Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake

NCT04761692 | Withdrawn DMC

• 1 other identifier: vaccineinc
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Influenza; Pneumonia; Vaccine Refusal

Keywords

African American; Latinx; Vaccine; Hispanic; Latino; COVID19 Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Behavioral: Full VEPMP Intervention

Arm 2

EXPERIMENTAL

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

Behavioral: Partial VEPMP Intervention

Arm 3

EXPERIMENTAL

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

Interventions

Full VEPMP Intervention BEHAVIORAL

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.)

Arm 1

Partial VEPMP Intervention BEHAVIORAL

Delivery of iAND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)

Arm 2

Delayed VEPMP Intervention BEHAVIORAL

Delayed implementation of delivery of intrapersonal/interpersonal AND organizational after 1 year of study start

Arm 3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Study Sites (1)

Charles R. Drew University of Medicine & Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

COVID-19; Influenza, Human; Pneumonia; Vaccination Refusal

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mohsen Bazargan, PhD

  Charles R. Drew University of Medicine & Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 21, 2021
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)