Research Summary

RCT: Mobile Services For Injectable Drug Users Do Not Increase Use of PrEP or Meds for Opioid Use Disorder

Edited by:
Brian McCurdy

Key Highlights

  • The trial randomized 409 adults across 5 US cities to integrated mobile services or peer navigation to community services.
  • Confirmed PrEP and MOUD use were similar between groups at 26 and 52 weeks.
  • Four deaths occurred in the mobile-service group versus 13 in the control group (HR, 0.29; 95% CI, 0.1–0.9).

Mobile delivery of integrated HIV prevention and addiction services did not improve the primary outcomes of HIV preexposure prophylaxis (PrEP) or medication for opioid use disorder (MOUD) use beyond peer navigation alone in the HPTN 094 randomized clinical trial, according to a study in JAMA Psychiatry. However, all-cause mortality was significantly lower in the intervention group at 52 weeks.

The 2-group, open-label trial ran from May 2021 through September 2024 in Houston, Los Angeles, New York, Philadelphia, and Washington, DC. Eligible participants were adults currently injecting drugs who did not have HIV, had opioid use disorder, and were not receiving MOUD but were willing to consider it.

Of 842 people screened, 409 were randomized. The intervention group included 203 participants receiving 26 weeks of manualized peer navigation plus mobile delivery of integrated PrEP, MOUD, and limited clinical and supportive services. The 206 control participants received 26 weeks of manualized peer navigation to existing community-based PrEP, MOUD, harm reduction, and supportive services.

The co–primary outcomes were PrEP and MOUD use at 26 weeks. Secondary outcomes included medication use at 52 weeks, HIV incidence, and all-cause mortality.

Study Findings

At 26 weeks, confirmed PrEP use was 5.4% in the intervention group versus 2.9% in the control group, while MOUD use was 14.8% versus 10.7%. At 52 weeks, reported PrEP use was 2.0% versus 1.9%, and MOUD use was 13.3% versus 14.1%, with no between-group improvement identified.

One HIV acquisition occurred in the intervention group and 2 in the control group. Overall HIV incidence was 0.9 per 100 person-years (95% CI, 0.2–2.6). Four deaths were confirmed among intervention participants compared with 13 among controls, corresponding to a hazard ratio of 0.29 (95% CI, 0.1–0.9; P = .03).

Clinical Implications

According to the authors, integrated mobile services did not improve PrEP or MOUD use beyond peer navigation to existing services. They nevertheless highlighted the significantly lower all-cause death rate as a finding warranting replication when evaluating integrated care for people who inject drugs.

Expert Commentary

“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,” the researchers concluded.

Reference

Shoptaw S, El-Bassel N, Hanscom B, et al. Mobile units for integrated addiction and HIV prevention services for people who inject drugs: the HPTN 094 randomized clinical trial. JAMA Psychiatry. Published online November 4, 2026. doi:10.1001/jamapsychiatry.2026.3644