Uganda HIV Voluntary Counseling and Testing Study

The Uganda HIV Voluntary Counseling and Testing (VCT) Study is a randomized clinical trial to evaluate strategies for optimizing risk reduction within the context of routine HIV VCT (rVCT) and fully integrating inpatient counseling and testing with post-discharge HIV medical care to ensure that diagnosed individuals receive access to care.

The first intervention compares, in a non-inferiority study design, in-patient/outpatient routine counseling and testing (rVCT) with traditional HIV pre- and post-test counseling and testing (tVCT). The second intervention compares, in a superiority design, an “enhanced linkage to care” model for seropositive persons to increase uptake and long-term utilization of HIV-specific medical care compared to routine discharge and referral.

Comunidades Positivas “Positive Communities”

Also known as Prevention For Positives (P4P), this is a five-year, NIMH-funded study that tests two interventions  — one behavioral and one biomedical — to prevent HIV and STI (sexually transmitted infection) transmission among HIV- and/or STI-positive men who have sex with men in Lima, Peru.

This study evaluates two interventions carried-out simultaneously – one which is community-based and focuses on behavioral modification, and the other to improve access and service coverage for contacts of index cases for various sexually transmitted infections (STIs) – in order to prevent the transmission of HIV and STIs in Peru. Comunidades Positivas, the behavioral intervention, is designed to reduce the frequency of unprotected sex with non-primary partners. The biomedical intervention is designed to evaluate the effectiveness of enhanced partner therapy for incident STIs with the goal of reducing re-infection rates and therefore, incident STIs.

 

Penile Hygiene

This feasibility study investigates promotion of an existing social norm, post-coital penile cleansing, and its potential as an HIV prevention behavioral intervention.

We test participants’ ability to understand the study-specific counseling and consistently adhere to a genital hygiene regimen. One feature of this HIV prevention feasibility trial will be the ability to measure participants’ adherence to respective randomization arms by taking penile swabs before, during and at the end of the study.

If the approach proves efficacious, which would require a randomized controlled trial, it would provide an additional alternative for those men who are unwilling to undergo male circumcision and/or use condoms or reduce the number of sexual partners, but who wish to protect themselves from HIV.

Ai Shi Zi

Ai Shi Zi is a five-year NIMH-funded prevention and treatment study, the goal of which is to teach physicians how to enhance prevention and care for HIV and STIs. Because HIV and STIs are closely linked, prevention requires both state-of-the-art treatment and changes in sexual behavior. This study aims to teach physicians how to focus on both of these elements.

A total of 60 counties in China’s Anhui Province will be randomly assigned to one of two conditions: 1) primary and secondary training, in which county-level physicians are trained and, in turn, train township-level physicians; and 2) delayed-intervention control, in which physicians receive training only at the end of the 12-month assessment. Our primary endpoint is a hypothesized reduction in the one-year incidence of Chlamydia and gonorrhea among patients of trained county- and township-level physicians relative to delayed-intervention controls. Physicians and patients at the county- and township-levels will also be assessed using questionnaires at baseline and at 6 and 12 months following baseline.

Local significance (How has this project impacted the immediate population?):

This project provides training to county- and township-level physicians in Anhui Province, China and, hopefully, improved  care and treatment to their patients at risk for STIs, including HIV.

International significance (How has this project impacted the global community?):

This study may provide a useful model for training of physicians in a variety of developing country settings who care for patients at risk for STIs, including HIV.

NIMH Project Accept

Project Accept is a Phase III randomized controlled trial of community mobilization, mobile testing, same-day results, and post-test support for HIV in in sub-Saharan Africa and Thailand. Thirty-four communities in Africa (South Africa, Tanzania, and Zimbabwe) and 14 communities in Thailand are randomized to receive either a community-based HIV voluntary counseling and testing (CBVCT) intervention plus standard clinic-based VCT (SVCT), or SVCT alone. The CBVCT intervention has three major strategies: (1) to make VCT more available in community settings; (2) to engage the community through outreach; and (3) to provide post-test support. These strategies are designed to change community norms and reduce risk for HIV infection among all community members, irrespective of whether they participated directly in the intervention.

