CATCH-UP Vaccines: Engaged Approaches to Testing in Community/Healthcare Settings for the Underserved (COVID-19)
NCT ID: NCT05236270
Last Updated: 2024-05-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
312 participants
INTERVENTIONAL
2022-03-25
2023-08-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
NCT04870307
Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination
NCT05977192
COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement
NCT05582746
Evaluating Public Health Interventions to Improve COVID-19 Testing Among Underserved Populations
NCT05270694
Equitable Access to COVID-19 Vaccines
NCT04952376
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
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.
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.
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.
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.
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.
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.
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.
Text Message
Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
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.
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.
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.
Text Message
Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
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.
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.
Text Message
Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
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.
Text Message
Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Text Message
Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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).
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
National Institute of General Medical Sciences (NIGMS)
NIH
University of Oklahoma
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Judith A James, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oklahoma Clinical and Translational Science Institute
Oklahoma City, Oklahoma, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. No abstract available.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13436
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.