, P; Adler, M; Doval, A S; Barker, M; Kelly, J A; Kegeles, S M; Rebchook, G M; Adams, J; Terry, M A; Neumann, M S

    2000-01-01

    This article examines the role of technical assistance (TA) in supporting the replication of proven HIV interventions. A case study of the replication of the VOICES/VOCES intervention elucidates the level and types of TA provided to support new users through the adoption process. TA included help in garnering administrative support, identifying target audiences, recruiting groups for sessions, maintaining fidelity to the intervention's core elements, tailoring the intervention to meet clients' needs, strengthening staff members' facilitation skills, troubleshooting challenges, and devising strategies to sustain the intervention. Two to four hours per month of TA were provided to each agency adopting the intervention, at an estimated monthly cost of $206 to $412. Findings illustrate how TA supports replication by establishing a conversation between the researcher TA providers experienced with the intervention and new users. This communication helps preserve key program elements and contributes to ongoing refinement of the intervention.

  8. Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa: Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Collins C Iwuji

    2016-08-01

    Full Text Available The 2015 WHO recommendation of antiretroviral therapy (ART for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population. We investigated this approach in a cluster-randomised trial in a high HIV prevalence setting in rural KwaZulu-Natal. We present findings from the first phase of the trial and report on uptake of home-based HIV testing, linkage to care, uptake of ART, and community attitudes about ART.Between 9 March 2012 and 22 May 2014, five clusters in the intervention arm (immediate ART offered to all HIV-positive adults and five clusters in the control arm (ART offered according to national guidelines, i.e., CD4 count ≤ 350 cells/μl contributed to the first phase of the trial. Households were visited every 6 mo. Following informed consent and administration of a study questionnaire, each resident adult (≥16 y was asked for a finger-prick blood sample, which was used to estimate HIV prevalence, and offered a rapid HIV test using a serial HIV testing algorithm. All HIV-positive adults were referred to the trial clinic in their cluster. Those not linked to care 3 mo after identification were contacted by a linkage-to-care team. Study procedures were not blinded. In all, 12,894 adults were registered as eligible for participation (5,790 in intervention arm; 7,104 in control arm, of whom 9,927 (77.0% were contacted at least once during household visits. HIV status was ever ascertained for a total of 8,233/9,927 (82.9%, including 2,569 ascertained as HIV-positive (942 tested HIV-positive and 1,627 reported a known HIV-positive status. Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial, 559 (47.5% visited their cluster trial clinic within 6 mo. In the intervention arm, 89% (194/218 initiated ART within 3 mo of their first clinic visit. In the control arm, 42.3% (83/196 had a CD4 count ≤ 350 cells/μl at first

  9. "Wan Kanyakla" (We are together): Community transformations in Kenya following a social network intervention for HIV care.

    Science.gov (United States)

    Salmen, Charles R; Hickey, Matthew D; Fiorella, Kathryn J; Omollo, Dan; Ouma, Gor; Zoughbie, Daniel; Salmen, Marcus R; Magerenge, Richard; Tessler, Robert; Campbell, Harold; Geng, Elvin; Gandhi, Monica; Bukusi, Elizabeth A; Cohen, Craig R

    2015-12-01

    In sub-Saharan Africa, failure to initiate and sustain HIV treatment contributes to significant health, psychosocial, and economic impacts that burden not only infected individuals but diverse members of their social networks. Yet, due to intense stigma, the responsibility for managing lifelong HIV treatment rests solely, and often secretly, with infected individuals. We introduce the concept of "HIV risk induction" to suggest that social networks of infected individuals share a vested interest in improving long-term engagement with HIV care, and may represent an underutilized resource for improving HIV/AIDS outcomes within high prevalence populations. In 2012, we implemented a 'microclinic' intervention to promote social network engagement in HIV/AIDS care and treatment. A microclinic is a therapy management collective comprised of a small group of neighbors, relatives, and friends who are trained as a team to provide psychosocial and adherence support for HIV-infected members. Our study population included 369 patients on ART and members of their social networks on Mfangano Island, Kenya, where HIV prevalence approaches 30%. Here we report qualitative data from 18 focus group discussions conducted with microclinic participants (n = 82), community health workers (n = 40), and local program staff (n = 39). Participants reported widespread acceptability and enthusiasm for the microclinic intervention. Responses highlight four overlapping community transformations regarding HIV care and treatment, namely (1) enhanced HIV treatment literacy (2) reduction in HIV stigma, (3) improved atmosphere for HIV status disclosure and (4) improved material and psychosocial support for HIV-infected patients. Despite challenges, participants describe an emerging sense of "collective responsibility" for treatment among HIV-infected and HIV-uninfected members of social networks. The lived experiences and community transformations highlighted by participants enrolled in this social

  10. Abriendo Puertas: Feasibility and Effectiveness a Multi-Level Intervention to Improve HIV Outcomes Among Female Sex Workers Living with HIV in the Dominican Republic.

    Science.gov (United States)

    Kerrigan, Deanna; Barrington, Clare; Donastorg, Yeycy; Perez, Martha; Galai, Noya

    2016-09-01

    Female sex workers (FSW) are disproportionately affected by HIV. Yet, few interventions address the needs of FSW living with HIV. We developed a multi-level intervention, Abriendo Puertas (Opening Doors), and assessed its feasibility and effectiveness among a cohort of 250 FSW living with HIV in the Dominican Republic. We conducted socio-behavioral surveys and sexually transmitted infection and viral load testing at baseline and 10-month follow-up. We assessed changes in protected sex and adherence to antiretroviral therapy (ART) with logistic regression using generalized estimating equations. Significant pre-post intervention changes were documented for adherence (72-89 %; p sex (71-81 %; p sex (AOR 1.76; 95 % CI 1.09-2.84). Illicit drug use was negatively associated with both ART adherence and protected sex. Abriendo Puertas is feasible and effective in improving behavioral HIV outcomes in FSW living with HIV.

