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

February 2, 2026 updated by: HIV Prevention Trials Network

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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). The intervention arm receiving health services in the mobile unit will be supported by peer navigation. An active control arm will receive peer navigation to health services available at community-based agencies. Impact (cost-effectiveness, mathematical modeling) and implementation factors (mixed methods to identify barriers and facilitators of the interventions) will contextualize findings from the efficacy analysis. The impact of the COVID-19 epidemic in the study population will also be assessed.

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Vine Street Clinic
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • George Washington University CRS
    • New York
      • The Bronx, New York, United States, 10451
        • Bronx Prevention Center CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Prevention CRS
    • Texas
      • Houston, Texas, United States, 77030
        • Houston AIDS Research Team CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Urine testing that is not negative for methadone within 30 days prior to Enrollment is exclusionary, unless verified hospital records show methadone received as a medication for hospitalization only during the screening period. A volunteer may provide a sample for urine testing more than once during the screening period in order to achieve a negative result. If this criterion cannot be met within 30 days from the start of screening, the individual will be considered a screen failure and the volunteer has up to two more screening chances to successfully complete the screening process again.
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated health services delivered in the mobile unit and peer navigation
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)
MOUD for OUD
Diagnostic test: HIV testing
HIV testing
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
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
Active Comparator: Peer navigation to connect them to health services available at community-based agencies
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
HIV testing
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site
Time Frame: 26 weeks

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
Time Frame: 26 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Percentage of Participants With Documented Current Use of MOUD at Week 52 by Site
Time Frame: 52 weeks
• Documented use of MOUD: alive, retained, with biological evidence of MOUD (as defined above) at the week 52 visit and a MOUD prescription at 52 weeks after enrollment or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics) at the week 52 visit
52 weeks
Number and Percentage of Participants With Viral Suppression Among People Enrolled Living With HIV, at 26 and 52 Weeks by Site
Time Frame: 26 weeks and 52 weeks
• Among participants living with HIV at enrollment: alive, retained, and virally suppressed (VL <200 copies/mL) at the week 26 and 52 visits, separately.
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
Time Frame: 26 weeks and 52 weeks

Evaluate whether the intervention increases use of PrEP among participants without HIV at enrollment, compared to the active control condition, by assessing the following endpoint(s):

  • Among participants without HIV at enrollment: alive, retained, HIV negative, with detectable PrEP drugs in DBS at the week 52 visit
  • Among participants without HIV at enrollment: alive, retained, HIV negative, with protective levels of PrEP drugs in DBS samples at the week 26 and 52 visits

A protective level of oral PrEP is defined as:

