一款基于手机的应用程序（MyChoices），用于提高男男性行为者对艾滋病毒检测和暴露前预防的接受度：一项试点随机对照试验方案。
A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial.
作者信息
Biello Katie B, Marrow Elliot, Mimiaga Matthew J, Sullivan Patrick, Hightow-Weidman Lisa, Mayer Kenneth H
机构信息
Center for Health Equity Research, Brown University School of Public Health, Providence, RI, United States.
Department of Behavioral & Social Sciences, Brown University School of Public Health, Providence, RI, United States.
出版信息
JMIR Res Protoc. 2019 Jan 7;8(1):e10694. doi: 10.2196/10694.
BACKGROUND
HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM.
OBJECTIVE
The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app.
METHODS
This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY.
RESULTS
App refinement is underway. Enrollment for the pilot RCT began in October 2018.
CONCLUSIONS
MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10694.
背景
在美国，男男性行为青年（YMSM）中的艾滋病毒发病率增长最为迅速。大量证据表明，常规检测和扩大暴露前预防（PrEP）的使用将大幅减轻艾滋病毒的人群负担；然而，这两种干预措施在年轻人中的接受程度都不理想。YMSM对手机应用程序的使用非常普遍，这可能为公共卫生干预提供独特的机会。MyChoices是一款基于理论的应用程序，旨在增加艾滋病毒检测和PrEP的使用。它由一个跨学科团队根据来自不同YMSM样本的反馈开发而成。
目的
本文旨在描述对MyChoices应用程序进行优化、测试版测试和试点随机对照试验（RCT）的方案，以检验该应用程序的可接受性和可行性。
方法
这项分三个阶段的研究包括4个用于应用程序优化的剧场测试组，共有约30名YMSM参与；进行测试版测试，包括定量评估和退出访谈，在2个月内约有15名YMSM参与；以及对60名YMSM进行试点随机对照试验。该试点将评估MyChoices应用程序与仅进行转诊相比，在增加艾滋病毒检测和PrEP使用方面的可行性、可接受性和初步疗效。所有参与者将在马萨诸塞州波士顿和纽约州布朗克斯的iTech临床研究站点招募。
结果
应用程序优化正在进行中。试点随机对照试验的招募工作于2018年10月开始。
结论
MyChoices是首批专门为YMSM设计的全面、基于理论的艾滋病毒预防应用程序之一。如果MyChoices在这项试点随机对照试验中证明具有可接受性和可行性，计划在iTech内部对该应用程序和另一个针对青年优化的应用程序（LYNX）与标准护理进行多城市、三臂随机对照疗效试验。如果证明有效，该应用程序将具有可扩展性，能够覆盖美国各地的YMSM，并且能够根据地理位置进行个性化设置，应用程序内容与当地的预防和检测活动相结合。
国际注册报告标识符（IRRID）：PRR1-10.2196/10694。
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