Research Methods:  

  • Community Engagement
  • Baseline Behavioral Assessment
  • Community Matching
  • Qualitative Assessment
    • Community Mapping and Ethnography
    • In-Depth Interviews
  • CBVCT Communities
    • Community Mobilization
    • Easy Access to VCT
    • Post-Test Support Services
    • Quality Assurance
  • Control Communities
    • Clinic-Based VCT
    • Quality Assurance
  • Post-Intervention Assessment
    • Post-Intervention Biological Assessment
    • Post-Intervention Behavioral Assessment
  • Cost-Effectiveness Analysis

From the perspective of national AIDS control planners in hard-hit countries, evidence-based strategies that have maximum epidemic impact are critically needed. These planners need interventions that are sustainable and can be adapted to the context of their local cultures. This is the first randomized controlled Phase III trial to determine the efficacy of a behavioral/social science intervention with an HIV incidence endpoint in the developing world. Provided that we can document efficacy with regard to HIV incidence and incremental cost-effectiveness, we expect that resources for widespread implementation of community-based VCT will become available from USAID or the Global Fund. We have worked closely with representatives of national AIDS programs in the host countries to ensure that the intervention is sustainable even in countries with limited resources.

 

Promoting Migrant Health Through HIV Awareness

For some Mexican migrants, the opportunities for receiving HIV-related interventions may be quite limited, especially for migrants who are in transition from one locale to another and who may not have the residential stability oftentimes required by HIV prevention programs.  Such transient populations may benefit from HIV prevention programs provided by individuals with similar backgrounds as theirs who are able to provide HIV-related information in informal one-on-one settings in the migrants’ own environments.  This project seeks to determine whether a peer education intervention with Mexican migrants is just as effective as a provider-based small group HIV prevention lecture as measured by the recipients’ HIV knowledge, HIV-related risk reduction skills, self-efficacy with respect to such skills, and intentions to engage in low-risk practices.

A total of 612 Mexican migrants will be recruited.  Mexican migrants from three migrant shelters in Mexicali will be trained as peer educators of a theory-driven HIV prevention intervention.  Each peer educator will conduct individual educational interventions with other Mexican migrants.  An outcome evaluation will be conducted to determine the extent to which those who received the peer education intervention differed from the recipients of the small group HIV prevention lecture with regards to the areas mentioned above and how both interventions differed from a no-treatment control group.

 

Testing of an HIV Prevention Card Game for the Angolan Armed Forces

Brief overview: The goals of this pilot study are to evaluate the effectiveness and cultural applicability of a game that promotes greater awareness of HIV/AIDS prevention messages.  By using a consumer driven approach and adapting innovations from computer and video gaming, a low-cost prevention tool can be produced and utilized throughout a resource-poor country that is threatened by rising HIV infections. Specifically, this proposal aims 1) To assess the added benefit of learning a novel, entertaining and culturally appropriate HIV prevention card game on HIV-related knowledge, attitudes and behaviors among Angolan soldiers receiving a standard HIV prevention intervention, and 2) To assess the diffusion of the game to others residing on the same base where the game is being taught and determine its impact on their HIV related knowledge, attitudes and behaviors.

Creating a culturally appropriate and enjoyable card game that promotes HIV/AIDS prevention has the potential to substantially increase awareness of risk behaviors and prevention methods in a high risk group. In the long-term, prevention materials that engage and entertain may have greater and longer lasting impact than other types of prevention strategies particularly in low resource settings where there are fewer opportunities for novel entertainment.

