INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
NCT04804072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 447
Last updated 2026-02-20
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).
Conditions
- HIV Infections
- Drug Use
- Opioid Use
- Opioid-use Disorder
Interventions
- DRUG
-
Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)
MOUD for OUD
- DIAGNOSTIC_TEST
-
HIV testing
HIV testing
- DRUG
-
HIV treatment for participants living with HIV not already in care
HIV treatment for participants living with HIV not already in care
- DRUG
-
PrEP for participants without HIV
PrEP for participants without HIV
- DIAGNOSTIC_TEST
-
Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)
Testing and referral for vaccination or treatment for HAV and HBV
- DIAGNOSTIC_TEST
-
Testing and referral for treatment for hepatitis C virus (HCV)
Testing and referral for treatment for HCV
- DIAGNOSTIC_TEST
-
Sexually transmitted infection (STI) testing and treatment
STI testing and treatment
- OTHER
-
Primary care
Primary care
- BEHAVIORAL
-
Harm reduction services
Harm reduction services
- BEHAVIORAL
-
Peer navigation
Peer navigation
- DIAGNOSTIC_TEST
-
COVID-19 testing and referral for further evaluation, care and/or treatment
COVID-19 testing and referral for further evaluation, care and/or treatment
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
National Institute on Drug Abuse (NIDA)
collaborator NIH -
HIV Prevention Trials Network
lead NETWORK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-02
- Primary Completion
- 2024-12-17
- Completion
- 2024-12-17
Countries
- United States
Study Locations
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