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NCT Number: NCT05769218

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 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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center Faster Paths Bridge Clinic, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHORUS+

Behavioral

The CHORUS+ intervention will include a baseline interview with a peer recovery coach to encourage uptake of HIV PrEP (pre-exposure prophylaxis) and medications for opioid use disorder (MOUD) through motivational interviewing (MI). Participants will also be offered HIV self-testing on the day of recruitment, HIV PrEP (if they are HIV negative) and MOUD. Participants will then receive peer coaching for 6 months to increase adherence to PrEP and or MOUD.

Standard of care

Other

Normal protocols for care of participants who inject opioids will be followed.

Primary outcomes

  1. Adherence to HIV PrEP at 6 months Adherence to HIV PrEP

    Time frame: 6 months

    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.

Secondary outcomes

  1. Adherence to PrEP at 3 and 12 months

    Time frame: 3 months. 12 months

    Adherence will be assessed by self-report and chart review of active medication refills for PrEP and appointments attended.

  2. Receipt of medication for opioid use disorder (MOUD)

    Time frame: 3 months, 6 months, and 12 months

    Receipts will be assessed by any of the following: (1) chart review of active medication refills for MOUD, (2) self-report, (3) urine toxicology results checked during study visit, and (4) chart review for appointments attended.

  3. Test results for gonorrhea

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Results will be assessed as negative or positive.

  4. Test results for chlamydia

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Results will be assessed as negative or positive.

  5. Test results for syphilis

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Results will be assessed as negative or positive.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina A Assoumou, MD MPH

CONTACT

[email protected]

617-414-2857

Sarah Miller

CONTACT

[email protected]

617-414-2857

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Victory Programs Mobile Prevention Services Van and Navigation Center

Registry information

Acronym: CHORUS+

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 15, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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