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: 8731601
• 负责人: Anthony DeFulio
• 金额: $ 28.71万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8731601
• 关键词: AIDS/HIV problem; Adherence; Administrator; Adult; Agonist; Anti-Retroviral Agents; Behavior Therapy; CD4 Lymphocyte Count; Calendar; Caring; Consultations; Counseling; Crack Cocaine; Data; Development; Developmental Process; Dose; Drug usage; Drug user; Effectiveness; Electronics; Enrollment; Feedback; Focus Groups; Goals; HIV; Health; Health Benefit; Health Personnel; Incentives; Individual; Intervention; Life Expectancy; Modification; North America; Opiates; Participant; Patients; Pharmaceutical Preparations; Pharmacotherapy; Pilot Projects; Population; Primary Care Physician; Primary Health Care; Probability; Process; Provider; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Research Personnel; Resistance development; Rewards; Services; Staging; Target Populations; Techniques; Technology; Testing; Training; Treatment Protocols; Viral Load result; antiretroviral therapy; base; cocaine use; contingency management; design; directly administered antiretroviral therapy; experience; fight against; health literacy; high risk; improved; injection drug use; innovation; member; methadone maintenance; novel; post intervention; public health relevance; 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. 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.

描述（由申请人提供）：抗逆转录病毒疗法 (ART) 可以延长 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，ART 依从干预措施是抗击艾滋病毒/艾滋病的重要组成部分。注射毒品和强效可卡因的使用是艾滋病毒传播的主要因素，并且与不遵守抗逆转录病毒治疗有关。几种类型的干预措施，最显着的是直接给予抗逆转录病毒治疗（直接观察抗逆转录病毒治疗和患者支持）和应急管理（根据坚持的客观证据提供激励），已有效促进吸毒者坚持抗逆转录病毒治疗。然而，所有 ART 依从性干预措施的一个核心问题是，干预措施停止后其效果不会持续。干预后效果消失的常见发现表明，对于吸毒者来说，ART 依从性干预可能需要成为 ART 的长期甚至永久辅助手段。第一阶段行为治疗开发项目计划在 3 年时间内开发强化干预措施，其中纳入促进吸毒者坚持 ART 的最有效技术，并以允许大规模实施的方式作为 ART 的长期甚至永久辅助手段。因此，我们将把一组有针对性的有效干预措施捆绑到智能手机应用程序中，该应用程序易于患者使用，易于管理，并为所有利益相关者提供最大程度的便利。我们的最终目标是制定高效且可扩展的干预措施。为此，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咨询 (2) 在剂量逾期时提供提醒，(3) 提供服药情况的电子远程观察，以及 (4) 奖励 ART 依从性。拟议的干预措施具有高度创新性：以前的 ART 依从性干预措施均未涉及直接观察药物管理和应急管理，尽管它们各自单独有效。开发过程将包括来自提供者、健康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，还将对 50 名可检测到病毒载量的 HIV+ 成年人进行一项试点研究，这些成年人正在接受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 SteadyRX 智能手机干预。该试点研究的数据将用于证明干预措施的可行性和可接受性，并提供规划全面随机对照试验所需的功效数据。总体而言，SteadyRX 干预措施可以满足对高效且可扩展的长期干预措施的迫切需求，以提高吸毒者对抗逆转录病毒治疗的依从性。