# HPTN 094 trial, 409 participants: 4 deaths with mobile units vs 13 in the control arm

- Published: 2026-11-05 15:00 UTC
- Section: Life & Health › Medicine
- Tags: HPTN 094, mobile medical units, HIV preexposure prophylaxis, medication for opioid use disorder, people who inject drugs, peer navigation, all-cause mortality, randomized clinical trial, JAMA Psychiatry, NIDA
- URL: https://realtech.media/news/rt-134cd05e87cbbe0fa41d634f_hptn_094_trial/

**In a randomized trial in five US cities, mobile PrEP and opioid-treatment services did not raise their use at 26 weeks, but deaths were fewer in that arm.**

![HPTN 094 trial, 409 participants: 4 deaths with mobile units vs 13 in the control arm](https://sgzwpqqelzmajkcubgkl.supabase.co/storage/v1/object/public/rt-media/2026/11/e9c2c33ac0aa321b.jpg)
*U.S. Army photo by Sgt. Griffin Payne, Wikimedia Commons, Public domain*

Results of the HPTN 094 randomized clinical trial, published in JAMA Psychiatry, show that integrated HIV prevention and addiction services delivered on a mobile unit did not increase use of preexposure prophylaxis (PrEP) or medication for opioid use disorder (MOUD) compared with peer navigation alone. The open-label trial ran from May 2021 to September 2024 in Houston, Los Angeles, New York, Philadelphia and Washington, DC. Of 842 people who inject drugs who were screened, 409 were randomized [1].

## Design of the trial

Participants were aged 18 years and older, currently injecting drugs, without HIV, with opioid use disorder, not taking MOUD, but willing to consider it. Of those randomized, 134 (32.8%) were female. The intervention arm (n = 203) received 26 weeks of manualized peer navigation plus integrated PrEP, MOUD and limited clinical and supportive services on a mobile unit. The active control arm (n = 206) received 26 weeks of manualized peer navigation to available community-based PrEP, MOUD, harm reduction and supportive services. The co-primary outcomes were PrEP use and MOUD use at 26 weeks [1].

## Use of PrEP and MOUD, HIV and deaths

At 26 weeks, confirmed PrEP use was 11/203 (5.4%) in the intervention arm and 6/206 (2.9%) in the control arm. MOUD use was 30/203 (14.8%) and 22/206 (10.7%). At 52 weeks, confirmed PrEP use was 4/203 (2.0%) and 4/206 (1.9%), and MOUD use was 27/203 (13.3%) and 29/206 (14.1%). The authors describe the arms as similar on these measures [1].

One HIV acquisition occurred in the intervention arm and 2 in the control arm; the HIV incidence rate was 0.9 per 100 person-years (95% CI, 0.2-2.6). Four deaths were confirmed in the intervention arm and 13 in the control arm (hazard ratio, 0.29; 95% CI, 0.1-0.9). The NIH release describes this as a 71% reduction in all-cause deaths. Mortality was a secondary outcome [1].

The authors conclude that the lower all-cause death rate at 52 weeks in the intervention arm bears replication. According to the researchers, the low use of oral PrEP even with structured peer navigation points to the importance of evaluating long-acting PrEP formulations in this population. The trial is registered as NCT04804072 and was funded by NIH through the National Institute on Drug Abuse [1].

## Sources

1. [JAMA Psychiatry](https://doi.org/10.1001/jamapsychiatry.2026.3644)
2. [EurekAlert](https://www.eurekalert.org/news-releases/1150409)

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Source: RealTech, realtech.media — https://realtech.media/news/rt-134cd05e87cbbe0fa41d634f_hptn_094_trial/