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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04804072
Recruitment Status : Enrolling by invitation
First Posted : March 18, 2021
Last Update Posted : June 14, 2021
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
HIV Prevention Trials Network

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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug Use Opioid Use Opioid-use Disorder Drug: Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) Diagnostic Test: HIV testing Drug: HIV treatment for HIV-positive participants not already in care Drug: PrEP for HIV-negative participants Diagnostic Test: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV) Diagnostic Test: Testing and referral for treatment for hepatitis C virus (HCV) Diagnostic Test: Sexually transmitted infection (STI) testing and treatment Other: Primary care Behavioral: Harm reduction services Behavioral: Peer navigation Diagnostic Test: COVID-19 testing and referral for further evaluation, care and/or treatment Not Applicable

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 Coronavirus Disease 2019 (COVID-19) epidemic in the study population will also be assessed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 1:1 study of 860 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.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 2, 2021
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Integrated health services delivered in the mobile unit and peer navigation
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
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 HIV-positive participants not already in care
HIV treatment for HIV-positive participants not already in care

Drug: PrEP for HIV-negative participants
PrEP for HIV-negative participants

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

Active Comparator: Peer navigation to connect them to health services available at community-based agencies
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.
Diagnostic Test: HIV testing
HIV testing

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

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




Primary Outcome Measures :
  1. Evaluate whether the intervention improves use of MOUD [ Time Frame: 26 weeks ]

    Evaluate whether the intervention improves use of MOUD, as measured at 26 weeks, by assessing the following endpoint:

    • Documented current use of MOUD: alive, retained, with biological evidence of MOUD (any detectable medications) at the week 26 visit and a MOUD prescription current at 26 weeks after enrollment


  2. Evaluate whether the intervention increases rates of viral suppression among HIV-positive individuals [ Time Frame: 26 weeks ]

    Evaluate whether the intervention increases rates of viral suppression among HIV-positive individuals, as measured at 26 weeks, by assessing the following endpoint:

    • In the HIV-positive cohort: alive, retained, and virally suppressed (VL<200 copies/mL) at the week 26 visit


  3. Evaluate whether the intervention increases use of PrEP among HIV-negative individuals [ Time Frame: 26 weeks ]

    Evaluate whether the intervention increases use of PrEP among HIV-negative individuals, as measured at 26 weeks, by assessing the following endpoint:

    • In the HIV-negative cohort: alive, retained, HIV negative, with detectable PrEP drugs in dried blood spot (DBS) samples at the week 26 visit



Secondary Outcome Measures :
  1. Evaluate whether the intervention improves use of MOUD [ Time Frame: 52 weeks ]

    Evaluate whether the intervention improves use of MOUD, compared to the active control condition, by assessing the following endpoints:

    • Documented current use of MOUD: alive, retained, with biological evidence of MOUD (any detectable medications) at the week 52 visit and a MOUD prescription current at 52 weeks after enrollment
    • Documented use of MOUD during the study: a MOUD prescription documented during the 52 weeks of study follow-up

  2. Evaluate whether the intervention increases rates of viral suppression among HIV-positive individuals [ Time Frame: 52 weeks ]

    Evaluate whether the intervention increases rates of viral suppression among HIV-positive individuals, compared to the active control condition, by assessing the following endpoint:

    • In the HIV-positive cohort: alive, retained, and virally suppressed (VL <200 copies/mL) at the week 52 visit


  3. Evaluate whether the intervention increases use of PrEP among HIV-negative individuals [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether the intervention increases use of PrEP among HIV-negative individuals, compared to the active control condition, by assessing the following endpoint(s):

    • In the HIV-negative cohort: alive, retained, HIV negative, with detectable PrEP drugs in DBS at the week 52 visit
    • In HIV-negative cohort: alive, retained, HIV negative, with protective levels of PrEP drugs in DBS samples at the week 26 and 52 visits

  4. Evaluate whether the intervention reduces opioid and polysubstance use at 26 and 52 weeks [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether the intervention reduces opioid and polysubstance use at 26 and 52 weeks, compared to the active control condition, by assessing the following endpoint:

    • Alive, retained, and no opioids (natural or synthetic), stimulants (methamphetamine, cocaine) or benzodiazepines detected in urine samples at the week 26 and 52 visits


  5. Evaluate whether the intervention reduces prevalence of bacterial STIs [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether the intervention reduces prevalence of bacterial STIs, compared to the active control condition, by assessing the following endpoint:

    • Alive, retained and no evidence of gonorrhea, chlamydia, or new or recurrent syphilis infection detected at the week 26 and 52 visits


  6. Evaluate whether the intervention reduces the rate of fatal overdose events by 26 and 52 weeks [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether the intervention reduces the rate of fatal overdose events by 26 and 52 weeks, compared to the active control condition, by assessing the following endpoint:

    • Death, with overdose as cause


  7. Evaluate whether the intervention reduces the rate of non-fatal overdose events by 26 and 52 weeks [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether the intervention reduces the rate of non-fatal overdose events by 26 and 52 weeks, compared to the active control condition, by assessing the following endpoint:

