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

Recruiting now · Not applicable

Conditions studied: Opioid Use Disorder

In brief

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).

Key facts

Study ID

NCT05769218

Run by

Boston Medical Center

People needed

284

Starts

2024-12-19

Expected to finish

2028-06-30

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Boston Medical Center Faster Paths Bridge Clinic — Boston, Massachusetts, United States (enrolling)
• Victory Programs Mobile Prevention Services Van and Navigation Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.