Journal Article

A systems analysis and improvement approach to optimizing syringe services programs’ delivery of HIV testing and referrals: Study protocol for a parallel-group randomized controlled trial (SAIA-SSP-HIV)

Morgan-Lopez, Antonio, Lambdin, Barrot H., Laurano, Rose, Bazzi, Angela R., Akiba, Christopher F., Smith, Jessica, Roth, Alexis M., Huffaker, Shelby L., Zarkin, Gary A., Orme, Stephen, Patel, Sheila V.

2025

Overview

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 .

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Analysis / Biology and Life Sciences / Care and treatment / Chronic diseases / Computer and Information Sciences / Control / Cost effectiveness / Cost-Benefit Analysis / COVID-19 / Disease prevention / Disease transmission / Evidence-based medicine / Health services / HIV / HIV (Viruses) / HIV Infections - diagnosis / HIV Infections - prevention & control / HIV testing / HIV Testing - economics / HIV Testing - methods / Human immunodeficiency virus / Humans / Infectious diseases / Management / Medical referral / Medicine and Health Sciences / Methods / Needle-Exchange Programs / Optimization / Physical Sciences / Prevention / Process mapping / Quality control / Randomized Controlled Trials as Topic / Referral and Consultation / Research and Analysis Methods / Sexually transmitted diseases / Social Sciences / Strategy / Study Protocol / Substance Abuse, Intravenous - complications / Syringes / Systems Analysis / United States