ATN 082 Death Report Primary Dataset in Acceptability and Feasibility of a Pre-Exposure Prophylaxis Trial With Young Men Who Have Sex With Men

Dataset with no observations
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

无观测数据的数据集
研究概况
本研究为探索性混合方法研究，旨在对比两种方案的效果：其一为单一艾滋病行为预防干预（Many Men, Many Voices，简称3MV），其二为3MV联合生物医学干预——暴露前预防（Pre-exposure Prophylaxis，简称PrEP）。受试者完成3MV干预后，将被随机分配至三个研究组之一：1）每日服用含恩曲他滨与替诺福韦的PrEP药物（FTC/TDF）；2）安慰剂对照组；3）“无服药”对照组。研究人员在基线期及后续每4周收集一次行为与生物医学数据，数据收集周期共计24周。研究结束时，将对部分受试者开展质性访谈，以探索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，将邀请其完成一份关于PrEP的简短意见调查问卷。此外，研究团队还将针对符合全部入组标准但仅年龄不符的16-17岁男男性行为青年开展焦点小组讨论，以探讨若未来开展同类试验时，该群体参与的可行性与可接受性。
研究对象：18-22岁男男性行为青年