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

数据源自不良事件评估表：诊断模块 [CRF 95，第一部分——诊断]
研究描述
本研究为一项探索性混合方法研究，旨在对比单纯行为类艾滋病预防干预方案「多名男性，多种声音（Many Men, Many Voices，简称3MV）」与3MV联合生物医学干预措施——暴露前预防用药（Pre-exposure Prophylaxis，简称PrEP）的应用效果。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（FTC/TDF）复方制剂的PrEP组；2）安慰剂对照组；3）「无服药」对照组。
研究于基线期及每4周开展一次数据采集，持续时长共计24周，收集行为学与生物医学相关数据。研究结束阶段，将对部分受试者开展定性访谈，以评估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，本研究还针对16至17岁的男男性行为青年开展了焦点小组讨论：该群体虽满足其余所有入组条件，但因年龄不符合要求未能入组，本次讨论旨在探讨若未来开展同类试验时，该群体参与的可行性与接受度相关问题。
研究对象为18-22岁男男性行为青年