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Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake

Primary Purpose

Covid19, Influenza, Pneumonia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full VEPMP Intervention
Partial VEPMP Intervention
Delayed VEPMP Intervention
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19 focused on measuring African American, Latinx, Vaccine, Hispanic, Latino, COVID19 Vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Charles R. Drew University of Medicine & Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan

This arm will include 5 churches who will receive some study activities in the Vaccine Education Promotion Management Plan

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
February 2, 2021
Last Updated
August 17, 2022
Sponsor
Charles Drew University of Medicine and Science
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1. Study Identification

Unique Protocol Identification Number
NCT04761692
Brief Title
Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study not funded
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles Drew University of Medicine and Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Influenza, Pneumonia, Vaccine Refusal
Keywords
African American, Latinx, Vaccine, Hispanic, Latino, COVID19 Vaccine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The VEPMP will consist of recruited churches in 15 cohorts of 2 churches per cohort (total n = 30). Each cohort of church will include an AA and a Latinx church. The 15 church cohorts will be randomized to three arms based on a 1:1:1 ratio, using an online random number generator.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
This arm will include 5 churches who will receive all study activities in the Vaccine Education Promotion Management Plan
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
This arm will include 5 churches who will receive some study activities in the Vaccine Education Promotion Management Plan
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Full VEPMP Intervention
Intervention Description
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.)
Intervention Type
Behavioral
Intervention Name(s)
Partial VEPMP Intervention
Intervention Description
Delivery of iAND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)
Intervention Type
Behavioral
Intervention Name(s)
Delayed VEPMP Intervention
Intervention Description
Delayed implementation of delivery of intrapersonal/interpersonal AND organizational after 1 year of study start
Primary Outcome Measure Information:
Title
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report
Description
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.
Time Frame
Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Adherence to COVID-19, influenza, and pneumonia vaccination schedules Risk Using the NIH Toolbox Surveys on COVID-19
Description
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.
Time Frame
Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Title
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
Description
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
Time Frame
Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Title
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
Description
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
Time Frame
Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen Bazargan, PhD
Organizational Affiliation
Charles R. Drew University of Medicine & Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles R. Drew University of Medicine & Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake

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