Harm Reduction Services

NYU Langone Health200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

200

Conditions

Drug Use Substance Abuse Mental Illness

Interventions

Integrated Harm Reduction Intervention (IHRI)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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Yale University

New Haven, Connecticut, United States

RECRUITING

NYU Langone Health

New York, New York, United States

NOT_YET_RECRUITING

Nathan Kline Institute

Orangeburg, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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

Measure of engagement.

Time frame: Up to Week 8

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

Measure of engagement.

Time frame: Up to Week 8

Secondary Outcomes

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

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.

Time frame: Baseline, Week 8

Change from Baseline in Overdose Risk Assessment Tool Score

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.

Time frame: Baseline, Week 8

Change from Baseline in Brief Quality of Life Scale Score

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.

Time frame: Baseline, Week 8

Central Contacts

Ayana Jordan, MD, PhD

CONTACT

(203) 787-8032 Ayana.Jordan@nyulangone.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.