Conditions: HIV
Keywords: Pre-exposure prophylaxis HIV Prevention Truvada Many Men, Many Voices Emtricitabine Tenofovir disoproxil fumarate Young men who have sex with men HIV Seronegativity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: yes

Brief summary:
This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.

Detailed description:

Arms:
arm 1: Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention arm 2: Blinded administration of placebo pill; HIV behavioral intervention arm 3: Subjects receive HIV behavioral intervention but no pill.

Interventions: intervention 1: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP intervention 2: Placebo intervention 3: Many Men, Many Voices (3MV)
Intervention descriptions: intervention 1: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks. intervention 2: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. intervention 3: Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Protocol document: