CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 447 enrolled / 447 target
Drug / intervention
Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) +10 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04804072
NCT04804072N/ACompletedOn Track (7.3/mo)Completion was 18mo ago
CompareCT.gov

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

HIV Prevention Trials Network·interventional·Posted Mar 18, 2021·Updated Jun 10, 2026

In Brief

A clinical study evaluating Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing, and 9 other interventions for HIV Infections and 3 related conditions. Completed, enrolled 447 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 18, 2021
Enrollment StartJun 2, 2021
Primary CompletionDec 17, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.3 years ago

Arms & Interventions

Integrated health services delivered in the mobile unit and peer navigationexperimental

Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.

Drug: Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)Diagnostic Test: HIV testingDrug: HIV treatment for participants living with HIV not already in careDrug: PrEP for participants without HIVDiagnostic Test: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)Diagnostic Test: Testing and referral for treatment for hepatitis C virus (HCV)Diagnostic Test: Sexually transmitted infection (STI) testing and treatmentOther: Primary careBehavioral: Harm reduction servicesBehavioral: Peer navigationDiagnostic Test: COVID-19 testing and referral for further evaluation, care and/or treatment
Peer navigation to connect them to health services available at community-based agenciesactive_comparator

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.

Diagnostic Test: HIV testingDiagnostic Test: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)Diagnostic Test: Testing and referral for treatment for hepatitis C virus (HCV)Diagnostic Test: Sexually transmitted infection (STI) testing and treatmentBehavioral: Harm reduction servicesBehavioral: Peer navigationDiagnostic Test: COVID-19 testing and referral for further evaluation, care and/or treatment

Interventions

Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)drug

MOUD for OUD

HIV testingother

HIV testing

HIV treatment for participants living with HIV not already in caredrug

HIV treatment for participants living with HIV not already in care

PrEP for participants without HIVdrug

PrEP for participants without HIV

Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)other

Testing and referral for vaccination or treatment for HAV and HBV

Testing and referral for treatment for hepatitis C virus (HCV)other

Testing and referral for treatment for HCV

Sexually transmitted infection (STI) testing and treatmentother

STI testing and treatment

Primary careother

Primary care

Harm reduction servicesbehavioral

Harm reduction services

Peer navigationbehavioral

Peer navigation

COVID-19 testing and referral for further evaluation, care and/or treatmentother

COVID-19 testing and referral for further evaluation, care and/or treatment