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NCT05769218 · ClinicalTrials.gov registry record · NA
PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
A NA study of Opioid Use Disorder, sponsored by Boston Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 284
- Enrollment target
- 2
- Study locations
NCT05769218: Recruiting NA study of Opioid Use Disorder, sponsored by Boston Medical Center.
NCT05769218 is a NA study of Opioid Use Disorder that is actively recruiting participants, run by Boston Medical Center. The registered enrollment target is 284 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05769218, a NA study of Opioid Use Disorder, is actively recruiting participants, sponsored by Boston Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 284 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Standard of care
- BEHAVIORAL CHORUS+
Study Locations (2)
Massachusetts
- Boston Medical Center Faster Paths Bridge Clinic - Boston
- Victory Programs Mobile Prevention Services Van and Navigation Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
What NCT05769218 shows while recruiting
NCT05769218 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Standard of care is the first listed.
NCT05769218 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05769218 about?
NCT05769218 is a clinical study titled "PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study". 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 orde...
What is the current status of trial NCT05769218?
This trial is currently recruiting. It is a NA study. The enrollment target is 284 participants. The study started on 2024-12-19. Estimated completion is 2028-06-30.
What conditions does trial NCT05769218 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT05769218?
The interventions under investigation include: Standard of care (OTHER), CHORUS+ (BEHAVIORAL).
Who is sponsoring clinical trial NCT05769218?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05769218 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05769218's enrollment target sits among peer trials
284 64th of 257 higher than 194 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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