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

项目总结 坚持每天一次的替诺福韦富马酸异丙酯/恩曲他滨作为暴露前预防(PrEP)是 近99%的人在预防艾滋病毒感染方面有效，但坚持治疗仍然具有挑战性，特别是在 与患有物质使用障碍的男性(MSM)发生性关系。男男性接触者继续经历不成比例的情况 艾滋病毒风险；2018年美国新增艾滋病毒感染者中有10%是男男性接触者。物质使用是一种 高风险性行为、共用针头、 杂乱无章的例行公事和难以学习坚持技能。在患有SUD的MSM中，测量依从性 对于了解支持高危人群遵守PrEP的方法仍然至关重要。一个 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，明胶胶囊 包膜PrEP可直接确认PrEP摄取事件。这些项目所处的环境 发生的事件可以为不遵守的原因和可能存在的挑战提供重要的见解 通过个性化的行为干预得到解决。我们目前的工作已经证明，MSM与 SUD将接受并运行DPS以衡量PrEP的遵守情况，并愿意接受 解释了数字药片中PrEP的摄取模式。这个Avenir奖冒着高风险，但回报却很高 通过开发SmartSteps来推进，SmartSteps是一种情景感知的事前干预，可以消化PrEP的遵守情况 来自数字药片的数据，将其与数字表型相结合，以预测潜在的PrEP不依从性。在 面对预期的不遵守，SmartSteps将提供经验性的纠正反馈，从而减轻PrEP 在它发生之前不坚持。这项提议将包括两个阶段。在第一阶段，我们会通知 使用智能手机数字表型特征(位置、蓝牙、 充电、加速测量、应用程序使用、电话和文本使用)来预测PrEP不遵守 数字药丸。我们将利用数字表型应用程序beewe，它安全且匿名地收集原始数据 智能手机使用数据。我们将招募N=40名有物质使用的MSM，以利用数字药丸进行PrEP 坚持与北威合作超过60天，以生成将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，与 HIV阴性MSM合并药物使用障碍的常规治疗，主要结果为 了解SmartSteps在减少不遵守和全面改善两者方面的潜在影响 每周坚持一次。这项提议的总体影响将是建立一种背景感知的、可预见的 在艾滋病毒预防和SUD中推进坚持科学干预的干预措施。SmartSteps将 还作为一个架构框架，为开发类似的干预措施提供信息，这些干预措施预计 在其他慢性病中不坚持。

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.