HPTN 094: Mobile PrEP and MOUD Did Not Improve 26-Week Use
Key Takeaways
- Among adults who inject drugs and have opioid use disorder in five US cities, mobile integrated care plus peer navigation did not improve either week-26 medication-use outcome compared with navigation to community services.
- At week 52, confirmed PrEP use was 2% with mobile care versus 1.9% with community navigation, while MOUD use was also similar.
- One HIV acquisition occurred with mobile care and two with community navigation during follow-up.
- Fewer deaths occurred with mobile care at 52 weeks, but mortality was a secondary outcome and investigators called for replication.
The two-group, open-label HPTN 094 randomized clinical trial ran from May 2021 through September 2024 in Houston, Los Angeles, New York, Philadelphia, and Washington, DC. Investigators randomized 409 adults without HIV who currently injected drugs and had opioid use disorder.
Mobile care was assigned to 203 participants and active-control community-service navigation to 206. Both groups received 26 weeks of manualized peer navigation. The mobile group also received integrated PrEP, MOUD, and limited clinical and supportive services; the control group received navigation to community services. Week-26 PrEP and MOUD use were co-primary outcomes. Secondary outcomes included week-52 medication use, HIV incidence, and all-cause mortality.
At week 26, confirmed PrEP use was 5.4% with mobile care versus 2.9% with active-control navigation. Confirmed use was assessed against the same active-navigation comparator in both groups.
MOUD use at week 26 was 14.8% with mobile care versus 10.7% with active-control navigation. Investigators concluded that mobile integrated care did not improve either co-primary outcome beyond peer navigation. Confirmed PrEP and MOUD use at week 52 were also similar between groups.
At 52 weeks, 4 deaths had occurred in the mobile group versus 13 in the active-control group. All-cause mortality was a secondary outcome, separate from the medication-use co-primary outcomes.
The reported mortality hazard ratio was 0.29 (95% confidence interval, 0.1-0.9); P = .03. Investigators said the mortality finding bears replication.
Both randomized groups received active peer navigation, so the comparison tested added mobile services against navigation to community care, not against an absence of navigation. The open-label design and secondary status of mortality limit interpretation of the death difference. The few HIV acquisitions during follow-up do not establish comparative protection against HIV.
Investigators concluded that mobile delivery of integrated HIV prevention and addiction services did not improve co-primary PrEP or MOUD use beyond peer navigation. They called for replication of the lower secondary death rate rather than treating it as an established survival benefit.
Clinician Questions
Were people already taking medication for opioid use disorder eligible for HPTN 094's mobile-care comparison?
Eligible adults currently injected drugs, had opioid use disorder and no HIV, were not taking MOUD at enrollment, and were willing to consider MOUD. Adults already taking MOUD did not meet the stated eligibility criteria.
What community services did peer navigation connect HPTN 094 participants to?
Active-control peer navigators connected adults who injected drugs and had opioid use disorder to available community-based PrEP, MOUD, harm-reduction, and supportive services.
Recommended Reading
- For more on PrEP use and adherence: Sticking Points: Managing Injection Site Reactions From Long-Acting Injectable Medications for HIV Care
This content is intended for healthcare professionals for educational purposes. The article and its image were developed with AI assistance and reviewed by members of the ReachMD team prior to publication. Please refer to the original source linked for the complete and most up-to-date information.