Phase 3
N=7,122
Health Information Technology for COVID-19 Testing in Schools (SCALE-UP Counts)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05112900 ↗Enrolled (actual)
7,122
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households — .1603; .2552; .2484 Valid response to message on testing
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Text Messaging (TM) (Behavioral); Text Messaging + Health Navigation (TM+HN) (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households |
.1603; .2552; .2484 | — |
| SECONDARY Missed School Days |
.25; .37; .38 | — |
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 around COVID-19 testing. In addition, some parents will receive a health navigator (HN) follow-up to ensure that tests are completed. Families 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. The outcomes in this study utilized parent/student reported data. Staff data were also collected but will not be reflected in primary outcome analyses.
Eligibility Criteria
Inclusion Criteria
Students
- Attends school at any of the participating schools from the districts the research team is working with
Parents
- Legal guardian/parent of the student
- Has a functioning cellular phone that can receive calls and text messages
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05112900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.