Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake

Not Applicable

Withdrawn

• Conditions: Pneumonia; Covid19; Vaccine Refusal; Influenza
• Interventions: Behavioral: Delayed VEPMP Intervention; Behavioral: Full VEPMP Intervention; Behavioral: Partial VEPMP Intervention

• Registration Number: NCT04761692
• Lead Sponsor: Charles Drew University of Medicine and Science

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19
• Study Start: 2022-10-01
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Delayed VEPMP Intervention	This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan following completion of Arm 1 and 2.
Arm 1	Full VEPMP Intervention	This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan
Arm 2	Partial VEPMP Intervention	This arm will include 5 churches who will receive some study activities in the Vaccine Education Promotion Management Plan

Primary Outcome Measures

Name	Time	Method
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report	Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
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	Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention	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
Percentage of Participants Achieving Adherence to COVID-19, influenza, and pneumonia vaccination schedules Risk Using the NIH Toolbox Surveys on COVID-19	Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention	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.
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	Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention	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

Trial Locations

Locations (1)

Charles R. Drew University of Medicine & Science; 🇺🇸 Los Angeles, California, United States