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: 10687240
• 负责人: Angela Robertson Bazzi
• 金额: $ 97.84万
• 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/10687240
• 关键词: AIDS prevention; Address; Anti-Retroviral Agents; Area; Client; Clinical; Consensus; Cost Analysis; Country; County; Data; Data Collection; Disease Outbreaks; Education; Effectiveness; Eligibility Determination; Epidemic; Equity; Ethnic Origin; Evidence based intervention; Fentanyl; 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; Population; Populations at Risk; Positioning Attribute; Poverty; Prevention strategy; Process; Race; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Running; Series; Services; Site; Specialist; System; Systems Analysis; Testing; Time; Training; Translating; Trust; Vulnerable Populations; acceptability and feasibility; 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; manufacture; marginalization; member; novel; overdose education; pre-exposure prophylaxis; prevent; prevention service; psychostimulant; recruit; scale up; service delivery; sex; social; social stigma; 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.

摘要 几十年来，艾滋病毒感染率首次在注射毒品者中上升。预处理 暴露预防（PrEP）是一种安全，有效，以证据为基础的艾滋病毒预防策略，建议在 风险PWID。然而，尽管PrEP在PWID中是可接受的，但可获得性仍然很低， 远远落后于其他弱势群体。我们的初步研究表明， 注射器服务计划（SSP）是唯一准备改善PrEP访问，许多已经提供 沿着PrEP提供级联的一些服务，包括PrEP教育，HIV检测，以及与现场 和外部医疗服务。尽管是改善PWID中PrEP获取的理想场所，但我们的数据 证明这些机构需要额外的支持，以最佳实施基于SSP的PrEP交付 级联。这项新的随机对照试验（RCT）使用中断时间序列设计来测试是否 基于证据的组织级干预措施，即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之间的PrEP服务的提供 辖区3个月导入期后，SSP将随机接受SAIA（n=16）与治疗 正常（n=16）。SAIA将由经过培训的专家在12个月内通过五个周期性步骤进行：（1） 分析SSP的PrEP交付级联，以确定系统改进的优先领域，（2）映射流程 并围绕方案修改建立共识，以解决优先领域，（3）实施方案 修改，（4）评估方案修改对提供级联服务的影响，以及（5）重复 步骤1-4根据需要。SSP将使用电子数据收集系统报告结果，包括 接受（1）PrEP教育、（2）HIV检测、（3）PrEP联系和（4）PrEP启动的SSP客户数量 验证将在随机化前的3个月导入期内收集数据，然后进行 额外的24个月，使我们能够在12个月后确定SAIA的初步影响（目标1）， 24个月的影响（目标2）。结果将按性别和种族/民族分列，以便进行程序 监测方案变化，以解决提供服务方面的公平问题。我们还将估算成本， SAIA相对于常规治疗的成本效益，使用基于活动的成本计算方法（目标3）。到 据我们所知，这将是第一个组织级干预的RCT，以优化基于SSP的 PrEP递送级联。如果成功，SAIA可以在全国和全球范围内传播到≥430个SSP 在艾滋病毒持续传播的情况下，在PWID中具有特殊影响的潜力。