---
title: "INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit"
nct_id: NCT04804072
overall_status: COMPLETED
phase: NA
sponsor: HIV Prevention Trials Network
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04804072.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04804072"
ct_last_update_post_date: 2026-02-20
last_seen_at: "2026-05-12T07:12:55.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit

**Official Title:** 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

**NCT ID:** [NCT04804072](https://clinicaltrials.gov/study/NCT04804072)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 447
- **Lead Sponsor:** HIV Prevention Trials Network
- **Collaborators:** National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA)
- **Conditions:** HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
- **Start Date:** 2021-06-02
- **Completion Date:** 2024-12-17
- **CT.gov Last Update:** 2026-02-20

## 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).

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **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.
- **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.

## Interventions

- **Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)** (DRUG) — MOUD for OUD
- **HIV testing** (DIAGNOSTIC_TEST) — HIV testing
- **HIV treatment for participants living with HIV not already in care** (DRUG) — HIV treatment for participants living with HIV not already in care
- **PrEP for participants without HIV** (DRUG) — PrEP for participants without HIV
- **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
- **Testing and referral for treatment for hepatitis C virus (HCV)** (DIAGNOSTIC_TEST) — Testing and referral for treatment for HCV
- **Sexually transmitted infection (STI) testing and treatment** (DIAGNOSTIC_TEST) — STI testing and treatment
- **Primary care** (OTHER) — Primary care
- **Harm reduction services** (BEHAVIORAL) — Harm reduction services
- **Peer navigation** (BEHAVIORAL) — Peer navigation
- **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

## Primary Outcomes

- **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)
- **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

## Secondary Outcomes

- **Number and Percentage of Participants With Documented Current Use of MOUD at Week 52 by Site** _(time frame: 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)_
- **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)_
- **Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks** _(time frame: 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)_
- **Incidence Rate and CI for All Cause and Fatal Overdose Mortality at 26 and 52 Weeks** _(time frame: 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)_
- **Number and Percentage of Participants With Undetectable HCV RNA Among Those With Chronic HCV Infection at Enrollment** _(time frame: 26 weeks and 52 weeks)_
- **Incidence Rate and CI for HCV Incidence** _(time frame: 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)_
- **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)_
- **Number and Percentage of Participants in the Intervention Arm for Viral Suppression at 26 and 52 Weeks** _(time frame: 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)_
- **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)_
- **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)_
- **Assess the Prevalence of SARS-CoV-2 Seropositivity at Baseline, 26 and 52 Weeks** _(time frame: Baseline, 26 weeks, and 52 weeks)_

## Locations (5)

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

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ucla vine street clinic|los angeles|california|united states` — added _(2026-05-12)_
- `locations.george washington university crs|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.bronx prevention center crs|the bronx|new york|united states` — added _(2026-05-12)_
- `locations.penn prevention crs|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.houston aids research team crs|houston|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04804072.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04804072*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*