  11. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials.

    Science.gov (United States)

    Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E; Kabwigu, Samuel; Scheckter, Rachel; Piper, Jeanna; Watts, Heather; O'Rourke, Colin; Torjesen, Kristine; Brown, Elizabeth R; Hillier, Sharon L; Beigi, Richard

    2018-02-01

    Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. To date, participants from two phase I studies and two effectiveness trials have participated in MTN-016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.

  12. Integrating eHealth in HIV/AIDS intervention programmes in South Africa

    Directory of Open Access Journals (Sweden)

    Babasile D. Osunyomi

    2015-03-01

    Objective: The key aim of this article is to explore the status quo of the implementation of information and communication technologies (ICTs in selected intervention programmes in the South African HIV/AIDS care delivery value chain. The contribution of this article is the mapping of key intervention activities along an HIV care value chain and to suggest a roadmap towards the integration of ICTs in service delivery programmes. Method: 20 managers of HIV/AIDS intervention programmes were surveyed, followed by semi-structured in-depth interviews with these respondents. A further five in-depth interviews were conducted with experts in the ICT area for exploring the uses of and barriers to integrating ICTs in the HIV/AIDS care delivery value chain. Results: The researchers mapped the barriers to implementation and ICT tools utilised within the HIV/AIDS care delivery value chain, which proves to be a useful tool to explore the status quo of technology in such service delivery programmes. The researchers then considered the wider policy environment and provided a roadmap based on the analysis and the South Africa eHealth strategy for driving development in this sector. Conclusion: The authors found that South Africa’s eHealth environment is still nascent and that the South African eHealth strategy does not place enough emphasis on systems integration and stakeholder engagement or the planning and process of uptake of ICTs by target audiences.

  13. HIV-related knowledge and perceptions by academic major: Implications for university interventions

    Directory of Open Access Journals (Sweden)

    Matthew Lee Smith

    2014-03-01

    Full Text Available Most universities offer human sexuality courses, although they are not required for graduation. While students in health-related majors may receive sexuality education in formal settings, majority of college students never receive formal sexual health or HIV/AIDS-related education, which may lead to elevated engagement in high-risk sexual behaviors. This study examines perceived knowledge about HIV/AIDS, perceived risk, and perceived consequences among college students by two distinct classifications of academic majors. Data were collected from 510 college students. Binary and multinomial logistic regressions were performed to compare HIV-related covariates by academic major category. Limited differences were observed by Science, Technology, Engineering, and Mathematics (STEM categorization. Relative to health and kinesiology (HK majors, those who self-reported being completely knowledgeable about HIV were less likely to be physical sciences, math, engineering, business (PMEB [OR=0.41, P=0.047] or education, humanities, and social sciences (EHS majors [OR=0.25, P=0.004]. PMEB majors were less likely to report behavioral factors as a risk for contracting HIV [OR=0.86, P=0.004] and perceived acquiring HIV would be more detrimental to their quality of life [OR=2.14, P=0.012], but less detrimental to their mental wellbeing [OR=0.58, P=0.042]. Findings can inform college-wide campaigns and interventions to raise HIV/AIDS awareness and improve college health.

  14. The intersection of gender and ethnicity in HIV risk, interventions, and prevention: new frontiers for psychology.

    Science.gov (United States)

    Wyatt, Gail E; Gómez, Cynthia A; Hamilton, Alison B; Valencia-Garcia, Dellanira; Gant, Larry M; Graham, Charles E

    2013-01-01

    This article articulates a contextualized understanding of gender and ethnicity as interacting social determinants of HIV risk and acquisition, with special focus on African Americans and Hispanics/Latinos--2 ethnic groups currently at most risk for HIV/AIDS acquisition in the United States. First, sex and gender are defined. Second, a conceptual model of gender, ethnicity, and HIV risk and resilience is presented. Third, a historical backdrop of gender and ethnic disparities is provided, with attention to key moments in history when notions of the intersections between gender, ethnicity, and HIV have taken important shifts. Finally, new frontiers in psychology are presented, with recommendations as to how psychology as a discipline can better incorporate considerations of gender and ethnicity as not only HIV risk factors but also as potential avenues of resilience in ethnic families and communities. Throughout the article, we promulgate the notion of a syndemic intersectional approach, which provides a critical framework for understanding and building the conditions that create and sustain overall community health by locating gendered lived experiences and expectations within the layered conceptual model ranging from the biological self to broader societal structures that define and constrain personal decisions, behaviors, actions, resources, and consequences. For ethnic individuals and populations, health disparities, stress and depression, substance abuse, and violence and trauma are of considerable concern, especially with regard to HIV risk, infection, and treatment. The conceptual model poses new frontiers for psychology in HIV policy, research, interventions, and training.

  15. Testing the efficacy of an HIV stigma reduction intervention with medical students in Puerto Rico: the SPACES project.

    Science.gov (United States)

    Varas-Díaz, Nelson; Neilands, Torsten B; Cintrón-Bou, Francheska; Marzán-Rodríguez, Melissa; Santos-Figueroa, Axel; Santiago-Negrón, Salvador; Marques, Domingo; Rodríguez-Madera, Sheilla

    2013-11-13

    Stigma associated with HIV has been documented as a barrier for accessing quality health-related services. When the stigma manifests in the health care setting, people living with HIV receive substandard services or even be denied care altogether. Although the consequences of HIV stigma have been documented extensively, efforts to reduce these negative attitudes have been scarce. Interventions to reduce HIV stigma should be implemented as part of the formal training of future health care professionals. The interventions that have been tested with health care professionals and published have several limitations that must be surpassed (i.e. lack of comparison groups in research designs and longitudinal follow-up data). Furthermore, Latino health care professionals have been absent from these intervention efforts even though the epidemic has affected this population disproportionately. In this article, we describe an intervention developed to reduce HIV stigma among medical students in Puerto Rico. A total of 507 medical students were randomly introduced into our intervention and control conditions. The results show statistically significant differences between the intervention and control groups; intervention group participants had lower HIV stigma levels than control participants after the intervention. In addition, differences in HIV stigma levels between the groups were sustained for a 12-month period. The results of our study demonstrate the efficacy of the modes of intervention developed by us and serve as a new training tool for future health care professionals with regard to stigma reduction.

