INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit

Completed · Not applicable

Conditions studied: HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder

In brief

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).

Key facts

Study ID

NCT04804072

Run by

HIV Prevention Trials Network

People needed

447

Starts

2021-06-02

Expected to finish

2024-12-17

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Co-enrollment in any other interventional study unless approved by the Clinical Management Committee (CMC)

Where it is running

• UCLA Vine Street Clinic — Los Angeles, California, United States
• George Washington University CRS — Washington D.C., District of Columbia, United States
• Bronx Prevention Center CRS — The Bronx, New York, United States
• Penn Prevention CRS — Philadelphia, Pennsylvania, United States
• Houston AIDS Research Team CRS — Houston, Texas, United States

Full record on ClinicalTrials.gov

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