A Multilevel Tailored Web App-Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized Controlled Trial.

A Multilevel Tailored Web App-Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized Controlled Trial.
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DOI:
10.2196/10444
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发表时间:
2018-08-02
影响因子:
1.7
通讯作者:
Stephenson R
Stephenson R
中科院分区:
其他
文献类型:
--
作者:
Bauermeister JA;Golinkoff JM;Horvath KJ;Hightow-Weidman LB;Sullivan PS;Stephenson R

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男男性行为青年中艾滋病毒流行的特点是种族差异很大,人们对是否有机会获得文化上适当的艾滋病毒预防和护理服务感到关切。“连接”是一项基于网络的干预措施,采用个人和系统层面的定制技术,以减少艾滋病毒预防护理的障碍(例如,艾滋病毒或性传播感染[STI]检测、暴露前预防[PrEP]),是为青年男男性行为者(15-24岁)开发的。该方案详细介绍了一个2阶段项目的设计和程序,其中包括神秘购物和随机对照试验(RCT),以测试在费城,亚特兰大和休斯顿的YMSM之间建立联系的有效性。神秘购物的目的是检查当地艾滋病毒或性传播感染检测点内YMSM的艾滋病毒检测咨询和PrEP相关转介的质量。该随机对照试验的目的是测试在12个月的时间内,与对照组相比,Get Connected在增加HIV阴性或HIV未知YMSM成功接受HIV预防服务(例如,常规HIV或STI检测)、PrEP意识和开始PrEP的可能性(PrEP意愿)方面的有效性。在第一阶段,我们将在每个城市建立一个艾滋病毒和性传播感染检测点的总名单。我们将在每个城市招募和培训10-15名神秘购物者;每个测试地点将分别由2名神秘购物者进行访问和评估。每次访问网站后,神秘购物者将完成网站评估,以记录他们对各种措施的看法,包括女同性恋,男同性恋,双性恋,变性人,酷儿的可见性和包容性,隐私和保密性,提供者与患者的互动,以及诊所环境。对于II期,我们将在3个iTech城市招募480名YMSM,为期12个月,进入2组前瞻性RCT。随机分配到对照条件的参与者被引导到AIDSVu.org测试站点定位器。随机分配到干预条件的受试者将被授予访问Web应用程序的权限,该应用程序的内容针对其特定的人口统计学特征(例如,年龄,种族或民族,位置和关系状态),HIV和STI风险行为(例如,HIV和STI检测史,药物使用,与伴侣的沟通状态)和社会文化背景(例如,无家可归,监禁)。研究评估将在入组时和治疗后1、3、6、9和12个月进行。Get Connected研究活动始于2016年9月,目前正在进行中。迄今为止,机构审查委员会(IRB)的提交已经完成,其他几所大学的IRB授权协议正在等待批准。通过移动优化的Web应用程序部署Get Connected旨在优化YMSM中干预措施的可接受性、可访问性、可用性和长期可负担性。ClinicalTrials.gov(NCT 03132415); https://clinicaltrials.gov/ct2/show/NCT03132415(由WebCite存档于http://www.webcitation.org/70j4gSFbZ)RR 1 -10.2196/10444
HIV epidemic among young men who have sex with men (YMSM) is characterized by strong racial disparities and concerns about the availability and access to culturally appropriate HIV prevention and care service delivery. Get Connected, a Web-based intervention that employs individual- and system-level tailoring technology to reduce barriers to HIV prevention care (eg, HIV or sexually transmitted infection [STI] testing, pre-exposure prophylaxis [PrEP]), was developed for YMSM (age 15-24 years). This protocol details the design and procedures of a 2-phase project that includes mystery shopping and a randomized controlled trial (RCT) to test the efficacy of Get Connected among YMSM in Philadelphia, Atlanta, and Houston. The objective of mystery shopping is to examine the quality of HIV test counseling and PrEP-related referrals for YMSM within local HIV or STI testing sites. The objective of the RCT is to test the efficacy of Get Connected for increasing HIV-negative or HIV-unknown YMSM’s successful uptake of HIV prevention services (eg, routine HIV or STI testing), PrEP awareness, and likelihood to start PrEP (PrEP willingness), compared with those in the control condition, over a 12-month period. For Phase 1, we will create a master list of HIV and STI testing sites in each city. We will enroll and train 10-15 mystery shoppers per city; each testing site will be separately visited and assessed by 2 mystery shoppers. After each site visit, the mystery shoppers will complete a site evaluation to record their perceptions of various measures including lesbian, gay, bisexual, transgender, queer visibility and inclusivity, privacy and confidentiality, provider-patient interactions, and clinic environment. For Phase 2, we will enroll 480 YMSM for 12 months across the 3 iTech cities into a 2-arm prospective RCT. Participants randomized to the control condition are directed to the AIDSVu.org testing site locator. Participants randomized to the intervention condition will be granted access to a Web app with content tailored to their specific demographic characteristics (eg, age, race or ethnicity, location, and relationship status), HIV and STI risk behaviors (eg, HIV and STI testing history, substance use, communication with partners regarding status) and sociocultural context (eg, homelessness, incarceration). Study assessments will occur at enrollment and at 1, 3, 6, 9, and 12 months postenrollment. Get Connected research activities began in September 2016 and are ongoing. To date, institutional review board (IRB) submission is complete and IRB authorization agreements are pending at several other universities. The deployment of Get Connected through a mobile-optimized Web app seeks to optimize the intervention’s acceptability, accessibility, availability, and long-term affordability among YMSM. ClinicalTrials.gov (NCT03132415); https://clinicaltrials.gov/ct2/show/NCT03132415 (Archived by WebCite at http://www.webcitation.org/70j4gSFbZ) RR1-10.2196/10444