SAIA-PrEP: a systems analysis and improvement approach to optimize PrEP implementation in syringe service programs

SAIA-PrEP：一种系统分析和改进方法，用于优化注射器服务项目中 PrEP 的实施

• 批准号: 10524701
• 负责人: Angela Robertson Bazzi
• 金额: $ 85.87万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10524701
• 关键词: AIDS prevention; Address; Anti-Retroviral Agents; Area; Client; Clinical; Consensus; Cost Analysis; Country; County; Data; Data Collection; Disease Outbreaks; Education; Effectiveness; Epidemic; Ethnic Origin; Evidence based intervention; Goals; HIV; HIV Seronegativity; Harm Reduction; Human immunodeficiency virus test; Improve Access; Incidence; Injecting drug user; Injections; Institution; Interruption; Intervention; Maps; Medical; Methamphetamine; Modification; Monitor; Naloxone; Needle-Exchange Programs; Outcome; Periodicity; Population; Positioning Attribute; Poverty; Prevention strategy; Process; Race; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Running; Series; Services; Site; Specialist; System; Systems Analysis; Testing; Time; Training; Translating; Trust; Vulnerable Populations; acceptability and feasibility; base; cost; cost effectiveness; cost estimate; data portal; design; drug market; effectiveness evaluation; effectiveness testing; electronic data; evidence base; follow-up; health care service utilization; implementation strategy; improved; innovation; member; novel; overdose education; pre-exposure prophylaxis; prevent; prevention service; psychostimulant; recruit; scale up; service delivery; sex; social stigma; social structure; therapy design; transmission process; treatment as usual; uptake

ABSTRACT For the first time in decades, HIV incidence is increasing among people who inject drugs (PWID). Pre- exposure prophylaxis (PrEP) is a safe, effective, evidence-based HIV prevention strategy recommended for at- risk PWID. However, despite the acceptability of PrEP among PWID, access remains low, and uptake has lagged far behind that observed in other vulnerable populations. Our preliminary research demonstrates that syringe service programs (SSPs) are uniquely poised to improve PrEP access, and many already provide some services along the PrEP delivery cascade, including PrEP education, HIV testing, and linkage to onsite and external medical services. Despite being ideal venues for improving PrEP access among PWID, our data demonstrate that these agencies need additional support to optimally implement the SSP-based PrEP delivery cascade. This novel randomized controlled trial (RCT) uses an interrupted time series design to test whether an evidence-based, organization-level intervention, the Systems Analysis and Improvement Approach (SAIA), can improve the delivery of PrEP services among 32 SSPs located in Ending the HIV Epidemic priority jurisdictions. After a 3-month run-in period, SSPs will be randomized to receive SAIA (n=16) versus treatment as usual (n=16). SAIA will be delivered by trained specialists through five cyclical steps over 12 months: (1) analyze SSPs’ PrEP delivery cascade to identify priority areas for system improvements, (2) map processes and build consensus around programmatic modifications to address priority areas, (3) implement programmatic modifications, (4) assess effects of programmatic modifications on delivery of cascade services, and (5) repeat steps 1-4 as needed. SSPs will use an electronic data collection system to report on outcomes including numbers of SSP clients receiving (1) PrEP education, (2) HIV testing, (3) PrEP linkage, and (4) PrEP initiation verification. Data will be collected during the 3-month run-in period prior to randomization, and then for an additional 24 months, allowing us to identify initial impacts of SAIA after 12 months (Aim 1) and sustained impacts at 24 months (Aim 2). Outcomes will be disaggregated by sex and race/ethnicity to allow for process monitoring of programmatic changes to address equity in service delivery. We will also estimate the cost and cost-effectiveness of SAIA relative to treatment as usual using an activity-based costing approach (Aim 3). To our knowledge, this will be the first RCT of an organizational-level intervention to optimize the SSP-based PrEP delivery cascade. If successful, SAIA could be disseminated to the ≥430 SSPs nationally and in global settings, carrying the potential for exceptional impact amidst persistent HIV transmission in PWID.

抽象的 注射吸毒者 (PWID) 中的艾滋病毒感染率几十年来首次出现上升。 暴露预防 (PrEP) 是一种安全、有效、循证的艾滋病毒预防策略，推荐用于以下人群： 然而，尽管注射吸毒者对 PrEP 的接受度很高，但其获得率仍然很低，而且采用率也很低。 我们的初步研究表明，远远落后于其他弱势群体的观察结果。 注射器服务计划 (SSP) 旨在改善 PrEP 的可及性，许多计划已经提供 PrEP 交付级联中的一些服务，包括 PrEP 教育、HIV 检测以及现场联系 尽管我们的数据是改善吸毒者获得 PrEP 的理想场所， 证明这些机构需要额外的支持来最佳地实施基于 SSP 的 PrEP 交付 这项新颖的随机对照试验 (RCT) 使用间断时间序列设计来测试是否存在级联。 基于证据的组织级干预措施，系统分析和改进方法（SAIA）， 可以改善位于结束艾滋病毒流行优先事项的 32 个 SSP 中的 PrEP 服务的提供 经过 3 个月的磨合期后，SSP 将被随机分配接受 SAIA (n=16) 与治疗。 与往常一样 (n=16)，SAIA 将由经过培训的专家在 12 个月内通过五个循环步骤进行：(1) 分析 SSP 的 PrEP 传递级联以确定系统改进的优先领域，(2) 绘制流程 并围绕解决优先领域的计划修改达成共识，(3) 实施计划 修改，(4) 评估计划修改对级联服务交付的影响，以及 (5) 重复 SSP 将根据需要使用电子数据收集系统来报告结果，包括： 接受 (1) PrEP 教育、(2) HIV 检测、(3) PrEP 连接和 (4) PrEP 启动的 SSP 客户数量 数据将在随机化之前的 3 个月磨合期内收集，然后进行验证。 额外的 24 个月，使我们能够在 12 个月（目标 1）后确定 SAIA 的初步影响和持续影响 24 个月时的影响（目标 2）将按性别和种族/民族分类，以便进行处理。 监控服务交付中股权地址的程序性变更。 SAIA 相对于使用基于活动的成本计算方法的常规治疗的成本效益（目标 3）。 据我们所知，这将是第一个组织层面干预的随机对照试验，旨在优化基于 SSP 的 PrEP 传递级联如果成功，SAIA 可以传播到全国和全球 ≥ 430 个 SSP。 在吸毒者中持续传播艾滋病毒的情况下，可能会产生特殊影响。