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

HPTN 094

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).

2021-06-02

2024-09-30

2024-09-30

450

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, 1:1 study of 450 participants. Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks. Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}

2023-08-01