Screening and Enrollment CRF in P3 (Prepared, Protected, emPowered): A Study to Test the Efficacy of a Social Networking, Gamification, and Adherence Support App to Improve PrEP Adherence

Screening and Enrollment CRF CSV
Study Description
This study had three phases, usability testing, field testing, and a randomized-controlled trial (RCT). In usability testing the investigators tested beta versions of the app and gained feedback about the intervention from the target population, identified any technical issues, and got feedback on app content. Field testing was to ensure that the features, platform and content of P3 and P3+ are acceptable to the target population and that there are no technical challenges or user concerns with either the app, the dried blood spot (DBS), hair, or mitra sampling collection.

The last phase was an RCT that tested the efficacy of P3, a novel, theory-based mobile app that utilized game mechanics and social networking features to improve PrEP adherence, retention in PrEP care, and PrEP persistence among young men who have sex with men (YMSM) and young trans women (YTW) who have sex with men, ages 16-24. The investigators tested the efficacy of P3 and P3+, which added adherence counseling through the app, against PrEP standard of care. Participants were randomized to P3, P3+, or standard of care.

For adherence, P3/P3+ was associated with a higher proportion adherent compared to SOC for both outcome measures. The estimated increase in proportion adherent was 0.13 (95% CI: -0.01, 0.27, p-value 0.06) and 0.12 (95% CI: -0.03, 0.26, p-value = 0.11) for TFV and FTC, respectively. There was no evidence of a treatment effect for persistence. Sensitivity analyses led to similar results. Overall, P3/P3+ is associated with an increase in PrEP adherence among YMSM and YTWSM at 3 months. The study population included young men who have sex with men (YMSM) and young trans women (YTW) assigned male at birth who have sex with men, ages 16-24 who started PrEP or were non-adherent to PrEP.

筛查与入组病例报告表（CRF）CSV数据集
研究概况
本研究共分为三个阶段，即可用性测试、现场测试与随机对照试验（Randomized-Controlled Trial, RCT）。在可用性测试阶段，研究者对该应用的测试版进行验证，从目标人群中收集针对干预方案的反馈，排查技术问题，并获取应用内容相关的改进建议。
现场测试阶段旨在确认P3与P3+的功能、平台及内容均获目标人群认可，且应用、干血斑（Dried Blood Spot, DBS）采集、毛发采集或米特拉采样采集流程均不存在技术障碍或用户顾虑。
最后一个阶段为随机对照试验（RCT），用于评估P3的干预效果：P3是一款基于理论框架开发的新型移动应用，融合游戏机制与社交网络功能，旨在提升16至24岁男男性行为青年（Young Men Who Have Sex with Men, YMSM）及与男性发生性行为的跨性别青年女性（Young Trans Women Who Have Sex with Men, YTW）的暴露前预防（Pre-Exposure Prophylaxis, PrEP）依从性、PrEP护理留存率与PrEP坚持性。研究者对比了P3、新增应用内依从性咨询功能的P3+与PrEP标准护理（Standard of Care, SOC）的干预效果，将受试者随机分配至P3组、P3+组或标准护理组。
在依从性结局方面，两项指标的依从人群占比均以P3/P3+组更高。其中替诺福韦（Tenofovir, TFV）对应的依从人群占比预估提升0.13（95%置信区间：-0.01, 0.27，p值=0.06），恩曲他滨（Emtricitabine, FTC）对应的预估提升幅度为0.12（95%置信区间：-0.03, 0.26，p值=0.11）。针对PrEP坚持性未观察到显著干预效应，敏感性分析结果与此一致。整体而言，在随访3个月时，P3/P3+可提升YMSM及与男性发生性行为的出生指派男性跨性别青年女性的PrEP依从性。本研究的受试者为16至24岁、已启动PrEP治疗或PrEP依从性不佳的男男性行为青年（YMSM），以及与男性发生性行为、出生时被指派为男性的跨性别青年女性（YTW）。