Mobile Units for Integrated Addiction and HIV Prevention Services for People Who Inject Drugs
Steven Shoptaw, Nabila El-Bassel, Brett Hanscom, Timothy Skalland, Cecile Denis, David Goodman-Meza, Irene Kuo, Jordan E. Lake, Ellen A.B. Morrison, Amy M. Richards, Jessica M. Fogel, Paul Richardson, Mark A. Marzinke, William Clarke, Rahul PaulChoudhury, Jayla Harris-Wisecarver, Melissa Cummings, Redonna Chandler, Dale R. Burwen, Philip AndrewImportance
Integrated models to deliver HIV preexposure prophylaxis (PrEP) and medication for opioid use disorder (MOUD) for people who inject drugs are needed.
Objective
To determine whether integrated PrEP and MOUD services delivered on a mobile unit with manualized peer navigation improved PrEP and MOUD use compared with peer navigation to existing community-based services.
Design, Setting, and Participants
This 2-group, open-label, randomized clinical trial was conducted between May 2021 and September 2024 in Houston, Texas; Los Angeles, California; New York, New York; Philadelphia, Pennsylvania; and Washington, DC, among people aged 18 years and older currently injecting drugs, without HIV, with OUD, and not taking MOUD but willing to consider MOUD.
Interventions
The intervention arm (n = 203) consisted of 26 weeks of manualized peer navigation plus integrated PrEP, MOUD, and limited clinical and supportive services delivered on a mobile unit. The active control arm (n = 206) consisted of 26 weeks of manualized peer navigation to available community-based PrEP, MOUD, harm reduction, and supportive services.
Main Outcomes and Measures
The co–primary outcomes were PrEP use and MOUD use at 26 weeks. Secondary outcomes included PrEP and MOUD use at 52 weeks, HIV incidence, and all-cause mortality.
Results
Of 842 people who inject drugs who were screened, 409 were randomized: 134 (32.8%) female; 146 (11.2%) aged 30 years and younger vs older than 30 years. At the 26-week visit, the intervention and active control arms were similar for confirmed PrEP use: 11/203 (5.4%) vs 6/206 (2.9%) and MOUD use: 30/203 (14.8%) vs 22/206 (10.7%), respectively. At the 52-week visit, intervention and active control arms were similar for confirmed PrEP and MOUD: 4/203 (2.0%) vs 4/206 (1.9%) and MOUD use: 27/203 (13.3%) vs 29/206 (14.1%). One HIV acquisition occurred in the intervention and 2 in the active control arms; HIV incidence rate of 0.9 per 100 person-years (95% CI, 0.2-2.6). Four deaths were confirmed in the intervention arm and 13 in the active control arm (hazard ratio, 0.29; 95% CI, 0.1-0.9; P = .03).
Conclusions and Relevance
In this randomized clinical trial, mobile delivery of integrated HIV prevention, addiction, and navigation services did not improve primary outcomes beyond peer navigation alone. The significantly lower all-cause death rate at 52 weeks in the intervention arm bears replication for delivering integrated PrEP and MOUD services to people who inject drugs.
Trial Registration
ClinicalTrials.gov Identifier: