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Status
Completed
Phase
Demo Project
Open Label
II
Principal Investigator(s)
Sybil Hosek, PhD
Objective
Designed to explore the safety, acceptability, and feasibility of PrEP among young men who have sex with men (YMSM) who are at risk for HIV infection. This study will take place at clinical sites across the US with about 300 HIV-uninfected YMSM.
**Results reported in July 2016 show the majority of participants achieved protective drug levels during monthly visits, yet adherence decreased with quarterly visits. HIV incidence was still high despite PrEP provision, suggesting high background incidence. Regulatory approvals for youth under 18 years are required to foster support for youth-friendly settings that will optimize PrEP use.**
Prevention Option(s)
PrEP
Study Design
Non-randomized
Open label
Arms and Assigned Interventions
Description
Behavioral: 3MV
Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.
Other Name: Many Men, Many Voices
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Behavioral: PCC
Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe in as much detail, a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.
Other Name: Personalized Cognitive Counseling
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Products
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
Trial Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2013
March 2016
Enrollment
100
15
Years
17
Years
Population
MSM
Sites
Children's Hospital of Los Angeles
Los Angeles, California
United States of America
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado
United States of America
Stroger Hospital and the CORE Center
Chicago, Illinois
United States of America
Tulane University
New Orleans, Louisiana
United States of America
Fenway Institute
Boston, Massachusetts
United States of America
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
United States of America