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

• Status: Enrolling by invitation
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HIV Prevention Trials Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid

Criteria

Inclusion Criteria:

• 18 to 60 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:

• 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)