This study is accepting new patients by invitation only

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

a study on HIV/AIDS Drug Use Opioid Use Hepatitis C

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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).

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

Details

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.

Keywords

HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder, PrEP, MOUD, PWID, HIV, ART, Opioid Use Disorder, Opioid-Related Disorders, Opioid Analgesics, Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing, HIV treatment for participants living with HIV not already in care, PrEP for participants without HIV, Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV), Testing and referral for treatment for hepatitis C virus (HCV), Sexually transmitted infection (STI) testing and treatment, Primary care, Harm reduction services, Peer navigation, COVID-19 testing and referral for further evaluation, care and/or treatment, Integrated health services delivered in the mobile unit and peer navigation, Peer navigation to connect them to health services available at community-based agencies

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCLA Vine Street Clinic
    Los Angeles California 90095 United States
  • Houston AIDS Research Team CRS
    Houston Texas 77030 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
HIV Prevention Trials Network
ID
NCT04804072
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated