Harm Reduction Services (HRS)

NYU Langone Health

Status: Enrolling

Conditions: Mental Illness; Substance Abuse; Drug Use

Treatments: Behavioral: Integrated Harm Reduction Intervention (IHRI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05776316

22-01089

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

IHRI

Experimental group

Description:

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.

Treatment:

Behavioral: Integrated Harm Reduction Intervention (IHRI)

HR SAU

No Intervention group

Description:

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.