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

摘要 最大限度地提供服务和最大限度地降低提供服务的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，我们进行了一项阶梯楔形集群随机务实试验，以催化规模- 在25个公共艾滋病毒诊所中增加PrEP提供（合作伙伴扩大项目）。我们证明了 可利用现有工作人员在非洲公共卫生设施提供PrEP：> 8 000人启动PrEP（53%为女性） 在返回的人中有合理的延续和高度的坚持。该研究还强调了主要健康 系统障碍包括具有多个站点的长时间访问（即，分诊艾滋病检测 咨询，药房），负担卫生系统。对于健康的未感染艾滋病毒的人， 诊所，远离工作的时间，以及前往访问的成本挑战的人采取PrEP。 这些战略可以降低成本，有可能提高客户参与度，并使服务能够提供给 更多的人。在一项由NIH和PEPFAR联合资助的短期试点研究中， 一站式PrEP提供（即，在总统艾滋病紧急救援计划支持的诊所， 结果显示，一站式服务是可行的，并得到PrEP用户和提供者的高度接受。一站式 显著缩短等待时间（>80%），而不减少提供者-客户接触时间; PrEP启动保持不变 稳定，并有建议，更好的早期延续和按时就诊，表明一个- 停止PrEP可能会提高PrEP系统的效率，而不会影响质量。在我们从 随机试验和先导研究，我们建议进行一个有效实施集群， 一站式随机试验，以评估改善PrEP输送效率和持续性的有效性， 严格研究卫生系统因素。我们将随机选择12个已建立PrEP的公共卫生设施 在肯尼亚西部的方案1：1招募和跟踪1800名新启动PrEP的未感染艾滋病毒的人进行测试 一站式护理路径与常规护理路径相比的有效性（目标1）。在大项目中， 我们将建立一个随机选择的PrEP使用者的嵌套观察队列（n=150，包括 开始但中止），以研究纵向艾滋病毒预防行为，包括中止的原因， 客户如何将PrEP使用与艾滋病毒风险相结合。共同主要结局将是通过以下指标量化的持续性和依从性 干血斑中的替诺福韦二磷酸盐水平。我们将使用系统分析和普罗克特的实现 评估卫生系统、设施、提供者和客户层面实施成果的框架（目标2）。 最后，我们将进行微观成本计算和时间和运动研究，以评估成本和模型的预算 一站式PrEP计划影响和可负担性（目标3）。我们已经证明了PrEP 可以由现有工作人员在肯尼亚的公共设施中提供;这项工作将进一步扩大， 效率和成本节约，减少供应商的工作量，减轻客户负担，以及更好的PrEP持续性。

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.