Simplifying PrEP delivery: One-stop service pathway to improve PrEP care efficiency and continuation in Kenya

摘要 最大限度地获得机会和最大限度地减少交付成本是优化公共卫生影响的关键挑战 艾滋病毒暴露前预防(PrEP)。2017年1月至2019年12月，作为肯尼亚国家 公共部门PrEP的推出，我们进行了阶梯式楔形群组随机务实试验，以催化规模- 在25个公共艾滋病毒诊所整合了PrEP的提供(合作伙伴扩大项目)。我们证明了这一点 可以利用现有的工作人员在非洲公共卫生机构提供PREP：&gt；8000人发起PrEP(53%是妇女) 在那些返回的人中，合理的继续和高度的坚持。这项研究还强调了主要健康问题 系统障碍，包括多次停靠的长时间探视(例如，分流、艾滋病毒检测、 咨询、药房)，给卫生系统带来负担。对于健康的未感染艾滋病毒的人，在 诊所、离开工作的时间和就诊的费用对服用PrEP的人构成了挑战。高效交付 战略可以降低成本，潜在地提高客户参与度，并允许向 更多的人。在NIH和PEPFAR联合资助的一项短期试点研究中，我们测试了可行性 在由PEPFAR资助的诊所提供一站式PrEP服务(即在一个房间提供所有PrEP服务)和 表明一站式服务是可行的，并为PrEP用户和提供者高度接受。一站式 显著缩短等待时间(&gt；80%)，而不减少提供商与客户的联系时间；PrEP启动暂停 情况稳定，有建议较好地尽早延续和按时出访，表明有一项- 停止PrEP可能会在不影响质量的情况下提高PrEP系统的效率。在我们学习的基础上 在随机试验和试点研究中，我们建议进行有效性-实施集群-- 一站式随机试验以评估提高PrEP和PrEP的交付效率和连续性的有效性 严格研究卫生系统因素。我们将随机选择12家公共卫生机构，建立PrEP 肯尼亚西部计划1：1招募和跟踪1800名新启动PrEP的艾滋病毒未感染者进行检测 一站式护理路径与常规护理路径的有效性比较(目标1)。在这个大项目中， 我们将建立随机选择的PrEP用户嵌套观察队列(n=150，包括以下客户 开始但停止)研究纵向艾滋病毒预防行为，包括停止的原因和 客户如何使PrEP的使用与艾滋病毒风险保持一致。共同初选的结果将继续进行，遵守情况将由 干血斑中的替诺福韦-二磷酸水平。我们将使用系统分析和Proctor的实施 评估卫生系统、设施、提供者和客户一级执行成果的框架(目标2)。 最后，我们将进行微观成本计算和时间和动作研究，以评估成本和建立预算模型 一站式PrEP方案的影响和可负担性(目标3)。我们已经证明了PrEP 可由现有工作人员在肯尼亚公共设施提供；这项工作将进一步扩展，目标是实现更大的 效率和成本节约、减少提供商工作负载、减轻客户端负担以及更好的PrEP连续性。

ABSTRACT Maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact of HIV pre-exposure prophylaxis (PrEP). Between January 2017 and December 2019, as part of Kenya's national public sector PrEP roll-out, we conducted a stepped-wedge cluster-randomized pragmatic trial to catalyze scale- up of PrEP delivery integrated in 25 public HIV clinics (The Partners Scale Up Project). We demonstrated that PrEP can be delivered in African public health facilities using existing staff: >8000 initiated PrEP (53% women) with reasonable continuation and high adherence among those returning. The study also highlighted major health system barriers including lengthy visits with multiple stops (i.e., separate rooms for triage, HIV testing, counseling, pharmacy) that burden the health system. For healthy HIV uninfected persons, long waiting at the clinic, time away from work, and costs for getting to visits challenge persons taking PrEP. Efficient delivery strategies could reduce costs, potentially improve client engagement and allow services to be available to a larger number of people. In a short-term pilot study jointly funded by NIH and PEPFAR, we tested the feasibility of one-stop PrEP provision (i.e., all PrEP services provided in a single room) at PEPFAR-supported clinics and showed that one-stop service was feasible and highly acceptable to both PrEP users and providers. One-stop significantly shortened wait time (>80%) without reducing provider-client contact time; PrEP initiation stayed stable and there was suggestion of better early continuation and on-time visit attendance, indicating that one- stop PrEP might add efficiencies to PrEP systems, without undermining quality. Building on our learning from the randomized trial and the pilot study, we propose to conduct an effectiveness-implementation cluster- randomized trial of one-stop to assess effectiveness to improve delivery efficiency and continuation on PrEP and to rigorously study health system factors. We will randomize 12 public health facilities with established PrEP programs in Western Kenya 1:1 to recruit and follow 1800 HIV-uninfected persons newly initiating PrEP to test the effectiveness of one-stop care pathway compared to usual care pathway (Aim 1). Within the large program, we will establish a randomly selected nested observational cohort of PrEP users (n=150, including clients who start but discontinue) to study longitudinal HIV prevention behavior, including reasons for discontinuation and how clients align PrEP use with HIV risk. Co-primary outcomes will be continuation and adherence quantified by tenofovir-diphosphate levels in dried blood spots. We will use the Systems Analysis and Proctor's implementation framework to evaluate implementation outcomes at the health system, facility, provider, and client-level (Aim 2). Finally, we will conduct micro costing and time and motion studies to evaluate the costs and model the budget impact and affordability of PrEP program with One-stop model (Aim 3). We have already demonstrated that PrEP can be delivered in Kenyan public facilities by existing staff; this work will extend further, aiming for greater efficiency and cost-saving, reduced provider workload, diminished client burden, and better PrEP continuation.