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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT05769218
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CHORUS+ — BEHAVIORAL
    The CHORUS+ intervention will include a baseline interview with a peer recovery coach to encourage uptake of HIV PrEP (pre-exposure prophylaxis) and medications for opioid use disorder (MOUD) through motivational interviewing (MI). Participants will also be offered HIV self-testing on the day of recruitment, HIV PrEP (if they are HIV negative) and MOUD. Participants will then receive peer coaching for 6 months to increase adherence to PrEP and or MOUD.
  • Standard of care — OTHER
    Normal protocols for care of participants who inject opioids will be followed.

Study Details

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).

Key Dates

Start date
Dec 19, 2024
Status verified
Mar 2026
Primary completion
Jul 1, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
284 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CHORUS+
    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.
  • Active Comparator: Usual care- control
    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.

Primary Outcome Measure

Adherence to HIV PrEP at 6 months Adherence to HIV PrEP [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Medical Center Faster Paths Bridge ClinicBostonMassachusetts02118-
Victory Programs Mobile Prevention Services Van and Navigation CenterBostonMassachusetts02118-

Find similar trials in Boston, MA

By research site
Boston Medical Center Faster Paths Bridge Clinic· Boston, MAVictory Programs Mobile Prevention Services Van and Navigation Center· Boston, MA

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