Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial
Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial
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DOI：
10.2196/resprot.8811
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发表时间：
2018-04-01
影响因子：
1.7
通讯作者：
Hightow-Weidman, Lisa B.
中科院分区：
文献类型：
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作者：
LeGrand, Sara;Muessig, Kathryn E.;Hightow-Weidman, Lisa B.
工作背景：在美国，男男性行为者（YMSM）和男男性行为者（YTWSM）的跨性别女性承担着不成比例的流行和偶发艾滋病毒感染负担。一旦确诊，许多YMSM和YTWSM努力从事艾滋病毒护理，坚持抗逆转录病毒疗法（ART），并实现病毒抑制。基于计算机的干预措施，包括那些专注于行为改变，被认为是有效的工具，从事youth.Objective：本协议中描述的研究的目的是评估史诗盟友，一个基于理论的移动的手机应用程序，利用游戏机制和社交网络功能，以提高参与艾滋病毒护理，ART摄取，ART坚持，和病毒抑制之间的艾滋病毒阳性YMSM和YTWSM的疗效。该研究还定性评估干预的可接受性，感知的影响，和sustainable.Methods：这是一个两组，积极控制随机对照试验的史诗盟友应用程序。YMSM和YTWSM年龄16至24岁，含，可检测到的艾滋病毒载量随机1：1内分层的新的护理（新进入艾滋病毒医疗保健12个月前基线访视）干预或控制条件。干预条件通过药物提醒和依从性监测、跟踪选择的依从性相关行为来解决ART依从性障碍（例如，酒精和大麻使用），一个交互式仪表板，显示参与者的依从性相关行为，并提供量身定制的反馈，来自其他用户的鼓励信息，每日HIV/ART教育文章和游戏化功能（例如，小游戏、积分、徽章），以增加行为改变和应用参与的动力。控制条件的特点是每周基于电话的通知，以鼓励参与者在控制应用程序中查看教育信息。在13周，26周和39周时对每组进行随访评估。主要结局指标是病毒抑制。次要结局指标包括参与护理，ART摄取，ART依从性，以及参与护理和ART依从性的心理障碍，包括心理困扰，耻辱和社会supports.Results：基线招募于2015年9月开始，并于2016年9月完成（n=146），干预结果评估持续到2017年8月。主要和次要结局指标的结果预计将于2018年4月30日在ClinicalTrials.gov上报告。结论：如果成功，Epic Allies将代表美国受艾滋病毒影响不成比例的群体的新型依从性干预。坚持治疗的患者将需要更少的门诊次数，经历更少的艾滋病毒相关继发感染，从而减少医疗保健费用和艾滋病毒传播。Epic Allies可以很容易地扩展和采用，用于YMSM和YTWSM的更大人群、其他艾滋病毒阳性人群以及被诊断患有糖尿病和高血压等其他慢性疾病的人群。
Background: In the United States, young men who have sex with men (YMSM) and transgender women who have sex with men (YTWSM) bear a disproportionate burden of prevalent and incident HIV infections. Once diagnosed, many YMSM and YTWSM struggle to engage in HIV care, adhere to antiretroviral therapy (ART), and achieve viral suppression. Computer-based interventions, including those focused on behavior change, are recognized as effective tools for engaging youth.Objective: The purpose of the study described in this protocol is to evaluate the efficacy of Epic Allies, a theory-based mobile phone app that utilizes game mechanics and social networking features to improve engagement in HIV care, ART uptake, ART adherence, and viral suppression among HIV-positive YMSM and YTWSM. The study also qualitatively assesses intervention acceptability, perceived impact, and sustainability.Methods: This is a two-group, active-control randomized controlled trial of the Epic Allies app. YMSM and YTWSM aged 16 to 24 inclusive, with detectable HIV viral load are randomized 1:1 within strata of new to care (newly entered HIV medical care 12 months before baseline visit) to intervention or control conditions. The intervention condition addresses ART adherence barriers through medication reminders and adherence monitoring, tracking of select adherence-related behaviors (eg, alcohol and marijuana use), an interactive dashboard that displays the participant's adherence-related behaviors and provides tailored feedback, encouragement messages from other users, daily HIV/ART educational articles, and gamification features (eg, mini-games, points, badges) to increase motivation for behavior change and app engagement. The control condition features weekly phone-based notifications to encourage participants to view educational information in the control app. Follow-up assessments are administered at 13, 26, and 39 weeks for each arm. The primary outcome measure is viral suppression. Secondary outcome measures include engagement in care, ART uptake, ART adherence, and psychosocial barriers to engagement in care and ART adherence, including psychological distress, stigma, and social support.Results: Baseline enrollment began in September 2015 and was completed in September 2016 (n=146), and assessment of intervention outcomes continued through August 2017. Results for primary and secondary outcome measures are expected to be reported in ClinicalTrials.gov by April 30, 2018.Conclusions: If successful, Epic Allies will represent a novel adherence intervention for a group disproportionately impacted by HIV in the United States. Adherent patients would require less frequent clinic visits and experience fewer HIV-related secondary infections, thereby reducing health care costs and HIV transmission. Epic Allies could easily be expanded and adopted for use among larger populations of YMSM and YTWSM, other HIV-positive populations, and for those diagnosed with other chronic diseases such as diabetes and hypertension.