SteadyRx: Smartphone ART adherence intervention for drug users

抗逆转录病毒疗法（ART）增加了HIV感染者的预期寿命和生活质量，并可以减少HIV传播的机会，但需要高度坚持ART才能实现这些益处。不幸的是，北美只有59%的患者报告ART依从性> 90%。因此，坚持抗逆转录病毒疗法的干预措施是防治艾滋病毒/艾滋病斗争的一个关键部分。注射毒品和快克可卡因的使用是艾滋病毒传播的主要因素，并与不坚持抗逆转录病毒疗法有关。几种类型的干预措施，最主要的是直接给予抗逆转录病毒疗法（直接观察抗逆转录病毒药物的施用和患者支持）和应急管理（根据坚持的客观证据提供奖励），在促进吸毒者坚持抗逆转录病毒疗法方面一直有效。然而，所有抗逆转录病毒疗法依从性干预措施的一个核心问题是，在干预措施停止后，其效果不会持续。干预后效果消散的共同发现表明，抗逆转录病毒疗法依从性干预措施可能需要长期甚至永久地阻止吸毒者接受抗逆转录病毒疗法。第一阶段行为疗法开发项目计划在3年内开发一种强化干预措施，其中包括促进吸毒者坚持抗逆转录病毒疗法的最有效技术，并以允许其作为长期甚至永久性抗逆转录病毒疗法的大规模实施的方式提供这些技术。我们将把目标群体的有效成分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措施。为此，在该项目下开发的SteadyRX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）在剂量过期时提供提醒，（3）提供药物服用的电子远程观察，以及（4）奖励ART依从性。拟议的干预措施是高度创新的：以前没有ART依从性干预措施涉及直接观察药物管理和应急管理，尽管它们各自的有效性孤立。开发过程将包括来自提供者、卫生管理人员和患者的反馈，并将对应用程序和相关培训材料进行广泛的小规模测试。除了开发这种基于智能手机的干预措施外，还将在50名参加阿片类激动剂药物治疗的可检测病毒载量的HIV+成人中进行试点研究。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SteadyRX智能手机干预。本初步研究的数据将用于证明干预的可行性和可接受性，并提供计划全面随机对照试验所需的有效性数据。总体而言，SteadyRX干预可以满足对高效和可扩展的长期干预的迫切需求，以增加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. 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 patient supports) and contingency management (the provision of incentives contingent upon objective evidence of adherence) have been effective in promoting 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 long-term or even permanent adjuncts to ART for drug users. A Stage 1 Behavior Therapy Development project is planned over 3 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. Thus, we 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 SteadyRX 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. 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. The development process will include feedback from providers, health administrators, and patients and will feature extensive small scale testing of the application and associated training materials. 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 SteadyRX 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 SteadyRX intervention could fill the urgent need for a highly effective and scalable long-term intervention to increase adherence to antiretroviral therapy in drug users.