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

摘要 与男性发生性行为的非裔美国人男性(AAMSM)艾滋病毒感染率高，不成比例 死亡率。结束艾滋病毒流行的关键是努力通过优化抗逆转录病毒疗法来减少艾滋病毒传播 坚持和抑制病毒载量。我们建议在以下领域使用响应式电子遵从性监控(EAM 一种从最低资源利用率到最高资源利用率的分层方法，其中eAM设备在 当2或7时，检测到不遵守的时间以及预先确定的社会支持人员或案例经理 分别检测到连续未遵守的天数。我们把我们的方法称为“A团队”(抗逆转录病毒 治疗电子依从性监测)，因为我们为人们提供一个服务于共同目标的团队 与坚持作斗争。这种干预利用情境信息动机行为技能 模型，并从新兴的社会支持文献中了解到。实时监测ART遵守情况 对错过剂量的分诊反应实时通知患者每个潜在的不依从性事件， 激励服药依从性，并积极影响依从性行为技能，导致病毒感染 压制。这项研究将第一次发现社会支持人员和个案经理是如何看待 这种方法，他们可能会有什么顾虑，以及他们如何响应一个或多个未接通知 剂量。此应用程序的目的是确定实时遵守的可接受性和可行性 在AAMSM的支持人员和案例经理中进行监控，并试行分流的实时响应 监控AAMSM的遵从性干预。我们将实施为期6个月的试点随机对照试验 在54名感染艾滋病毒的AAMSM患者中，测量ART依从性和病毒抑制(主要结果)。 从该项目中吸取的经验教训可能会对这些人和其他与之生活在一起的人的坚守领域有所帮助 艾滋病毒和其他疾病。

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.