TFV-DP concentrations ≥ 800 fmol/punch in DBS among those tested for Truvada (TDF-FTC) TFV-DP concentrations ≥ 950 fmol/punch in DBS among those tested for Descovy (TAF-FTC)
26 weeks and 52 weeks
Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks
Time Frame: 26 weeks and 52 weeks
  • Opioid Use: Opioids (natural or synthetic) detected in urine samples for those retained at the week 26 and 52 visits (visits analyzed separately). Opioid use is defined as fentanyl use, and/or opiates and synthetic opioids use detected in urine samples at baseline, week 26 and week 52. Tests were performed at central lab.
  • Polysubstance use: Opioids (natural or synthetic) detected, along with stimulants (methamphetamine, cocaine), xylazine and/or benzodiazepines detected in urine samples at the week 26 and 52 visits (visits analyzed separately). Polysubstance use is defined as opioid use, along with stimulant, benzodiazepine, cocaine and/or xylazine use, as detected in urine samples at baseline, week 26 and week 52. Tests were performed at central lab.
26 weeks and 52 weeks
Number and Percentage of Participants With Bacterial STIs at Enrollment, Week 26 and Week 52
Time Frame: 26 weeks and 52 weeks
Gonorrhea, chlamydia, or new or prevalent syphilis infection detected via local labs for those retained at the week 26 and 52 visits (visits analyzed separately). This objective will be analyzed only in those giving a specimen and having a valid test result at the respective visit (week 26 or week 52).
26 weeks and 52 weeks
Incidence Rate and CI for All Cause and Fatal Overdose Mortality at 26 and 52 Weeks
Time Frame: 26 weeks and 52 weeks
  • All Cause Mortality : All cause death, collected on or before 26- and on or before 52-week visits, separately.
  • Overdose-Related Mortality: Death, with overdose as cause, collected on or before 26- and on or before 52-week visits, separately.
26 weeks and 52 weeks
Incidence Rate for Self-reported Non-fatal Overdose Events by 26 and 52 Weeks
Time Frame: Enrollment, 26 weeks and 52 weeks
Self-report of non-fatal overdose, collected the last 30 days of the visits separately. Incidence rates reflect the number of events per 100 person years. Each participant reports the number of overdoses within the last 30 days, so each participant contributes 30 days of person time at each of enrollment, week 26 and week 52.
Enrollment, 26 weeks and 52 weeks
Number and Percentage of Participants With Undetectable HCV RNA Among Those With Chronic HCV Infection at Enrollment
Time Frame: 26 weeks and 52 weeks
Undetectable HCV RNA at the week 26 and 52 visits (visits analyzed separately) among participants with chronic HCV at enrollment. No formal statistical test is performed for Week 26 and Week 52 separately.
26 weeks and 52 weeks
Incidence Rate and CI for HCV Incidence
Time Frame: 52 weeks
HCV antibody positive at the week 52 visit among participants who are HCV antibody negative at enrollment. Person time is defined as the number of days/year between enrollment and (a) HCV infection - for participants who became HCV infected, and (b) date of the most recent negative HCV test result - for participants who do not have HCV. HCV incidence will be modeled using Poisson regression (GLM with log link), with treatment arm and site as covariates and person years as an offset.
52 weeks
Number and Percentage of Participants in the Intervention Arm for Documented MOUD Use at Week 26 and 52
Time Frame: 26 weeks and 52 weeks
In the intervention arm, change over time in the use of MOUD during the study, comparing documented use of MOUD (biological evidence of MOUD - any detectable medications - and a current MOUD prescription) or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics)) at 26 and 52 weeks to documented use of MOUD at enrollment. MOUD use is assumed to be zero at enrollment due to study exclusion criteria. Follow-up endpoints will be defined as alive, retained, and having documented MOUD use.
26 weeks and 52 weeks
Number and Percentage of Participants in the Control Arm With Documented MOUD Use at Week 26 and 52
Time Frame: 26 weeks and 52 weeks
In the active control arm, change over time in the use of MOUD during the study, comparing documented use of MOUD (biological evidence of MOUD - any detectable medications - and a current MOUD prescription) or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics)) at 26 and 52 weeks to documented MOUD use at enrollment. MOUD use is assumed to be zero at enrollment due to study exclusion criteria. Follow-up endpoints will be defined as alive, retained, and having documented MOUD use.
26 weeks and 52 weeks
Number and Percentage of Participants in the Intervention Arm for Viral Suppression at 26 and 52 Weeks
Time Frame: 26 weeks and 52 weeks
Among participants living with HIV at enrollment: change over time in the percentage of people with viral suppression (VL<200 copies/mL), comparing 26 and 52 weeks to enrollment. Follow-up endpoints will be defined as alive, retained, and virally suppressed.
26 weeks and 52 weeks
Number and Percentage of Participants in the Control Arm for Viral Suppression at 26 and 52 Weeks
Time Frame: 26 weeks and 52 weeks
Among participants living with HIV at enrollment: change over time in the percentage of people with viral suppression (VL<200 copies/mL), comparing 26 and 52 weeks to enrollment. Follow-up endpoints will be defined as alive, retained, and virally suppressed.
26 weeks and 52 weeks
Number and Percentage of Participants in the Intervention Arm With Documented Use of PrEP at 26 and 52 Weeks
Time Frame: 26 weeks and 52 weeks
Among participants who were without HIV at enrollment: change over time in the percentage of people with detectable PrEP drugs in DBS at 26 and 52 weeks compared to enrollment. Follow-up endpoints will be defined as alive, retained, and having detectable PrEP.
26 weeks and 52 weeks
Number and Percentage of Participants in the Control Arm With Documented Use of PrEP at 26 and 52 Weeks
Time Frame: 26 weeks and 52 weeks
Among participants who were without HIV at enrollment: change over time in the percentage of people with detectable PrEP drugs in DBS at 26 and 52 weeks compared to enrollment. Follow-up endpoints will be defined as alive, retained, and having detectable PrEP.
26 weeks and 52 weeks
Assess the Prevalence of SARS-CoV-2 Seropositivity at Baseline, 26 and 52 Weeks
Time Frame: Baseline, 26 weeks, and 52 weeks

Assess the prevalence of SARS-CoV-2 seropositivity at baseline, 26 and 52 weeks, the following endpoint will be assessed:

• Laboratory evidence of antibodies to SARS-CoV-2
Baseline, 26 weeks, and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HIV Prevention Trials Network

Collaborators

National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Actual)

December 17, 2024

Study Completion (Actual)

December 17, 2024

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPTN 094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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