Harm Reduction Services

Substance Abuse Clinical Trial

— HRS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05776316
• Other study ID #: 22-01089
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: February 2027

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Ayana Jordan, MD, PhD
• Phone: 646-754-4858
• Email: Ayana.Jordan[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2027
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Use
• Mental Disorders
• Mental Illness
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Integrated Harm Reduction Intervention (IHRI)
8-week program targeting areas rooted in the 8 principles of harm reduction. Includes weekly education lessons and informed referrals to social service organizations.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	NYU Langone Health	New York	New York
United States	Nathan Kline Institute	Orangeburg	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session	Measure of engagement.	Up to Week 8
Primary	Percentage of Participants who Attend at least 3 HR Sessions in Total	Measure of engagement.	Up to Week 8
Secondary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8