Harm Reduction Services (HRS)

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).

Study Overview

• Status: Recruiting
• Conditions: Mental Illness; Substance Abuse; Drug Use
• Intervention / Treatment: Behavioral: Integrated Harm Reduction Intervention (IHRI)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayana Jordan, MD, PhD; Phone Number: (203) 787-8032; Email: Ayana.Jordan@nyulangone.org

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
      • Principal Investigator: Kimberly Sue, MD
  • New York
    • New York, New York, United States, 10016
      • Not yet recruiting
      • NYU Langone Health
      • Contact: Ayana Jordan, MD, PhD; Email: Ayana.Jordan@nyulangone.org
    • Orangeburg, New York, United States, 10962
      • Recruiting
      • Nathan Kline Institute
      • Principal Investigator: Ayana Jordan, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: HR SAU; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Ayana Jordan, MD, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): March 28, 2028

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cocaine; Opioids; Drug Use; Black/African American; Harm Reduction; Latinx/Hispanix; Methamphetamines
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Behavior; Substance-Related Disorders; Mental Disorders; Harm Reduction
• Other Study ID Numbers: 22-01089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No