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Clinical Trials/NCT05776316
NCT05776316
Recruiting
Not Applicable

Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs

NYU Langone Health3 sites in 1 country200 target enrollmentNovember 26, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Drug Use
Sponsor
NYU Langone Health
Enrollment
200
Locations
3
Primary Endpoint
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 26, 2024
End Date
March 28, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session

Time Frame: Up to Week 8

Measure of engagement.

Percentage of Participants who Attend at least 3 HR Sessions in Total

Time Frame: Up to Week 8

Measure of engagement.

Secondary Outcomes

  • Change from Baseline in Brief Quality of Life Scale Score(Baseline, Week 8)
  • 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)

Study Sites (3)

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