CATCH-UP Vaccines: Engaged Approaches to Testing in Community/Healthcare Settings for the Underserved (COVID-19)

University of Oklahoma (OU)

Status: Completed

Conditions: COVID-19; Vaccine Refusal

Treatments: Behavioral: Text Message; Behavioral: Electronic Educational Message with Tailored Questions/Prompts; Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05236270

13436

3U54GM104938-09S3 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 312 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 years of age and older

2. Must be eligible to receive a COVID-19 vaccine dose at the time of consent based on the following criteria:

   a. Eligible for one bivalent mRNA vaccine i. No previous doses of any COVID-19 vaccine ii. At least 8 weeks since a previous vaccine dose of any manufacturer b. Eligible for second bivalent mRNA vaccine i. Adults 65 year of age and older can receive one additional bivalent mRNA vaccine at least 4 months after the first dose of a bivalent mRNA vaccine.

   ii. Those who are immunocompromised can receive one additional bivalent mRNA vaccine at least 2 months after the first dose of a bivalent mRNA vaccine.

3. Ability to read and speak English

Exclusion criteria

1. Those who have received all eligible doses of any approved COVID-19 vaccine.
2. Those with active COVID-19 disease (either through self-reported positive test within the last 10 days or viral test at the event if available).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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312 participants in 8 patient groups

Condition 1

No Intervention group

Description:

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.

Condition 2

Experimental group

Description:

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.

Treatment:

Behavioral: Electronic Educational Message with Tailored Questions/Prompts

Condition 3

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Interviewing

Condition 4

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Interviewing

Behavioral: Electronic Educational Message with Tailored Questions/Prompts

Condition 5

Experimental group

Description:

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.

Treatment:

Behavioral: Text Message

Behavioral: Motivational Interviewing

Behavioral: Electronic Educational Message with Tailored Questions/Prompts

Condition 6

Experimental group

Description:

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.

Treatment:

Behavioral: Text Message

Behavioral: Motivational Interviewing

Condition 7

Experimental group

Description:

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.

Treatment:

Behavioral: Text Message

Condition 8

Experimental group

Description:

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.

Treatment:

Behavioral: Text Message

Behavioral: Electronic Educational Message with Tailored Questions/Prompts