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

Study acronym: CHORUS+
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 20 wordsv15
  2. Notable Primary completion date: Jun 2026 to Jul 1, 2027
    • Study completion date: Jun 2026 to Jun 30, 2028
    v14
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2024 to Dec 19, 2024
    • Site details revised at 2 of 2 sites
    v13
  4. Minor Start date: Nov 2024 to Dec 2024v12
  5. Minor Start date: Oct 2024 to Nov 2024
    • Eligibility criteria expanded, about 14 words
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Notable Start date: Aug 15, 2024 to Oct 2024v10
  2. Minor Study title shortened, about 1 wordv9
  3. Notable Start date: May 2024 to Aug 15, 2024v8
  4. Notable Start date: Feb 2024 to May 2024v7
  5. Minor Re-verified, no change to tracked fieldsv6
  6. Minor Collaborators: 1 to 2v5
  7. Notable Start date: Aug 2023 to Feb 2024v4
  8. Minor Start date: Jul 2023 to Aug 2023v3
  9. Notable Start date: May 2023 to Jul 2023v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05769218
Lead Sponsor Boston Medical Center
Collaborators: National Institute on Drug Abuse (NIDA), Victory Programs Mobile Prevention Services Van and Navigation Center
Conditions
(from sponsor)
Opioid Use Disorder
Related terms Opioid-Related Disorders
Enrollment 284 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov