N/A
Completed N=447
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
HIV · Drug Use · Opioid Use Disorder
Source: ClinicalTrials.gov NCT04804072 ↗
Enrolled (actual)
447
Serious AEs
29.1%
Results posted
Feb 2026
Primary outcomePrimary: Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site — 30; 22; 6; 4 Participants — p=0.213
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site |
30; 22; 6; 4; 4; 7 | 0.213 |
| PRIMARY Number and Percentage of Participants With Documented Current Use of PrEP at Week 26 by Site |
11; 6; 2; 0; 5; 1 | .204 |
| SECONDARY Number and Percentage of Participants With Documented Current Use of MOUD at Week 52 by Site |
27; 29; 5; 6; 3; 7 | 0.819 |
| SECONDARY Number and Percentage of Participants With Viral Suppression Among People Enrolled Living With HIV, at 26 and 52 Weeks by Site |
8; 7; 1; 1; 1; 1 | — |
| SECONDARY Number and Percentage of Participants With Documented Use of PrEP Among Participants Living Without HIV at Enrollment by Site at Week 26 and 52 |
4; 4; 0; 0; 2; 0 | 0.983 |
| SECONDARY Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks |
221; 214; 156; 152; 148; 132 | .954 |
| SECONDARY Number and Percentage of Participants With Bacterial STIs at Enrollment, Week 26 and Week 52 |
24; 9; 13; 11; 11; 13 | 0.747 |
| SECONDARY Incidence Rate and CI for All Cause and Fatal Overdose Mortality at 26 and 52 Weeks |
2.8; 9.7; 1.9; 7.8; 1.8; 4.9 | 0.066 |
| SECONDARY Incidence Rate for Self-reported Non-fatal Overdose Events by 26 and 52 Weeks |
179.4; 208.4; 88.4; 117.6; 190.4; 94.8 | 0.693 |
| SECONDARY Number and Percentage of Participants With Undetectable HCV RNA Among Those With Chronic HCV Infection at Enrollment |
19; 15; 22; 12 | — |
| SECONDARY Incidence Rate and CI for HCV Incidence |
11.30; 8.32 | — |
| SECONDARY Number and Percentage of Participants in the Intervention Arm for Documented MOUD Use at Week 26 and 52 |
30; 27 | — |
| SECONDARY Number and Percentage of Participants in the Control Arm With Documented MOUD Use at Week 26 and 52 |
22; 29 | — |
| SECONDARY Number and Percentage of Participants in the Intervention Arm for Viral Suppression at 26 and 52 Weeks |
6; 8; 4 | — |
| SECONDARY Number and Percentage of Participants in the Control Arm for Viral Suppression at 26 and 52 Weeks |
6; 7; 7 | — |
| SECONDARY Number and Percentage of Participants in the Intervention Arm With Documented Use of PrEP at 26 and 52 Weeks |
11; 4 | — |
| SECONDARY Number and Percentage of Participants in the Control Arm With Documented Use of PrEP at 26 and 52 Weeks |
6; 4 | — |
| SECONDARY Assess the Prevalence of SARS-CoV-2 Seropositivity at Baseline, 26 and 52 Weeks |
— | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04804072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.