Harm Reduction Services
- Conditions
- Drug UseSubstance AbuseMental Illness
- Interventions
- Behavioral: Integrated Harm Reduction Intervention (IHRI)
- Registration Number
- NCT05776316
- Lead Sponsor
- NYU Langone Health
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IHRI Integrated Harm Reduction Intervention (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.
- Primary Outcome Measures
Name Time Method Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session Up to Week 8 Measure of engagement.
Percentage of Participants who Attend at least 3 HR Sessions in Total Up to Week 8 Measure of engagement.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Brief Quality of Life Scale Score Baseline, Week 8 12-item assessment of quality of life. Each item is ranked on a 5-point Likert scale ranging from 0 (do not agree at all) to 4 (agree completely). The total score is the sum of responses and ranges from 0 to 48; higher scores indicate higher quality of life. An increase in scores indicates quality of life increased during the observation period.
Change from Baseline in Number of Days of Opioid/Other Stimulant Use Baseline, Week 8 Number of days of opioid/other stimulant use will be calculated using the timeline follow back method, which asks participants to estimate how many days over the previous 30 days that they used opioids/other stimulants.
Change from Baseline in Overdose Risk Assessment Tool Score Baseline, Week 8 20-item assessment of overdose risk. Each item prompts a "Yes" or "No" response. If the response is "Yes," a score is assigned for that item. If the answer is "No," no score is assigned for that item. The total score is the sum of responses and ranges from 0 to 42; lower scores indicate low risk, higher scores indicate higher risk. A decrease in scores indicates risk of overdose decreased during the observatioN period.
Trial Locations
- Locations (3)
Yale University
🇺🇸New Haven, Connecticut, United States
NYU Langone Health
🇺🇸New York, New York, United States
Nathan Kline Institute
🇺🇸Orangeburg, New York, United States