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Recruiting NCT05769218

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

No phase Interventional Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHORUS+, Standard of care.
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Behavioral CHORUS+
    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.
  • Other Standard of care
    Normal protocols for care of participants who inject opioids will be followed.

Primary outcome measures

  • Adherence to HIV PrEP at 6 months Adherence to HIV PrEP [Time frame: 6 months]
Secondary outcome measures (5)
  • Adherence to PrEP at 3 and 12 months [Time frame: 3 months. 12 months]
  • Receipt of medication for opioid use disorder (MOUD) [Time frame: 3 months, 6 months, and 12 months]
  • Test results for gonorrhea [Time frame: Baseline, 3 months, 6 months, and 12 months]
  • Test results for chlamydia [Time frame: Baseline, 3 months, 6 months, and 12 months]
  • Test results for syphilis [Time frame: Baseline, 3 months, 6 months, and 12 months]

Eligibility criteria

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
  • Are medically cleared to take PrEP and MOUD (normal renal and PrEP-related labs)

Exclusion criteria

  • Persons with previous HIV diagnosis (by self-report; confirmed via HIV test result)
  • Express desire to harm themselves or others
  • Individuals who are pregnant at baseline
  • Individuals who are already enrolled in an interventional study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Boston Medical Center Faster Paths Bridge Clinic — Boston
  • Victory Programs Mobile Prevention Services Van and Navigation Center — Boston

Publications

  • 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- PMID 41449454

Identifiers

NCT: NCT05769218 · H-43487 · R01DA058367

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