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Sponsor: HIV Prevention Trials Network
Conditions: HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
Interventions: Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing, HIV treatment for participants living with HIV not already in care, PrEP for participants without HIV, Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)
Countries: United States
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).
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria:
* 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 Criteria:
* 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)- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- The Bronx, New York, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States