ATN 110

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
DescriptionBehavioral: 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 DeliveryTablet
ARMsExperimental
DescriptionBehavioral: 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
Mode of Delivery
ARMsExperimental
Official Code: NCT01772823
Trial Sponsors: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start Date
End Date
November 30, 2012
November 30, 2015
Enrollment:200
Age range: 18 Years ↔ 22 Years
Population:Cisgender Men