Study Stopped
Participant recruitment proved futile.
Engaging Church Health Ministries to Decrease Coronavirus Disease-19 Vaccine Hesitancy in Underserved Populations
ENGAGE
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2023
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedStudy Start
First participant enrolled
April 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedApril 27, 2023
April 1, 2023
3 months
September 7, 2022
April 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Vaccine/Booster Uptake from Baseline to 3 Weeks
Baseline and three weeks
Study Arms (2)
COVID-19 Education Group
EXPERIMENTALParticipants 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
Delayed Control Group
NO INTERVENTIONParticipants 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.
Interventions
The intervention will involve meetings with the church health ministers to discuss COVID-19 vaccines and booster shots.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70809, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter T Katzmarzyk, PhD
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 15, 2022
Study Start
April 15, 2023
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
April 27, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be made available 1 year after publication of the primary outcomes manuscript.
- Access Criteria
- Data will be available upon reasonable request.
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.