Clinical trial NCT04804072: INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Drug Use
Opioid Use
Opioid-use Disorder
Keywords: PrEP
MOUD
PWID
HIV
ART
Opioid Use Disorder
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-03-18
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, 1:1 study of 450 participants. Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks. Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
Primary purpose: PREVENTION

Brief 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.

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)

Primary outcomes:
measure: Evaluate whether the intervention improves use of MOUD
timeFrame: 26 weeks
measure: Evaluate whether the intervention increases use of PrEP among people without HIV
timeFrame: 26 weeks
Secondary outcomes:
measure: Evaluate whether the intervention improves use of MOUD
timeFrame: 52 weeks
measure: Evaluate whether the intervention increases rates of viral suppression among people living with HIV
timeFrame: 52 weeks
measure: Evaluate whether the intervention increases use of PrEP among participants without HIV at enrollment
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether the intervention reduces opioid and polysubstance use at 26 and 52 weeks
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether the intervention reduces prevalence of bacterial STIs
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether the intervention reduces the rate of fatal overdose events by 26 and 52 weeks
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether the intervention reduces the rate of non-fatal overdose events by 26 and 52 weeks
timeFrame: 26 weeks and 52 weeks
measure: Assess whether the intervention increases the proportion of participants with undetectable HCV RNA among those with chronic HCV infection at enrollment
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether the intervention reduces HCV incidence
timeFrame: 52 weeks
measure: Evaluate whether the intervention increases rates of viral suppression among participants living with HIV at enrollment
timeFrame: 26 weeks
measure: Evaluate whether 26 weeks of "one stop" integrated health services delivered in a mobile health delivery unit, supported by peer navigation, increases MOUD use
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether 26 weeks of "one stop" integrated health services delivered in a mobile health delivery unit, supported by peer navigation, increases viral suppression at 26 and 52 weeks
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether 26 weeks of "one stop" integrated health services delivered in a mobile health delivery unit, supported by peer navigation, increases PrEP use at 26 and 52 weeks
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases MOUD use at 26 and 52 weeks
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases viral suppression at 26 and 52 weeks
timeFrame: 26 weeks and 52 weeks
measure: Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases PrEP use at 26 and 52 weeks
timeFrame: 26 weeks and 52 weeks
measure: Assess the prevalence of SARS-CoV-2 seropositivity at baseline, 26 and 52 weeks
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Document the impact of the COVID-19 epidemic on participants' experiences of seeking, obtaining and/or maintaining health services, housing, food security and drugs
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Vine Street Clinic
state: California
city: Washington
country: United States
facility: George Washington University CRS
state: District of Columbia
city: Bronx
country: United States
facility: Bronx Prevention Center CRS
state: New York
city: Philadelphia
country: United States
facility: Penn Prevention CRS
state: Pennsylvania
city: Houston
country: United States
facility: Houston AIDS Research Team CRS
state: Texas
Study officials:
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