  16. Participation in two phase II prophylactic HIV vaccine trials in the UK.

    Science.gov (United States)

    Gray, Kimberly; Legg, K; Sharp, A; Mackie, N; Olarinde, F; De Souza, C; Weber, J; Peters, B

    2008-06-02

    There will be a continued imperative to recruit large numbers of healthy volunteers to early phase prophylactic HIV vaccine (PHV) trials. We studied mechanisms associated with participation in two related phase II PHV trials. The most cited reasons for volunteering were altruism and a personal connection to HIV. The most successful recruiting strategies targeted organisations dealing with HIV, health or social issues, or were directed to large audiences through the mass media. However, circulated emails and word of mouth were the most resource-effective approaches. Group discussions and the collection of a pool of potential volunteers were much less effective than one-to-one discussions and immediate screening after recruitment. We utilised our findings to devise key recommendations to assist PHV trial teams who are planning future studies.

  17. Community-led trials: Intervention co-design in a cluster randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil

    2017-05-30

    In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

  18. Community-led trials: Intervention co-design in a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

  19. HIV risk inside U.S. prisons: a systematic review of risk reduction interventions conducted in U.S. prisons.

    Science.gov (United States)

    Valera, Pamela; Chang, Yvonne; Lian, Zi

    2017-08-01

    HIV prevalence in correctional populations is approximately five times that of the general adult population. This systematic review examines the broad question of HIV prevention and interventions to reduce inmate HIV-related risk behaviors in U.S. federal and state prisons. We conducted a systematic review of multiple databases and Google Scholar to identify behavioral, biomedical, social, and policy studies related to HIV among U.S. prison populations from 1980-2014. Studies were excluded if they did not focus on HIV, prison inmates, if they were conducted outside of the U.S., if they involved juvenile offenders, or if they included post-release outcomes. Twenty-seven articles met the study criteria. Evidence suggests that research related to the HIV care continuum, risk behaviors, gender, prevention (e.g., peer education), and policy are key topics to enhance HIV prevention interventions in the criminal justice system. This review provides a prison-specific overview of HIV in U.S. correctional populations and highlight effective interventions, including inmate peer education. There is an urgent need to continue to implement HIV prevention interventions across all prisons and improve the quality of life among those at heightened risk of HIV infection.

  20. Developing FAITHH: Methods to Develop a Faith-Based HIV Stigma-Reduction Intervention in the Rural South.

    Science.gov (United States)

    Bradley, Erin L P; Sutton, Madeline Y; Cooks, Eric; Washington-Ball, Brittney; Gaul, Zaneta; Gaskins, Susan; Payne-Foster, Pamela

    2018-01-01

    Human immunodeficiency virus (HIV) disproportionately affects Blacks/African Americans, particularly those residing in the southern United States. HIV-related stigma adversely affects strategies to successfully engage people in HIV education, prevention, and care. Interventions targeting stigma reduction are vital as additional tools to move toward improved outcomes with HIV prevention and care, consistent with national goals. Faith institutions in the South have been understudied as partners in HIV stigma-reduction efforts, and some at-risk, Black/African American communities are involved with southern faith institutions. We describe the collaborative effort with rural, southern faith leaders from various denominations to develop and pilot test Project Faith-based Anti-stigma Initiative Towards Healing HIV/AIDS (FAITHH), an HIV stigma-reduction intervention that built on strategies previously used with other nonrural, Black/African American faith communities. The eight-module intervention included educational materials, myth-busting exercises to increase accurate HIV knowledge, role-playing, activities to confront stigma, and opportunities to develop and practice delivering a sermon about HIV that included scripture-based content and guidance. Engaging faith leaders facilitated the successful tailoring of the intervention, and congregation members were willing participants in the research process in support of increased HIV awareness, prevention, and care.

  1. Woman to Woman (W2W): Adapting an HIV risk reduction intervention for older women.

    Science.gov (United States)

    Conner, Laneshia R; Engstrom, Malitta; Junious, Eric; Edwards-Knight, Kevin

    2017-05-03

    Woman to Woman (W2W) is a novel adaptation of the Sisters Informing Sisters about Topics on AIDS (SISTA) HIV prevention program. This article describes the process of adapting and piloting W2W based on recommendations from existing HIV prevention research. Six older women, all of whom had histories of homelessness and the majority of whom identified as African American, enrolled in the study, which piloted the adapted intervention and materials, evaluated the acceptability of the program, and assessed the measures related to the intervention. Participants described satisfaction with the program and had high rates of attendance; observations regarding the measures suggest the need to further develop assessments of HIV knowledge, condom use self-efficacy, and risk behaviors in this context.

  2. Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    van Vuuren Cloete

    2008-04-01

    Full Text Available Abstract Background A major barrier to accessing free government-provided antiretroviral treatment (ART in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. Methods/design This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a 7400 registering with the programme with CD4 counts of ≤ 350 cells/mL (mainly to evaluate treatment initiation and b 4900 already receiving ART (to evaluate ongoing treatment and monitoring. The primary outcomes will be time to death (in the first group and viral suppression (in the second group. Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register. Trial registration Controlled Clinical Trials ISRCTN46836853

