DOT Diary (D2): Developing a mobile app with combined automated DOT and daily sexual diary for monitoring and improving PrEP adherence

 说明(申请人提供)：暴露前预防(每日抗逆转录病毒疗法，以防止有性行为接触的未感染者感染艾滋病毒)的几项疗效试验因药物依从性差而失败。为了确保准确、纵向地测量药片摄入量并进行实时监测，我们计划开发DOT Diary(D2)，这是一款智能手机应用程序，使用人工智能来测量使用直接观察疗法的药片摄入量。这项专利技术将与日常性日记结合在一起，用于未来的PrEP观察和疗效试验。这种方法提供了单个参与者、研究地点和整个试验的汇总数据，有助于实时反馈以最大限度地遵守。我们计划了一个构建和评估D2的三个阶段的过程。首先，我们将评估DOT自动化工具的可靠性和有效性，以确定 试图“作弊”和过度报告服用避孕药，以及评估该措施对检测到1至3周的避孕药使用中断的敏感性。其次，我们将开发和优化D2对参与者和研究人员跟踪参与时间的可行性和可接受性，并向研究参与者提供实时依从性反馈。最后，我们将为男男性行为的高危男性进行一项为期24周的D2试点研究，以评估该工具可在未来的PrEP试验中成功用于衡量和优化依从性的可能性。

 DESCRIPTION (provided by applicant): Several efficacy trials of pre-exposure prophylaxis (daily antiretroviral therapy to prevent HIV acquisition in uninfected persons with sexual exposures) have failed because of poor adherence to medications. To ensure accurate, longitudinal measurement of pill ingestion with real-time monitoring, we plan to develop DOT Diary (D2), a smartphone application that uses artificial intelligence for measuring pill taking using Directly Observed Therapy. This patented technology will be combined with a daily sexual diary for use in future PrEP observational and efficacy trials. Such an approach provides aggregated data for individual participants, study sites, and trials overall, that facilitates realtime feedback to maximize adherence. We plan a 3 stage process for building and evaluating D2. First, we will assess the assess the reliability and validity of the automated DOT tool to identify attempts to "cheat" and over-report pill taking, as well as to evaluate the sensitivity of the measure to detecting 1- to 3-week interruptions in pill use. Second, we will develop and optimize the feasibility and acceptability of D2 for participants and study staff in tracking participation ver time, and providing real-time adherence feedback to study participants. Lastly, we will run a 24-week pilot study of D2 for high-risk men who have sex with men to evaluate the plausibility that this tool can be successfully used to measure and optimize adherence in future PrEP trials.