ART-based safer conception for HIV+ South African men who want to have children

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DESCRIPTION (provided by applicant): Background- Many HIV-infected men desire children, putting uninfected partners at risk for acquiring HIV. Men are motivated to have uninfected children, yet most prevention programs do not accommodate fertility desires. Advances in biomedical prevention create opportunities to reduce periconception HIV transmission risk. Based on formative work in South Africa, we developed a Periconception Risk Behavior Conceptual Framework that we apply to develop a male-focused safer conception intervention to promote disclosure and prevention interventions, including early ART, for men who want to have children with at-risk partners. Approach- We propose to develop and pilot a combination intervention that leverages men's motivations to have healthy babies in a South African district where antenatal clinic HIV prevalence is 42%.The draft intervention applies our conceptual framework and uses cognitive behavior therapy techniques including education, communication skills, problem-solving and motivational interviewing to help men communicate conception goals with partners, support HIV disclosure, understand serodiscordance, and adopt and adhere to safer conception behaviors (including initiating ART). In Phase 1 we will hone the intervention through qualitative methods and a participatory development process. In Phase 2 we will conduct an open phase, iterative pilot of the intervention to enhance acceptability and retention. In Phase 3 we will conduct a pilot randomized controlled trial of the final intervention among 120 men who want to have children with uninfected or unknown status female partners. Men will be randomized into the intervention versus a time- matched jobs training comparison condition. Early ART will be offered in both arms; the primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility. Innovation- Minimizing HIV transmission in the context of desired conception is critical to reducing sexual and perinatal HIV transmission. We propose to develop and pilot a patient-centered safer conception intervention which is well-grounded in formative work. Our intervention is unique in addressing HIV risk reduction in the context of the fertility goals of me, leveraging the desires of men to have uninfected children to promote HIV risk reduction, and exploring uptake and adherence to early ART for prevention in an HIV-endemic setting. Our team of experts in safer conception (Matthews, Smit, Bangsberg), intervention development (Safren, Psaros, Harrison, Smit), intervention testing in South Africa (Smit, Harrison), adherence (Bangsberg, Safren), and qualitative methods (Harrison, Smit, Safren) is well positioned to successfully complete this work. Significance- This proposal will provide acceptability and feasibility data and initial effect size estimates to design a randomized controlled efficacy trialto test a safer conception intervention promoting early ART for HIV-infected men who want to conceive with at-risk partners.