    • Self-report of non-fatal overdose, collected at week 26 and 52 visits


  8. Assess whether the intervention increases the proportion of participants with undetectable HCV RNA among those with chronic HCV infection at enrollment [ Time Frame: 26 weeks and 52 weeks ]

    Assess whether the intervention increases the proportion of participants with undetectable HCV RNA among those with chronic HCV infection at enrollment, compared to the active control condition, the following endpoint(s) will be assessed:

    • Undetectable HCV RNA at the week 26 and 52 visits among participants with chronic HCV at enrollment


  9. Evaluate whether the intervention reduces HCV incidence [ Time Frame: 52 weeks ]

    Evaluate whether the intervention reduces HCV incidence, compared to the active control condition, the following endpoint(s) will be assessed:

    • HCV antibody positive at the week 52 visit among participants who are HCV antibody negative at enrollment


  10. Evaluate whether 26 weeks of "one stop" integrated health services delivered in a mobile health delivery unit, supported by peer navigation, increases MOUD use [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether 26 weeks of "one stop" integrated health services delivered in a mobile health delivery unit, supported by peer navigation, increases MOUD use, by assessing the following endpoint:

    • In the intervention arm, change over time in the use of MOUD during the study, comparing documented use of MOUD (biological evidence of MOUD - any detectable medications - and a current MOUD prescription) at 26 and 52 weeks to documented use of MOUD at enrollment. MOUD use is assumed to be zero at enrollment due to study exclusion criteria. Follow-up endpoints will be defined as alive, retained, and having documented MOUD use.


  11. 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 [ Time Frame: 26 weeks and 52 weeks ]

    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 compared to enrollment, by assessing the following endpoint:

    • In the intervention arm of the HIV-positive cohort: change over time in the proportion of people with viral suppression (VL<200 copies/mL), comparing 26 and 52 weeks to enrollment. Follow-up endpoints will be defined as alive, retained, and virally suppressed.


  12. 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 [ Time Frame: 26 weeks and 52 weeks ]

    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 compared to enrollment, by assessing the following endpoint:

    • In the intervention arm of the HIV-negative cohort: change over time in the proportion of people with detectable PrEP drugs in DBS at 26 and 52 weeks compared to enrollment. Follow-up endpoints will be defined as alive, retained, and having detectable PrEP.


  13. Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases MOUD use at 26 and 52 weeks [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases MOUD use at 26 and 52 weeks compared to enrollment, by assessing the following endpoint:

    • In the active control arm, change over time in the use of MOUD during the study, comparing documented use of MOUD (biological evidence of MOUD - any detectable medications - and a current MOUD prescription) at 26 and 52 weeks to documented MOUD use at enrollment. MOUD use is assumed to be zero at enrollment due to study exclusion criteria. Follow-up endpoints will be defined as alive, retained, and having documented MOUD use.


  14. Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases viral suppression at 26 and 52 weeks [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases viral suppression at 26 and 52 weeks compared to enrollment, by assessing the following endpoint:

    • In the active control arm of the HIV-positive cohort: change over time in the proportion of people with viral suppression (VL<200 copies/mL), comparing 26 and 52 weeks to enrollment. Follow-up endpoints will be defined as alive, retained, and virally suppressed.


  15. Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases PrEP use at 26 and 52 weeks [ Time Frame: 26 weeks and 52 weeks ]

    Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases PrEP use at 26 and 52 weeks compared to enrollment, by assessing the following endpoint:

    • In the active control arm of the HIV-negative cohort: change over time in the proportion of people with detectable PrEP drugs in DBS at 26 and 52 weeks compared to enrollment. Follow-up endpoints will be defined as alive, retained, and having detectable PrEP.


  16. Assess the prevalence of SARS-CoV-2 seropositivity at baseline, 26 and 52 weeks [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

    Assess the prevalence of SARS-CoV-2 seropositivity at baseline, 26 and 52 weeks, the following endpoint will be assessed:

    • Laboratory evidence of antibodies to SARS-CoV-2


  17. Document the impact of the COVID-19 epidemic on participants' experiences of seeking, obtaining and/or maintaining health services, housing, food security and drugs [ Time Frame: Up to 52 weeks ]

    Document the impact of the COVID-19 epidemic on participants' experiences of seeking, obtaining and/or maintaining health services, housing, food security and drugs, the team will:

    • Document self-reported subjective experiences linked to COVID-19 when seeking MOUD, HIV care (ART, PrEP), STI testing and treatment, hepatitis screening and treatment, primary care, and harm reduction counseling.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804072


Locations
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United States, California
UCLA Vine Street Clinic
Los Angeles, California, United States, 90095
United States, District of Columbia
George Washington University CRS
Washington, District of Columbia, United States, 20007
United States, New York
Bronx Prevention Center CRS
Bronx, New York, United States, 10451
United States, Pennsylvania
Penn Prevention CRS
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston AIDS Research Team CRS
Houston, Texas, United States, 77030
Sponsors and Collaborators
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Drug Abuse (NIDA)
  Study Documents (Full-Text)

Documents provided by HIV Prevention Trials Network:
Publications:

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Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT04804072    
Other Study ID Numbers: HPTN 094
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by HIV Prevention Trials Network:
PrEP
MOUD
PWID
HIV
ART
Opioid Use Disorder
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents