Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pneumonia; Covid19; Influenza; Vaccine Refusal
• Intervention / Treatment: Behavioral: Full VEPMP Intervention; Behavioral: Partial VEPMP Intervention; Behavioral: Delayed VEPMP Intervention

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90059
      • Charles R. Drew University of Medicine & Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan	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.)
Experimental: Arm 2; This arm will include 5 churches who will receive some study activities in the Vaccine Education Promotion Management Plan	Behavioral: Partial VEPMP Intervention; Delivery of iAND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)
Experimental: Arm 3; 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.	Behavioral: Delayed VEPMP Intervention; Delayed implementation of delivery of intrapersonal/interpersonal AND organizational after 1 year of study start

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Charles Drew University of Medicine and Science

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Vaccine; African American; Hispanic; Latino; Latinx; COVID19 Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; Orthomyxoviridae Infections; COVID-19; Pneumonia; Influenza, Human
• Other Study ID Numbers: vaccineinc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No