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，并与抗逆转录病毒治疗(ART)的次优坚持、不良的临床结果和性风险有关。此外，男男性接触者代表着一个独特的人群，他们的干预需求与他们的异性恋同行不同。出于这些原因，使用HIV阳性兴奋剂的男男性接触者(HIV+SU-MSM)需要根据他们独特的背景、关切和生活方式进行ART依从性干预。尽管有这种迫切的需求，但尚未开发出专门针对HIV+SU-MSM需求的基于技术的抗逆转录病毒治疗依从性干预措施，并评估其对这一人群的可行性和可接受性。我们将使用三阶段方法来开发和评估智能手机应用程序(APP)艺术遵守干预的可行性和可接受性，该干预措施针对HIV+SU-MSM的需求而量身定做，以信息-动机-行为技能(IMB)模型为基础。目标1将由4个在线焦点小组(每个小组8-10名男性)组成，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HIV+SU-MSM对下载ART坚持应用程序的兴趣，启动其使用，并随着时间的推移保持与该应用程序的参与度。此外，焦点小组参与者将被要求描述他们对艺术坚持信息、动机和行为技能的需求。Aim 2将利用焦点小组的经验教训，开发一款为HIV+SU-MSM量身定做的新型智能手机应用程序，以提高他们对艺术的坚持。干预部分将包括定制的信息信息、激励性个人干预指南、药物提醒、艺术和药物使用自我监测、自我反省和战略演练。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。将在AIM 3的76名HIV+SU-MSM中进行初步测试。干预组(n=38)将参加为期60天的智能手机APP干预，而对照组(n=38)参与者将通过现有医疗照常接受治疗。小组依从性结果将在基线、干预后以及3个月和6个月的随访中进行比较。在被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APP组件的使用、服用ART剂量的百分比、克服依从性障碍的建议策略的评级、药物渴望和使用兴奋剂的经历。将在整个研究期间收集这些和其他可行性(例如，每周获得干预的天数、总体保留率)和可接受性(例如，自我报告的可接受性和用户参与度)指标，以便为随后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对抗逆转录病毒药物的依从性，并降低男男性接触者中艾滋病毒的传播率。如果被发现有效，智能手机应用程序干预将随时可用于扩大规模，通过与高负担地区以及低资源和农村地区的艾滋病毒诊所合作，在全国范围内传播。

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.