  3. Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bryan R. Garner

    2017-11-01

    Full Text Available Abstract Background In 2010, the first comprehensive National HIV/AIDS Strategy for the United States was released and included three goals: (1 reducing the number of people who become infected with HIV, (2 increasing access to care and improving health outcomes for people living with HIV, and (3 reducing HIV-related health disparities and health inequities. In 2013, as part of its effort to help address the National HIV/AIDS Strategy, the National Institute on Drug Abuse (NIDA funded a type 2 effectiveness-implementation hybrid trial titled the Substance Abuse Treatment to HIV Care (SAT2HIV Project. Aim 1 of the SAT2HIV Project tests the effectiveness of a motivational interviewing-based brief intervention (MIBI for substance use as an adjunct to usual care within AIDS Service Organizations (ASOs as part of its MIBI Experiment. Aim 2 of the SAT2HIV Project tests the effectiveness of implementation and sustainment facilitation (ISF as an adjunct to the Addiction Technology Transfer Center (ATTC model for training staff in motivational interviewing as part of its ISF Experiment. The current paper describes the study protocol for the ISF Experiment. Methods As part of a multisite randomized controlled trial, individuals with comorbid HIV/AIDS and problematic substance use are randomized to receive either the ASOs’ usual care (control condition or usual care plus a MIBI for substance use (experimental condition delivered by trained ASO case-management staff. Primary outcome measures are reductions in days of primary substance use, number of substance-related problems, times engaging in risky behaviors, days of non-adherence to HIV medications, and increases in substance use treatment. As part of this paper, we describe the trial protocol in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines. Discussion If successfully able to implement MIBI as an effective adjunct to usual care, the current trial may

  4. Opening communication channels with people living with HIV using mobile phone text messaging: insights from the CAMPS trial.

    Science.gov (United States)

    Mbuagbaw, Lawrence; Thabane, Lehana; Ongolo-Zogo, Pierre

    2013-04-04

    Using two-way mobile phone text messages to improve adherence to antiretroviral medication enhances communication between patients and health workers. We describe the implications of participants' responses to text messages in the Cameroon Mobile Phone SMS (CAMPS) trial. This is a cross-sectional analysis of data from the intervention arm of the CAMPS trial. CAMPS was a randomized controlled trial of motivational text messaging versus usual care to improve adherence to antiretroviral medication among people living with HIV in Yaounde, Cameroon (n = 200) over a 6 month period. Participants in the intervention arm (n = 101) were given a contact phone number, but were not required to respond to their reminder messages. If they did, their responses were noted and reported as counts and percentages. We received 99 phone calls and 55 text messages (154 responses) from 48 participants during the study period. The median number of responses was 1 (first quartile [Q1]: 1; third quartile [Q3]: 3). Half (n = 79, 51.1%) of them were expressions of gratitude. The rest included requests for logistical (n = 21, 13.6%), medical (n = 20, 12.9%) and financial (n = 11, 7.1%) support. Initiating two-way mobile communication opens more channels for people living with HIV to express unmet needs. Researchers, policy makers and clinicians should be ready to respond to the needs expressed by patients who respond to text messages. Pan-African Clinical Trials Registry: PACTR201011000261458;

  5. HIV prevention interventions for young male commercial sex workers.

    Science.gov (United States)

    Ballester-Arnal, R; Gil-Llario, M D; Salmeron-Sánchez, P; Giménez-García, C

    2014-03-01

    The sex industry, where men sell sexual services to other men or women, has grown in recent years. These men who offer sexual services are particularly vulnerable to HIV infection due to such factors as: frequency of risky sexual practices, number of sex partners, drug-taking, prevalence of sexually-transmitted infections (STI) and their specific situation of social exclusion which may hinder access to health services. These multi-faceted realities faced by sex workers explain the burgeoning interest in new avenues of scientific research. There are too few preventive programs however aimed at this population group and the studies that evaluate their effectiveness are fewer still. In this article we survey more recent studies on the difficulties of implementing programs for HIV prevention in male sex workers (MSW), as well as the studies that have gauged the impact of preventive programs in this group.

  6. Reorienting the HIV response in Niger toward sex work interventions: from better evidence to targeted and expanded practice.

    Science.gov (United States)

    Fraser, Nicole; Kerr, Cliff C; Harouna, Zakou; Alhousseini, Zeinabou; Cheikh, Nejma; Gray, Richard; Shattock, Andrew; Wilson, David P; Haacker, Markus; Shubber, Zara; Masaki, Emiko; Karamoko, Djibrilla; Görgens, Marelize

    2015-03-01

    Niger's low-burden, sex-work-driven HIV epidemic is situated in a context of high economic and demographic growth. Resource availability of HIV/AIDS has been decreasing recently. In 2007-2012, only 1% of HIV expenditure was for sex work interventions, but an estimated 37% of HIV incidence was directly linked to sex work in 2012. The Government of Niger requested assistance to determine an efficient allocation of its HIV resources and to strengthen HIV programming for sex workers. Optima, an integrated epidemiologic and optimization tool, was applied using local HIV epidemic, demographic, programmatic, expenditure, and cost data. A mathematical optimization algorithm was used to determine the best resource allocation for minimizing HIV incidence and disability-adjusted life years (DALYs) over 10 years. Efficient allocation of the available HIV resources, to minimize incidence and DALYs, would increase expenditure for sex work interventions from 1% to 4%-5%, almost double expenditure for antiretroviral treatment and for the prevention of mother-to-child transmission, and reduce expenditure for HIV programs focusing on the general population. Such an investment could prevent an additional 12% of new infections despite a budget of less than half of the 2012 reference year. Most averted infections would arise from increased funding for sex work interventions. This allocative efficiency analysis makes the case for increased investment in sex work interventions to minimize future HIV incidence and DALYs. Optimal HIV resource allocation combined with improved program implementation could have even greater HIV impact. Technical assistance is being provided to make the money invested in sex work programs work better and help Niger to achieve a cost-effective and sustainable HIV response.

  7. Determination of the underlying cause of death in three multicenter international HIV clinical trials

    DEFF Research Database (Denmark)

    Lifson, Alan R; Lundgren, Jens; Belloso, Waldo H

    2008-01-01

    PURPOSE: Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials. METHOD: Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36...... information or supporting documentation to determine cause of death. Half (51%) of deaths reviewed by the ERC required follow-up adjudication; consensus was eventually always reached. CONCLUSION: ERCs can successfully provide blinded, independent, and systematic determinations of underlying cause of death...

