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)
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). Assignment to behavioral intervention, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC), will occur at the level of the site. Subjects will first complete the behavioral intervention offered at their respective site 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 more closely monitor longer-term outcome of potential concerns.
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Project PrEPare - 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) in the United States|
- Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Change in serum creatinine from baseline, bone mineral density change from baseline, and change in behavioral disinhibition/risk compensation endpoints (e.g., number of sexual partners, number of times engaged in each type of sex act with and without condom, number of partners of each HIV serostatus, alcohol or recreational drug use before or during last sexual encounter, exchanged sex for money, drugs, food or a place to stay during last sexual encounter, HIV risk reduction measures taken with last sexual partner)
- Acceptability, patterns of use, rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.
Feasibility of PrEP as measured by process indicators (e.g., number of subjects screened, number eligible, number enrolled, and number choosing to take PrEP)
Medication adherence as measured by number of days of missed medication per total number of days, period of time that a subject's supply of study medication is assumed to be exhausted based on refill dates, and levels of drug exposure as measured by dried blood spot (DBS), plasma, and peripheral blood mononuclear cell (PBMC) samples.
- Behavioral disinhibition/risk compensation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Changes in behavioral disinhibition/risk compensation as measured by number of sexual partners, number of times engaged in each type of sex act with and without condom, number of partners of each HIV serostatus, alcohol or recreational drug use before or during last sexual encounter, exchanged sex for money, drugs, food or a place to stay during last sexual encounter, HIV risk reduction measures taken with last sexual partner etc.
- Evaluation of the process of protocol implementation [ Time Frame: Two years ] [ Designated as safety issue: No ]Brief phone interviews and review of written institutional review board (IRB) correspondence will be conducted for all sites whether the study is approved at that site or not. If approved, the steps needed for approval and how barriers were addressed will be examined. If the study was rejected, the reasons for disapproval, the IRB's interpretation of the risk of PrEP, and other barriers will be examined. In addition, data from a survey specific to each site's IRB's responses of minor YMSM inclusion in PrEP studies will be evaluated.
- Acceptability and feasibility of two types of efficacious sexual risk reduction interventions as measured by session evaluation (i.e., was session interesting, was it relevant to their life, and did they learn from the session) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Acceptability and feasibility of text message reminders as measured by subject rating of the reasons for missing medications on a 4-point Likert scale. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Demographic and/or behavioral difference between study groups. Behavioral disinhibition/risk compensation endpoints will be compared. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Explore potential demographic and/or behavioral differences between youth who are interested in participating in a PrEP study versus those who are not. Behavioral disinhibition/risk compensation endpoints will be compared. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: 3MV Behavioral Intervention Group
3MV Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
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 VoicesDrug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Experimental: PCC Behavioral Intervention Group
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
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 CounselingDrug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
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 PrEP from prior studies. The study will also examine patterns of sexual risk behavior among high-risk HIV-1 uninfected YMSM in the U.S. who are provided with open label FTC/TDF (Truvada®) as PrEP. The study will also explore the feasibility and acceptability of implementing two different types of efficacious risk reduction interventions prior to the provision of PrEP - 3MV and PCC. The inclusion of a behavioral intervention in this project not only addresses our ethical responsibility of providing at least the minimum risk reduction education to all subjects given the high HIV risk of our 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 this 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 guardians.
|Contact: Nancy Liu||(718) email@example.com|
|United States, California|
|Children's Hospital of Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Diane Tucker, BA 323-361-3914 firstname.lastname@example.org|
|Principal Investigator: Marvin Belzer, MD|
|United States, Colorado|
|University of Colorado - The Children's Hospital of Denver||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Emily A Barr, CPNP,CNM,MSN 720-777-6752 Emily.Barr@childrenscolorado.org|
|Contact: Amy Witte, FNP 720-777-4495 email@example.com|
|Principal Investigator: Elizabeth J McFarland, MD|
|United States, Illinois|
|Stoger Hospital of Cook County||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Kelly Bojan, ND, RN, FNP 312-572-4571 firstname.lastname@example.org|
|Principal Investigator: Jaime Martinez, MD|
|United States, Louisiana|
|Tulane Medical Center||Recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Leslie Kozina, RN 504-988-5348 email@example.com|
|Principal Investigator: Sue Ellen Abdalian, MD|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|Contact: Emily George, RN 617-927-6246 firstname.lastname@example.org|
|Principal Investigator: Kenneth Mayer, MD|
|United States, Pennsylvania|
|Childrens Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Adrienne DiBenedetto, BSN 267-426-5527 email@example.com|
|Principal Investigator: Steven Douglas, MD|
|Study Chair:||Sybil Hosek, PhD||Stroger Hospital of Cook County|