Recruiting

Harm Reduction

Sponsor:

NYU Langone Health

Code:

NCT05776316

Conditions

Drug Use

Substance Abuse

Mental Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Integrated Harm Reduction Intervention (IHRI)

Study Details

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).

Conditions

Drug Use

Substance Abuse

Mental Illness

Study ID

NCT05776316

Start date

Nov 25, 2024

Status verified date

Aug, 2026

Completion date

Mar 28, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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 ]
  • Percentage of Participants who Attend at least 3 HR Sessions in Total [ Time Frame: Up to Week 8 ]

Central Contacts and Locations

Central contacts

Ayana Jordan, MD, PhD

(203) 787-8032Ayana.Jordan@nyulangone.org

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Principal Investigator:

Kimberly Sue, MD

Nathan Kline Institute

Recruiting

Orangeburg, New York, United States, 10962

Principal Investigator:

Ayana Jordan, MD, PhD

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Harm Reduction
  • Latinx/Hispanix
  • Black/African American
  • Drug Use
  • Cocaine
  • Opioids
  • Methamphetamines

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-20.