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: 10547902
• 负责人: Elizabeth Anne BUKUSI
• 金额: $ 63.32万
• 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/10547902
• 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 Savings; Counseling; Data; Detection; Diphosphates; 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; Prevention; Proctor framework; Provider; Public Facilities; Public Health; Public Sector; 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; implementation evaluation; implementation framework; implementation outcomes; implementation process; implementation strategy; improved; innovation; microcosting; opportunity cost; patient oriented; pragmatic trial; pre-exposure prophylaxis; preference; primary outcome; programs; randomized trial; recruit; satisfaction; scale up; skills; social stigma; treatment as usual; treatment program; uptake; 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 Savings; Counseling; Data; Detection; Diphosphates; 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; Prevention; Proctor framework; Provider; Public Facilities; Public Health; Public Sector; 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; implementation evaluation; implementation framework; implementation outcomes; implementation process; implementation strategy; improved; innovation; microcosting; opportunity cost; patient oriented; pragmatic 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 最大化访问权限并最大程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）。在2017年1月至2019年12月之间，作为肯尼亚国家的一部分 公共部门的准备推出，我们进行了一项跨过朝北的集群务实的务实试验，以催化量表 - 在25个公共艾滋病毒诊所（合作伙伴扩大项目）中集成了预备送货。我们证明了这一点 可以使用现有员工在非洲公共卫生设施中进行准备：> 8000个启动Prep（53％的女性） 在返回的人中有合理的延续和高度依从性。该研究还强调了主要健康 系统障碍，包括多次停靠的长期访问（即，分类房间，艾滋病毒测试， 咨询，药房），负担卫生系统。对于健康的艾滋病毒未感染的人，很长时间等待 诊所，下班时间以及去探望的费用挑战参加准备的人。有效的交付 策略可以降低成本，有可能改善客户参与度，并允许服务可用于 更多的人。在NIH和PEPFAR共同资助的一项短期试点研究中，我们测试了可行性 PEPFAR支持的诊所的一站式准备条款（即，单室提供的所有预备服务）和 表明，一站式服务对于准备用户和提供商都是可行的，并且高度可接受。一站式 明显缩短了等待时间（> 80％），而不会减少提供商 - 客户接触时间；准备启动保持 稳定，有人建议更好的早期延续和准时访问出勤，这表明一个 - 停止准备可能会增加准备系统的效率，而不会破坏质量。以我们从学习为基础 随机试验和试点研究，我们建议进行有效性实践集群 - 一站式的随机试验评估有效性提高交付效率和PREP和PREP的延续 严格研究卫生系统因素。我们将通过既定的预备随机将12个公共卫生设施随机 肯尼亚西部的节目1：1招募并关注1800名艾滋病毒未感染的人新发起准备进行测试 与通常的护理途径相比，一站式护理途径的有效性（AIM 1）。在大计划中， 我们将建立一个随机选择的嵌套观察者队列的准备用户（n = 150，包括客户 开始但停止研究纵向艾滋病毒预防行为，包括中断和 客户如何使PREP使用与艾滋病毒风险。共同结果将是继续和依从性。 干血点中的替诺福韦 - 二磷酸盐水平。我们将使用系统分析和Proctor的实现 评估卫生系统，设施，提供商和客户层的实施成果的框架（AIM 2）。 最后，我们将进行微成本和时间和运动研究，以评估成本并建模预算 使用一站式模型的准备计划的影响和负担能力（AIM 3）。我们已经证明了准备 现有员工可以在肯尼亚公共设施中交付；这项工作将进一步扩展，旨在更大 效率和节省成本，减少提供商的工作量，减轻客户负担以及更好的准备。