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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Intervention 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.
Primary Purpose
Prevention
Masking
None (Open Label)
Masking Description
Investigators who are providing the intervention and conducting analysis will be masked to study assignment

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Condition 1 		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 		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
    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.
Experimental
Condition 3 		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
    Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.
Experimental
Condition 4 		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
    Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.
  • Behavioral: Electronic Educational Message with Tailored Questions/Prompts
    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.
Experimental
Condition 5 		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
    Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
  • Behavioral: Motivational Interviewing
    Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.
  • Behavioral: Electronic Educational Message with Tailored Questions/Prompts
    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.
Experimental
Condition 6 		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
    Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
  • Behavioral: Motivational Interviewing
    Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.
Experimental
Condition 7 		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
    Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
Experimental
Condition 8 		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
    Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
  • Behavioral: Electronic Educational Message with Tailored Questions/Prompts
    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.

Recruiting Locations

More Details

NCT ID
NCT05236270
Status
Completed
Sponsor
University of Oklahoma

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.