NCT05769218Recruiting
PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 284 (estimated)
- First submitted
- 3 Mar 2023
- Start date
- 19 Dec 2024
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Boston Medical Center
- Diseases
- HIV
- NCT number
- NCT05769218
What you commit to
- Study type: Interventional
- Planned participants: 284
- From 19 Dec 2024 to the primary completion date, 1 Jul 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persons with previous HIV diagnosis (by self-report; confirmed via HIV test result)
Other
- Express desire to harm themselves or others
- Individuals who are pregnant at baseline
- Individuals who are already enrolled in an interventional study
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Victory Programs Mobile Prevention Services Van and Navigation Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Boston Medical Center Faster Paths Bridge Clinic Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
Related publications
- 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 · PMID 41449454
This page is information, not medical advice. Discuss any trial with your doctor.