Harm Reduction Services

NCT ID: NCT05776316

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-26

Study Completion Date

2028-03-28

Brief Summary

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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).

Detailed Description

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Conditions

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Drug Use Substance Abuse Mental Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Integrated Harm Reduction Intervention (IHRI)

Intervention Type BEHAVIORAL

8-week program targeting areas rooted in the 8 principles of harm reduction. Includes weekly education lessons and informed referrals to social service organizations.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayana Jordan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

NYU Langone Health

New York, New York, United States

Site Status NOT_YET_RECRUITING

Nathan Kline Institute

Orangeburg, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ayana Jordan, MD, PhD

Role: CONTACT

646-754-4858

Facility Contacts

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Ayana Jordan, MD, PhD

Role: primary

646-754-4858

Other Identifiers

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22-01089

Identifier Type: -

Identifier Source: org_study_id

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