Comparative effectiveness trial of clinic-based delivery of an HIV risk reduction intervention for YMSM

青年男男性行为者(YMSM)仍然是需要经验支持的关键人群 改进自我管理的方法，以促进减少艾滋病毒性危险行为和药物使用。 青年男子健康项目(YMHP)，一个结构化和手册化的4节干预措施，利用 针对HIV阴性者的激励性访谈、个性化反馈和解决问题的技能培养方法 或未经测试的年轻人被发现在显著减少药物使用和无避孕套方面有效 18-29岁青年男性接触者的肛交(CAS)。到目前为止，这是所有已发表的试验或疾控中心的第一次也是唯一一次随机对照试验 Debi与YMSM合作，显示出物质使用和性风险的显著减少。美国疾病控制与预防中心最近对 YMHP被评为“最佳证据”，并被列入循证干预和最佳方案纲要 艾滋病毒预防实践。YMHP通过在研究中心环境中进行的疗效试验进行测试 众多包含和排除标准，因此，基于真实世界的复制是关键的下一步 研究由一线工作人员提供给客户的干预措施在现实世界中的有效性。我们 将进行两种YMHP分娩方式的比较有效性试验(CET)--基于诊所的和基于诊所的 电话-在洛杉矶、费城和迈阿密的三个艾滋病毒诊所地点。具体目标是： 1)使YMHP干预措施适用于社区卫生工作者在艾滋病毒诊所提供诊所和电话服务 (CHWS)；2)在以下情况下比较基于诊所和基于电话的基督教青年会的有效性 获得保健，评估自我管理的两种方式和五个组成部分的成本效益 模型；以及3)在现实世界的青少年艾滋病毒中测试YMHP实施的可持续模型 诊所。建议的研究将分两个阶段进行。在第一阶段，我们将进行定性 与我们合作诊所的工作人员进行研究(了解实施问题)和15-17岁的YMSM(至 使有效的基督教青年会干预措施适合于发展)。在第二阶段，我们将随机化270 基督教青年会年龄15-24岁，可通过电话或亲自到诊所接受基督教青年会。评估将包括行为 自我报告措施、尿液药物使用测试和性健康结果的性传播感染测试。劳作 与我们的诊所合作伙伴一起，帮助解决提供服务第一线的实际问题 为减少YMSM中HIV感染的全面计划铺平道路。如果有效，我们的计划 有可能对行为干预的有效性产生持续而强大的影响 为基督教青年会。

Young men who have sex with men (YMSM) remain a critical population in need of empirically supported approaches to improve self-management to promote reduced HIV sexual risk behaviors and substance use. The Young Men’s Health Project (YMHP), a structured and manualized 4-session intervention utilizing motivational interviewing, personalized feedback, and problem-solving skills building approaches for HIV-negative or untested youth was found to be efficacious in significantly reducing substance use and condomless anal sex (CAS) among YMSM ages 18-29. To date, this is the first and only RCT of any published trial or CDC DEBI with YMSM to show significant reductions in both substance use and sexual risk. The CDC recently rated YMHP as “Best Evidence” and placed it on the compendium of Evidence Based Interventions and Best Practices for HIV Prevention. YMHP was tested through an efficacy trial in a research center environment with numerous inclusion and exclusion criteria, and thus, a real-world-based replication is the crucial next step in studying the intervention’s effectiveness in the real world when delivered by front-line staff to their clients. We will conduct a comparative effectiveness trial (CET) with two modalities of YMHP delivery – clinic-based and telephone-based — at three HIV clinic sites in Los Angeles, Philadelphia, and Miami. The Specific Aims are to: 1) adapt the YMHP intervention for clinic and phone delivery in HIV clinics by community health workers (CHWs); 2) compare the effectiveness of clinic-based versus phone-based delivery of YMHP in the context of health care access, assessing the cost effectiveness of both modalities and the five components of the selfmanagement model; and 3) test a sustainable model of YMHP implementation in real-world adolescent HIV clinics. The proposed study will be implemented over two phases. In Phase 1 we will conduct qualitative research with staff at our collaborating clinics (to understand implementation issues) and YMSM ages 15-17 (to adapt the efficacious YMHP intervention to be developmentally appropriate). In Phase 2 we will randomize 270 YMSM ages 15-24, to receive YMHP by phone or in person at the clinic. Assessments will include behavioral self-report measures, urine testing for substance use, and STI testing for sexual health outcomes. Working together with our clinic collaborators will help to address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce HIV infection among YMSM. If effective, our program has the potential to exert a sustained and powerful influence on the effectiveness of behavioral interventions for YMSM.