Partners Demo Project
Rationale
Antiretroviral-based HIV-1 prevention strategies – including antiretroviral treatment (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons to prevent HIV-1 acquisition – are among the most promising new approaches for dramatically decreasing HIV-1 spread. Clinical trials have recently demonstrated that both ART and PrEP have high efficacy for HIV-1 protection. A priority population for implementation of ART and PrEP for HIV-1 prevention is HIV-1 serodiscordant couples (i.e., one member is HIV-1 infected and the other uninfected). Stable, heterosexual African HIV-1 serodiscordant couples face high risk of HIV-1 transmission, from within the partnership and from outside partners, and are a priority population for prevention interventions.
Critical unanswered questions to move from clinical trials to successful implementation of antiretroviral-based HIV-1 prevention in an African public health setting include how to prioritize these strategies for the highest-risk couples and whether HIV-1 infected persons would accept ART to reduce their risk for transmitting HIV-1, at-risk HIV-1 negative persons would use PrEP, and both would sustain high adherence needed for high effectiveness. Guidance from the World Health Organization has emphasized the potential for both ART and PrEP to reduce new HIV-1 infections in HIV-1 serodiscordant couples and has called for projects to demonstrate implementation strategies for these interventions.
Study Description
The Partners Demonstration Project is a multi-national collaborative study to evaluate implementation of ART and PrEP for HIV-1 prevention in African heterosexual HIV-1 serodiscordant couples. Approximately 1000 couples at high risk for HIV-1 transmission will participate in this project, from four research sites in Kenya and Uganda. Enrollment into the project began in November 2012 and the study will be complete in 2015. The project is evaluating delivery of PrEP and ART for HIV-1 prevention in this important population, factors influencing adherence to ART and PrEP, and the decision processes couples follow in making HIV-1 prevention choices. ART will be provided to HIV-1 infected members of couples, following Kenyan and Ugandan HIV-1 treatment guidelines. PrEP will be offered to HIV-1 uninfected partners as a “bridge” to ART use in the HIV-1 infected partner and it will be discontinued after the HIV-1 infected partner successfully initiates and sustains ART use. This model has been designed, in consultation with national and international stakeholders, to evaluate one potential approach to optimize resources for HIV-1 treatment and prevention programs as countries consider how to implement PrEP and ART for HIV-1 prevention in couples.
The ICRC is working with a team of scientists from Kenya, Uganda, and the United States to conduct the Partners Demonstration Project. Participating institutions include the University of Washington, the Infectious Disease Institute of Makerere University, the Kabwohe Clinical Research Centre, the Kenya Medical Research Institute, Kenyatta National Hospital, Massachusetts General Hospital, and Harvard University. Funding for the study is provided by the National Institute of Mental Health of the US National Institutes of Health, the Bill & Melinda Gates Foundation, and the United States Agency for International Development. PrEP medication (Truvada®) is donated by Gilead Sciences.
