Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Integrated Harm Reduction Intervention (IHRI) (Behavioral)
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.
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)