Trials / Completed
CompletedNCT04804072
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 447 (actual)
- Sponsor
- HIV Prevention Trials Network · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) | MOUD for OUD |
| DIAGNOSTIC_TEST | HIV testing | HIV testing |
| 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 |
| 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 |
Timeline
- Start date
- 2021-06-02
- Primary completion
- 2024-12-17
- Completion
- 2024-12-17
- First posted
- 2021-03-18
- Last updated
- 2026-02-20
- Results posted
- 2026-02-20
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04804072. Inclusion in this directory is not an endorsement.