Promoting PrEP Adherence for Men Who Have Sex with Men of Color: More Options, Less Barriers

项目摘要 与有色人种发生性关系的年轻男性（YMSM）继续经历不成比例的艾滋病毒感染率 与美国（US）其他人群相比，尽管有高效的每日 青年男同性恋者口服艾滋病毒暴露前预防（PrEP）、PrEP的吸收和坚持率仍然很低。数据 支持YMSM表示有兴趣探索不同剂量和输送策略， 更多的PrEP吸收，特别是在那些没有成功坚持每日方案的人中。 基于证据的提供者和患者教育和支持工具（EBT）可用，但尚未推出 常规用于临床环境，以增加PrEP筛查、咨询、启动、依从性， YMSM的持久性。到目前为止，还缺乏对现有EBT影响的研究。 PrEP规定，或如何定制这些材料，以满足不同的供应商和YMSM的需求 背景可以增强其效果。此外，现有的EBT不承认或纳入 关于不断增加的预防产品库的信息，也没有最大限度地增加参与 关于这些产品的共享决策（SDM）过程。我们的跨学科专家团队建议 调整和加强现有的EBT，以促进PrEP SDM，培训提供者使用EBT，并评估 在种族和地理上多样化的YMSM纵向队列的影响。我们的申请依赖于 探索、准备、实施和维持（EPIS）模式作为实施框架 用于研究这些工具与现实世界临床环境的整合。在目标1中，我们将进行迭代 与提供者和患者一起进行形成性评估，以告知现有患者的适应和增强 提供PrEP EBT。调查结果将为现有EBT的适应和改进提供信息， 在实施之前，通过咨询研讨会与供应商和YMSM进行反复审查。在aim中 2.我们将培训供应商使用基于定制动机面试的新开发的EBT (TMI)培训模式，一个可扩展的，集中的，文化和发展定制的模式， 显示出对自主性的影响，支持和减少耻辱的沟通。供应商在不同的 临床研究中心将参加虚拟培训研讨会，然后进行基于能力的电子辅导。培训 将侧重于EBT的实施，以确保提高他们参与PrEP筛查的能力， 咨询，启动，并为坚持和坚持提供支持。在目标3中，我们将测试新的 通过进行混合型2有效性-实施务实临床，开发/完善EBT 试验（N=540 YMSM年龄18至39），以评估有效性和实施结果。一个全面发展的 经验证的基于移动的应用程序的平台支持持续的参与者参与和监测。我们的研究 建立在我们现有的基础设施上，支持严格的临床试验、移动健康工具、实施 科学、知识以及与受影响人口和社区倡导者的联系。

PROJECT SUMMARY Young men who have sex with men (YMSM) of color continue to experience disproportionate rates of HIV infection compared to other groups in the United States (US). Despite the availability of highly effective daily oral HIV pre-exposure prophylaxis (PrEP), uptake and adherence to PrEP among YMSM remains low. Data support that YMSM show interest in exploring different dosing and delivery strategies which may translate into greater uptake of PrEP, particularly among those have not been successful adhering to a daily regimen. Evidence-based provider and patient education and support tools (EBT) are available but are not being routinely used in clinical settings to increase PrEP screening, counseling, initiation, adherence, and persistence by YMSM. To date, there has been a lack of research on the impact that existing EBT have on PrEP provision, or how tailoring these materials to meet the needs of providers and YMSM from diverse backgrounds could enhance their effects. Further, available EBT do not acknowledge or incorporate information about a growing arsenal of prevention products nor are they maximizing opportunities to engage in a shared decision-making (SDM) process about these products. Our interdisciplinary team of experts proposes to adapt and enhance existing EBT to facilitate PrEP SDM, train providers on the use of the EBT and evaluate the impact within a longitudinal cohort of racially and geographically diverse YMSM. Our application relies upon the Exploration, Preparation, Implementation, and Sustainment (EPIS) model as the implementation framework for studying the integration of these tools into real-world clinical settings. In aim 1, we will conduct an iterative formative assessment with providers and patients to inform adaptation and enhancement of existing patient and provider PrEP EBT. Findings will inform the adaptation and refinement of existing EBT which will be iteratively reviewed with providers and YMSM through Consultative Workshops prior to implementation. In aim 2, we will train providers on use of newly developed EBT grounded in the Tailored Motivational Interviewing (TMI) training model, a scalable, centralized, culturally and developmentally tailored model that has demonstrated impacts on autonomy supportive and stigma reducing communication. Providers at diverse clinical sites will participate in a virtual training workshop, followed by competency-based eCoaching. Training will focus on implementation of the EBT to ensure increases in their ability to engage in PrEP screening, counseling, initiation, and provide support for adherence and persistence. In aim 3, we will test the newly developed/refined EBT through the conduct of a hybrid type 2 effectiveness-implementation pragmatic clinical trial (N=540 YMSM ages 18 to 39) to assess effectiveness and implementation outcomes. A fully-developed and validated mobile app-based platform supports ongoing participant engagement and monitoring. Our study builds on our existing infrastructure that supports the rigorous clinical trials, mHealth tools, implementation science, and knowledge of, and linkages with, affected populations and community advocates.