NCT05769218 PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
| NCT ID | NCT05769218 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 284 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 284 participants in total. It began in 2024-12-19 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Sabrina A Assoumou, MD MPH
PRINCIPAL INVESTIGATOR
Boston Medical Center, Infectious Diseases
Frequently Asked Questions
Who can join the NCT05769218 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05769218 currently recruiting?
Yes, NCT05769218 is actively recruiting participants. Contact the research team at sabrina.assoumou@bmc.org for enrollment information.
Where is the NCT05769218 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT05769218 clinical trial?
NCT05769218 is sponsored by Boston Medical Center. The principal investigator is Sabrina A Assoumou, MD MPH at Boston Medical Center, Infectious Diseases. The trial plans to enroll 284 participants.