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

NCT05236270 | Completed Results

• 2 other identifiers: 134363U54GM104938-09S3
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Vaccine Refusal

Keywords

COVID-19 Vaccine Hesitancy; MOST (multiphase optimization strategy)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants Who Self-report COVID-19 Vaccine Uptake

  Baseline to Month 2

Study Arms (8)

Condition 1

NO INTERVENTION

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

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

Condition 3

EXPERIMENTAL

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

Condition 4

EXPERIMENTAL

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; Behavioral: Electronic Educational Message with Tailored Questions/Prompts

Condition 5

EXPERIMENTAL

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

Condition 6

EXPERIMENTAL

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; Behavioral: Motivational Interviewing

Condition 7

EXPERIMENTAL

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

Condition 8

EXPERIMENTAL

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; Behavioral: Electronic Educational Message with Tailored Questions/Prompts

Interventions

Text Message BEHAVIORAL

Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.

Condition 5; Condition 6; Condition 7; Condition 8

Motivational Interviewing BEHAVIORAL

Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.

Condition 3; Condition 4; Condition 5; Condition 6

Electronic Educational Message with Tailored Questions/Prompts BEHAVIORAL

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.

Condition 2; Condition 4; Condition 5; Condition 8

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• Ability to read and speak English

You may not qualify if:

• Those who have received all eligible doses of any approved COVID-19 vaccine.
• 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).

Sponsors & Collaborators

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

Study Sites (1)

Oklahoma Clinical and Translational Science Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (9)

• 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.

  PMID: 19664226 BACKGROUND

• 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.

  PMID: 31274411 BACKGROUND

• 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.

  PMID: 29734944 BACKGROUND

• 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.

  PMID: 26890168 BACKGROUND

• 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.

  PMID: 33571174 BACKGROUND

• 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.

  PMID: 20957426 BACKGROUND

• 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.

  PMID: 19104929 BACKGROUND

• 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. No abstract available.

  PMID: 32430225 BACKGROUND

• Janitz AE, Neil JM, Bray LA, Jervis LL, Ross L, Campbell JE, Doescher MP, Spicer PG, Williams ML, Lopez AK, Uribe-Frias CA, Chen S, James JA, VanWagoner TM. CATCH-UP vaccines: protocol for a randomized controlled trial using the multiphase optimization strategy (MOST) framework to evaluate education interventions to increase COVID-19 vaccine uptake in Oklahoma. BMC Public Health. 2023 Jun 14;23(1):1146. doi: 10.1186/s12889-023-16077-w.

  PMID: 37316843 DERIVED

Related Links

• 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
• CPSTF Findings for Increasing Vaccination

MeSH Terms

Conditions

COVID-19; Vaccination Refusal

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Amanda Janitz
• Organization: University of Oklahoma Health Sciences

amanda-janitz@ouhsc.edu

405-271-2229

Study Officials

• Judith A James, MD, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Investigators who are providing the intervention and conducting analysis will be masked to study assignment
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 11, 2022
• Study Start: March 25, 2022
• Primary Completion: June 28, 2023
• Study Completion: August 26, 2023
• Last Updated: May 22, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-05

Locations

US (1)