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| ID | Type | Description | Link |
|---|---|---|---|
| 3U54GM104938-09S3 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Message | Behavioral | Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
18 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A James, MD, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma Clinical and Translational Science Institute | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19664226 | Background | 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. | |
| 31274411 | 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. |
| Label | URL |
|---|---|
| COVID Data Tracker | View source |
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After participants provided informed consent and HIPAA authorization, participants were randomized to a treatment condition.
Participants were recruited from March 25, 2022 through June 27, 2023 from 21 sites across Oklahoma. Recruitment sites included community events, employee wellness events at healthcare facilities, and conferences.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Condition 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2023 |
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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.
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Investigators who are providing the intervention and conducting analysis will be masked to study assignment
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 29734944 | 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. |
| 26890168 | 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. |
| 33571174 | 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. |
| 20957426 | 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. |
| 19104929 | 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. |
| 32430225 | 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. |
| 42106514 | Derived | Janitz AE, Upadhaya S, Grunsted P, Chen S, Pan SJ, Campbell JE, Homco J, VanWagoner TM, Comiford A. Chronic Health Conditions and Uptake of COVID-19 Testing and Vaccination Among Native Americans in Oklahoma in the RADx-UP Consortium. J Racial Ethn Health Disparities. 2026 May 9. doi: 10.1007/s40615-026-02945-9. Online ahead of print. |
| 37316843 | Derived | 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. |
| COVID-19 Vaccination Communication: Applying Behavioral and Social Science to Address Vaccine Hesitancy and Foster Vaccine Confidence | View source |
| Low-Income and Communities of Color at Higher Risk of Serious Illness if Infected with Coronavirus | View source |
| CPSTF Findings for Increasing Vaccination | View source |
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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Information on sex was missing for 8 participants across treatment groups. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Baseline to Post-Intervention Survey (approximately 15-30 minutes) |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Analysis includes participants who completed the 60-day follow-up survey (n=47) | Posted | Count of Participants | Participants | Baseline to Month 2 |
|
Adverse event data were collected during the primary study visit, which lasted approximately 30 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG001 | 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. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG003 | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG004 | 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. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG005 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG006 | 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. | 0 | 41 | 0 | 41 | 0 | 41 |
| EG007 | 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. | 0 | 44 | 0 | 44 | 0 | 44 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Janitz | University of Oklahoma Health Sciences | 405-271-2229 | 48081 | amanda-janitz@ouhsc.edu |
| Mar 7, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2022 | Nov 21, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000072758 | Vaccination Refusal |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Not provided
| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
|
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|
|
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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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