Engaging Church Health Ministries to Decrease Coronavirus Disease-19 Vaccine Hesitancy in Underserved Populations

Study Overview
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Brief Summary
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This study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities.

Detailed Description
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This study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities. A total of 98 participants from three-to-five churches will be randomized to an intervention group that will receive counseling from their health ministers on the benefits of getting vaccinated, boosted, and tested, or to a delayed intervention control group. The effects of the intervention on the primary outcome, change in vaccine/booster hesitancy, will be assessed by a questionnaire that will be administered to both groups at baseline and after three weeks. Following the three-week control period, the delayed intervention control group will also receive the intervention and again be administered the questionnaire. Questionnaires will be used to obtain more granular information on sources of vaccine/booster hesitancy and for their vaccine-related decisions.

Official Title
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Engaging Church Health Ministries to Decrease COVID-19 (COVID-19) Vaccine Hesitancy in Underserved Populations in Baton Rouge

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: Active Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 y Not having received an initial COVID-19 vaccine or a booster vaccine at the recommended interval Having vaccine or booster hesitancy Able to understand and speak English Willing to engage with the church's health ministry via in-person or virtual/phone sessions Exclusion Criteria: None

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 Education Group<br>Participants randomized to the intervention will be engaged over a three-week period in discussions by their health ministries; any identified concerns or barriers around the initial vaccination series and/or booster vaccinations will be addressed and the importance of continued COVID-19 testing will be emphasized. Evidence-based vaccine strategies that focus on positive framing will be employed | Behavioral: Active Intervention Group<br>* The intervention will involve meetings with the church health ministers to discuss COVID-19 vaccines and booster shots.<br>|
| No Intervention: Delayed Control Group<br>Participants in the delayed intervention control group will not receive any outreach during the three-week control period. Subsequent to completing the follow-up questionnaire, they will then be invited to join the intervention for the next three weeks. A follow-up questionnaire will be administered following their intervention period to be used in later analyses. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in COVID-19 Vaccine/Booster Hesitancy from Baseline to 3 Weeks | Vaccine hesitancy will be measured in those who indicate that they have not received the initial vaccine in a single or 2-series protocol using a single question: How likely are you to get an approved COVID-19 vaccine? Responses are recorded on a 7-point scale, with 1 being not at all likely and 7 being very likely. Vaccine hesitancy will be defined as a score of 1 to 4 on the scale. Among individuals who have received the initial vaccine series, but not the booster, booster hesitancy will be measured using the following question: How likely are you to get an approved COVID-19 booster shot? Responses are recorded on a 7-point scale, with 1 being not at all likely and 7 being very likely. Booster hesitancy will be defined as a score of 1 to 4 on the scale. | Baseline and three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vaccine/Booster Uptake from Baseline to 3 Weeks | Change in vaccine or booster status | Baseline and three weeks |