SteadyRx: Smartphone ART adherence intervention for drug users

SteadyRx：针对吸毒者的智能手机 ART 依从性干预

• 批准号: 9064486
• 负责人: Anthony DeFulio
• 金额: $ 24.28万
• 依托单位: WESTERN MICHIGAN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9064486
• 关键词: AIDS/HIV problem; Adherence; Adult; Agonist; Anti-Retroviral Agents; Behavior Therapy; CD4 Lymphocyte Count; Calendar; Caring; Cellular Phone; Consult; Consultations; Counseling; Crack Cocaine; Data; Development; Dose; Drug usage; Drug user; Effectiveness; Electronics; Enrollment; Goals; HIV; Health; Health Benefit; Incentives; Individual; Intervention; Life Expectancy; North America; Opiates; Participant; Patients; Pharmaceutical Preparations; Pharmacotherapy; Pilot Projects; Population; Primary Health Care; Probability; Provider; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Research Personnel; Resistance development; Rewards; Services; Staging; Techniques; Treatment Protocols; Viral Load result; antiretroviral therapy; base; cocaine use; contingency management; directly administered antiretroviral therapy; experience; fight against; health literacy; high risk; improved; injection drug use; innovation; methadone maintenance; novel; post intervention; therapy adherence; therapy design; therapy development; transmission process; treatment as usual; virtual

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.

抗逆转录病毒疗法（ART）增加了艾滋病毒感染者的预期寿命和生活质量，并可以减少艾滋病毒传播的机会，但对大多数人来说，要实现这些益处，需要高度坚持ART。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。最显著的是直接施用的抗逆转录病毒疗法（直接观察抗逆转录病毒治疗和患者支持）和应急管理（根据依从性的客观证据提供奖励）在促进吸毒者短期坚持抗逆转录病毒疗法方面是有效的。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作为吸毒者长期甚至永久的抗逆转录病毒疗法替代品来实施。第一阶段行为疗法开发项目计划在2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，并以一种允许其大规模实施的方式交付，这种ART依从性干预将有效成分干预的目标组捆绑到智能手机应用程序中，患者使用方便，管理简单，最大限度地方便了所有利益相关者。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） 当剂量过期时提供提醒，（3）提供药物服用的电子远程观察，和（4）奖励ART依从性（咨询-提醒-观察-奖励; CROW）。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。重要的是，目前正在开发的任何移动的/远程干预都没有CROW那么密集。除了开发这种基于智能手机的干预措施外，还将在50名接受阿片类激动剂药物治疗的可检测病毒载量的HIV阳性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CROW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，CROW干预可以满足对高效和可扩展的长期干预的迫切需求，以增加吸毒者对抗逆转录病毒治疗的依从性。