Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT01769456
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2013-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
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)
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: