Pre-Exposure Prophylaxis in YMSM

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.

Conditions

• HIV

Interventions

DRUG

coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP

Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

DRUG

Placebo

Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

BEHAVIORAL

Many Men, Many Voices (3MV)

Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Sybil Hosek, PhD · Adolescent Trials Network

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

22 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• United States

Study Locations