Tailoring Overdose Education for Black Churches
Primary Purpose
Opioid Overdose
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COEST
Sponsored by
About this trial
This is an interventional health services research trial for Opioid Overdose
Eligibility Criteria
Inclusion Criteria: Identify as one of the following group members of the Black church: Clergy; Individual with OUD and/or stimulant use disorder; Family member or friend of an individual with OUD; Formerly incarcerated. Age 18 and older. Exclusion Criteria: Unable to provide informed consent. Less than 18 years old. Does not identify as belonging to one of the four stakeholder groups.
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adapted Comprehensive Overdose Education and Skills Training (COEST)
Arm Description
Outcomes
Primary Outcome Measures
Change in Frequency of Naloxone Utilization/Overdose Intervention
All study participants will receive an overdose response kit containing two doses of intranasal naloxone. Participants are asked to notify study staff immediately if they utilize naloxone in an attempt to reverse an opioid overdose.
Secondary Outcome Measures
Opioid Overdose Knowledge Scale (OOKS)
The OOKS measures knowledge about risk factors for having an opioid overdose, signs of an opioid overdose, actions to be taken in an overdose situation, naloxone effects and administration, adverse effects and aftercare procedures. The scale also identifies misinformation. The OOKS is a 14-item scale (Score Range: 0-45).
Brief Opioid Stigma Scale (BOOS)
The BOSS was developed to assess stereotype awareness ("aware"), stereotype agreement ("agree"), and self-esteem decrement ("harm") surrounding opioid dependence. The BOSS is a 12-item scale (Score Range: 12-60)
Full Information
NCT ID
NCT05645016
First Posted
November 30, 2022
Last Updated
August 8, 2023
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT05645016
Brief Title
Tailoring Overdose Education for Black Churches
Official Title
Church-Tailored Opioid Overdose Education and Naloxone Distribution to Target Overdose and Stigma Among African-American Communities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
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
Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. For Overdose Education and Naloxone Distribution (OEND) to be efficacious in Black churches, tailoring may be needed. For this audience, standard OEND curricula may need to be adapted to their level of knowledge of substance use disorders (SUDs), and limited general mental health literacy, and specifically address stigma related to SUDs and medications for opioid use disorder (MOUD). Finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. The proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., COEST) to target Black communities of faith. In a pilot randomized controlled trial (RTC) of adapted COEST in a stepped-wedge design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Overdose
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The design is a two-arm cluster randomized trial with randomization at the level of the church (4 Churches), and analyses at the level of the individual participants (i.e., church members).
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adapted Comprehensive Overdose Education and Skills Training (COEST)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
COEST
Intervention Description
Adapted version of our COEST training, targeting Black church members.
Primary Outcome Measure Information:
Title
Change in Frequency of Naloxone Utilization/Overdose Intervention
Description
All study participants will receive an overdose response kit containing two doses of intranasal naloxone. Participants are asked to notify study staff immediately if they utilize naloxone in an attempt to reverse an opioid overdose.
Time Frame
Baseline and 6 Months after COEST training
Secondary Outcome Measure Information:
Title
Opioid Overdose Knowledge Scale (OOKS)
Description
The OOKS measures knowledge about risk factors for having an opioid overdose, signs of an opioid overdose, actions to be taken in an overdose situation, naloxone effects and administration, adverse effects and aftercare procedures. The scale also identifies misinformation. The OOKS is a 14-item scale (Score Range: 0-45).
Time Frame
Baseline and 6 Months after COEST training
Title
Brief Opioid Stigma Scale (BOOS)
Description
The BOSS was developed to assess stereotype awareness ("aware"), stereotype agreement ("agree"), and self-esteem decrement ("harm") surrounding opioid dependence. The BOSS is a 12-item scale (Score Range: 12-60)
Time Frame
Baseline and 6 Months after COEST training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Identify as one of the following group members of the Black church: Clergy; Individual with OUD and/or stimulant use disorder; Family member or friend of an individual with OUD; Formerly incarcerated.
Age 18 and older.
Exclusion Criteria:
Unable to provide informed consent.
Less than 18 years old.
Does not identify as belonging to one of the four stakeholder groups.
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Tailoring Overdose Education for Black Churches
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