Clinical trial NCT04761692: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Covid19
Influenza
Pneumonia
Vaccine Refusal
Keywords: African American
Latinx
Vaccine
Hispanic
Latino
COVID19 Vaccine
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report
timeFrame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Secondary outcomes:
measure: Percentage of Participants Achieving Adherence to COVID-19, influenza, and pneumonia vaccination schedules Risk Using the NIH Toolbox Surveys on COVID-19
timeFrame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
measure: 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
timeFrame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
measure: 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
timeFrame: Intervention: 12 months; Follow-up Point: 9 & 18 months post-intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles R. Drew University of Medicine & Science
state: California
Study officials:
affiliation: Charles R. Drew University of Medicine & Science
name: Mohsen Bazargan, PhD
role: PRINCIPAL_INVESTIGATOR
References: