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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05776316




Registration number
NCT05776316
Ethics application status
Date submitted
6/03/2023
Date registered
20/03/2023

Titles & IDs
Public title
Harm Reduction Services
Scientific title
Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs
Secondary ID [1] 0 0
22-01089
Universal Trial Number (UTN)
Trial acronym
HRS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug Use 0 0
Substance Abuse 0 0
Mental Illness 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Integrated Harm Reduction Intervention (IHRI)

Experimental: IHRI - 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.

No intervention: HR SAU - 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.


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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Timepoint [1] 0 0
Up to Week 8
Primary outcome [2] 0 0
Percentage of Participants who Attend at least 3 HR Sessions in Total
Timepoint [2] 0 0
Up to Week 8
Secondary outcome [1] 0 0
Change from Baseline in Number of Days of Opioid/Other Stimulant Use
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [2] 0 0
Change from Baseline in Overdose Risk Assessment Tool Score
Timepoint [2] 0 0
Baseline, Week 8
Secondary outcome [3] 0 0
Change from Baseline in Brief Quality of Life Scale Score
Timepoint [3] 0 0
Baseline, Week 8

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/02/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
NYU Langone Health
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of General Medical Sciences (NIGMS)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ayana Jordan, MD, PhD
Address 0 0
NYU Langone Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ayana Jordan, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
646-754-4858
Fax 0 0
Email 0 0
Ayana.Jordan@nyulangone.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05776316