Geographical Location: Angola

Targeted risk group: Soldiers

Intervention Model: Randomized Control Trial

Research methods: Community-based randomize control trial with participants randomized to either an HIV prevention lecture or an HIV prevention lecture in which they are also taught to play the card game.  Knowledge of HIV assessed at pre- and post-intervention

Local and International significance: In very low resource settings with low literate populations, low cost, low tech prevention solutions that are culturally congruent may work best.  Among soldiers a card game that also teaches an HIV prevention message may be an effective strategy to increase knowledge of HIV and help reduce risk.

Evaluating Locally Developed “Homegrown” HIV Prevention Interventions for African American and Hispanic/Latino MSM

Funded by the Centers for Disease Control and Prevention (CDC), this project is a collaboration between In The Meantime Men’s Group, Inc. (ITMT) and Los Angeles County Department of Public Health HIV Epidemiology Program. The objectives of the project are to recruit and enroll 530 African American MSM, ages 18-29 years, for a randomized controlled trial (RCT) to test the efficacy of the MyLife MyStyle group-level, HIV prevention intervention to reduce unprotected anal sex among intervention participants over a six-month follow-up period. Specific activities required to evaluate the RCT include development of a program theory/logic model, refinement of the “home-grown” intervention curriculum, process evaluation of participant enrollment and retention, fidelity monitoring of the intervention facilitator to the MyLife MyStyle curriculum, development of quantitative and qualitative instruments, and evaluation of program outcomes at three and six month follow-up assessments.

This project is currently in progress. The assessments, curriculum, protocol, are project documents being prepared for CDC review. They are not available for release. Dr. Rosemary Veniegas of CHIPTS serves as the Evaluation Consultant on the project.

Electronic HIV Prevention in Los Angeles

Electronic, Technology, HIV Messaging

This pilot study conducted and analyzed responses from eight focus groups (6-8 people each) with staff and clients from community-based organizations (CBOs) which provide HIV prevention services to women.

The specific aims of this project are:

  1. To gather initial information on which electronic communication channels (e.g., the Internet, personal digital assistants (PDAs), or cell phones, or some combination) minority women would prefer to receive electronic HIV (e-HIV) prevention messaging.
  2. To develop and solicit responses to sample brief e-HIV prevention messaging.

P-QUAD Study

PQUAD is a pilot project to evaluate the acceptability, safety, and feasibility of delivering community-based HIV post-exposure prophylaxis in diverse Los Angeles County communities. It is a joint venture of UCLA, the Los Angeles Office of AIDS Programs and Policy (OAPP), the Department of Public Health Sexually Transmitted Disease Program, AIDS Project Los Angeles (APLA), and pharmaceutical industry partners.

Originally conceived in December, 2007, P-QUAD is now operational at 2 sites in epicenters of the HIV epidemic in Los Angeles: The Los Angeles Gay and Lesbian Center (opened March 2, 2010 in the Hollywood/West Hollywood area of Los Angeles with a largely MSM catchment), and The OASIS Clinic (opened April 15, 2010 in the south central area of Los Angeles with a largely lower socioeconomic status, at risk African-American and Latino catchment). The study provides dual or triple-agent ART for 28 days as post-exposure prophylaxis for HIV infection to individuals exposed sexually or via injection-drug works sharing, when presenting within 72 hours of an appropriately high-risk exposure. Additionally, substance use, mental health, and behavioral risk reduction referrals/linkages are provided as appropriate. Efficacy, safety, adherence, tolerability and behavioral outcomes are being collected. In the event of seroconversions, longitudinal specimens are stored for virologic analyses.

The program currently is providing Truvada (tenofovir + emtricitabine), or Combivir (zidovudine + lamivudine) with or without Kaletra (ritonavir + lopinavir). An upcoming amendment will offer Isentress (raltegravir) as an alternative to Kaletra for intolerance. An IND has been filed with the FDA for the use of these agents in a non-FDA approved study context (IND # 104,989) and the study is overseen and all study documents approved by the UCLA Institutional Review Board. Since opening the program, the P-QUAD has enrolled 30 participants as of May 6, 2010 [29 at LAGLC and 1 at OASIS], with an initially planned enrollment of 100 participants (50 at each site).