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Status
Completed
Phase
II
Principal Investigator(s)
Peter Havens, MD, MACC Fund Research Center
Objective
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)
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.
Other Names:
FTC/TDF
Truvada®
Emtricitabine/tenofovir
PrEP
Mode of Delivery
Tablet
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.
Other Names:
FTC/TDF
Truvada®
Emtricitabine/tenofovir
PrEP
Products
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
Similar Trials
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
Men
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