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

简化 PrEP 交付：提高肯尼亚 PrEP 护理效率和持续性的一站式服务途径

• 批准号: 10688130
• 负责人: Elizabeth Anne BUKUSI
• 金额: $ 61.47万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-22 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10688130
• 关键词: AIDS prevention; Adherence; Adoption; Affect; Africa; African; Behavior; Behavioral; Benchmarking; Blood; Budgets; Caring; Client; Clinic; Clinic Visits; Clinical; Cluster randomized trial; Collaborations; Consultations; Contacting Client; Cost Analysis; Cost Savings; Counseling; Data; Detection; Diphosphates; Dryness; Effectiveness; Enrollment; Epidemic; Evaluation; Funding; Future; Guidelines; HIV; HIV risk; HIV/STD; Health; Health care facility; Health system; Human immunodeficiency virus test; Intervention; Kenya; Learning; Longitudinal Studies; Methods; Modeling; Motivation; Oral; Outcome; Parents; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Pharmacy facility; Pilot Projects; Policy Maker; Prevention; Proctor framework; Provider; Public Facilities; Public Health; Public Sector; Random Allocation; Randomized; Randomized, Controlled Trials; Readiness; Resources; Risk; Service delivery model; Services; Spottings; Suggestion; Supervision; System; Systems Analysis; Tenofovir; Testing; Time; Time and Motion Studies; Training; Translating; Triage; United States National Institutes of Health; Visit; Wait Time; Woman; Work; Workload; arm; budget impact; cohort; cost; cost estimate; design; effectiveness evaluation; effectiveness testing; experience; feasibility testing; health assessment; implementation evaluation; implementation framework; implementation outcomes; implementation process; implementation strategy; implementation/effectiveness; improved; innovation; microcosting; opportunity cost; patient oriented; pragmatic randomized trial; pre-exposure prophylaxis; preference; primary outcome; programs; randomized trial; recruit; satisfaction; scale up; skills; social stigma; treatment as usual; treatment program; uptake

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.

抽象的 最大限度地提高获取机会并最大限度地降低交付成本是优化公共卫生影响的关键挑战 HIV暴露前预防（PrEP）。 2017 年 1 月至 2019 年 12 月期间，作为肯尼亚国家计划的一部分 公共部门 PrEP 推出后，我们进行了一项阶梯楔形集群随机务实试验，以促进规模化 在 25 个公共 HIV 诊所整合了 25 家 PrEP 服务（合作伙伴扩大项目）。我们证明了 非洲公共卫生机构可以使用现有工作人员提供 PrEP：超过 8000 名已启动 PrEP（53% 为女性） 回国者的合理延续和高度依从性。该研究还强调了主要健康 系统障碍，包括多次停留的长时间就诊（即单独的房间进行分诊、艾滋病毒检测、 咨询、药房）给卫生系统带来负担。对于健康的艾滋病毒感染者来说，在医院等待很长时间 诊所、下班时间和就诊费用对采取 PrEP 的人提出了挑战。高效交付 战略可以降低成本，有可能提高客户参与度，并允许服务提供给 人数较多。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 PEPFAR 支持的诊所提供一站式 PrEP 服务（即在一个房间内提供所有 PrEP 服务），以及 表明一站式服务是可行的，并且对 PrEP 用户和提供者来说都高度可接受。一站式 显着缩短等待时间 (>80%)，而不减少提供商与客户的联系时间；保留 PrEP 启动 稳定，并且有人建议更好地尽早继续和按时就诊，这表明一- 停止 PrEP 可能会提高 PrEP 系统的效率，而不会降低质量。以我们的学习为基础 通过随机试验和试点研究，我们建议进行有效性实施集群 一站式随机试验，评估提高 PrEP 交付效率和持续性的有效性 严格研究卫生系统因素。我们将随机抽取 12 个已建立 PrEP 的公共卫生机构 在肯尼亚西部开展 1:1 计划，招募并跟踪 1800 名新开始 PrEP 的未感染者进行测试 与常规护理途径相比，一站式护理途径的有效性（目标 1）。在大程序中， 我们将建立一个随机选择的 PrEP 用户嵌套观察队列（n=150，包括 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 客户如何将 PrEP 的使用与 HIV 风险结合起来。共同主要结果将是持续性和依从性，量化为 干血斑中替诺福韦二磷酸盐的水平。我们将使用系统分析和 Proctor 的实现 评估卫生系统、设施、提供者和客户层面的实施结果的框架（目标 2）。 最后，我们将进行微观成本计算以及时间和动作研究，以评估成本并建立预算模型 一站式模式（目标 3）的 PrEP 计划的影响和承受能力。我们已经证明 PrEP 可由现有工作人员在肯尼亚公共设施内提供服务；这项工作将进一步扩展，旨在取得更大的成果 效率和成本节约、减少提供者的工作量、减轻客户的负担以及更好的 PrEP 持续性。