Status:
COMPLETED
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
Lead Sponsor:
HIV Prevention Trials Network
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Drug Use
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2024
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT04804072
Start Date
June 2 2021
End Date
December 17 2024
Last Update
January 16 2025
Active Locations (5)
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1
UCLA Vine Street Clinic
Los Angeles, California, United States, 90095
2
George Washington University CRS
Washington D.C., District of Columbia, United States, 20007
3
Bronx Prevention Center CRS
The Bronx, New York, United States, 10451
4
Penn Prevention CRS
Philadelphia, Pennsylvania, United States, 19104