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

描述（由申请人提供）：兴奋剂使用在男男性行为者（MSM）中很普遍，并与抗逆转录病毒治疗（ART）的次优依从性、不良临床结果和性冒险相关。此外，男同性恋者代表着一个独特的群体，他们的干预需求与异性恋者不同。由于这些原因，使用艾滋病毒阳性兴奋剂的男男性行为者（HIV+ SU-MSM）需要根据其独特的背景、关注点和生活方式量身定制抗逆转录病毒治疗依从性干预措施。尽管存在这一迫切需求，但目前还没有针对艾滋病毒阳性男性男性行为者的需求开发并评估其可行性和可接受性的基于技术的抗逆转录病毒治疗依从性干预措施。我们将采用一种基于信息-动机-行为技能（IMB）模型的智能手机应用程序（“应用程序”）开发和评估抗逆转录病毒治疗依从性干预的可行性和可接受性，该干预是根据HIV+ SU-MSM的需求量身定制的。目标1将包括4个在线焦点小组（每个小组8-10名男性），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男性男性男性对下载抗逆转录病毒治疗依从性应用程序的兴趣，开始使用该应用程序，并长期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抗逆转录病毒治疗依从性信息、动机和行为技能需求。从焦点小组获得的经验教训将用于目标2，开发一款针对艾滋病毒阳性男男性行为者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。干预部分将包括量身定制的信息信息、激励性个人干预指南、药物提醒、抗逆转录病毒治疗和药物使用自我监测、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。开发的干预措施将在第三阶段的76名艾滋病毒阳性男男性行为者中进行试点试验。HIV+ SU-MSM随机分为干预组（n=38）参与智能手机应用干预60天，对照组（n=38）参与者通过现有医疗照护照旧。各组依从性结果将在基线、干预后、3个月和6个月随访时进行比较。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情况、服用ART剂量的百分比、克服依从性障碍的建议策略的评级、药物渴望的经历和兴奋剂的使用。这些和其他可行性（例如，每周使用干预措施的天数，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）指标将在整个研究期间收集，以便为后续的大规模随机对照试验提供信息。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，并降低男同性恋者之间的艾滋病毒传播率。如果发现有效，智能手机应用程序干预将随时可用，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，扩大在全国范围内的传播。

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.