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

• Sponsor: University of Oklahoma (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05236270
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute of General Medical Sciences (NIGMS) (NIH)
• Enrollment: 2,000
• Location: 1
• Arms: 8
• Anticipated Duration (Months): 5.3
• Patients Per Site Per Month: 380.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Vaccine Refusal	Behavioral: Text Message; Behavioral: Motivational Interviewing; Behavioral: Electronic Educational Message with Tailored Questions/Prompts	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• 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.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 (Investigator, Outcomes Assessor)
• Masking Description: Investigators who are providing the intervention and conducting analysis will be masked to study assignment
• Primary Purpose: Prevention
• Official Title: CATCH-UP Vaccines: Extension of Community - Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
• Actual Study Start Date: Mar 25, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Percentage of participants who plan to receive a COVID-19 vaccine post-intervention [Baseline to Month 2]

   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

Secondary Outcome Measures

1. Percentage of participants who self-report COVID-19 vaccine uptake [Baseline to Month 2]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: 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:

3. No previous doses of a COVID-19 vaccine (Pfizer-BioNTech, Moderna, or Janssen)

4. At least 21 days since first dose of Pfizer-BioNTech to be eligible for a second dose

5. At least 28 days since first dose of Moderna to be eligible for a second dose

6. 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.

7. 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

8. At least 2 months since completing the Janssen single dose to be eligible for booster of any authorized COVID-19 vaccine

9. Ability to read and speak English

Exclusion Criteria:

1. Those who have received a third dose or booster dose of any approved COVID-19 vaccine.

2. Those with active COVID-19 disease (either through self-report, symptoms consistent with COVID-19, or viral test at the event if available).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oklahoma Clinical and Translational Science Institute	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of Oklahoma
• National Institutes of Health (NIH)
• National Institute of General Medical Sciences (NIGMS)

Investigators

• Principal Investigator: Judith A James, MD, PhD, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• COVID Data Tracker
• COVID-19 Vaccination Communication: Applying Behavioral and Social Science to Address Vaccine Hesitancy and Foster Vaccine Confidence
• Low-Income and Communities of Color at Higher Risk of Serious Illness if Infected with Coronavirus
• COVID-19: Oklahoma State Department of Health
• CPSTF Findings for Increasing Vaccination

Publications

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
• Escoffery C, Riehman K, Watson L, Priess AS, Borne MF, Halpin SN, Rhiness C, Wiggins E, Kegler MC. Facilitators and Barriers to the Implementation of the HPV VACs (Vaccinate Adolescents Against Cancers) Program: A Consolidated Framework for Implementation Research Analysis. Prev Chronic Dis. 2019 Jul 3;16:E85. doi: 10.5888/pcd16.180406.
• Garbutt JM, Dodd S, Walling E, Lee AA, Kulka K, Lobb R. Barriers and facilitators to HPV vaccination in primary care practices: a mixed methods study using the Consolidated Framework for Implementation Research. BMC Fam Pract. 2018 May 7;19(1):53. doi: 10.1186/s12875-018-0750-5.
• Jacobs-Wingo JL, Espey DK, Groom AV, Phillips LE, Haverkamp DS, Stanley SL. Causes and Disparities in Death Rates Among Urban American Indian and Alaska Native Populations, 1999-2009. Am J Public Health. 2016 May;106(5):906-14. doi: 10.2105/AJPH.2015.303033. Epub 2016 Feb 18.
• Nguyen KH, Srivastav A, Razzaghi H, Williams W, Lindley MC, Jorgensen C, Abad N, Singleton JA. COVID-19 Vaccination Intent, Perceptions, and Reasons for Not Vaccinating Among Groups Prioritized for Early Vaccination - United States, September and December 2020. MMWR Morb Mortal Wkly Rep. 2021 Feb 12;70(6):217-222. doi: 10.15585/mmwr.mm7006e3.
• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
• Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health. 2009 Jan;36(1):24-34. doi: 10.1007/s10488-008-0197-4. Epub 2008 Dec 23.
• Raifman MA, Raifman JR. Disparities in the Population at Risk of Severe Illness From COVID-19 by Race/Ethnicity and Income. Am J Prev Med. 2020 Jul;59(1):137-139. doi: 10.1016/j.amepre.2020.04.003. Epub 2020 Apr 27.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT05236270
• Other Study ID Numbers: 13436
• First Posted: Feb 11, 2022
• Last Update Posted: Apr 6, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Oklahoma: COVID-19 Vaccine Hesitancy; MOST (multiphase optimization strategy)
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Apr 6, 2022