  8. Examining diffusion to understand the how of SASA!, a violence against women and HIV prevention intervention in Uganda.

    Science.gov (United States)

    Starmann, Elizabeth; Heise, Lori; Kyegombe, Nambusi; Devries, Karen; Abramsky, Tanya; Michau, Lori; Musuya, Tina; Watts, Charlotte; Collumbien, Martine

    2018-05-11

    A growing number of complex public health interventions combine mass media with community-based "change agents" and/or mobilisation efforts acting at multiple levels. While impact evaluations are important, there is a paucity of research into the more nuanced roles intervention and social network factors may play in achieving intervention outcomes, making it difficult to understand how different aspects of the intervention worked (or did not). This study applied aspects of diffusion of innovations theory to explore how SASA!, a community mobilisation approach for preventing HIV and violence against women, diffused within intervention communities and the factors that influenced the uptake of new ideas and behaviours around intimate partner relationships and violence. This paper is based on a qualitative study of couples living in SASA communities and secondary analysis of endline quantitative data collected as part of a cluster randomised control trial designed to evaluate the impact of the SASA! The primary trial was conducted in eight communities in Kampala, Uganda between 2007 and 2012. The secondary analysis of follow up survey data used multivariate logistic regression to examine associations between intervention exposure and interpersonal communication, and relationship change (n = 928). The qualitative study used in-depth interviews (n = 20) and framework analysis methods to explore the intervention attributes that facilitated engagement with the intervention and uptake of new ideas and behaviours in intimate relationships. We found communication materials and mid media channels generated awareness and knowledge, while the concurrent influence from interpersonal communication with community-based change agents and social network members more frequently facilitated changes in behaviour. The results indicate combining community mobilisation components, programme content that reflects peoples' lives and direct support through local change agents can

  9. ‘It’s not about money, it’s about my health’: determinants of participation and adherence among women in an HIV-HSV2 prevention trial in Johannesburg, South Africa

    Directory of Open Access Journals (Sweden)

    MacPhail C

    2012-08-01

    Full Text Available Catherine MacPhail,1 Sinead Delany-Moretlwe,1 Philippe Mayaud21Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa; 2Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UKAbstract: High levels of adherence in clinical trials are essential for producing accurate intervention efficacy estimates. Adherence to clinical trial products and procedures is dependent on the motivations that drive participants. Data are presented to document reasons for trial participation and adherence to daily aciclovir for HSV-2 and HIV-1 genital shedding suppression among 300 HIV-1/HSV-2 seropositive women in South Africa. In-depth interviews after exit from the trial with 31 randomly selected women stratified by age and time since HIV diagnosis confirmed high levels of adherence measured during the trial. Main reasons for trial participation were related to seeking high-quality health care, which explains high levels of adherence in both study arms. Concerns that women would abuse reimbursements, fabricate data, and share or dump pills were not corroborated. Altruism is not a primary motivator in these settings where access to quality services is an issue. This study provides further evidence that good adherence of daily medication is possible in developing countries, particularly where study activities resonate with participants or fill an unmet need.Keywords: adherence, trial, HIV prevention, South Africa

  10. SOMOS: Evaluation of an HIV Prevention Intervention for Latino Gay Men

    Science.gov (United States)

    Vega, Miriam Y.; Spieldenner, Andrew R.; DeLeon, Dennis; Nieto, Bolivar X.; Stroman, Carolyn A.

    2011-01-01

    Latino gay men face multiple barriers to human immunodeficiency virus (HIV) prevention, in particular a lack of intervention programs that integrate prevention messages with cultural norms and address issues of social marginalization from multiple communities (gay community and Latino community), homophobia and racism. In order to address these…

  11. Quasi-Experimental Evaluation of a National Primary School HIV Intervention in Kenya

    Science.gov (United States)

    Maticka-Tyndale, Eleanor; Wildish, Janet; Gichuru, Mary

    2007-01-01

    This study examined the impact of a primary-school HIV education initiative on the knowledge, self-efficacy and sexual and condom use activities of upper primary-school pupils in Kenya. A quasi-experimental mixed qualitative-quantitative pre- and 18-month post-design using 40 intervention and 40 matched control schools demonstrated significant…

  12. Mediation Analysis of an Adolescent HIV/STI/Pregnancy Prevention Intervention

    Science.gov (United States)

    Glassman, Jill R.; Franks, Heather M.; Baumler, Elizabeth R.; Coyle, Karin K.

    2014-01-01

    Most interventions designed to prevent HIV/STI/pregnancy risk behaviours in young people have multiple components based on psychosocial theories (e.g. social cognitive theory) dictating sets of mediating variables to influence to achieve desired changes in behaviours. Mediation analysis is a method for investigating the extent to which a variable…

  13. An HIV-Prevention Intervention for Sex Workers in Tijuana, Mexico: A Pilot Study

    Science.gov (United States)

    Patterson, Thomas L.; Semple, Shirley J.; Fraga, Miguel; Bucardo, Jesus; Davila-Fraga, Wendy; Strathdee, Steffanie A.

