PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
CHORUS+
2 other identifiers
interventional
284
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedStudy Start
First participant enrolled
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 13, 2025
May 1, 2025
2.5 years
March 3, 2023
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to HIV PrEP at 6 months Adherence to HIV PrEP
This outcome will be assessed by the proportion of individuals who have dried blood spot tenofovir-diphosphate (TFV-DP) blood level 700 fmol/punch or greater at 6 months post-enrollment.
6 months
Secondary Outcomes (5)
Adherence to PrEP at 3 and 12 months
3 months. 12 months
Receipt of medication for opioid use disorder (MOUD)
3 months, 6 months, and 12 months
Test results for gonorrhea
Baseline, 3 months, 6 months, and 12 months
Test results for chlamydia
Baseline, 3 months, 6 months, and 12 months
Test results for syphilis
Baseline, 3 months, 6 months, and 12 months
Study Arms (2)
CHORUS+
EXPERIMENTALThe 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.
Usual care- control
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Normal protocols for care of participants who inject opioids will be followed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Boston Medical Center Faster Paths Bridge Clinic
Boston, Massachusetts, 02118, United States
Victory Programs Mobile Prevention Services Van and Navigation Center
Boston, Massachusetts, 02118, United States
Related Publications (1)
Miller SE, Dukes KA, Damato-MacPherson C, Psaros C, Scott NA, Taylor JL, Muroff J, Winter MR, Skiba LE, Lugo H, Cruz R, Ruiz-Mercado G, Crawford ND, Mayer KH, Assoumou SA. Pre-exposure prophylaxis (PrEP) and medications for opioid use disorder for persons who inject drugs: the CHORUS + randomized controlled trial study protocol. Addict Sci Clin Pract. 2025 Dec 25;21(1):17. doi: 10.1186/s13722-025-00634-2.
PMID: 41449454DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabrina A Assoumou, MD MPH
Boston Medical Center, Infectious Diseases
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 15, 2023
Study Start
December 19, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share