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

NCT ID: NCT04804072

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2024-12-17

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.

Conditions

HIV Infections; Drug Use; Opioid Use; Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)

Intervention Type: DRUG

MOUD for OUD

HIV testing

Intervention Type: DIAGNOSTIC_TEST

HIV testing

HIV treatment for participants living with HIV not already in care

Intervention Type: DRUG

HIV treatment for participants living with HIV not already in care

PrEP for participants without HIV

Intervention Type: DRUG

PrEP for participants without HIV

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

Intervention Type: DIAGNOSTIC_TEST

Testing and referral for vaccination or treatment for HAV and HBV

Testing and referral for treatment for hepatitis C virus (HCV)

Intervention Type: DIAGNOSTIC_TEST

Testing and referral for treatment for HCV

Sexually transmitted infection (STI) testing and treatment

Intervention Type: DIAGNOSTIC_TEST

STI testing and treatment

Primary care

Intervention Type: OTHER

Primary care

Harm reduction services

Intervention Type: BEHAVIORAL

Harm reduction services

Peer navigation

Intervention Type: BEHAVIORAL

Peer navigation

COVID-19 testing and referral for further evaluation, care and/or treatment

Intervention Type: DIAGNOSTIC_TEST

COVID-19 testing and referral for further evaluation, care and/or treatment

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.

Group Type: ACTIVE_COMPARATOR

HIV testing

Intervention Type: DIAGNOSTIC_TEST

HIV testing

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

Intervention Type: DIAGNOSTIC_TEST

Testing and referral for vaccination or treatment for HAV and HBV

Testing and referral for treatment for hepatitis C virus (HCV)

Intervention Type: DIAGNOSTIC_TEST

Testing and referral for treatment for HCV

Sexually transmitted infection (STI) testing and treatment

Intervention Type: DIAGNOSTIC_TEST

STI testing and treatment

Harm reduction services

Intervention Type: BEHAVIORAL

Harm reduction services

Peer navigation

Intervention Type: BEHAVIORAL

Peer navigation

COVID-19 testing and referral for further evaluation, care and/or treatment

Intervention Type: DIAGNOSTIC_TEST

COVID-19 testing and referral for further evaluation, care and/or treatment

Interventions

Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)

MOUD for OUD

Intervention Type: DRUG

HIV testing

HIV testing

Intervention Type: DIAGNOSTIC_TEST

HIV treatment for participants living with HIV not already in care

HIV treatment for participants living with HIV not already in care

Intervention Type: DRUG

PrEP for participants without HIV

PrEP for participants without HIV

Intervention Type: DRUG

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

Intervention Type: DIAGNOSTIC_TEST

Testing and referral for treatment for hepatitis C virus (HCV)

Testing and referral for treatment for HCV

Intervention Type: DIAGNOSTIC_TEST

Sexually transmitted infection (STI) testing and treatment

STI testing and treatment

Intervention Type: DIAGNOSTIC_TEST

Primary care

Primary care

Intervention Type: OTHER

Harm reduction services

Harm reduction services

Intervention Type: BEHAVIORAL

Peer navigation

Peer navigation

Intervention Type: BEHAVIORAL

COVID-19 testing and referral for further evaluation, care and/or treatment

COVID-19 testing and referral for further evaluation, care and/or treatment

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

HIV Prevention Trials Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCLA Vine Street Clinic

Los Angeles, California, United States

George Washington University CRS

Washington D.C., District of Columbia, United States

Bronx Prevention Center CRS

The Bronx, New York, United States

Penn Prevention CRS

Philadelphia, Pennsylvania, United States

Houston AIDS Research Team CRS

Houston, Texas, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

HPTN 094

Identifier Type: -

Identifier Source: org_study_id