ATN 113 Adverse Event Evaluation Dataset in 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

Data from Adverse Event Evaluation Form [CRF 95]
Study Description
This pre-exposure prophylaxis (PrEP) demonstration project and phase II safety study aimed to obtain additional data on the safety of emtricitabine/tenofovir (FTC/TDF (Truvada®)). Patterns of use, rates of adherence, and patterns of sexual risk behavior among YMSM (inclusive of transgender women) who were provided with open label FTC/TDF (Truvada®) and information on the safety and efficacy of PrEP from prior studies were evaluated. Furthermore, this project explored the feasibility and acceptability of implementing two different types of efficacious risk reduction interventions prior to the provision of PrEP – Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC).
HIV-1 uninfected 15 to 17 year old young men who have sex with men

不良事件评估表[病例报告表95（CRF 95）]相关数据
研究概况
本暴露前预防（pre-exposure prophylaxis, PrEP）示范项目暨II期安全性研究，旨在补充获取恩曲他滨（emtricitabine, FTC）/替诺福韦（tenofovir, TDF，商品名舒发泰®（Truvada®））的安全性相关数据。本研究对接受开放标签恩曲他滨/替诺福韦（FTC/TDF，商品名舒发泰®（Truvada®））干预、且已掌握既往研究中暴露前预防（PrEP）安全性与有效性信息的男男性行为青年（含跨性别女性）的用药模式、服药依从性率及性风险行为模式进行了评估。此外，本项目还探索了在提供暴露前预防（PrEP）前，实施两种不同类型的有效风险降低干预措施的可行性与可接受性——即「众男众声」（Many Men, Many Voices, 3MV）项目与个性化认知咨询（Personalized Cognitive Counseling, PCC）。
研究对象为HIV-1抗体阴性的15至17岁男男性行为青年。