Synthesizing Best Practice to Accelerate Access to Emerging HIV Prevention Modalities

7.项目摘要/摘要 有无数新的艾滋病毒暴露前预防(PrEP)药物配方和给药方式 在临床开发中，预计很快将有一系列生物医学艾滋病毒预防方案 可用。为了使这些选项能够对公共卫生产生最大影响，迫切需要创建 生物行为基础设施(即经验性验证的知识、指南和工具)将：a)允许 将这些新选项集成到现有的PrEP交付系统中；b)支持在 新的艾滋病毒预防服务系统；以及c)通过确保新的预防措施促进卫生公平 备选方案将艾滋病毒预防覆盖范围扩大到最优先的人群。然而，现有的有限研究表明 从现有的实施工作中吸取经验教训，并开发数据驱动的工具 被研究和临床实践用来加速推广经过验证的预防策略。作为对.的回应 本项目的具体目标是：(1)综合PrEP服务的干预成分 联邦政府指定的七个结束艾滋病毒流行(ETH)热点县的服务模式 美国，代表不同的地理环境、患者群体和交付环境；(2)可操作 一套可用于评估服务忠诚度的PrEP服务交付流程和结果指标 每日口服PrEP的交付模式和新兴模式，并衡量加强 生物医学预防吸收、持久性和公平覆盖；以及(3)定义普遍性和模式-- 具体的实施前和实施活动，是整合新出现的环境所必需的 将预防方案转化为临床实践。这个项目建立在调查小组过去口头工作的基础上 筹备示范和实施项目，开发/测试新的预防模式，以及 传播临床实践的循证实施工具。为了实现我们的目标，我们将 应用实施科学文献中的两个开创性理论模型，并与七个 美国七个热点地区的临床合作伙伴，以及疾控中心资助的能力建设援助 (CBA)为全国各地的站点提供PrEP培训和技术援助的提供商。《知识》 这一项目产生的成果不仅将推动实施科学领域的发展，还将创造出有形的 可帮助诊所、卫生系统和政策决策者改进PrEP实施结果的工具 在人口层面上。该项目有可能对以下项目的质量产生重大和持续的影响 未来的执行工作，以及向最高层有效传播新模式的速度 优先人群。

7. PROJECT SUMMARY/ABSTRACT There are a myriad of new HIV pre-exposure prophylaxis (PrEP) drug formulations and delivery modalities under clinical development, and it is expected that a range of biomedical HIV prevention options will soon be available. To enable these options to have maximum public health impact there is an urgent need to create biobehavioral infrastructure (i.e., empirically validated knowledge, guidelines, and tools) that will: a) allow the integration of these new options into existing PrEP delivery systems; b) support adherence and retention in an emerging HIV prevention service system; and c) promote health equity by ensuring that new prevention options expand HIV prevention coverage to highest priority populations. However, limited research exists that integrates lessons from existing implementation efforts for oral PrEP and develops data-driven tools that can be used by research and clinical practice to accelerate diffusion of proven prevention strategies. In response to that need, the specific aims of this project are to: (1) Synthesize intervention components of PrEP service delivery models in seven federally designated Ending the HIV Epidemic (EtHE) hotspot counties across the US, representing diverse geographical contexts, patient populations, and delivery settings; (2) Operationalize a set of PrEP service delivery process and outcome metrics than can be used to assess fidelity to service delivery models for daily oral PrEP and emerging modalities and measure progress toward enhancing biomedical prevention uptake, persistence, and equitable coverage; and (3) Define universal and modality- specific pre-implementation and implementation activities necessary for settings to integrate emerging prevention options into clinical practice. This project builds on the past work of the investigative team in oral PrEP demonstration and implementation projects, development/testing of novel prevention modalities, and dissemination of evidence-based implementation tools for clinical practice. To accomplish our aims, we will apply two seminal theoretical models from the implementation science literature, and collaborate with seven clinical partners in seven EtHE hotspots across the US, as well as a CDC-funded Capacity Building Assistance (CBA) provider who delivers PrEP training and technical assistance to sites across the country. The knowledge generated by this project will not only advance the field of implementation science, but also create tangible tools that can help clinics, heath systems, and policy decision makers improve PrEP implementation outcomes at a population level. This project has the potential to make a significant and sustained impact on the quality of future implementation efforts, and the speed with which new modalities are effectively disseminated to highest priority populations.