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Clinical Trial Summary

This project will address key testing challenges in Utah schools by building on collaborations with public school districts, private schools, charter schools and with Utah Department of Health on coronavirus disease (COVID-19) testing and existing infrastructure. The study team will work closely with schools and the Utah public health system to implement and test a shovel-ready and scalable health information technology approach that delivers automated text messages (TM) to students' parents and faculty/staff members around COVID-19 testing. In addition, some students and faculty/staff will receive a health navigator (HN) follow-up to ensure that tests are completed. Families (both of students and faculty/staff members) will be offered the recently FDA-approved in-home serial testing approach if accessing in-person testing is a challenge. While this project is focused on COVID-19 testing, in the case that the COVID-19 vaccination becomes more relevant or is the priority of the school, the study team is able to tailor the intervention to focus on the vaccine as well.

Clinical Trial Description

Recruitment: The proposed study will partner with 30 or more elementary and middle schools from Utah school districts, as well as private and charter schools in the surrounding area. All students who attend partnering schools will be enrolled, with parents provided with a study information sheet/cover letter with details about the study and information on how to opt out. Staff at the participating schools/districts who wish to participate will also be enrolled and receive the same information sheet/cover letter and opt-out information. Intervention: Randomization of parent/student and staff participants will consist of two phases, both taking placed upon enrollment in the study. Phase 1 will consist of assigning participants to text messaging or to usual care groups. The Phase 2 randomization will take place among participants in the TM condition. They will be assigned a Phase 2 condition of continued TM or TM + health navigator (HN), which they will received during intervention cycles in which they are evaluated as non-compliant. Phase 1 Participants included in Phase 1 are those who did not opt-out of the study. Participants eligible for Phase 1 Randomization will either be assigned to 1) Usual Care (control, approximately 20% of participants) or 2) Text Messages (TM, approximately 80% of participants). - Usual Care- Participants will only receive public service announcement-type messaging on COVID-19 testing every 3 weeks (e.g., recommendation to obtain COVID-19 testing if exposed or experience symptoms; information on testing options through the school or district). - TM consists of a text message prompt asking if a participant has COVID-19 symptoms or if a participant has been exposed to a person that has tested positive for COVID-19. If a participant responds yes, they will receive a TM prompt for immediate testing and to re-test. Participants will be provided with information on testing options for COVID-19. After 24 hours, the participant will be asked if they tested and what their results are. After 3 days, participants will be prompted to re-test. Phase 2 For participants in the TM condition, the Phase 2 condition will be randomly assigned upon enrollment. Participants will receive their Phase 2 condition if they are non-compliant with the TM intervention. Participants will be evaluated as non-compliant if they had reported symptoms or contact and then stop responding to text messages or respond that they did not test. Participants will be randomized to 1) TM or 2) TM plus health navigator (TM+HN). - TM will continue to consist of prompts and reminders on COVID-19 testing options. - TM+HN consists of continued text messages about COVID-19 testing options with the addition of a brief telephone call from a health navigator (HN). These calls will be conducted using Motivation and Problem Solving (MAPS). MAPS is an empirically validated proactive coaching approach used to address barriers and motivate participants to utilize testing options if they are experiencing COVID-19 symptoms or have been exposed to someone that has tested positive for COVID-19. Assessments: The study team will collect survey data from students, staff members and parents at pre- and post-intervention as well as throughout the trial. COVID-19 test results of participants will be collected through self-report as well as through results reported to the "Ellume" testing app. Additionally, the study team will conduct stakeholder interviews with students, parents, and staff on ways to improve the interventions to better meet their needs and preferences. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05112900
Study type Interventional
Source University of Utah
Contact Leighann Kolp
Phone 801-646-4206
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date November 2021
Completion date June 2023

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