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

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05541393
Collaborator
(none)
98
1
2
8.5
11.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Active Intervention Group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Engaging Church Health Ministries to Decrease COVID-19 (COVID-19) Vaccine Hesitancy in Underserved Populations in Baton Rouge
Anticipated Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: COVID-19 Education Group

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
The intervention will involve meetings with the church health ministers to discuss COVID-19 vaccines and booster shots.

No Intervention: Delayed Control Group

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.

Outcome Measures

Primary Outcome Measures

  1. Change in COVID-19 Vaccine/Booster Hesitancy from Baseline to 3 Weeks [Baseline 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

  1. Change in Vaccine/Booster Uptake from Baseline to 3 Weeks [Baseline and three weeks]

    Change in vaccine or booster status

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70809

Sponsors and Collaborators

  • Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Peter T Katzmarzyk, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT05541393
Other Study ID Numbers:
  • PBRC 2021-047
First Posted:
Sep 15, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2022