SteadyRx: Smartphone ART adherence intervention for drug users

说明(申请人提供)：抗逆转录病毒疗法(ART)可增加艾滋病毒感染者的预期寿命和生活质量，并可减少艾滋病毒传播的机会，但需要高度遵守ART才能为大多数人实现这些好处。不幸的是，在北美，只有59%的患者报告了抗逆转录病毒治疗的依从性，而90%的患者报告了这一点。因此，遵守抗逆转录病毒疗法的干预措施是抗击艾滋病毒/艾滋病斗争的关键部分。注射吸毒和强效可卡因的使用是艾滋病毒传播的主要因素，并与不遵守抗逆转录病毒治疗有关。几种类型的干预措施，尤其是直接实施的抗逆转录病毒治疗(直接观察抗逆转录病毒治疗和患者支持)和应急管理(根据遵守情况的客观证据提供激励措施)在促进吸毒者短期坚持抗逆转录病毒药物方面是有效的。然而，所有ART依从性干预的一个核心问题是，在干预停止后，它们的效果不会持续下去。干预后效果消散的普遍发现表明，对于吸毒者来说，ART依从性干预可能需要作为ART的长期甚至永久辅助手段来实施。第一阶段行为疗法开发项目计划在两年内开发一种强化干预措施，其中包括促进吸毒者遵守ART的最有效技术，并以一种允许其作为ART的长期甚至永久附属物的大规模实施的方式提供这些技术。这种ART遵从性干预将把一组有针对性的有效组件干预捆绑到一个智能手机应用程序中，该应用程序易于患者使用、易于管理，并最大限度地方便所有利益相关者。我们的最终目标是产生一种高度有效和可扩展的干预。为此，在该项目下制定的干预措施将在很大程度上实现自动化，并将(1)促进与护理提供者的协商(2) 当一剂药过期时提供提醒，(3)提供服用药物的电子远程观察，以及(4)奖励艺术坚持(咨询-提醒-观察-奖励；乌鸦)。拟议的干预措施具有很高的创新性：以前没有一项ART依从性干预措施涉及直接观察用药和应急管理，尽管它们各自单独有效。重要的是，目前正在开发的移动/远程干预没有像Crow那样密集。除了开发这种基于智能手机的干预措施外，还将在50名可检测到病毒载量的HIV+成年人中进行一项试点研究，这些成年人参加了阿片激动剂药物治疗。在这项试点研究中，参与者将被随机分配接受常规护理，或常规护理加Crow智能手机干预。这项先导性研究的数据将用于证明干预的可行性和可接受性，并为计划一项全面的随机对照试验提供必要的疗效数据。总体而言，Crow干预可以满足对高效和可扩展的长期干预的迫切需求，以提高吸毒者对抗逆转录病毒治疗的依从性。

DESCRIPTION (provided by applicant): Antiretroviral therapy (ART) increases life expectancy and quality of life for individuals infected with HIV, and can reduce the chance of HIV transmission, but a high degree of adherence to ART is required to achieve these benefits for most people. Unfortunately, only 59% of patients in North America report ART adherence >90%. Thus, ART adherence interventions are a critical part of the fight against HIV/AIDS. Injection drug use and crack cocaine use are major factors in the transmission of HIV, and are associated with non-adherence to ART. Several types of interventions, most notably directly administered antiretroviral therapy (direct observation of antiretroviral administration and patien supports) and contingency management (the provision of incentives contingent upon objective evidence of adherence) have been effective in promoting short-term ART adherence in drug users. However, a core problem with all ART adherence interventions is that their effects do not last after the interventions are discontinued. The common finding of post-intervention dissipation of effects suggests that ART adherence interventions may need to be implemented as long-term or even permanent adjuncts to ART for drug users. A Stage 1 Behavior Therapy Development project is planned over 2 years to develop an intensive intervention that incorporates the most effective techniques for promoting ART adherence in drug users, and delivers them in a manner that allows for their large-scale implementation as long-term or even permanent adjuncts to ART. This ART adherence intervention will bundle a targeted group of effective component interventions into a Smartphone application that is easy for patients to use, simple to manage, and maximally convenient for all stakeholders. Our ultimate goal is to produce an intervention that is highly effective and scalable. Toward that end, the intervention to be developed under this project will be largely automated and will (1) facilitate consultation with care providers (2) provide reminders when a dose is overdue, (3) provide electronic remote observation of medication-taking, and (4) reward ART adherence (Consult-Remind-Observe-reWard; CROW). The proposed intervention is highly innovative: no previous ART adherence intervention has involved direct observation of medication administration and contingency management, despite their respective effectiveness in isolation. Importantly, no mobile/remote intervention currently under development is as intensive as CROW. In addition to developing this Smartphone-based intervention, a pilot study will be conducted in 50 HIV+ adults with a detectable viral load who are enrolled in opiate agonist pharmacotherapy. In this pilot study, participants will be randomly assigned to receive usual care, or usual care plus the CROW Smartphone intervention. The data from this pilot study will serve to demonstrate the feasibility and acceptability of the intervention, and to provide efficacy data necessary to plan a full-scaled randomized controlled trial. Overall, the CROW intervention could fill the urgent need for a highly effective and scalabl long-term intervention to increase adherence to antiretroviral therapy in drug users.