Improving the HIV PrEP Cascade using an Intervention for Healthcare Providers

摘要/项目摘要： 暴露前预防（PrEP）已被证明是非常有效的艾滋病毒预防， 随机临床试验，但在美国PrEP的吸收有限。PrEP的障碍之一 实施是缺乏医疗保健提供者（HCP）的知识和意愿，以规定它。 报告了在现实世界环境和不同人群中的当前PrEP制剂， 如果引入新的制剂，HCP将继续需要支持和指导，以优化临床和 这一宝贵的艾滋病毒预防战略对公共卫生的影响。我们提出了PrEP优化干预措施 以HCP为目标，以增加有艾滋病毒感染风险的人群中PrEP的吸收和持续性。这 干预措施包括：（1）一个集成的基于网络的面板管理工具，称为PrEP-Rx，提供 结构化的艾滋病毒风险评估，自动提醒实验室检测和预约，并报告 患者的PrEP使用史;以及（2）由临床支持人员监督的集中PrEP协调 （称为PrEP协调员），他们可以通过直接患者识别艾滋病毒高风险个体 联系人或通过审查性传播感染（STI）登记以及谁可以支持多个HCP。 我们提出以下目标： 主要目的：评价PrEP优化干预（PrEP协调员+ PrEP-Rx）的有效性， 在10个初级保健诊所中通过阶梯楔形设计增加PrEP处方。我们假设 当诊所使用PrEP时，发出的处方平均数量将显着增加 干预与不干预的对比。 次要目标： 1-探索PrEP启动、使用持续时间和基于患者的停药原因的差异 年龄、人种/种族和性别，以及研究诊所中的诊所和HCP特征。 2-在阶梯楔形阶段后的8个月随访期间探索干预的可持续性。 3-调查PrEP提供的促进者和障碍以及拟议PrEP干预的经验 通过与HCP、PrEP协调员和研究诊所的诊所主任进行定性访谈。 PrEP协调员加上PrEP-Rx的组合有可能改善治疗的所有步骤。 PrEP通过识别艾滋病毒感染高风险个体， 标准化艾滋病毒风险评估，帮助PrEP启动，系统化随访或实验室检查 评估，并就新出现的PrEP数据对HCP进行教育。这些目标可以有一个显着的公众 健康影响，并在对现有诊所资源的负担最小的情况下实现。我们使用创新的 提供PrEP的方法，这将导致对HCP进行培训，以增加能够 最终，拟议的研究有可能减少PrEP级联中的差距。

Abstract/Project Summary: HIV pre-exposure prophylaxis (PrEP) has been shown to be highly effective for HIV prevention in randomized clinical trials but uptake of PrEP in the U.S. has been limited. One of the barriers to PrEP implementation is lack of healthcare provider (HCP) knowledge and willingness to prescribe it. As outcomes of current PrEP formulations in real-world settings and different populations are reported and novel PrEP formulations are introduced, HCPs will continue to require support and guidance to optimize the clinical and public health impact of this valuable HIV prevention strategy. We propose a PrEP optimization intervention targeted at HCPs to increase PrEP uptake and persistence among those at risk for HIV acquisition. This intervention includes: (1) an integrated web-based panel management tool called PrEP-Rx, which provides structured HIV risk assessment, automates reminders for laboratory testing and appointments, and reports patients' history of PrEP use; and (2) a centralized PrEP coordination overseen by a clinical support staff (referred to as the PrEP coordinator) who can identify individuals at high risk for HIV through direct patient contact or by reviewing registries for sexually transmitted infections (STIs) and who can support multiple HCPs. We propose the following aims: Primary Aim: Evaluate the efficacy of the PrEP optimization intervention (PrEP Coordinator + PrEP-Rx) to increase PrEP prescriptions through a stepped-wedge design among 10 primary care clinics. We hypothesize that the mean number of prescriptions issued will be significantly higher when the clinics use the PrEP intervention versus when they do not. Secondary Aims: 1- Explore differences in PrEP initiation, duration of use, and reasons for discontinuation based on patient's age, race/ethnicity, and sex/gender, and by clinic and HCP characteristics among study clinics. 2- Explore sustainability of the intervention during an eight-month follow-up after the stepped-wedge Phase. 3- Investigate facilitators and barriers of PrEP delivery and experiences with the proposed PrEP intervention through qualitative interviews with HCPs, PrEP Coordinators, and clinic directors of study clinics. The combination of the PrEP Coordinator plus PrEP-Rx has the potential to improve all steps of the PrEP continuum and enhance overall care by identifying individuals at high risk of HIV acquisition, standardizing HIV risk assessment, helping in PrEP initiation, systematizing follow-up visits or laboratory assessments, and educating HCPs about emerging PrEP data. These goals can have a significant public health impact and be attained with minimal burden on existing clinic resources. We are using innovative approaches for PrEP delivery which will result in training of HCPs to increase the number of HCPs capable of offering PrEP. Ultimately, the proposed research has the potential to reduce gaps in the PrEP cascade.