Overview

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

Status:
Enrolling by invitation
Trial end date:
2024-11-30
Target enrollment:
0
Participant gender:
All
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
HIV Prevention Trials Network
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Drug Abuse (NIDA)
Treatments:
Analgesics, Opioid
Criteria
Inclusion Criteria:

- 18 to 60 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:

- 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)