ATN 082 Adverse Event Diagnoses Dataset in Acceptability and Feasibility of a Pre-Exposure Prophylaxis Trial With Young Men Who Have Sex With Men

Data from Adverse Event Evaluation Form: Diagnoses [CRF 95, Section I – Diagnoses]
Study Description
An exploratory mixed-methods study comparing a behavioral HIV-prevention intervention (Many Men, Many Voices or 3MV) alone to 3MV combined with a biomedical intervention (Pre-exposure Prophylaxis or PrEP). After completing the 3MV intervention, participants were randomly assigned to one of three study arms: 1) daily PrEP with emtricitabine and tenofovir (FTC/TDF); 2) placebo pill control; or 3) “no pill” control. Behavioral and biomedical data were collected at baseline and every 4 weeks for 24 weeks. Qualitative interviews with a subset of participants were completed at the end of the study to explore the feasibility and acceptability of the trial. Eligible youth who declined to participate were asked to complete a brief opinion survey about PrEP. In addition, a focus group was conducted with young men ages 16-17 years who have sex with men and who met all eligibility requirements except for age to discuss issues of feasibility and acceptability should they be eligible to enroll in a future similar trial.
Young men ages 18-22 years who have sex with men

不良事件评估表诊断模块数据【病例报告表（Case Report Form，CRF）95，第一部分——诊断】

研究概况
本研究为一项探索性混合方法研究，旨在对比单纯行为学艾滋病预防干预方案「多男性，多心声（Many Men, Many Voices，简称3MV）」与3MV联合生物医学干预方案「暴露前预防（Pre-exposure Prophylaxis，简称PrEP）」的干预效果。受试者完成3MV干预后，将被随机分配至三个研究组之一：① 每日服用恩曲他滨替诺福韦（emtricitabine and tenofovir，缩写FTC/TDF）制剂的PrEP；② 安慰剂对照组；③ 无服药对照组。
研究将在基线期及随后每4周一次、共计24周的随访周期内，收集受试者的行为学与生物医学数据。研究结束后，将对部分受试者开展质性访谈，以探究本试验的可行性与可接受性。对于符合入组标准但拒绝参与本研究的青年群体，将邀请其完成一份关于PrEP的简短意见调查问卷。
此外，研究将针对16至17岁的男男性行为青年开展焦点小组讨论：该群体除年龄未达标外，其余均符合全部入组标准，讨论内容围绕若未来开展同类试验时，该群体参与的可行性与可接受性相关问题。
本研究的目标人群为18至22岁的男男性行为青年。