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Integrated Harm Reduction for Substance Use Disorders (HRS Trial)

N/A

Waitlist Available

Led By Ayana Jordan, MD, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two approaches to help Black & Latinx PWUD reduce drug-related harm: an IHRI & regular HR services.

Who is the study for?

This trial is for English or Spanish-speaking adults who self-identify as misusing opioids and/or other substances, confirmed by an interview. It's specifically aimed at Black and Latinx individuals. People with severe mental health disorders, active suicidal or homicidal thoughts, prisoners, or those unable to consent are not eligible.

What is being tested?

The study is testing whether a specific program called Integrated Harm Reduction Intervention (IHRI) can improve service utilization among people who use drugs compared to the usual harm reduction services offered.

What are the potential side effects?

Since this trial involves harm reduction services rather than medication, traditional side effects are not applicable. However, participants may experience emotional discomfort when discussing substance use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Change from Baseline in Brief Quality of Life Scale Score

Change from Baseline in Number of Days of Opioid/Other Stimulant Use

Change from Baseline in Overdose Risk Assessment Tool Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IHRIExperimental Treatment1 Intervention

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 II: HR SAUActive Control1 Intervention

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.

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