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

男男性行为青年（YMSM）仍然是一个需要实证支持的关键人群， 改善自我管理的方法，以促进减少艾滋病毒风险性行为和药物使用。 青年男子健康项目（YMHP）是一个结构化和手动化的4次干预，利用 动机性访谈，个性化反馈和解决问题的技能建设方法，为艾滋病毒阴性 或未经测试的年轻人被发现在显着减少物质使用和无避孕套方面有效 肛交（CAS）在YMSM年龄18-29。到目前为止，这是第一个也是唯一一个发表的试验或CDC的随机对照试验。 DEBI与YMSM显示显着减少物质使用和性风险。疾病控制和预防中心最近 YMHP作为“最佳证据”，并将其列入循证干预和最佳 预防艾滋病毒的做法。YMHP通过在研究中心环境中的有效性试验进行了测试， 许多纳入和排除标准，因此，基于现实世界的复制是关键的下一步， 研究干预措施在真实的世界中由一线工作人员向其客户提供时的有效性。我们 将进行一项比较有效的试验（CET），采用两种YMHP提供模式-基于诊所和 在洛杉矶、费城和迈阿密的三个艾滋病诊所，具体目标是： 1)调整YMHP干预措施，使其适用于社区卫生工作者在艾滋病毒诊所的诊所和电话交付 （CHW）; 2）比较在以下情况下，以诊所为基础与以电话为基础的YMHP交付的有效性 卫生保健的获得，评估两种模式的成本效益和自我管理的五个组成部分， 模型;和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。拟议的研究将分两个阶段进行。在第一阶段，我们将进行定性分析， 与我们合作诊所的工作人员进行研究（以了解实施问题）和15-17岁的YMSM（以 调整有效的YMHP干预措施，使其适合发展）。在第二阶段，我们将随机抽取270名 15-24岁的YMSM，通过电话或亲自到诊所接受YMHP。评估将包括行为 自我报告措施，药物使用的尿液检测，性健康结果的STI检测。工作 与我们的诊所合作者一起，将有助于解决服务提供前线的实际问题。 为一项全面的计划铺平道路，以减少青年男同性恋者的艾滋病毒感染。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 关于YMSM

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.