Smart Steps: A context-aware adherence intervention to improve PrEP adherence among men who have sex with men (MSM) with substance use disorder

项目摘要 坚持每日一次替诺福韦酯/恩曲他滨作为暴露前预防（PrEP） 近99%的预防艾滋病毒感染的有效性，但坚持仍然具有挑战性，特别是在男性中， 与患有物质使用障碍（SUD）的男性发生性关系（MSM）。MSM继续经历不成比例的 艾滋病毒的风险; 2018年美国10%的新艾滋病毒感染者是男男性行为者。物质使用是一种 由于危险性活动、共用针头 无组织的日常工作和难以学习坚持技能。在患有SUD的MSM中，测量依从性 仍然是至关重要的理解方法，以支持PrEP坚持之间的风险个人。一 一种数字药丸系统（DPS），包括集成到明胶胶囊中的可摄取射频发射器， PrEP胶囊可以提供PrEP摄入事件的直接确认。在这种背景下， 事件的发生可以提供对不依从病因学的重要见解，以及可能 通过个性化的行为干预来解决。我们目前的工作表明，MSM与 SUD将接受并操作DPS以衡量PrEP依从性，并愿意接受以下干预措施： 说明了从数字药丸中摄取PrEP的模式。这个Avenir奖需要高风险，但高回报 通过开发SmartSteps（一种环境感知的先行干预措施，可提高PrEP依从性）来推进 来自数字药丸的数据，将其与数字表型相结合，以预测潜在的PrEP不依从性。在 面对预期的不依从性，SmartSteps将提供经验性纠正反馈，从而减轻PrEP 在它发生之前不遵守。这项建议将包括两个阶段。在第一阶段，我们将通知 使用智能手机数字表型特征（位置，蓝牙， 充电、加速度测量、应用程序使用、电话和文本使用），以预测 数字药丸我们将利用一个数字表型应用程序Beiwe，它可以安全和匿名地收集原始数据。 智能手机使用数据。我们将招募N=40名使用药物的MSM，以利用数字药丸进行PrEP 与Beiwe合作超过60天，以生成用于训练算法的数据集 在SmartSteps后面。在第二阶段，我们将进行一项SmartSteps的试点随机对照试验， 在HIV阴性的MSM物质使用障碍患者中进行常规治疗， 了解SmartSteps在减少不依从性和改善总体效果方面的潜力 每周坚持。这一建议的总体影响将是制定一个环境意识，预期 干预，推进艾滋病毒预防和SUD坚持干预的科学。SmartSteps将 也可以作为一个架构框架，为类似干预措施的开发提供信息， 其他慢性疾病中的不依从性。

PROJECT SUMMARY Adherence to once daily tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis (PrEP) is nearly 99% effective in preventing HIV infection yet adherence remains challenging especially among men who have sex with men (MSM) with substance use disorder (SUD). MSM continue to experience disproportionate risk of HIV; 10% of new HIV infections in the United States in 2018 were among MSM. Substance use is a significant comorbidity and risk factor for HIV infection due to increased risky sexual activity, needle sharing, disorganized routines and difficulty learning adherence skills. Among MSM with SUD, measuring adherence remains critical to understanding methods in which to support PrEP adherence among at risk individuals. A digital pill system (DPS) comprising an ingestible radiofrequency emitter integrated into a gelatin capsule which overencapsulates PrEP can provide direct confirmation of PrEP ingestion events. The context in which these events occur can provide important insights into the etiology of nonadherence and challenges that may be addressed through personalized behavioral interventions. Our current work has demonstrated that MSM with SUD will accept and operate the DPS to measure PrEP adherence and are willing to accept interventions that account for patterns of PrEP ingestion from the digital pill. This Avenir Award takes a high risk, yet high reward advance by developing SmartSteps, a context aware, antecedent intervention that digests PrEP adherence data from the digital pill, combines it with digital phenotyping to anticipate potential PrEP nonadherence. In the face of anticipated nonadherence SmartSteps will deliver empiric corrective feedback thereby mitigating PrEP nonadherence before it occurs. This proposal will consist of two phases. In phase I, we will inform the specification of an algorithm that utilizes smartphone digital phenotyping features (location, Bluetooth, charging, accelerometry, app usage, phone and text usage) to anticipate PrEP nonadherence annotated by the digital pill. We will utilize a digital phenotyping app, Beiwe, which securely and anonymously collects raw smartphone use data. We will recruit N=40 MSM with substance use to utilize the digital pill for PrEP adherence in concert with Beiwe over 60 days to generate a dataset that will be used to train the algorithm behind SmartSteps. In phase II, we will conduct a pilot randomized controlled trial of SmartSteps compared to treatment as usual among HIV negative MSM with substance use disorder with a primary outcome of understanding the potential for an effect of SmartSteps in mitigating nonadherence and improving both overall and weekly adherence. The overall impact of this proposal will be to develop a context aware, anticipatory intervention that advances the science of adherence interventions in HIV prevention and SUD. SmartSteps will also serve as an architectural framework to inform the development of similar interventions that anticipate nonadherence in other chronic diseases.