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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804072 on ClinicalTrials.gov