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Harm Reduction Services

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05776316
Acronym
HRS
Enrollment
200
Registered
2023-03-20
Start date
2024-11-25
Completion date
2028-03-28
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use, Mental Illness, Substance Abuse

Keywords

Harm Reduction, Latinx/Hispanix, Black/African American, Drug Use, Cocaine, Opioids, Methamphetamines

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).

Interventions

BEHAVIORALIntegrated 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.

Sponsors

NYU Langone Health
Lead SponsorOTHER
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR SessionUp to Week 8Measure of engagement.
Percentage of Participants who Attend at least 3 HR Sessions in TotalUp to Week 8Measure of engagement.

Secondary

MeasureTime frameDescription
Change from Baseline in Number of Days of Opioid/Other Stimulant UseBaseline, Week 8Number 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 ScoreBaseline, Week 820-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.
Change from Baseline in Brief Quality of Life Scale ScoreBaseline, Week 812-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.

Countries

United States

Contacts

CONTACTAyana Jordan, MD, PhD
Ayana.Jordan@nyulangone.org(203) 787-8032
PRINCIPAL_INVESTIGATORAyana Jordan, MD, PhD

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026