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

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Intervention Group
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

COVID-19 Education Group

Delayed Control Group

Arm 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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Vaccine/Booster Uptake from Baseline to 3 Weeks
Change in vaccine or booster status

Full Information

First Posted
September 7, 2022
Last Updated
April 25, 2023
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05541393
Brief Title
Engaging Church Health Ministries to Decrease Coronavirus Disease-19 Vaccine Hesitancy in Underserved Populations
Acronym
ENGAGE
Official Title
Engaging Church Health Ministries to Decrease COVID-19 (COVID-19) Vaccine Hesitancy in Underserved Populations in Baton Rouge
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Participant recruitment proved futile.
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 Education Group
Arm Type
Experimental
Arm 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
Arm Title
Delayed Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Active Intervention Group
Intervention Description
The intervention will involve meetings with the church health ministers to discuss COVID-19 vaccines and booster shots.
Primary Outcome Measure Information:
Title
Change in COVID-19 Vaccine/Booster Hesitancy from Baseline to 3 Weeks
Description
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.
Time Frame
Baseline and three weeks
Secondary Outcome Measure Information:
Title
Change in Vaccine/Booster Uptake from Baseline to 3 Weeks
Description
Change in vaccine or booster status
Time Frame
Baseline and three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter T Katzmarzyk, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified individual-level dataset will be made available to researchers making a reasonable request to the principal investigator. Data will be made available 1 year after publication of the primary outcomes manuscript.
IPD Sharing Time Frame
Data will be made available 1 year after publication of the primary outcomes manuscript.
IPD Sharing Access Criteria
Data will be available upon reasonable request.

Learn more about this trial

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

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