Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Influenza, Pneumonia, Vaccine Refusal

Intervention / Treatment
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* Behavioral: Full VEPMP Intervention
* Behavioral: Partial VEPMP Intervention
* Behavioral: Delayed VEPMP Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American, Latinx, Vaccine, Hispanic, Latino, COVID19 Vaccine