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

Not Applicable
Withdrawn
Conditions
COVID-19
Interventions
Behavioral: Active Intervention Group
Registration Number
NCT05541393
Lead Sponsor
Pennington Biomedical Research Center
Brief Summary

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

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
COVID-19 Education GroupActive Intervention GroupParticipants 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
Primary Outcome Measures
NameTimeMethod
Change in COVID-19 Vaccine/Booster Hesitancy from Baseline to 3 WeeksBaseline and three 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.

Secondary Outcome Measures
NameTimeMethod
Change in Vaccine/Booster Uptake from Baseline to 3 WeeksBaseline and three weeks

Change in vaccine or booster status

Trial Locations

Locations (1)

Pennington Biomedical Research Center

🇺🇸

Baton Rouge, Louisiana, United States

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