Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial
Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial
复制标题
DOI：
10.2196/11184
复制
发表时间：
2019-05-01
影响因子：
1.7
通讯作者：
Naar, Sylvie
中科院分区：
文献类型：
--
作者：
Parsons, Jeffrey T.;Starks, Tyrel;Naar, Sylvie
背景：男男性行为者（YMSM）感染艾滋病毒和性传播感染的风险过高。青年男性健康项目（YMHP）是一项有效的干预措施，旨在减少青年男性行为者的药物使用和无安全套肛交（CAS），在迈阿密、底特律和费城的诊所对该项目进行调整并测试其有效性，有可能减少城市青年男性行为者中艾滋病毒和性传播感染的差异。目的：本研究（艾滋病毒/艾滋病干预青少年医学试验网络[ATN] 145 YMHP）旨在调整YMHP，使其适用于诊所和现有诊所工作人员的远程交付，并比较其在真实的-世界青少年艾滋病诊所。该协议的一部分，ATN规模它在最近发表的文章中所描述的Naar等。方法：这是一个比较有效的混合型2试验的YMHP干预与2交付格式-诊所为基础的与远程交付-提供以下艾滋病毒咨询和检测。第一阶段包括与青年进行重点小组讨论，以获得关于实施YMHP干预措施和干预措施组成部分的反馈意见，以确保文化上胜任，可行和可扩展的实施。第2阶段包括招募和入组270名15至24岁的YMSM，3个研究中心各90名。招募将仅限于HIV阴性YMSM谁报告最近的物质使用和CAS或阳性STI测试结果。参与者将随机接受YMHP干预，无论是亲自或远程交付。这两个条件涉及完成4个YMHP课程和提供暴露前预防信息和导航服务。将对至少2名社区卫生工作者（CHW）进行培训，以在每个研究中心提供干预课程。会议将录音动机访谈治疗完整性（MITI）保真度编码，CHW和主管将在整个研究期间得到实施支持。结果：第1阶段焦点小组于2017年7月完成（n=25）。来自3个研究中心的这些焦点小组的反馈为YMHP干预手册的调整、干预的实施和第2阶段的招募计划提供了信息。第2阶段的基线入组于2018年11月开始，评估将在干预后立即进行（IP），3个月，6个月，9个月和12个月。在收集基线和后续数据，我们将比较的有效性和成本效益的诊所为基础的远程交付YMHP的背景下，卫生保健access.Conclusions：我们正在进行YMHP在3个城市的YMSM艾滋病毒和性传播感染的风险率高。当适应现实世界的诊所，这项研究将有助于物质使用YMSM在艾滋病毒和性传播感染的风险，并允许我们检查的有效性和成本的差异交付的方法。
Background: Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men's Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM.Objective: This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al.Methods: This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats-clinic-based versus remote delivery-offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period.Results: Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access.Conclusions: We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery.