Tailoring Overdose Education for Black Churches

Study Overview
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Brief Summary
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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.

Official Title
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Church-Tailored Opioid Overdose Education and Naloxone Distribution to Target Overdose and Stigma Among African-American Communities

Conditions
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Opioid Overdose

Intervention / Treatment
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* Behavioral: COEST


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted Comprehensive Overdose Education and Skills Training (COEST)<br> | Behavioral: COEST<br>* Adapted version of our COEST training, targeting Black church members.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 Months after COEST training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and 6 Months after COEST training | 
| 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) | Baseline and 6 Months after COEST training |