Background: This study examined the feasibility of a combination prevention intervention for young men who have sex with men (YMSM), an anticipated target population for Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as HIV pre-exposure prophylaxis (PrEP).
Methods: Project PrEPare, a pilot study using a 3-arm design, compared an efficacious behavioral HIV-prevention intervention (3MV) alone, 3MV combined with PrEP, and 3MV combined with placebo. Eligible participants were 18–22-year-old HIV-uninfected men who reported unprotected anal intercourse (UAI) in the past year. Participants were screened for preliminary eligibility at youth venues and community organizations and were also referred through social networks. Laboratory screening determined final eligibility. Behavioral and biomedical data were collected at baseline and every 4 weeks thereafter for 24 weeks.