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

COVID-19 Clinical Trial

— ENGAGE  

Official title:

Engaging Church Health Ministries to Decrease COVID-19 (COVID-19) Vaccine Hesitancy in Underserved Populations in Baton Rouge

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05541393
• Other study ID #: PBRC 2021-047
• Status: Withdrawn
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Active Intervention Group
The intervention will involve meetings with the church health ministers to discuss COVID-19 vaccines and booster shots.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Vaccine/Booster Uptake from Baseline to 3 Weeks	Change in vaccine or booster status	Baseline and three weeks