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 worldwide. 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).  In Kenya, heterosexual HIV-1 serodiscordant couples face high risk of HIV-1 transmission and account for a substantial fraction of new infections.  Over the past decade, randomized trials and other clinical investigations have definitively demonstrated that both ART and PrEP have high HIV-1 protection efficacy when used by members of HIV-1 serodiscordant couples.  A pragmatic, integrated approach to providing ART and PrEP, with ART promoted for the HIV-1 infected partner in all couples and PrEP offered until six months after ART initiation by the HIV-1 infected partner to permit time to achieve virologic suppression (a strategy called “PrEP as a bridge to ART”), resulted in near-elimination of HIV-1 transmission in a demonstration project among HIV-1 serodiscordant couples.  

The World Health Organization recommends ART at any CD4 count for persons with HIV-1 infection, particularly those with HIV-1 uninfected partners, and PrEP for persons at high risk of HIV-1 acquisition.  The Kenya Ministry of Health has developed an ambitious HIV Prevention Revolution Road Map 2030, including provision of ART regardless of CD4 count and PrEP for HIV-1 serodiscordant couples. In July 2016, the Ministry of Health in Kenya released “Guidelines on use of Antiretroviral Drugs for Treating and Preventing HIV infections in Kenya” which recommend initiation of ART for all HIV infected persons irrespective of CD4 count and oral PrEP for HIV-1 uninfected persons with substantial ongoing risk of HIV infection, including HIV discordant couples. Nevertheless, delivery approaches that will catalyze scale-up of PrEP and ART have not been implemented.  HIV-1 care in Kenya is principally delivered through public health HIV-1 care centers, thus offering an existing platform for incorporating clinical prevention services for couples.  This project will scale-up integrated PrEP and ART for HIV-1 serodiscordant couples in Kenya to HIV-1 care centers in several counties in Kenya, including 12 in Central Kenya (former central and Nairobi province).  It will include a delivery component in which PrEP will be delivered according to Kenyan national guidelines, utilizing the integrated PrEP as a bridge to ART approach. We will conduct monitoring and evaluation activities to identify implementation barriers and solutions, characterize costs, and provide best practices for further scale-up.  A research component will establish prospective open cohorts of couples at each clinic, who will be offered PrEP and ART according to Kenyan national guidelines; follow-up in the cohorts will evaluate impact and facilitators and barriers to implementation at levels from the patient to the health system. 

Design:  Prospective, open-label cohort study at HIV-1 care centers in Kenya including 12 in central Kenya.  The PrEP as a bridge to ART intervention will be introduced into clinics according to national guidelines in a staged fashion, stratified by clinic size & region (a stepped wedge design).  Follow-up will be for up to 36 months at each care center.

Population:   Heterosexual HIV-1 serodiscordant couples, ≥18 years of age, mutually disclosed.  Up to 200 couples per clinic will participate in the prospective open cohort research evaluation.  Up to 200 key delivery informants will participate in qualitative interviews about PrEP delivery.