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.**
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.
Mode of Delivery
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.
Mode of Delivery
Official Code: NCT01769456
Trial Sponsors: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 31, 2013
March 31, 2016
Age range: 15 Years ↔ 17 Years
Population:Gay and Bisexual Men Who Have Sex with Men