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NCT Number: NCT05776316

Harm Reduction Services

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).

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Key information

Conditions

Drug Use Behavior Chemically-Induced Disorders Harm Reduction Mental Disorders Mental Illness Substance Abuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Up to Week 8

    Measure of engagement.

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

    Time frame: Up to Week 8

    Measure of engagement.

Secondary outcomes

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

    Time frame: 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.

  2. Change from Baseline in Overdose Risk Assessment Tool Score

    Time frame: 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.

  3. Change from Baseline in Brief Quality of Life Scale Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayana Jordan, MD, PhD

CONTACT

[email protected]

(203) 787-8032

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Acronym: HRS

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 20, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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