A Smart Phone App to Improve ART Adherence among HIV+ Stimulant-using MSM

描述（由申请人提供）：与男性发生性行为的hiv阳性男性使用甲基苯丙胺与次优依从性、不良临床结果、性冒险和更高水平的生活混乱有关。由于这些原因，使用甲基苯丙胺的男男性行为者（HIV阳性MU-MSM）需要根据其独特的情况、关注点和生活方式量身定制抗逆转录病毒治疗（ART）依从性干预措施。该项目的总体目标是开发和评估一种智能手机应用程序（“应用程序”）抗逆转录病毒治疗依从性干预措施的可行性和可接受性，该干预措施是根据艾滋病毒+ MU-MSM的需求量身定制的，并以信息-动机-行为技能（IMB）模型的改编版本为基础。尽管IMB模型核心结构中的大部分内容可能适用于这一人群，但影响HIV+ MU-MSM中依从性信息、动机和行为技能的独特内容和情境因素尚未得到实证确定。此外，还没有开展专门针对艾滋病毒阳性男男性行为者需求的基于技术的抗逆转录病毒治疗依从性干预措施。为了解决这些理论和干预差距，我们提出了一个四阶段的研究。在第一阶段，将进行四个在线焦点小组，以充分阐明HIV+ MU-MSM的IMB模型，并为目标人群调整与IMB相关的依从性措施。第二阶段的目标是测量、表征和评估HIV+ MU-MSM的抗逆转录病毒治疗依从性，以及第一阶段开发的抗逆转录病毒治疗依从性的适应IMB模型。HIV+ MU-MSM （n=209）将被在线招募参加一项关于抗逆转录病毒治疗依从性、适应的imb相关措施、药物使用和经验得出的依从性差的决定因素（如抑郁症）的调查。此外，参与者将报告他们的技术使用情况和对智能手机应用程序内容的偏好，以告知干预措施的发展。第三阶段是开发针对HIV+ MU-MSM的智能手机应用ART依从性干预并进行可用性测试。干预部分将包括量身定制的信息信息、激励个人干预指南、药物提醒和监测、自我反思和策略排练。在最终确定外观和内容之前，干预将在五名参与者中进行可用性测试。智能手机应用程序ART依从性干预将在艾滋病毒阳性MU-MSM中进行第四阶段的试点测试。随机分配到实验组的HIV+ MU-MSM将参加为期60天的智能手机应用干预。实验组（n=30）和对照组（n=30）的依从性水平将在基线、干预后和2个月时进行比较。整个研究期间将收集过程（例如每周访问干预措施的天数，总体保留率）以及用户可接受性和满意度的措施。拟议的研究对公共卫生的主要意义是提高药物使用人群的抗逆转录病毒治疗依从性，并降低男男性行为者中的艾滋病毒传播率。如果发现有效，干预措施可迅速扩大推广，并适用于其他物质使用人群。

DESCRIPTION (provided by applicant): Methamphetamine use among HIV-positive men who have sex with men is associated with sub-optimal adherence, poor clinical outcomes, sexual risk-taking, and higher levels of life chaos. For these reasons, HIV- positive methamphetamine-using men who have sex with men (HIV+ MU-MSM) require antiretroviral therapy (ART) adherence interventions tailored to their unique context, concerns, and lifestyle. The overall aim of this project is to develop and assess the feasibility and acceptability of a smart phone application ("app") ART adherence intervention tailored to the needs of HIV+ MU-MSM and grounded in an adapted version of the Information-Motivation-Behavioral Skills (IMB) model. Although much of the content within the core constructs of the IMB model are likely applicable to this population, unique content and situational factors that influence adherence information, motivation, and behavioral skills among HIV+ MU-MSM have not been empirically determined. Moreover, no technology-based ART adherence interventions specifically tailored to the needs of HIV-positive MSM have been conducted. To address these theoretical and intervention gaps, we propose a four-phase study. In Phase 1, four online focus groups will be conducted to fully explicate the IMB model for HIV+ MU-MSM and to adapt IMB-related adherence measures for the target population. The goal of Phase 2 is to measure, characterize, and evaluate ART adherence in HIV+ MU-MSM and the adapted IMB model of ART adherence developed in Phase 1. HIV+ MU-MSM (n=209) will be recruited online to participate in a survey of ART adherence, the adapted IMB-related measures, substance use, and empirically derived determinants of poor adherence (e.g., depression). In addition, participants will report their technology use and preferences for smart phone application content to inform intervention development. Phase 3 is to develop and conduct usability testing on the smart phone application ART adherence intervention tailored for HIV+ MU-MSM. Intervention components will consist of tailored informational messages, a motivational personal intervention guide, medication reminders and monitoring, self-reflection and strategy rehearsal. The intervention will be usability tested among five participants prior to finalizing the look and content. The smar phone application ART adherence intervention will be pilot tested among HIV+ MU-MSM in Phase 4. HIV+ MU-MSM randomized to the experimental group will participate in the smart phone application intervention for 60 days. Adherence levels of the experimental (n=30) and treatment-as-usual control (n=30) groups will be compared at baseline, post-intervention, and 2 months. Process (e.g. days per week accessing the intervention, overall retention), as well as user acceptability and satisfaction, measures will be collected throughout the study period. The primary significance of the proposed research to public health is to improve ART adherence among substance-using populations and reduce rates of HIV transmission among men who have sex with men. If found effective, the intervention could be scaled-up rapidly for dissemination and adapted to other substance-using populations.