CATCH-UP Vaccines: Extension of Community - Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations (COVID-19)

Study Overview
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Brief Summary
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Oklahoma has high COVID-19 incidence, particularly among underserved minority and rural Oklahomans. Oklahoman's are also reporting SARS-CoV-2 vaccine hesitancy and signs of slowing vaccine uptake, with increased hesitancy among American Indian and rural populations. The project aims to work with ongoing community testing events to implement interventions to improve vaccine uptake among Oklahoma's underserved populations.

Detailed Description
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This proposal unites academic and community partners to solve a dire need for SARS-CoV-2 vaccine uptake in rural, underserved minority, and at-risk populations. Oklahoma has high COVID-19 incidence, high vaccine hesitancy, and signs of a slowing SARS-CoV-2 vaccine uptake. Oklahoma's cumulative incidence is higher in rural compared to urban counties. AI people have a higher incidence of COVID-19 compared to white populations in Oklahoma. Despite high incidence, as of April 2021, an estimated 54% of Oklahomans who have not yet been vaccinated reported unwillingness to receive the SARS-CoV-2 vaccine. Vaccine hesitancy was even greater in AI people (62%). The most commonly reported concerns are vaccine side effects and safety (30%). Despite early progress in disseminating vaccines in Oklahoma, all signs point to waning interest in receiving a vaccine, with many vaccine clinics unable to fill all available slots, particularly in tribal clinics and rural areas. This proposal is an extension of the Oklahoma Shared Clinical Translational Resources (OSCTR) project CATCH-UP (Community-engaged Approaches to Testing in Community and Healthcare settings for Underserved Populations) in partnership with community organizations who work with underserved minority and rural populations. This project will build on existing strengths and infrastructure to improve SARS-CoV-2 vaccine uptake in these highly susceptible populations. The goal of the project is to pilot interventions to improve awareness and uptake of COVID-19 vaccination. The project aims to work with CATCH-UP community events to implement interventions to improve vaccine uptake among Oklahoma's underserved populations. To do so, the proposed study employs a multiphase optimization strategy (MOST). The proposed study uses the preparation and optimization phases of the MOST framework across the following aims: 1) Identify SARS-CoV-2 vaccination barriers/facilitators and assess acceptability and feasibility of a suite of evidence-based vaccine intervention strategies among Oklahoma's rural, minority, and high-risk populations to inform a targeted multicomponent intervention; and 2) Develop and optimize a multicomponent intervention to improve SARS-CoV-2 vaccination among Oklahoman's seeking SARS-CoV-2 testing at CATCH-UP testing events. Investigators will conduct a pilot of these interventions based on community input, which will be evaluated for inclusion in a future, full-scale implementation study.

Official Title
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CATCH-UP Vaccines: Extension of Community - Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations

Conditions
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COVID-19, Vaccine Refusal

Intervention / Treatment
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* Behavioral: Text Message
* Behavioral: Motivational Interviewing
* Behavioral: Electronic Educational Message with Tailored Questions/Prompts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Must be eligible to receive a COVID-19 vaccine dose at the time of consent based on the following criteria: No previous doses of a COVID-19 vaccine (Pfizer-BioNTech, Moderna, or Janssen) At least 21 days since first dose of Pfizer-BioNTech to be eligible for a second dose At least 28 days since first dose of Moderna to be eligible for a second dose For those who are severely immunocompromised, eligible for third Pfizer or Moderna dose at least 28 days after the second dose; eligible for 2nd dose Pfizer/Moderna at least 28 days after first Janssen. At least 5 months since completing the two dose Pfizer-BioNTech vaccine series or the Moderna vaccine series (for immunocompromised, at least 3 months after third dose of either of Pfizer/Moderna vaccines or 2 months after second dose if Janssen was the first dose) to be eligible for booster of any authorized COVID-19 vaccine At least 2 months since completing the Janssen single dose to be eligible for booster of any authorized COVID-19 vaccine Ability to read and speak English Exclusion Criteria: Those who have received a third dose or booster dose of any approved COVID-19 vaccine. Those with active COVID-19 disease (either through self-report, symptoms consistent with COVID-19, or viral test at the event if available).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Interventions will address three primary areas to improve vaccination uptake: (1) process (text messages); (2) teachable moment messaging (motivational interviewing); and (3) barrier elicitation and reduction (electronic survey with tailored questions/prompts). In a factorial research design, two or more independent variables are concurrently examined within the same trial. The three factors are crossed with one another to create a total of eight experimental conditions. An equal number of sites are randomly assigned to each condition, using a random number generator.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Condition 1<br>Participants will not receive a text message notifying participants about COVID-19 vaccine availability, standard interpretation of serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an attention control educational message. | |
| Experimental: Condition 2<br>Participants will not receive a text message notifying participants about COVID-19 vaccine availability, standard interpretation of serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an educational message about COVID-19 vaccines. | Behavioral: Electronic Educational Message with Tailored Questions/Prompts<br>* Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.<br>|
| Experimental: Condition 3<br>Patients will not receive a text message notifying participants about COVID-19 vaccine availability, motivational interviewing about serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an attention control educational message. | Behavioral: Motivational Interviewing<br>* Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.<br>|
| Experimental: Condition 4<br>Patients will not receive a text message notifying participants about COVID-19 vaccine availability, motivational interviewing about serology SARS-CoV-2 antibody results with vaccination discussion, and an educational message about COVID-19 vaccines. | Behavioral: Motivational Interviewing<br>* Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.<br>Behavioral: Electronic Educational Message with Tailored Questions/Prompts<br>* Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.<br>|
| Experimental: Condition 5<br>Patients will receive a text message notifying participants about COVID-19 vaccine availability, motivational interviewing about serology SARS-CoV-2 antibody results with vaccination discussion, and an educational message about COVID-19 vaccines. | Behavioral: Text Message<br>* Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.<br>Behavioral: Motivational Interviewing<br>* Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.<br>Behavioral: Electronic Educational Message with Tailored Questions/Prompts<br>* Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.<br>|
| Experimental: Condition 6<br>Patients will receive a text message notifying participants about COVID-19 vaccine availability, motivational interviewing about serology SARS-CoV-2 antibody results with vaccination discussion, and an attention control educational message. | Behavioral: Text Message<br>* Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.<br>Behavioral: Motivational Interviewing<br>* Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.<br>|
| Experimental: Condition 7<br>Patients will receive a text message notifying participants about COVID-19 vaccine availability, standard interpretation of serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an attention control educational message. | Behavioral: Text Message<br>* Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.<br>|
| Experimental: Condition 8<br>Patients will receive a text message notifying participants about COVID-19 vaccine availability, standard interpretation of serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an educational message about COVID-19 vaccines. | Behavioral: Text Message<br>* Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.<br>Behavioral: Electronic Educational Message with Tailored Questions/Prompts<br>* Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who plan to receive a COVID-19 vaccine post-intervention | Investigators will measure this with the question How likely are you to get an approved COVID-19 vaccine? and If you have received 1 dose of the Janssen vaccine or 2 doses of the Moderna or Pfizer vaccine, how likely are you to get an approved booster shot? We will compare intention to receive a COVID-19 vaccine or booster among those receiving the interventions compared to those not receiving the intervention | Baseline to Month 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who self-report COVID-19 vaccine uptake | The secondary outcome will be vaccine uptake, including self-report of receiving an initial dose of any approved vaccine, two doses of Pfizer or Moderna vaccines, or a booster of any approved vaccine. | Baseline to Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 Vaccine Hesitancy, MOST (multiphase optimization strategy)