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Peer-reviewedCC BY 4.0JAMA Psychiatry

Mobile Units for Integrated Addiction and HIV Prevention Services for People Who Inject Drugs

8 more authors
14 affiliations
  1. 1Department of Family Medicine, University of California, Los Angeles
  2. 2School of Social Work, Columbia University, New York, New York
  3. 3Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington
  4. 4Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia
  5. 5Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
  6. 6Milken Institute School of Public Health Department of Epidemiology, George Washington University, Washington, DC
  7. 7UTHealth-Houston, Houston, Texas
  8. 8ICAP at Columbia University, Mailman School of Public Health, New York, New York
  9. 9Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland
  10. 10Statistical Center for HIV/AIDS Research, Fred Hutchinson Cancer Center, Seattle, Washington
  11. 11FHI 360, Durham, North Carolina
  12. 12Previously at the National Institute on Drug Abuse, National Institutes of Health, Rockville, Maryland
  13. 13Previously at the Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland
  14. 14Now at the Division of Clinical Innovation, National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland

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

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BibTeX
@article{shoptaw2026mobile,
  title = {{Mobile Units for Integrated Addiction and HIV Prevention Services for People Who Inject Drugs}},
  author = {Steven Shoptaw and Nabila El-Bassel and Brett Hanscom and Timothy Skalland and Cecile Denis and David Goodman-Meza and Irene Kuo and Jordan E. Lake and Ellen A.B. Morrison and Amy M. Richards and Jessica M. Fogel and Paul Richardson and Mark A. Marzinke and William Clarke and Rahul PaulChoudhury and Jayla Harris-Wisecarver and Melissa Cummings and Redonna Chandler and Dale R. Burwen and Philip Andrew},
  journal = {JAMA Psychiatry},
  year = {2026},
  month = nov,
  doi = {10.1001/jamapsychiatry.2026.3644},
  url = {https://doi.org/10.1001/jamapsychiatry.2026.3644},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Mobile Units for Integrated Addiction and HIV Prevention Services for People Who Inject Drugs
AU  - Steven Shoptaw
AU  - Nabila El-Bassel
AU  - Brett Hanscom
AU  - Timothy Skalland
AU  - Cecile Denis
AU  - David Goodman-Meza
AU  - Irene Kuo
AU  - Jordan E. Lake
AU  - Ellen A.B. Morrison
AU  - Amy M. Richards
AU  - Jessica M. Fogel
AU  - Paul Richardson
AU  - Mark A. Marzinke
AU  - William Clarke
AU  - Rahul PaulChoudhury
AU  - Jayla Harris-Wisecarver
AU  - Melissa Cummings
AU  - Redonna Chandler
AU  - Dale R. Burwen
AU  - Philip Andrew
PY  - 2026
DA  - 2026/11/04
JO  - JAMA Psychiatry
DO  - 10.1001/jamapsychiatry.2026.3644
UR  - https://doi.org/10.1001/jamapsychiatry.2026.3644
AB  - 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
SN  - 2168-622X
SN  - 2168-6238
ER  -