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Table 3 Overview of medical care provided in the mobile unit for intervention arm participants

From: Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study)

Condition

Notes

OUD

MOUD counseling and initiation, management, and dispensing of buprenorphine-based medicine (buprenorphine/naloxone sublingual)

Participants who prefer methadone will be referred to community-based services if available

Stimulant use

Participants who also use stimulants (methamphetamine, cocaine) will be referred to 12-step meetings such as crystal meth anonymous, narcotics anonymous and alcoholics anonymous, and evidence-based behavioral treatment, where available.

HIV-ART

ART initiation and management for persons living with HIV who are not already in HIV care, including the following:

 • Dispensation of one first-line, single-pill regimen to participants for whom this is indicated

 • Prescription provided for fulfillment at a pharmacy if a different regimen is indicated

HIV-PrEP

PrEP initiation and management for persons without HIV, including the following:

 • Dispensation of single pill regimens for PrEP

 • Prescription provided for fulfillment at a pharmacy if a different regimen is indicated

Bacterial STI

Bacterial STI management including the following:

 • Provision of antibiotics for treatment of bacterial STIs tested for as part of the protocol (chlamydia, gonorrhea and syphilis)

 • Providing a prescription for fulfillment at a pharmacy, or a referral to community-available services, for any conditions not able to be treated on the mobile unit

Hepatitis C

Testing is part of the study procedures.

Those who test positive receive a referral for treatment.

Hepatitis A

Testing is part of the study procedures.

Those without evidence of immunity will be referred for vaccination.

Hepatitis B

Testing is part of the study procedures.

Those without evidence of immunity will be referred for vaccination.

Those with evidence of chronic infection who are living with HIV may be co-treated by an appropriate ART regimen dispensed on the mobile unit or through a prescription fulfilled at a local pharmacy.

Those with hepatitis B who are without HIV will be counseled on the risks/benefits of PrEP.

Mental health

Clinicians will screen for symptoms of mental health disorders during visits to the mobile unit.

 • For any issues identified, participants will be referred for further evaluation and/or care at community-based services, facilitated by peer navigation.

 • If a person appears to be at risk of harming themselves or others, 911 will be called

Pregnancy

Pregnant participants may utilize the mobile unit.

 • Participants who are pregnant will continue to be seen for MOUD, ART, PrEP, and other services on the mobile unit. All pregnant participants will be referred for obstetric care with a provider comfortable treating pregnant people who inject drugs treated with MOUD. Study clinicians will endeavor to coordinate with the obstetric care provider to optimize care.

Reproductive health

Limited reproductive health services:

 • Prescriptions for oral contraception

 • Condoms/lube

Basic primary care

Basic primary care includes the following:

 • Diagnosis and management of minor acute illnesses and infections such as upper respiratory tract infections, colds, flu, and diarrheal illness

 • Providing prescriptions for pharmacy fulfillment for such conditions if indicated.

 • Identifying more complex care needs and referring for further diagnostics and care from community-available services

More complex care needs and chronic conditions

Management of complex care needs or chronic conditions will be referred to community-available services, such as FQHCs or other clinics

Clinicians on the mobile unit may provide prescriptions for medications for chronic conditions that have been lost or stolen or are needed for continuity of care, including communication and coordination, as possible, with the provider managing the care of the chronic condition.

COVID-19

Clinicians will assess participants for COVID-19 at each encounter. Those with suspected COVID-19 or recent exposure will be referred for further evaluation, care, and treatment, as appropriate and available. CDC and local guidelines for discontinuation of isolation will direct when participants with suspected COVID-19 or recent exposure can resume in-person visits. Distance procedures to collect data and monitor health will be implemented to the extent possible.

  1. Abbreviations: ART Antiretroviral therapy, FQHC Federally qualified health centers, MOUD Medications for opioid use disorder, OUD Opioid use disorder, PrEP Pre-exposure prophylaxis, STI Sexually transmitted infection