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

HIV Prevention Trials Network

Status: Completed

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

Treatments: Diagnostic Test: COVID-19 testing and referral for further evaluation, care and/or treatment; Drug: PrEP for participants without HIV; Diagnostic Test: Sexually transmitted infection (STI) testing and treatment; Behavioral: Peer navigation; Diagnostic Test: Testing and referral for treatment for hepatitis C virus (HCV); Diagnostic Test: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV); Diagnostic Test: HIV testing; Behavioral: Harm reduction services; Drug: HIV treatment for participants living with HIV not already in care; Other: Primary care; Drug: Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT04804072

HPTN 094

Details and patient eligibility

About

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).

Full 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.

Enrollment: 447 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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447 participants in 2 patient groups

Integrated health services delivered in the mobile unit and peer navigation

Experimental group

Description:

Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.

Treatment:

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

Other: Primary care

Drug: HIV treatment for participants living with HIV not already in care

Behavioral: Harm reduction services

Diagnostic Test: Testing and referral for treatment for hepatitis C virus (HCV)

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

Diagnostic Test: HIV testing

Behavioral: Peer navigation

Diagnostic Test: Sexually transmitted infection (STI) testing and treatment

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

Drug: PrEP for participants without HIV

Peer navigation to connect them to health services available at community-based agencies

Active Comparator group

Description:

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.

Treatment:

Behavioral: Harm reduction services

Diagnostic Test: Testing and referral for treatment for hepatitis C virus (HCV)

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

Diagnostic Test: HIV testing

Behavioral: Peer navigation

Diagnostic Test: Sexually transmitted infection (STI) testing and treatment

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