Back to resultsHarm Reduction Services (HRS)
Primary Purpose
Drug Use, Substance Abuse, Mental Illness
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Harm Reduction Intervention (IHRI)
Sponsored by
About this trial
This is an interventional health services research trial for Drug Use focused on measuring Harm Reduction, Latinx/Hispanix, Black/African American, Drug Use, Cocaine, Opioids, Methamphetamines
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
IHRI
HR SAU
Arm Description
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.
Harm reduction services as usual (HR SAU). Participants will be exposed to service encounters through the mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution.
Outcomes
Primary Outcome Measures
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Measure of engagement.
Percentage of Participants who Attend at least 3 HR Sessions in Total
Measure of engagement.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05776316
First Posted
March 6, 2023
Last Updated
June 13, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT05776316
Brief Title
Harm Reduction Services
Acronym
HRS
Official Title
Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, Substance Abuse, Mental Illness
Keywords
Harm Reduction, Latinx/Hispanix, Black/African American, Drug Use, Cocaine, Opioids, Methamphetamines
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IHRI
Arm Type
Experimental
Arm Description
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.
Arm Title
HR SAU
Arm Type
No Intervention
Arm Description
Harm reduction services as usual (HR SAU). Participants will be exposed to service encounters through the mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Harm Reduction Intervention (IHRI)
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Description
Measure of engagement.
Time Frame
Up to Week 8
Title
Percentage of Participants who Attend at least 3 HR Sessions in Total
Description
Measure of engagement.
Time Frame
Up to Week 8
Secondary Outcome Measure Information:
Title
Change from Baseline in Number of Days of Opioid/Other Stimulant Use
Description
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
Title
Change from Baseline in Overdose Risk Assessment Tool Score
Description
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
Title
Change from Baseline in Brief Quality of Life Scale Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayana Jordan, MD, PhD
Phone
646-754-4858
Email
Ayana.Jordan@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayana Jordan, MD, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayana Jordan, MD, PhD
Phone
646-754-4858
Email
Ayana.Jordan@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data collected during the trial will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Ayana.Jordan@nyulangone.org]. The protocol, statistical analysis plan, informed consent form, and clinical study report will be made available on Clinicaltrials.gov.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal, as well as investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose, will be granted access to achieve the aims in the approved proposal. Requests should be directed to Ayana.Jordan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Harm Reduction Services
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