    2005-01-01

    Female sex workers (FSW) are at high risk of acquiring sexually transmitted infections (STIs), including HIV, and putting their clients and other partners at risk for infection. There is considerable evidence that Social Cognitive Theory (SCT)?based interventions are effective in reducing high-risk sexual behavior among at-risk populations in the…

  14. Effectiveness of Psycho-Educational Intervention in HIV Patients' Treatment.

    Science.gov (United States)

    Ribeiro, Clarisse; Sarmento E Castro, Rui; Dinis-Ribeiro, Mário; Fernandes, Lia

    2014-01-01

    Adherence to Highly Active Antiretroviral Therapy (HAART) is the main prognostic factor associated with HIV disease progression and death. The aim was to evaluate the effectiveness of a psycho-educational program to promote adherence to HAART in HIV patients. A longitudinal study (n = 102) over 9 months in an Infectious Diseases Hospital was carried out. Adherence to HAART was measured with standardized scales and values of viral load. Two groups were defined: adherents and non-adherents. In the latter, a psycho-educational program was implemented and 6 months later measured adherence to HAART. Knowledge about the infection, CD4 T lymphocytes and HIV-ribonucleic acid values were measured before and after this program. The sample was predominantly male (70%), heterosexual (78%), with a mean age of 49 (SD = 12.7) years, and 48% of participants were not adhering to HAART. After the program, non-adherence decreased to 21.6%. Knowledge about the infection increased from 79 to 97%. A significant increase in CD4 T lymphocytes (mean 540-580) and a decrease in viral load (mean 5411-3052) were observed, the latter of statistical significance. This program seems to be feasible and efficient, improving adherence to HAART.

  15. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

    Directory of Open Access Journals (Sweden)

    Craig R Cohen

    Full Text Available To determine if integration of family planning (FP and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices and decreased pregnancy rates.Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration sites and oversaw integrated services at the original intervention (early integration sites.Eighteen health facilities in Kenya.Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2."One-stop shop" approach to integrating FP and HIV services.Use of more effective contraceptive methods and incident pregnancy across two years of follow-up.Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR = 1.39 (1.19-1.63. Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%. Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87.Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model.ClinicalTrials.gov NCT01001507.

  16. Effective interventions to improve young adults' linkage to HIV care in Sub-Saharan Africa: a systematic review.

    Science.gov (United States)

    Mavegam, Bertille Octavie; Pharr, Jennifer R; Cruz, Patricia; Ezeanolue, Echezona E

    2017-10-01

    HIV/AIDS remains a major public health problem despite the efforts to prevent and decrease its spread. Sub-Saharan Africa (SSA) represents 70% of the global number of people living with HIV and 73% of all HIV/AIDS-related deaths. Young adults age 15-24 years are disproportionately impacted by HIV/AIDS in SSA with 34% of people living with HIV (PLWHIV) and 37% of newly diagnosed individuals being in this age group. It is important that PLWHIV be linked to care to facilitate antiretroviral therapy (ART) initiation and limit the spread of infection. We conducted a systematic literature review to identify effective interventions designed to improve linkage to care among HIV-infected young adults in SSA. One hundred and forty-six titles and abstracts were screened, 28 full-texts were reviewed, and 6 articles met the inclusion and exclusion criteria. Home-based HIV counseling and testing, home-based HIV self-testing, and mobile HIV counseling and testing followed by proper referral of HIV-positive patients to HIV care were effective for improving linkage of young adults to care. Other factors such as referral forms, transportation allowance, home initiation of HIV care, and volunteer escort to the HIV treatment clinic were effective in reducing time to linkage to care. There is a vast need for research and interventions that target HIV-positive young adults in SSA which aim to improve their linkage and access to HIV care. The results of this study illustrate effective interventions in improving linkage to care and reducing time to linkage to care of young adults in SSA.

  17. A pragmatic cluster randomised trial evaluating three implementation interventions

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    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  18. HIV-positive and HIV-negative consumers accept an instant soy ...

    African Journals Online (AJOL)

    HIV-positive and HIV-negative consumers accept an instant soy maize porridge. ... Health SA Gesondheid ... The objective of this study was to assess consumer acceptability, preference and consumption intent of an instant soy ... as a food supplement for HIV subjects in a subsequent nutrition intervention trial, to improve

  19. Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

    Science.gov (United States)

    Morrison, Susan; John-Stewart, Grace; Egessa, John J; Mubezi, Sezi; Kusemererwa, Sylvia; Bii, Dennis K; Bulya, Nulu; Mugume, Francis; Campbell, James D; Wangisi, Jonathan; Bukusi, Elizabeth A; Celum, Connie; Baeten, Jared M

    2015-01-01

    During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.

  20. Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

    Directory of Open Access Journals (Sweden)

    Susan Morrison

    Full Text Available During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART, despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.

  1. A psycho-educational HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: results from a non-randomized cohort pilot study.

    Directory of Open Access Journals (Sweden)

    Carmen H Logie

    impacts of HIV prevention strategies in disaster contexts. Study results may inform HIV prevention interventions among internally displaced women in Haiti and can be tested for applicability with internally displaced women globally. ClinicalTrials.gov: Identifier NCT01492829, URL: http://clinicaltrials.gov/ct2/show/NCT01492829?term=logie&rank=1.

  2. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial.

    Science.gov (United States)

    Leblanc, Judith; Rousseau, Alexandra; Hejblum, Gilles; Durand-Zaleski, Isabelle; de Truchis, Pierre; Lert, France; Costagliola, Dominique; Simon, Tabassome; Crémieux, Anne-Claude

    2016-02-01

    In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. Despite these recommendations, non-targeted screening has not been implemented and only physician-directed diagnostic testing is currently performed. A survey conducted in 2010 in 29 French Emergency Departments (EDs) showed that non-targeted nurse-driven screening was feasible though only a few new HIV diagnoses were identified, predominantly among high-risk groups. A strategy targeting high-risk groups combined with current practice could be shown to be feasible, more efficient and cost-effective than current practice alone. DICI-VIH (acronym for nurse-driven targeted HIV screening) is a multicentre, cluster-randomized, two-period crossover trial. The primary objective is to compare the effectiveness of 2 strategies for diagnosing HIV among adult patients visiting EDs: nurse-driven targeted HIV screening combined with current practice (physician-directed diagnostic testing) versus current practice alone. Main secondary objectives are to compare access to specialist consultation and how early HIV diagnosis occurs in the course of the disease between the 2 groups, and to evaluate the implementation, acceptability and cost-effectiveness of nurse-driven targeted screening. The 2 strategies take place during 2 randomly assigned periods in 8 EDs of metropolitan Paris, where 42 % of France's new HIV patients are diagnosed every year. All patients aged 18 to 64, not presenting secondary to HIV exposure are included. During the intervention period, patients are invited to fill a 7-item questionnaire (country of birth, sexual partners and injection drug use) in order to select individuals who are offered a rapid test. If the rapid test is reactive, a follow-up visit with an infectious disease specialist is scheduled within 72 h. Assuming an 80 % statistical power and a 5 % type 1 error, with 1.04 and 3.38 new diagnoses per 10,000 patients in

  3. How Best to Obtain Valid, Verifiable Data Online From Male Couples? Lessons Learned From an eHealth HIV Prevention Intervention for HIV-Negative Male Couples.

