Research Protocol LifeSteps for PrEP for young men who have sex with men: adapting a PrEP adherence intervention for high-risk youth

Background: New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is therefore essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among MSM; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed. Objective: To describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for PrEP for YMSM (LSPY). Methods: This study includes two phases: 1) formative qualitative interviews with approximately 20 YMSM and 10 key informants, for the purposes of intervention adaptation and refinement; and 2) a pilot RCT of up to 50 YMSM to assess feasibility, acceptability, and preliminary efficacy of the LifeSteps for PrEP for YMSM, compared to the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech Subject Recruitment Venues in the United States. Results: Phase 1 is expected to begin in late 2017, and enrollment of Phase 2 is anticipated to begin in early 2018. Conclusions: There are few rigorously developed and tested interventions designed to increase PrEP adherence among YMSM in community settings, despite this population’s high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize atrisk YMSM’s PrEP uptake and adherence, in order to decrease HIV incidence. Trial Registration: The study is in the process of being registered on ClinicalTrials.gov.