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

Pennington Biomedical Research Center

Status: Withdrawn

Conditions: COVID-19

Treatments: Behavioral: Active Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05541393

PBRC 2021-047

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

COVID-19 Education Group

Experimental group

Description:

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

Treatment:

Behavioral: Active Intervention Group

Delayed Control Group

No Intervention group

Description:

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.