    Science.gov (United States)

    Mitchell, Jason; Lee, Ji-Young; Stephenson, Rob

    2016-09-20

    As interest increases in the development of eHealth human immunodeficiency virus (HIV)-preventive interventions for gay male couples, Web-based methods must also be developed to help increase the likelihood that couples enrolled and data collected from them represent true unique dyads. Methods to recruit and collect reliable and valid data from both members of a couple are lacking, yet are crucial for uptake of novel sexual health and HIV-prevention eHealth interventions. Methods to describe best practices to recruit male couples using targeted advertisements on Facebook are also lacking in the literature, yet could also help in this uptake. The objective of our study was to describe challenges and lessons learned from experiences from two phases (developmental phase and online randomized controlled trial [RCT]) of an eHealth HIV-prevention intervention for concordant HIV-negative male couples in terms of (1) recruiting male couples using targeted advertisements on Facebook, (2) validating that data came from two partners of the couple, and (3) verifying that the two partners of the couple are in a relationship with each other. The developmental phase refined the intervention via in-person focus groups, whereas the pilot-testing phase included an online RCT. For both phases, couples were recruited via targeted Facebook advertisements. Advertisements directed men to a study webpage and screener; once eligible, participants provided consent electronically. A partner referral system was embedded in the consenting process to recruit the relationship partner of the participant. Both men of the couple had to meet all eligibility criteria-individually and as a couple-before they could enroll in the study. Verification of couples' relationships was assessed via the concurrence of predetermined screener items from both partners, done manually in the developmental phase and electronically in the pilot-testing phase. A system of decision rules was developed to assess the

  4. Combined Intimate Partner Violence and HIV/AIDS Prevention in Rural Uganda: Design of the SHARE Intervention Strategy

    Science.gov (United States)

    Wagman, Jennifer A.; King, Elizabeth J.; Namatovu, Fredinah; Kiwanuka, Deus; Kairania, Robert; Ssemanda, John Baptist; Nalugoda, Fred; Serwadda, David; Wawer, Maria J.; Gray, Ronald; Brahmbhatt, Heena

    2016-01-01

    Intimate partner violence (IPV) has a bidirectional relationship with HIV infection. Researchers from Rakai Health Sciences Program (RHSP), an HIV research and services organization in rural Uganda, conducted a combination IPV and HIV prevention intervention called the Safe Homes And Respect for Everyone (SHARE) Project between 2005–2009. SHARE was associated with significant declines in physical and sexual IPV and overall HIV incidence and its model could be adopted as a promising practice in other settings. In this paper we describe how SHARE’s IPV-prevention strategies were integrated into RHSP’s existing HIV programming and provide recommendations for replication of the approach. PMID:26086189

  5. Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).

    Science.gov (United States)

    Labhardt, Niklaus Daniel; Ringera, Isaac; Lejone, Thabo Ishmael; Masethothi, Phofu; Thaanyane, T'sepang; Kamele, Mashaete; Gupta, Ravi Shankar; Thin, Kyaw; Cerutti, Bernard; Klimkait, Thomas; Fritz, Christiane; Glass, Tracy Renée

    2016-04-14

    Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation. This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms. This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to

  6. Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.

    Science.gov (United States)

    Saber-Tehrani, Ali Shabahang; Springer, Sandra A; Qiu, Jingjun; Herme, Maua; Wickersham, Jeffrey; Altice, Frederick L

    2012-03-01

    HIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners. Sentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6 months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during the last intervention month. Both study groups were assessed for 6 months after the intervention period. Assessments occurred within 90 days pre-release (baseline), day of release, and then monthly for 12 months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12 months. The primary outcome was pre-defined as viral suppression (VLHIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences. Copyright © 2011 Elsevier Inc. All rights reserved.

  7. Effects of a Community-Based HIV Risk Reduction Intervention Among HIV-Positive Individuals: Results of a Quasi-Experimental Study in Nepal.

    Science.gov (United States)

    Poudel, Krishna C; Buchanan, David R; Poudel-Tandukar, Kalpana

    2015-06-01

    We evaluated the efficacy of a sexual risk reduction intervention utilizing protection motivation and social cognitive theories to address knowledge, threat and coping appraisals, and condom use intentions among HIV-positive individuals in Nepal. Using a quasi-experimental research design, we assigned 277 participants to intervention (n=146) and control (n=131) groups. The intervention group received six sessions on sexual risk reduction strategies and the control group six sessions on medication adherence, smoking, and mental health. Data were collected at baseline and immediately after the intervention. Results indicate that the sexual risk reduction intervention produced a significant increase in HIV transmission knowledge, perceived threat and coping appraisals, and intentions to use condoms with regular, HIV-positive, and HIV-negative partners. The positive effects of the intervention remained significant after adjusting for baseline scores and other potential confounders. In conclusion, our theory-based sexual risk reduction intervention was effective in improving HIV transmission knowledge, perceived threat and coping appraisals, and condom use intentions. Further studies are needed to evaluate the long-term efficacy of the intervention in increasing protection motivation and maintaining preventive behaviors.

