Bazzi Angela R, Roth Alexis M, Akiba Christopher F, Huffaker Shelby L, Patel Sheila V, Smith Jessica, Laurano Rose, Orme Stephen, Zarkin Gary A, Morgan-Lopez Antonio, Lambdin Barrot H
Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, California, United States of America.
Boston University School of Public Health, Boston, Massachusetts, United States of America.
PLoS One. 2025 Feb 25;20(2):e0319340. doi: 10.1371/journal.pone.0319340. eCollection 2025.
With changing drug supplies and associated drug consumption behaviors, HIV transmission has increased among people who inject drugs in the United States. HIV testing and referrals to effective prevention and treatment services are critical for individual and population health, yet multilevel barriers limit access to HIV testing for this population, even within syringe services programs (SSPs). In this organizational-level interrupted time series randomized controlled trial, we will assess the effectiveness and cost-effectiveness of an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), in optimizing HIV testing and referrals to appropriate clinical services among U.S. SSPs. From 01/12/2023 to 01/07/2025, we will recruit a diverse sample of 32 SSPs nationally that directly provide HIV testing to participants. SSPs will be randomized to the active implementation arm (i.e., SAIA-SSP-HIV) or an implementation-as-usual arm (n = 16 organizations per arm). SAIA-SSP-HIV is a flexible, data-driven implementation strategy designed to help optimize SSPs' delivery of HIV testing and referrals to appropriate clinical services for HIV prevention (e.g., pre-exposure prophylaxis) and treatment. In the active implementation arm, trained SAIA specialists will guide SSPs through three cyclical steps over 12 months: (1) process mapping to identify organization-specific needs, (2) cascade analysis and prioritization of areas for improvement, and (3) testing solutions through continuous quality improvement. In both arms, we will collect outcome data over 21 months (3-month lead-in period, 12-month implementation period, 6-month sustainment period). We will assess the initial and sustained effectiveness of SAIA and calculate its cost and cost-effectiveness. This trial presents a novel opportunity to test the effectiveness of an organization-level implementation strategy for optimizing the delivery of HIV screening and referrals in community settings that are frequented by an at-risk population. If successful, SAIA-SSP-HIV could be adapted for other infectious or chronic disease care cascades within SSPs. Trial registration: ClinicalTrials.gov: NCT06025435.
随着药品供应的变化以及相关的药物消费行为，美国注射毒品人群中的艾滋病毒传播有所增加。艾滋病毒检测以及转介至有效的预防和治疗服务对于个人和人群健康至关重要，然而多层次障碍限制了该人群获得艾滋病毒检测的机会，即使是在注射器服务项目（SSP）中也是如此。在这项组织层面的中断时间序列随机对照试验中，我们将评估一种实施策略——系统分析与改进方法（SAIA），在优化美国注射器服务项目中艾滋病毒检测及转介至适当临床服务方面的有效性和成本效益。从2023年12月1日至2025年7月1日，我们将在全国范围内招募32个直接为参与者提供艾滋病毒检测的多样化注射器服务项目样本。注射器服务项目将被随机分配到积极实施组（即SAIA-SSP-HIV）或常规实施组（每组n = 16个组织）。SAIA-SSP-HIV是一种灵活的、数据驱动的实施策略，旨在帮助优化注射器服务项目提供艾滋病毒检测以及转介至适当临床服务以进行艾滋病毒预防（例如暴露前预防）和治疗的工作。在积极实施组中，经过培训的SAIA专家将在12个月内指导注射器服务项目完成三个循环步骤：（1）流程映射以确定组织特定需求，（2）级联分析和改进领域的优先级确定，以及（3）通过持续质量改进测试解决方案。在两组中，我们将在21个月内（3个月导入期、12个月实施期、6个月维持期）收集结果数据。我们将评估SAIA的初始和持续有效性，并计算其成本和成本效益。这项试验为测试一种组织层面的实施策略在优化高危人群常去的社区环境中艾滋病毒筛查和转介工作方面的有效性提供了一个新机会。如果成功，SAIA-SSP-HIV可适用于注射器服务项目内的其他传染病或慢性病护理级联。试验注册：ClinicalTrials.gov：NCT06025435。
