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

Last updated: January 15, 2025
Sponsor: HIV Prevention Trials Network
Overall Status: Completed

Phase

N/A

Condition

Opioid Use Disorder

Drug Use

Hiv Infections

Treatment

Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)

PrEP for participants without HIV

HIV treatment for participants living with HIV not already in care

Clinical Study ID

NCT04804072
HPTN 094
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years of age

  • Urine test positive for recent opioid use and with evidence of recent injection druguse ("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 threemonths 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

Exclusion Criteria:

  • Urine testing that is not negative for methadone within 30 days prior to Enrollmentis exclusionary, unless verified hospital records show methadone received as amedication for hospitalization only during the screening period. A volunteer mayprovide a sample for urine testing more than once during the screening period inorder to achieve a negative result. If this criterion cannot be met within 30 daysfrom the start of screening, the individual will be considered a screen failure andthe volunteer has up to two more screening chances to successfully complete thescreening 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 ClinicalManagement Committee (CMC)

Study Design

Total Participants: 447
Treatment Group(s): 11
Primary Treatment: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)
Phase:
Study Start date:
June 02, 2021
Estimated Completion Date:
December 17, 2024

Study 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.

Connect with a study center

  • UCLA Vine Street Clinic

    Los Angeles, California 90095
    United States

    Site Not Available

  • George Washington University CRS

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Bronx Prevention Center CRS

    Bronx, New York 10451
    United States

    Site Not Available

  • Penn Prevention CRS

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Houston AIDS Research Team CRS

    Houston, Texas 77030
    United States

    Site Not Available

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