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

描述（由申请人提供）：兴奋剂的使用在男男性行为者（MSM）中很普遍，并且与抗逆转录病毒治疗（ART）的次优依从性、不良临床结局和性冒险有关。此外，男男性行为者代表了一个独特的人群，其干预需求不同于异性恋者。由于这些原因，HIV阳性兴奋剂使用MSM（HIV+ SU-MSM）需要根据其独特的背景，关注和生活方式进行ART依从性干预。尽管有这种迫切的需求，没有专门针对艾滋病毒+ SU-MSM的需求开发和评估的可行性和可接受性与这一人群的技术为基础的抗逆转录病毒治疗依从性干预措施。我们将使用一个三阶段的方法来开发和评估的可行性和可接受性的智能手机应用程序（“应用程序”）ART依从性干预艾滋病毒+ SU-MSM的需求量身定制，并在信息动机行为技能（IMB）模型的基础。目标1将包括4个在线焦点小组（每个小组8-10名男子），以确定智能手机应用程序的内容和功能，以最大限度地提高艾滋病毒阳性SU-MSM下载抗逆转录病毒疗法依从性应用程序的兴趣，开始使用该应用程序，并随着时间的推移保持与该应用程序的接触。此外，焦点小组参与者将被要求描述他们的ART依从性信息，动机和行为技能需求。焦点小组的经验教训将用于目标2，以开发针对艾滋病毒+ SU-MSM的新型智能手机应用程序，以提高他们的抗逆转录病毒治疗依从性。干预内容将包括量身定制的信息、激励性个人干预指南、药物提醒、抗逆转录病毒疗法和药物使用自我监测、自我反思和战略演练。在最终确定外观和内容之前，将在五名参与者中对干预措施进行可用性测试。制定的干预措施将在目标3的76名艾滋病毒阳性的SU-MSM中进行试点测试。随机分配到干预组的HIV+ SU-MSM（n=38）将参与60天的智能手机应用程序干预，而对照组（n=38）参与者将通过现有的医疗护理接受常规治疗。将在基线、干预后以及3个月和6个月随访时比较各组依从性结局。在随机分配到干预组的参与者中，将检查干预期间的日常模式，以评估应用程序组件的使用，接受ART剂量的百分比，克服依从性障碍的建议策略的评级，药物渴望和兴奋剂使用的经历。这些和其他可行性（例如每周访问干预的天数、总体保留）和可接受性（例如，自我报告的可接受性和用户参与度）测量，以通知后续的大规模RCT试验。拟议研究对公共卫生的主要意义是提高物质使用人群的抗逆转录病毒治疗依从性，降低男男性行为者的艾滋病毒传播率。如果发现有效，智能手机应用程序干预措施将随时可用于扩大规模，通过与高负担地区、低资源地区和农村地区的艾滋病毒诊所合作，在全国推广。

DESCRIPTION (provided by applicant): Stimulant use is prevalent among men who have sex with men (MSM) and is associated with sub-optimal adherence to antiretroviral therapy (ART), poor clinical outcomes, and sexual risk-taking. Moreover, MSM represent a unique population, whose intervention needs vary from their heterosexual counterparts. For these reasons, HIV-positive stimulant-using MSM (HIV+ SU-MSM) require ART adherence interventions tailored to their unique context, concerns, and lifestyle. Despite this urgent need, no technology-based ART adherence interventions specifically tailored to the needs of HIV+ SU-MSM have been developed and assessed for feasibility and acceptability with this population. We will use a three-phase approach to develop and assess the feasibility and acceptability of a smart phone application ("app") ART adherence intervention tailored to the needs of HIV+ SU-MSM and grounded in the Information-Motivation-Behavioral Skills (IMB) model. Aim 1 will consist of 4 online focus groups (8-10 men each) to identify smart phone app contents and functions to maximize interest among HIV+ SU-MSM in downloading an ART adherence app, initiating its use, and maintaining engagement with the app over time. In addition, focus group participants will be asked to describe their ART adherence informational, motivational and behavioral skills needs. Lessons from the focus groups will be used in Aim 2 to develop a novel smart phone app tailored to HIV+ SU-MSM to improve their ART adherence. Intervention components will consist of tailored informational messages, a motivational personal intervention guide, medication reminders, ART and drug use self-monitoring, self-reflection and strategy rehearsal. The intervention will be usability tested among five participants prior to finalizing the look and content. The developed intervention will be pilot tested among 76 HIV+ SU-MSM in Aim 3. HIV+ SU-MSM randomized to the intervention group (n=38) will participate in the smart phone app intervention for 60 days, while control group (n=38) participants will receive treatment-as-usual through their existing medical care. Group adherence outcomes will be compared at baseline, post-intervention, and 3- and 6-month follow-up. Among participants randomized to the intervention group, daily patterns during the intervention period will be examined to assess app component use, percent of ART doses taken, rating of suggested strategies to overcome adherence barriers, experiences of drug cravings and use of stimulants. These and other feasibility (e.g. days per week accessing the intervention, overall retention) and acceptability (e.g., self-reported acceptability and user engagement) measures will be collected throughout the study period to inform a subsequent large scale RCT trial. 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 MSM. If found effective, the smart phone app intervention will be readily available for scale-up for national dissemination through partnering with HIV clinics in high-burden regions, and in low-resource and rural areas.