NCT04804072Completed
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit to Link Persons Who Inject Drugs to Integrated Care and Prevention for Addiction, HIV, HCV and Primary Care
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to determine the efficacy of using a mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services - particularly medication for opioid use disorder (MOUD) and medication for HIV treatment and prevention - to people who inject drugs (PWID) with opioid use disorder (OUD) to improve uptake and use of MOUD, and uptake and use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 447 (actual)
- First submitted
- 18 Feb 2021
- Start date
- 2 Jun 2021
- Primary completion date
- 17 Dec 2024
- Lead sponsor
- HIV Prevention Trials Network
- Diseases
- HIV
- NCT number
- NCT04804072
What you commit to
- Study type: Interventional
- Participants enrolled: 447
- From 2 Jun 2021 to the primary completion date, 17 Dec 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Urine testing that is not negative for methadone within 30 days prior to Enrollment is exclusionary, unless verified hospital records show methadone received as a medication for hospitalization only during the screening period. A volunteer may provide a sample for urine testing more than once during the screening period in order to achieve a negative result. If this criterion cannot be met within 30 days from the start of screening, the individual will be considered a screen failure and the volunteer has up to two more screening chances to successfully complete the screening process again.
- Received MOUD in the 30 days prior to enrollment by self-report
Other
- Co-enrollment in any other interventional study unless approved by the Clinical Management Committee (CMC)
Who the study is looking for
- At least 18 years of age
- Urine test positive for recent opioid use and with evidence of recent injection drug use ("track marks")
- Diagnosed with OUD per Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
- Able and willing to give informed consent
- Willing to start MOUD treatment
- Able to successfully complete an Assessment of Understanding
- Self-reported sharing injection equipment and/or condomless sex in the last three months with partners of HIV-positive or unknown status
- Able to provide adequate locator information
- Confirmed HIV status, as defined in the HPTN 094 Study Specific Procedures Manual
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston AIDS Research Team CRS Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UCLA Vine Street Clinic Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Penn Prevention CRS Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Bronx Prevention Center CRS Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| George Washington University CRS Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
Related publications
- Mobile Units for Integrated Addiction and HIV Prevention Services for People Who Inject Drugs: The HPTN 094 Randomized Clinical Trial.JAMA Psychiatry · 2026 · PMID 42981102
This page is information, not medical advice. Discuss any trial with your doctor.