Feasibility, acceptability, and pilot trial of a real-time electronic adherence monitoring intervention for antiretroviral therapy

抗逆转录病毒治疗实时电子依从性监测干预措施的可行性、可接受性和试点试验

• 批准号: 10759928
• 负责人: Mark S Dworkin
• 金额: $ 71.07万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10759928
• 关键词: Accountability; Adherence; Affect; Antiretroviral drug resistance; Behavioral; Case Manager; Chicago; China; Cost Savings; Coupled; Data; Dedications; Disease; Dose; Empathy; Epidemic; Event; Goals; HIV; HIV Infections; Health; Individual; Interruption; Intervention; Interview; Knowledge; Learning; Literature; Measures; Mental Health; Methods; Modeling; Monitor; Morbidity - disease rate; Motivation; Notification; Outcome; Patients; Persons; Pharmaceutical Preparations; Population; Preparation; Prevention; Randomized, Controlled Trials; Reaction Time; Research; Resistance; Resources; Services; Social support; South Africa; Technology; Testing; Text; Time; Treatment Failure; Triage; Trust; Uganda; United States National Institutes of Health; Viral; Viral Load result; Virus; Wireless Technology; Work; acceptability and feasibility; antiretroviral therapy; behavioral adherence; black men; black men who have sex with men; electronic adherence monitoring; experience; flexibility; forgetting; improved; infection rate; medication compliance; men; men who have sex with men; monitoring device; mortality; pilot trial; primary outcome; randomized, clinical trials; real time monitoring; response; skills; social engagement; success; therapy adherence; transmission process; viral transmission; wireless electronic

ABSTRACT African American men who have sex with men (AAMSM) have high HIV infection rates and disproportionate mortality. Critical to ending the HIV epidemic are efforts to reduce HIV transmission by optimizing ART adherence and suppressing viral load. We propose using responsive electronic adherence monitoring (EAM) in a tiered approach from least to most resource utilization where the EAM device alerts the medication user at the time nonadherence is detected and a pre-identified social support person or case manager when 2 or 7 consecutive days of nonadherence are detected, respectively. We call our approach “A-Team” (Antiretroviral Therapy Electronic Adherence Monitoring) because we provide a team serving a common goal to persons struggling with adherence. This intervention draws on the situated Information Motivation Behavioral Skills Model and is informed by emerging social support literature. Real-time ART adherence monitoring with a triaged response to missed doses informs the patient in real-time of each potential nonadherence event, motivates medication adherence, and positively influences adherence behavioral skills, resulting in viral suppression. This study will be the first to discover how social support persons and case managers perceive this approach, what concerns they may have, and how they respond to one or multiple notifications of missed doses. The aims of this application are to determine the acceptability and feasibility of real-time adherence monitoring in support persons and case managers of AAMSM and to pilot a triaged responsive real-time monitoring adherence intervention for AAMSM. We will implement a 6-month pilot randomized controlled trial among 54 AAMSM living with HIV and measure ART adherence and viral suppression (the primary outcome). Lessons learned from this project may be useful to the field of adherence in these and other persons living with HIV and other diseases.

摘要 与男性发生性关系的非洲裔美国人（AAMSM）艾滋病毒感染率高， mortality.通过优化抗逆转录病毒疗法减少艾滋病毒传播的努力是结束艾滋病毒流行的关键 粘附和抑制病毒载量。我们建议使用响应式电子依从性监测（EAM）， 从最少到最多资源利用的分层方法，其中EAM设备在以下情况下提醒药物用户： 检测到不依从的时间，以及当2或7 分别检测到连续几天的不遵守。我们称我们的方法为“A-Team”（抗逆转录病毒 治疗电子依从性监测），因为我们提供了一个团队，为人们提供共同的目标 努力坚持。这种干预借鉴了情境信息动机行为技能 模型，并告知新兴的社会支持文献。实时ART依从性监测， 对漏服剂量的分诊响应实时通知患者每个潜在的不依从事件， 激励药物依从性，并积极影响依从性行为技能，导致病毒性 镇压本研究将首次探讨社会支持者与个案管理者对个案管理的认知 这种方法，他们可能有什么顾虑，以及他们如何回应一个或多个错过的通知， 剂量本申请的目的是确定实时依从性的可接受性和可行性 监测AAMSM的支持人员和病例管理员，并试点分类响应实时 监测AAMSM的依从性干预。我们将实施为期6个月的随机对照试验 在54名AAMSM艾滋病毒感染者中，测量ART依从性和病毒抑制（主要结局）。 从这个项目中吸取的经验教训可能对这些和其他生活在一起的人的遵守领域有用。 艾滋病毒和其他疾病。