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Project PrEPare (Adolescents 18-22)

Status
Ongoing
Phase
Demo Project
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.

**Preliminary results reported in July 2015 show initial PrEP uptake in the cohort was high, with the majority of participants achieving protective drug levels in their first monthly study visit; however, as visits decreased in frequency, so did adherence. Results also showed those at highest risk for HIV were also adhering to PrEP and concluded that providing access to PrEP in youth-friendly settings with tailored adherence support may help to maximize impact of PrEP.**
Prevention Option(s)
PrEP
Arms and Assigned Interventions
Description
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
NCT01772823
Trial Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2012
November 2015
Enrollment
200
18
Years
22
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

University of Miami

Miami, Florida
United States of America

University of South Florida

Tampa, Florida
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

Johns Hopkins University

Baltimore, Maryland
United States of America

Fenway Institute

Boston, Massachusetts
United States of America

Wayne State University

Detroit, Michigan
United States of America

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania
United States of America

St. Jude Childrens Research Hospital

Memphis, Tennessee
United States of America

Baylor College of Medicine

Houston, Texas
United States of America