Integrating HIV prevention services into care settings for people with opioid use disorder (OUD): a study protocol for implementation strategy development and modeling.

Background: The overlapping epidemics of opioid use disorder (OUD) and HIV present a critical public health challenge. Although people with OUD frequently engage with healthcare settings, uptake of HIV prevention services such as pre-exposure prophylaxis (PrEP) remains low. Integrating HIV prevention into routine OUD care could reduce new infections, but scalable, evidence-based strategies are lacking. Rhode Island offers a unique opportunity to design and evaluate such strategies using its robust data infrastructure and high OUD burden.

Methods: We will conduct a three-phase, sequential implementation study. In Aim 1, we will use the Rhode Island All-Payer Claims Database and State Emergency Department Database data to identify healthcare engagement patterns and gaps in HIV prevention service delivery among people with OUD, including rates of HIV screening, PrEP use, and medications for OUD uptake, across settings from 2012 to 2022. In Aim 2, we will convene a series of five stakeholder-engaged evidence-based quality improvement panels-including with providers, policymakers, and people with lived experience-to co-develop implementation strategies tailored to each care setting (i.e., primary care, mental health clinics, emergency department, and opioid use treatment centers). Finally, in Aim 3, we will develop an agent-based model (ABM) to simulate the population-level effect of implementation strategies developed for each care setting (as identified in Aim 2). The ABM will project outcomes such as HIV incidence, cases averted, and number needed to treat (NNT) over 5- and 10-year horizons under various scenarios. Model parameters will be based on literature and findings from Aim 1. Outputs from the ABM will be used to prioritize feasible, high-impact strategies for future real-world implementation.

Discussion: This study addresses critical gaps in HIV prevention for people with OUD by combining claims-based analysis, evidence-based quality improvement, and agent-based modeling. By leveraging real-world data and engaging diverse stakeholders, the study aims to generate actionable strategies tailored to clinical settings. Findings will inform future implementation efforts in Rhode Island and other jurisdictions facing overlapping HIV and opioid epidemics.

Trial Registration: This study does not meet the World Health Organization's definition of a clinical trial and, therefore, was not registered.