Opioid Use DisorderCHORUS+NCT05769218
PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
A study testing CHORUS+ in people with Opioid Use Disorder, run by Boston Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- CHORUS+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Boston Medical Center Faster Paths Bridge Clinic
Boston, Massachusetts, 02118
- Recruiting
Victory Programs Mobile Prevention Services Van and Navigation Center
Boston, Massachusetts, 02118
About this 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).
- Conditions
- Opioid Use Disorder
- Being tested
- CHORUS+, Standard of care
- Keywords
- Medication for opioid use disorder, Human immunodeficiency (HIV), Pre-exposure prophylaxis (PrEP), Peer recovery coaching (PRC), Motivational interviewing (MI), HIV self testing, People who inject opioids (PWIO)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHORUS+Behavioural
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 careOther
Normal protocols for care of participants who inject opioids will be followed.
| Study group | Role | What they receive |
|---|---|---|
| CHORUS+ | Experimental | The baseline questionnaire for participants in this arm will be followed by a 30-minute motivational interviewing (MI) session with the peer recovery coach (PRC), and will assess readiness for change and provide information about PrEP. The PRC will also assess readiness for MOUD, and this will be further explored during subsequent visits. Receives: Behavioral: CHORUS+ |
| Usual care- control | Active comparator | Participants in this arm will receive passive referral for care. there will be no PRC MI session and they will not be offered PrEP or MOUD. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to HIV PrEP at 6 months Adherence to HIV PrEP
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.
Measured: 6 months
Secondary outcomes (5)
Adherence to PrEP at 3 and 12 months
Adherence will be assessed by self-report and chart review of active medication refills for PrEP and appointments attended.
Measured: 3 months. 12 months
Receipt of medication for opioid use disorder (MOUD)
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.
Measured: 3 months, 6 months, and 12 months
Test results for gonorrhea
Results will be assessed as negative or positive.
Measured: Baseline, 3 months, 6 months, and 12 months
Test results for chlamydia
Results will be assessed as negative or positive.
Measured: Baseline, 3 months, 6 months, and 12 months
Test results for syphilis
Results will be assessed as negative or positive.
Measured: Baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start19 Dec 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Victory Programs Mobile Prevention Services Van and Navigation Center
- Responsible party
- Sponsor
- Investigators
- Sabrina A Assoumou, MD MPH, Principal investigator, Boston Medical Center, Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769218
- Sponsor's protocol ID
- H-43487
- Other IDs
- R01DA058367
- Acronym
- CHORUS+
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller SE, Dukes KA, Damato-MacPherson C, Psaros C, Scott NA, Taylor JL, Muroff J, Winter MR, Skiba LE, Lugo H, Cruz R, Ruiz-Mercado G, Crawford ND, Mayer KH, Assoumou SA. 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 Dec 25;21(1):17. doi: 10.1186/s13722-025-00634-2.
PubMed 41449454
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
- ClinicalTrials.gov ID
- NCT05769218
- Acronym / sponsor ID
- CHORUS+ / H-43487
- Conditions
- Opioid Use Disorder
- Keywords
- Medication for opioid use disorder, Human immunodeficiency (HIV), Pre-exposure prophylaxis (PrEP), Peer recovery coaching (PRC), Motivational interviewing (MI), HIV self testing, People who inject opioids (PWIO)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Victory Programs Mobile Prevention Services Van and Navigation Center
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHORUS+ | Experimental | Behavioral: CHORUS+The baseline questionnaire for participants in this arm will be followed by a 30-minute motivational interviewing (MI) session with the peer recovery coach (PRC), and will assess readiness for change and provide information about PrEP. The PRC will also assess readiness for MOUD, and this will be further explored during subsequent visits. |
| Usual care- control | Active comparator | Other: Standard of careParticipants in this arm will receive passive referral for care. there will be no PRC MI session and they will not be offered PrEP or MOUD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHORUS+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. | Behavioural | CHORUS+ |
| Standard of careNormal protocols for care of participants who inject opioids will be followed. | Other | Usual care- control |
Primary outcome
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.
5 secondary outcomes
Adherence to PrEP at 3 and 12 months
Time frame: 3 months. 12 months
Receipt of medication for opioid use disorder (MOUD)
Time frame: 3 months, 6 months, and 12 months
Test results for gonorrhea
Time frame: Baseline, 3 months, 6 months, and 12 months
Test results for chlamydia
Time frame: Baseline, 3 months, 6 months, and 12 months
Test results for syphilis
Time frame: Baseline, 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 41449454Miller SE, Dukes KA, Damato-MacPherson C, Psaros C, Scott NA, Taylor JL, Muroff J, Winter MR, Skiba LE, Lugo H, Cruz R, Ruiz-Mercado G, Crawford ND, Mayer KH, Assoumou SA. 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 Dec 25;21(1):17. doi: 10.1186/s13722-025-00634-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabrina A Assoumou, MD MPH principal investigator
Boston Medical Center, Infectious Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHORUS+ in people with Opioid Use Disorder, run by Boston Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina A Assoumou, MD MPH (617-414-2857, sabrina.assoumou@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to HIV PrEP at 6 months Adherence to HIV PrEP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05769218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.