Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake

Covid19 Clinical Trial

Official title:

Improving Vaccine Acceptance and Uptake Among Underresourced African American and Latinx Older Adults: A Multidisciplinary and Culturally Based Training Program for Minority Churches

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04761692
• Other study ID #: vaccineinc
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2022
• Source: Charles Drew University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposed study seeks to community knowledge and understand the experience of underserved communities in the exploration of reducing health disparities and increasing vaccine uptake and acceptability COVID-19, influenza, and pneumonia for AA and Latinx populations. Unique in its design, it has the following characteristics: 1) multifaceted, 2) culturally tailored, 3) community-based, and 4) mixed methods in which the outcomes of interest will be measured before and after the intervention with 18-month interval. Furthermore, we seek to enhance our partnerships and collaborations with churches in South Los Angeles by supporting efforts to encourage COVID-19, influenza, and pneumonia vaccination uptake among underserved minorities in one of the most challenged and hard-to-reach population areas in the nation.

Description:

This study seeks to augment community knowledge and increase vaccine uptake among under-resourced African American and Latinx communities in South LA via leveraging trusted church leaders, educators and influencers to delivering COVID-19, influenza, and pneumonia education on vaccination. Unique in its design, this study has the following characteristics, beneficial to the acceptability and success of the proposal, it is: 1) multifaceted, 2) culturally tailored, and 3) community-based, in which the outcomes of interest will be compared longitudinally between arms 1-3, including measurement before and after the intervention with 9- and 18-month interval.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Parishioner at a church receiving the VEPMP intervention
• Identify as African American or Latinx,
• at least 65 years and older
• Have Not received a vaccine for COVID-19, influenza, or pneumonia within the previous 24 months
• Agrees to study terms, which include follow-up interviews 9 and 18 months after study enrollment

Exclusion Criteria:

• Does not attend or identify as a Parishioner at a church receiving the VEPMP intervention
• Does not identify as African American or Latinx
• Under the age of 65 years
• Received all vaccine doses for COVID-19, influenza, or pneumonia within the previous 24 months

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Influenza
• Influenza, Human
• Pneumonia
• Vaccine Refusal

Intervention

Behavioral:
• Full VEPMP Intervention
Delivery of intrapersonal/interpersonal (i.e., motivational interviewing, vaccine educators, personal testimony, etc.), AND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)
• Partial VEPMP Intervention
Delivery of iAND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)
• Delayed VEPMP Intervention
Delayed implementation of delivery of intrapersonal/interpersonal AND organizational after 1 year of study start

Locations

Country	Name	City	State
United States	Charles R. Drew University of Medicine & Science	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report	By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, we anticipate the following compared to baseline: a 30% change in uptake for vaccination.	Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Secondary	Percentage of Participants Achieving Adherence to COVID-19, influenza, and pneumonia vaccination schedules Risk Using the NIH Toolbox Surveys on COVID-19	By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 30% change in adherence to COVID-19, influenza, and pneumonia vaccination schedules.	Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Secondary	Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19, influenza, and pneumonia Using the NIH Toolbox Surveys on COVID-19, influenza, and pneumonia	By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 40% change in vaccine hesitancy toward COVID-19, influenza, and pneumonia vaccination	Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Secondary	Percentage of Participants Achieving Decreased Levels of COVID-19, influenza, and pneumonia Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19, influenza, and pneumonia	By comparison of pre-, post- intervention, and 9 and 18-months follow-up data, we anticipate the following compared to baseline: a 40% change in mistrust and perceived barriers toward COVID-19, influenza, and pneumonia vaccination	Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention