Synthesizing Best Practice to Accelerate Access to Emerging HIV Prevention Modalities

7.项目概要/摘要 有无数新的艾滋病毒暴露前预防（PrEP）药物配方和交付方式 正在临床开发中，预计一系列生物医学艾滋病毒预防方案将很快被 available.为了使这些选择能够产生最大的公共卫生影响，迫切需要建立 生物行为基础结构（即，经验验证的知识，指导方针和工具），将：a）允许 将这些新选项整合到现有的PrEP提供系统中; B）支持在一个 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， 将艾滋病毒预防覆盖面扩大到最优先的人群。然而，有限的研究表明， 整合现有实施工作的经验教训，为口头PrEP和开发数据驱动的工具，可以 在研究和临床实践中使用，以加速已证明有效的预防战略的传播。响应于 该项目的具体目标是：（1）综合PrEP服务的干预成分 在全国七个联邦指定的结束艾滋病毒流行（EtHE）热点县的交付模式 美国，代表不同的地理环境、患者人群和分娩环境;（2）手术 一套PrEP服务交付流程和结果指标，可用于评估服务保真度 每日口服PrEP和新兴模式的交付模式，并衡量提高 生物医学预防的吸收、持久性和公平覆盖率;以及（3）界定普遍性和模式- 具体的实施前和实施活动， 预防方案纳入临床实践。该项目建立在调查小组过去在口头 PrEP示范和实施项目，开发/测试新的预防模式，以及 传播用于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EtHE热点地区的临床合作伙伴，以及CDC资助的能力建设援助 (CBA)提供者谁提供PrEP培训和技术援助的网站在全国各地。知识 该项目产生的技术不仅将推进实施科学领域，而且还将创造有形的 可以帮助诊所、卫生系统和政策决策者改善PrEP实施结果的工具 在人口水平上。该项目有可能对质量产生重大和持续的影响， 未来的执行工作，以及新模式有效传播到最高层的速度， 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.