PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study

Boston Medical Center (BMC)

Status: Enrolling

Conditions: Opioid Use Disorder

Treatments: Behavioral: CHORUS+; Other: Standard of care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05769218

R01DA058367 (U.S. NIH Grant/Contract)

H-43487

Details and patient eligibility

About

The US opioid overdose epidemic has been accompanied by an increase in human immunodeficiency (HIV) among persons who inject drugs. HIV pre-exposure prophylaxis (PrEP) is an FDA approved medication taken daily orally by individuals who are HIV negative, but who are at increased risk for HIV. In order to obtain PrEP, a prescription is needed. Before being prescribed HIV PrEP, it is recommended by the Centers for Disease Control and Prevention (CDC) to obtain an HIV test first. Although home HIV self-test kits are recommended by the CDC and are locally available, uptake remains low.

CHORUS+ (Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic +) is a theory-based, peer-delivered, mobile phone-supported intervention focused on enhancing uptake and adherence to HIV PrEP (primary outcome), and continuation of MOUD (secondary outcome) among persons who inject opioids. At recruitment, the intervention will include HIV self-testing, rapid initiation of PrEP and MOUD, and 6-month peer recovery coaching (PRC) to support adherence to these medications. This research study seeks to determine the efficacy of a novel intervention to increase the uptake of evidence-based measures to prevent HIV and treat opioid use disorder.

The efficacy of this multi-site, two-arm randomized control trial of CHORUS+ and usual care [passive referral]. This study is not testing the efficacy of PrEP or HIV home testing which is already known. In addition the investigators will determine the influence of HIV self-testing on PrEP uptake and adherence. In the CHORUS+/ intervention arm, there will be a baseline in-person session with the participant to encourage uptake of PrEP and MOUD using motivational interviewing (MI).

Enrollment: 284 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Injected opioids within the past 6 months (by self-report)
• Willingness to provide contact information for two family members or friends
• Willingness to sign medical records release forms
• Ability to speak English
• Plans to reside in Boston area for the next 6 months

Exclusion criteria

• Individuals with HIV (self report)
• Express desire to harm themselves or others
• Individuals who are pregnant at baseline
• Individuals who are already enrolled in an interventional study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

CHORUS+

Experimental group

Description:

The baseline questionnaire for participants in this arm will be followed by a 30-minute motivational interviewing (MI) session with the peer recovery coach (PRC), and will assess readiness for change and provide information about PrEP. The PRC will also assess readiness for MOUD, and this will be further explored during subsequent visits.

Treatment:

Behavioral: CHORUS+

Usual care- control

Active Comparator group

Description:

Participants in this arm will receive passive referral for care. there will be no PRC MI session and they will not be offered PrEP or MOUD.

Treatment:

Other: Standard of care