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

NCT04804072 | Completed Results DMC

• 1 other identifier: HPTN 094
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 5

Brief 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

Drug Use; Opioid Use; Opioid-use Disorder; HIV Infections

Keywords

PrEP; MOUD; PWID; HIV; ART; Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site

  Documented current use of MOUD. At the Week 26 visit: 1. Alive 2. Retained 3. Biological evidence of MOUD (any detectable Methadone or Buprenorphine) 4. A MOUD prescription current at the week 26 visit or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics)

  26 weeks

• Number and Percentage of Participants With Documented Current Use of PrEP at Week 26 by Site

  Evaluate whether the intervention increases use of PrEP among people without HIV, as measured at 26 weeks, by assessing the following endpoint: • Among participants who were without HIV at enrollment: alive, retained, without HIV, with detectable PrEP drugs (Truvada or Descovy) in dried blood spot (DBS) samples, or (Cabotegravir) in plasma samples, at the Week 26 visit

  26 weeks

Secondary Outcomes (16)

• Number and Percentage of Participants With Documented Current Use of MOUD at Week 52 by Site

  52 weeks

• Number and Percentage of Participants With Viral Suppression Among People Enrolled Living With HIV, at 26 and 52 Weeks by Site

  26 weeks and 52 weeks

• Number and Percentage of Participants With Documented Use of PrEP Among Participants Living Without HIV at Enrollment by Site at Week 26 and 52

  26 weeks and 52 weeks

• Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks

  26 weeks and 52 weeks

• Number and Percentage of Participants With Bacterial STIs at Enrollment, Week 26 and Week 52

  26 weeks and 52 weeks

Study Arms (2)

Integrated health services delivered in the mobile unit and peer navigation

EXPERIMENTAL

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 testing; Drug: HIV treatment for participants living with HIV not already in care; Drug: PrEP for participants without HIV; Diagnostic 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 treatment; Other: Primary care; Behavioral: Harm reduction services; Behavioral: Peer navigation; Diagnostic 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 agencies

ACTIVE 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 testing; Diagnostic 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 treatment; Behavioral: Harm reduction services; Behavioral: Peer navigation; Diagnostic 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

Integrated health services delivered in the mobile unit and peer navigation

HIV testing DIAGNOSTIC_TEST

HIV testing

Integrated health services delivered in the mobile unit and peer navigation; Peer navigation to connect them to health services available at community-based agencies

HIV treatment for participants living with HIV not already in care DRUG

HIV treatment for participants living with HIV not already in care

Integrated health services delivered in the mobile unit and peer navigation

PrEP for participants without HIV DRUG

PrEP for participants without HIV

Integrated health services delivered in the mobile unit and peer navigation

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

Testing and referral for treatment for HCV

Integrated health services delivered in the mobile unit and peer navigation; Peer navigation to connect them to health services available at community-based agencies

Sexually transmitted infection (STI) testing and treatment DIAGNOSTIC_TEST

STI testing and treatment

Integrated health services delivered in the mobile unit and peer navigation; Peer navigation to connect them to health services available at community-based agencies

Primary care OTHER

Primary care

Integrated health services delivered in the mobile unit and peer navigation

Harm reduction services BEHAVIORAL

Harm reduction services

Integrated health services delivered in the mobile unit and peer navigation; Peer navigation to connect them to health services available at community-based agencies

Peer navigation BEHAVIORAL

Peer navigation

Integrated health services delivered in the mobile unit and peer navigation; Peer navigation to connect them to health services available at community-based agencies

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

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

Integrated health services delivered in the mobile unit and peer navigation; Peer navigation to connect them to health services available at community-based agencies

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

Testing and referral for vaccination or treatment for HAV and HBV

Integrated health services delivered in the mobile unit and peer navigation; Peer navigation to connect them to health services available at community-based agencies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• HIV Prevention Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (5)

UCLA Vine Street Clinic

Los Angeles, California, 90095, United States

Location

George Washington University CRS

Washington D.C., District of Columbia, 20007, United States

Location

Bronx Prevention Center CRS

The Bronx, New York, 10451, United States

Location

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Houston AIDS Research Team CRS

Houston, Texas, 77030, United States

Location

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MeSH Terms

Conditions

HIV Infections; Opioid-Related Disorders

Interventions

Dosage Forms; HIV Testing; Seroconversion; Primary Health Care; COVID-19 Testing

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immune System Phenomena; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: HPTN Statistical Manager
• Organization: HPTN Statistical & Data Management Center

HPTN-Data-Access@scharp.org

206-667-4004

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 18, 2021
• Study Start: June 2, 2021
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)