An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the
      ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine
      Trial Units (AMTUs). Subjects will complete the behavioral intervention selected by all
      participating sites, Personalized Cognitive Counseling (PCC), and will then be provided with
      open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as pre-exposure prophylaxis (PrEP).
      Behavioral and biomedical data will be collected at baseline and at 0, 4, 8, 12, 24, 36 and
      48 weeks. Any subject who becomes HIV infected during the course of the study will be
      discontinued from the study agent and be followed for an additional 24 weeks after the study
      visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal
      criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an
      additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential
      concerns.
    

Detailed description: 
      The aims of the study are to obtain additional data on the safety of FTC/TDF (Truvada®) and
      to evaluate acceptability, patterns of use, rates of adherence, and measured levels of drug
      exposure when YMSM are provided with open label FTC/TDF (Truvada®) and information regarding
      safety and efficacy of FTC/TDF (Truvada®) as PrEP based on prior studies in adults. The study
      will also examine patterns of sexual risk behavior among HIV-uninfected YMSM in the U.S. at
      high risk of acquiring HIV infection who are provided with open label FTC/TDF (Truvada®) as
      PrEP. The study will also explore the feasibility and acceptability of implementing an
      efficacious risk reduction behavioral intervention prior to the provision of PrEP- PCC. The
      inclusion of a behavioral intervention in this project not only addresses the ethical
      responsibility of providing at least the minimum risk reduction education to all subjects
      given the high HIV risk of the study population, but also builds behavioral skills to assist
      subjects in reducing their risk when not taking PrEP. Furthermore, the study will evaluate
      the process of protocol implementation to better understand how to best implement PrEP
      research and program practice at adolescent medicine sites, including an evaluation of
      consent procedures and the acceptability/feasibility of allowing youth minors to consent for
      their own participation in HIV prevention intervention, to the extent allowable by local laws
      and regulations, and to allow youth minor participation in a clinical trial without requiring
      disclosure of their sexual orientation and risk behaviors to their parents or legal
      guardians.
    

Intervention name(s): PCC; Emtricitabine/tenofovir (FTC/TDF (Truvada®))
Intervention type(s): Behavioral; Drug
Intervention description(s): 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 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.; All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Other intervention name(s): Personalized Cognitive Counseling; FTC/TDF; Truvada®; Emtricitabine/tenofovir; PrEP
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV, PrEP, FTC/TDF, Truvada®