Mobile Units for Integrated Addiction and HIV Prevention Services for People Who Inject Drugs: The HPTN 094 Randomized Clinical Trial

Abstract

IMPORTANCE: 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: NCT04804072