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

摘要 数十年来，艾滋病毒在注射吸毒者(PWID)中的发病率首次上升。Pre- 暴露预防(PrEP)是一种安全、有效、循证的艾滋病毒预防策略，建议在 风险PWID。然而，尽管PrEP在PWID中被接受，但获得率仍然很低，使用率也有所下降。 远远落后于在其他弱势群体中观察到的情况。我们的初步研究表明 注射器服务计划(SSP)是改善PrEP获得的唯一准备，许多计划已经提供了 沿着PrEP交付级联的一些服务，包括PrEP教育、艾滋病毒检测和到现场的链接 和外部医疗服务。尽管是改善PWID中PrEP访问的理想场所，但我们的数据 证明这些机构需要额外支持以最佳方式实施基于SSP的PrEP交付 卡斯卡德。这项新的随机对照试验(RCT)使用中断的时间序列设计来检验 循证、组织级干预、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个战略规划机构中的PrEP服务的提供 司法管辖区。在3个月的磨合期后，SSP将随机接受SAIA(n=16)治疗与治疗 照常(n=16)。SAIA将由训练有素的专家在12个月内通过五个周期步骤提供：(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 并围绕方案修改达成共识，以解决优先领域，(3)实施方案 修改，(4)评估方案修改对级联服务交付的影响，以及(5)重复 根据需要执行步骤1-4。战略规划方案将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链接和(4)PrEP启动的SSP客户数量 核实。数据将在随机化之前的3个月磨合期内收集，然后在 另外24个月，使我们能够在12个月后确定SAIA的初步影响(目标1)和持续 24个月的影响(目标2)。结果将按性别和种族/族裔分列，以便进行这一进程 监测方案变更，以解决服务提供的公平性问题。我们还将估计成本和 SAIA相对于照常治疗的成本效益，采用基于活动的成本计算方法(目标3)。至 据我们所知，这将是第一次以组织层面的干预措施优化基于SSP的RCT 准备级联递送。如果成功，SAIA可以在全国和全球范围内传播到≥430 SSP 在PWID持续传播艾滋病毒的情况下，有可能产生特殊影响。

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.