  8. Peer outreach work as economic activity: implications for HIV prevention interventions among female sex workers.

    Directory of Open Access Journals (Sweden)

    Annie George

    Full Text Available Female sex workers (FSWs who work as peer outreach workers in HIV prevention programs are drawn from poor socio-economic groups and consider outreach work, among other things, as an economic activity. Yet, while successful HIV prevention outcomes by such programs are attributed in part to the work of peers who have dense relations with FSW communities, there is scant discussion of the economic implications for FSWs of their work as peers. Using observational data obtained from an HIV prevention intervention for FSWs in south India, we examined the economic benefits and costs to peers of doing outreach work and their implications for sex workers' economic security. We found that peers considered their payment incommensurate with their workload, experienced long delays receiving compensation, and at times had to advance money from their pockets to do their assigned peer outreach work. For the intervention these conditions resulted in peer attrition and difficulties in recruitment of new peer workers. We discuss the implications of these findings for uptake of services, and the possibility of reaching desired HIV outcomes. Inadequate and irregular compensation to peers and inadequate budgetary outlays to perform their community-based outreach work could weaken peers' relationships with FSW community members, undermine the effectiveness of peer-mediated HIV prevention programs and invalidate arguments for the use of peers.

  9. Enhanced prenatal HIV couple oriented counselling session and couple communication about HIV (ANRS 12127 Prenahtest Trial)

    NARCIS (Netherlands)

    Plazy, M.; Orne-Gliemann, J.; Balestre, E.; Miric, M.; Darak, S.; Butsashvili, M.; Tchendjou, P.; Dabis, F.; du Lou, A. Desgrees

    Background. - The Prenahtest study investigated the efficacy of a couple-oriented HIV counselling session (COC) in encouraging couple HIV counselling and testing, and improving intra-couple communication about sexual and reproductive health. We report here on the effect of COC on intra-couple

  10. Qualitative "trial-sibling" studies and "unrelated" qualitative studies contributed to complex intervention reviews.

    Science.gov (United States)

    Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash

    2016-06-01

    To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial

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    Fanaian Mahnaz

    2010-02-01

    Full Text Available Abstract Background Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP are the main behavioural risk factors for chronic disease. Primary health care (PHC has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. Methods/Design The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1 telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2 nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3 semi-structured interviews/focus with nurses, managers and clients

  12. Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.

    Directory of Open Access Journals (Sweden)

    Jairam R Lingappa

    Full Text Available The Partners HSV-2/HIV-1 Transmission Study (Partners Study is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2 suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed.Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9 with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (500 relative to <350, respectively, p<0.001.The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission.ClinicalTrials.gov NCT00194519.

  13. Achieving HIV risk reduction through HealthMpowerment.org, a user-driven eHealth intervention for young Black men who have sex with men and transgender women who have sex with men.

    Science.gov (United States)

    Muessig, Kathryn E; Baltierra, Nina B; Pike, Emily C; LeGrand, Sara; Hightow-Weidman, Lisa B

    Young, Black men who have sex with men and transgender women who have sex with men (YBMSM/TW) are at disproportionate risk for HIV and other sexually transmitted infections (HIV/STI). HealthMpowerment.org (HMP) is a mobile phone optimised online intervention that utilises behaviour change and gaming theories to reduce risky sexual behaviours and build community among HIV-positive and negative YBMSM/TW. The intervention is user-driven, provides social support, and utilises a point reward system. A four-week pilot trial was conducted with a diverse group of 15 YBMSM/TW. During exit interviews, participants described how HMP components led to behaviour changes such as asking partners' sexual history, increased condom use, and HIV/STI testing. The user-driven structure, interactivity, and rewards appeared to facilitate sustained user engagement and the mobile platform provided relevant information in real-time. Participants described the reward elements of exceeding their previous scores and earning points toward prizes as highly motivating. HMP showed promise for being able to deliver a sufficient intervention dose and we found a trend toward higher dose received and more advanced stages of behaviour change. In this pilot trial, HMP was well accepted and demonstrates promise for translating virtual intervention engagement into actual behaviour change to reduce HIV risk behaviours.

  14. 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.

  15. Recent mobile health interventions to support medication adherence among HIV-positive MSM.

    Science.gov (United States)

    Muessig, Kathryn E; LeGrand, Sara; Horvath, Keith J; Bauermeister, José A; Hightow-Weidman, Lisa B

    2017-09-01

    We describe recent mobile health (mHealth) interventions supporting antiretroviral therapy (ART) medication adherence among HIV-positive MSM. Keyword searches (1 January 2016-13 May 2017) identified 721 citations. Seven publications reporting on six studies met inclusion criteria. Five studies focused on MSM. Interventions primarily employed text messaging (n = 4), whereas two focused on smartphone apps and one on social media. Three studies measured intervention impact on adherence and found increased ART use intentions (n = 1), self-reported adherence (n = 1), and viral suppression (n = 1, no control group). Other mHealth interventions for HIV-positive MSM focused on status disclosure and reducing sexual risk. mHealth interventions to support ART adherence among MSM show acceptability, feasibility, and preliminary efficacy. No recent mHealth interventions for MSM measured impact on viral suppression compared with a control condition despite earlier (pre-2015) evidence for efficacy. Studies are underway that include multiple features designed to improve adherence within complex smartphone or internet-based platforms. Areas for future growth include overcoming measurement and engagement challenges, developing tools for coordinating patient and provider adherence data, testing combination interventions, and adapting efficacious interventions for new languages and geographic settings.

  16. Community-based interventions that work to reduce HIV stigma and discrimination: results of an evaluation study in Thailand.

    Science.gov (United States)

    Jain, Aparna; Nuankaew, Ratana; Mongkholwiboolphol, Nungruthai; Banpabuth, Arunee; Tuvinun, Rachada; Oranop Na Ayuthaya, Pakprim; Richter, Kerry

    2013-11-13

    HIV stigma and discrimination are major issues affecting people living with HIV in their everyday lives. In Thailand, a project was implemented to address HIV stigma and discrimination within communities with four activities: (1) monthly banking days; (2)