PrEP iT! A Pilot Test of a Mobile Peer Support Intervention to Optimize PrEP Adherence and Retention in PrEP Care

摘要 与男性发生性关系的年轻男性（YMSM），特别是那些黑人和西班牙裔/拉丁裔， 新的艾滋病毒感染的影响不成比例。暴露前预防（Pre-exposure prophylaxis，PrEP）是一种 有效的艾滋病毒预防工具，但其好处与药物依从性直接相关， 血液中足够的替诺福韦（TFV）水平。最近的研究（ATN 110和113）表明，年轻的男男性接触者 PrEP难以坚持，特别是当医疗保健预约从每月减少到每3次时 几个月，大多数人无法通过PrEP随着时间的推移保持保护性药物水平。这就要求年轻人-- 具体的干预措施，包括同行支持小组和YMSM频繁的医疗保健互动， 制备型拟议的研究直接响应这些建议，开发和试点测试一个移动的 同伴支持干预，以改善18-29岁YMSM在PrEP护理中的PrEP依从性和保留率， 称为“PrEP it Together”（或PrEP iT！）。PrEP iT！基于技术采用的原则 模型和信息，动机和行为技能（IMB）模型，包括虚拟同伴互动 和支持，以青年为中心的PrEP和性健康信息，坚持提醒和自我监测， 短信跟进青少年的坚持可能是摇摇欲坠，医疗保健预约提醒， 医疗保健提供者互动和游戏化组件，以优化参与度。首先，我们将发展 PrEP iT！通过YMSM的焦点小组进行移动的干预，并通过输入改进迭代 社区咨询委员会（CAB）。四个焦点小组将进行，以收集反馈意见， 现有的移动的平台，将被改编。接下来，YMSM的CAB将定期提供 迭代干预设计过程中的反馈。可用性测试，目标的6个成员 人口将进行，最终在PrEP iT的最终版本！第二，为筹备 随后的R 01试验，我们将进行一项初步随机对照试验，以评估可行性， PrEP iT的可接受性和初步影响！干预YMSM。80 YMSM最近 启动或重新启动PrEP将随机接受PrEP iT！或常规护理6个月， 在基线、3个月和6个月随访时间点收集生物学和自我报告的结局。 将收集干预使用数据，以评估哪些干预成分影响研究结局。出口 将对10名YMSM进行访谈，以进一步完善干预措施，进行更大规模的试验。PrEP iT！是 创新，因为它是第一个使用移动的电话技术来促进虚拟对等支持的干预， 该研究通过解决关键差距（坚持和保留）， YMSM之间的PrEP护理，并且是可持续的，因为它将建立在一个开源平台上， 整合到临床和社区设置服务YMSM。如果PrEP IT！干预被证明是 如果这种做法有效，就可以迅速扩大规模，广泛传播。

Abstract Young men who have sex with men (YMSM), especially those who are Black and Hispanic/Latino, are disproportionately impacted by new HIV infections. Pre-exposure prophylaxis (PrEP) is one of the most effective HIV prevention tools, however its benefits are directly correlated with medication adherence to sustain adequate tenofovir (TFV) levels in blood. Recent studies (ATN 110 & 113) show that young MSM prescribed PrEP struggle with adherence, especially when healthcare appointments are reduced from monthly to every 3 months, and most fail to maintain protective drug levels via PrEP over time. This has prompted calls for youth- specific interventions consisting of peer support groups and frequent healthcare interactions for YMSM on PrEP. The proposed study responds directly these recommendations by developing and pilot testing a mobile peer support intervention to improve PrEP adherence and retention in PrEP care for YMSM ages 18-29 years, called “PrEP it Together” (or PrEP iT!). PrEP iT! is grounded in the principles of the Technology Adoption Model and the Information, Motivation, and Behavioral Skills (IMB) model and includes virtual peer interaction and support, youth-centered PrEP and sexual health information, adherence reminders and self-monitoring, text message follow-up for youth whose adherence may be faltering, healthcare appointment reminders, healthcare provider interactions, and gamification components to optimize engagement. First, we will develop the PrEP iT! mobile intervention through focus groups with YMSM and refine iterations through input from a community advisory board (CAB). Four focus groups will be conducted to gain feedback on an existing mobile platform from which PrEP iT! will be adapted. Next, a CAB of YMSM will provide regular feedback during the iterative intervention design process. Usability testing with 6 members of the target population will be conducted, culminating in a final version of PrEP iT! Second, in preparation for a subsequent R01 trial, we will conduct a pilot randomized controlled trial to assess the feasibility, acceptability and preliminary impact of the PrEP iT! intervention for YMSM. Eighty YMSM recently initiating or restarting PrEP will be randomized to receive either PrEP iT! or usual care for 6 months, with biological and self-reported outcomes collected at baseline, and 3- and 6-month follow-up time points. Intervention use data will be collected to assess which intervention components impact study outcomes. Exit interviews of 10 YMSM will be conducted to further refine the intervention for a larger trial. PrEP iT! is innovative because it is the first intervention to use mobile phone technology to facilitate virtual peer support for YMSM on PrEP. The study advances PrEP science by addressing critical gaps (adherence & retention) in PrEP care among YMSM, and is sustainable because it will be built on an open source platform that may be integrated into clinical and community settings serving YMSM. If the PrEP iT! intervention is demonstrated to be effective, it may be quickly scaled up for wide-scale dissemination.