Harm Reduction Services
HRS
Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs
1 other identifier
interventional
200
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
November 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 28, 2028
March 19, 2026
March 1, 2026
1.8 years
March 6, 2023
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Measure of engagement.
Up to Week 8
Percentage of Participants who Attend at least 3 HR Sessions in Total
Measure of engagement.
Up to Week 8
Secondary Outcomes (3)
Change from Baseline in Number of Days of Opioid/Other Stimulant Use
Baseline, Week 8
Change from Baseline in Overdose Risk Assessment Tool Score
Baseline, Week 8
Change from Baseline in Brief Quality of Life Scale Score
Baseline, Week 8
Study Arms (2)
IHRI
EXPERIMENTALIntegrated 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 INTERVENTIONHarm 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.
Interventions
8-week program targeting areas rooted in the 8 principles of harm reduction. Includes weekly education lessons and informed referrals to social service organizations.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Yale University
New Haven, Connecticut, 06520, United States
NYU Langone Health
New York, New York, 10016, United States
Nathan Kline Institute
Orangeburg, New York, 10962, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayana Jordan, MD, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 20, 2023
Study Start
November 25, 2024
Primary Completion (Estimated)
September 29, 2026
Study Completion (Estimated)
March 28, 2028
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Researchers who provide a methodologically sound proposal, as well as investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose, will be granted access to achieve the aims in the approved proposal. Requests should be directed to Ayana.Jordan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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.