Drug UseHRSNCT05776316
Harm Reduction Services
A study testing Integrated Harm Reduction Intervention (IHRI) in people with Drug Use and Substance Abuse, run by NYU Langone Health at 3 sites in United States.
Trial summary
The purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve harm reduction service utilization among Black and Latinx people who use drugs (PWUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Use, Substance Abuse, Mental Illness
- What is being tested?
- Integrated Harm Reduction Intervention (IHRI)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Nov 2024to 28 Mar 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
- at least 18 years of age
- self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using DSM-5 criteria
- English or Spanish speaking
- able to provide informed consent.
Who cannot join
- inability to provide informed consent or participate in the study procedures as proposed in the consent
- active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder)
- an unwillingness to be randomized.
- are prisoners
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06520
Kimberly Sue, MD
- Not yet recruiting
NYU Langone Health
New York, New York, 10016
Ayana Jordan, MD, PhD, Ayana.Jordan@nyulangone.org
- Recruiting
Nathan Kline Institute
Orangeburg, New York, 10962
Ayana Jordan, MD, PhD
About this study
Official title: Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs
The purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve harm reduction service utilization among Black and Latinx people who use drugs (PWUD).
- Conditions
- Drug Use, Substance Abuse, Mental Illness
- Being tested
- Integrated Harm Reduction Intervention (IHRI)
- Keywords
- Harm Reduction, Latinx/Hispanix, Black/African American, Drug Use, Cocaine, Opioids, Methamphetamines
- Medical subject headings
- Substance-Related Disorders, Mental Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Harm Reduction Intervention (IHRI)Behavioural
8-week program targeting areas rooted in the 8 principles of harm reduction. Includes weekly education lessons and informed referrals to social service organizations.
| Study group | Role | What they receive |
|---|---|---|
| IHRI | Experimental | Integrated harm reduction intervention (IHRI) program tailored specifically for highly marginalized Black and Latinx people who use drugs (PWUDs). The IHRI lasts 8 weeks in duration, with the first 4 weeks consisting of weekly education lessons provided by the IHRI care coordinator. The subsequent 4 weeks will involve individualized identification of vulnerabilities in the social determinants of health (SDOH) for the purposes of making informed referrals to relevant partnering social service organizations. Participants will also be exposed to service encounters through mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution. Receives: Behavioral: Integrated Harm Reduction Intervention (IHRI) |
| HR SAU | No intervention | Harm reduction services as usual (HR SAU). Participants will be exposed to service encounters through the mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Measure of engagement.
Measured: Up to Week 8
Percentage of Participants who Attend at least 3 HR Sessions in Total
Measure of engagement.
Measured: Up to Week 8
Secondary outcomes (3)
Change from Baseline in Number of Days of Opioid/Other Stimulant Use
Number of days of opioid/other stimulant use will be calculated using the timeline follow back method, which asks participants to estimate how many days over the previous 30 days that they used opioids/other stimulants.
Measured: Baseline, Week 8
Change from Baseline in Overdose Risk Assessment Tool Score
20-item assessment of overdose risk. Each item prompts a "Yes" or "No" response. If the response is "Yes," a score is assigned for that item. If the answer is "No," no score is assigned for that item. The total score is the sum of responses and ranges from 0 to 42; lower scores indicate low risk, higher scores indicate higher risk. A decrease in scores indicates risk of overdose decreased during the observatioN period.
Measured: Baseline, Week 8
Change from Baseline in Brief Quality of Life Scale Score
12-item assessment of quality of life. Each item is ranked on a 5-point Likert scale ranging from 0 (do not agree at all) to 4 (agree completely). The total score is the sum of responses and ranges from 0 to 48; higher scores indicate higher quality of life. An increase in scores indicates quality of life increased during the observation period.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start25 Nov 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion28 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Ayana Jordan, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776316
- Sponsor's protocol ID
- 22-01089
- Acronym
- HRS
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data collected during the trial will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[Ayana.Jordan@nyulangone.org\]. The protocol, statistical analysis plan, informed consent form, and clinical study report will be made available on Clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs
- ClinicalTrials.gov ID
- NCT05776316
- Acronym / sponsor ID
- HRS / 22-01089
- Conditions
- Drug Use, Substance Abuse, Mental Illness
- Keywords
- Harm Reduction, Latinx/Hispanix, Black/African American, Drug Use, Cocaine, Opioids, Methamphetamines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 28 Mar 2028 (estimated)
- First posted
- 20 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 purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve harm reduction service utilization among Black and Latinx people who use drugs (PWUD).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IHRI | Experimental | Behavioral: Integrated Harm Reduction Intervention (IHRI)Integrated harm reduction intervention (IHRI) program tailored specifically for highly marginalized Black and Latinx people who use drugs (PWUDs). The IHRI lasts 8 weeks in duration, with the first 4 weeks consisting of weekly education lessons provided by the IHRI care coordinator. The subsequent 4 weeks will involve individualized identification of vulnerabilities in the social determinants of health (SDOH) for the purposes of making informed referrals to relevant partnering social service organizations. Participants will also be exposed to service encounters through mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution. |
| HR SAU | No intervention | –Harm reduction services as usual (HR SAU). Participants will be exposed to service encounters through the mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years of age
- self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using DSM-5 criteria
- English or Spanish speaking
- able to provide informed consent.
Key exclusion criteria (4 listed)
- inability to provide informed consent or participate in the study procedures as proposed in the consent
- active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder)
- an unwillingness to be randomized.
- are prisoners
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 |
|---|---|---|
| Integrated Harm Reduction Intervention (IHRI)8-week program targeting areas rooted in the 8 principles of harm reduction. Includes weekly education lessons and informed referrals to social service organizations. | Behavioural | IHRI |
Primary outcome
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Time frame: Up to Week 8
Measure of engagement.
Percentage of Participants who Attend at least 3 HR Sessions in Total
Time frame: Up to Week 8
Measure of engagement.
3 secondary outcomes
Change from Baseline in Number of Days of Opioid/Other Stimulant Use
Time frame: Baseline, Week 8
Change from Baseline in Overdose Risk Assessment Tool Score
Time frame: Baseline, Week 8
Change from Baseline in Brief Quality of Life Scale Score
Time frame: Baseline, Week 8
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 20 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data collected during the trial will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Ayana.Jordan@nyulangone.org]. The protocol, statistical analysis plan, informed consent form, and clinical study report will be made available on Clinicaltrials.gov.
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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.
Ayana Jordan, MD, PhD principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Harm Reduction Intervention (IHRI) in people with Drug Use and Substance Abuse, run by NYU Langone Health at 3 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 4 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Ayana Jordan, MD, PhD ((203) 787-8032, Ayana.Jordan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session (time frame: Up to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.