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ATN 110

Principal Investigator(s)
Peter Havens, MD, MACC Fund Research Center

Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. 

*Results presented in July, 2016 show evidence of impact on bone mineral density (BMD) caused by exposure to TDF/FTC. On average, HIV-seronegative YMSM who lost BMD during TDF/FTC PrEP experienced partial or full recovery of BMD during the 48 weeks following discontinuation of PrEP, but some Z-scores declined slightly from baseline. While the risk of slight BMD loss is counterbalanced by protection from HIV acquisition, these results highlight the continuing need for strategies to mitigate bone loss in at-risk YMSM.**

Prevention Option(s)
Study Design
Open label
Arms and Assigned Interventions
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. Other Names: FTC/TDF Truvada® Emtricitabine/tenofovir PrEP
Mode of Delivery
TDF/FTC (Truvada)
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. Other Names: FTC/TDF Truvada® Emtricitabine/tenofovir PrEP
TDF/FTC (Truvada)
Trial Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2012
November 2015

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