Strategies to Prevent HIV Acquisition for At-Risk Men in the US

PROJECT SUMMARY In the US, men at-risk of HIV acquisition and require tailored biobehavioral HIV prevention strategies. The goal of the proposed study is to assess the ability of digitally delivered peer-based strategies to improve PrEP uptake in PrEP-indicated HIV-negative adult men. This study proposes a digital open-label randomized 2x2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP uptake for men residing in high HIV incidence geographic hotspots in the Eastern and Southern US. The specific aims are to: (1) Compare the efficacy of individual (PrEP4T: one-on-one peer navigation) and group-based (LS4M: small group-based behavioral intervention) peer-delivered HIV prevention strategies implemented over 6 mo to increase PrEP uptake (primary outcome) in 300 PrEP-indicated HIV-negative adult men; (2) Examine mechanisms by which peer-delivered interventions impact PrEP uptake focusing on healthcare empowerment, community support, and information, motivation, and behavioral skills; and (3) Explore PrEP decision-making and intervention experiences qualitatively. Biobehavioral assessments will be conducted every 3 mo for 21 mo with self-administered surveys; remote HIV self-testing (4th gen tests) and biologic measures of PrEP via emtricitabine triphosphate (FTC-TP) and tenofovir diphosphate (TFV-DP) using dried blood spots (DBS) to evaluate uptake of approved TFV-based PrEP regimens; and STIs (gonorrhea, chlamydia, syphilis) via electronic medical record (EMR) releases. The team will use a participatory population perspective to work “with” not “on” communities ensuring meaningful participation of at-risk men. The proposed study is significant by addressing HIV prevention in high HIV burdened population and will fill critical gaps in biobehavioral HIV prevention and peer-engaged approaches. The study is aligned with US national priorities to implement integrated strategies for HIV prevention in at-risk populations and high HIV incidence geographic hotspots and will advance the 2021-2025 National Strategic Plan to End the HIV epidemic.