COVID-19 Clinical Trial
Official title:
CATCH-UP Vaccines: Extension of Community - Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
Verified date | May 2024 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 312 |
Est. completion date | August 26, 2023 |
Est. primary completion date | June 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Oklahoma Clinical and Translational Science Institute | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH) |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 Post-Intervention Survey (approximately 15-30 minutes) | |
Secondary | 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 |
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