NCT05112900

Health Information Technology for COVID-19 Testing in Schools (SCALE-UP Counts)

Completed Phase 3 Results posted Last updated 31 December 2024

What this trial tests

Phase 3 trial testing Text Messaging (TM) in COVID-19 in 7,122 participants. Completed in 31 July 2024.

Timeline

11 January 2022

Primary endpoint
31 July 2023

31 July 2024

Quick facts

Lead sponsor	University of Utah
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	7,122
Start date	11 January 2022
Primary completion	31 July 2023
Estimated completion	31 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Text Messaging (TM)
• Text Messaging + Health Navigation (TM+HN)

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

University of Utah

Who can join

Eligibility, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households Primary · Monthly (up to 16-months post-baseline)

The study team will examine whether students and/or members of their household tested by analyzing the number of valid responses that confirmed COVID-19 testing was completed by households

Group	Value	95% CI
Usual Care	.1603	± .3669
Text Messaging (TM)	.2552	± .4361
Text Messaging Plus Health Navigation	.2484	± .4322

Missed School Days Secondary · Monthly (up to 16-months post-baseline)

The study team will examine the number of missed school days enrolled students missed due to COVID-19 related reasons (e.g., exposure, testing).

Group	Value	95% CI
Usual Care	.25	± 1.11
Text Messaging (TM)	.37	± 1.27
Text Messaging Plus Health Navigation	.38	± 1.17

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preliminary Reach of an Information Technology Approach to Support COVID-19 Testing in Schools.
   Stump TK, Wetter DW, Kuzmenko T, Orleans B, et al · · 2023 · cited 3× · PMID 37394508 · DOI 10.1542/peds.2022-060352e
2. Mobile Intervention for Increasing COVID-19 Testing in K-12 Schools Serving Disadvantaged Communities: Randomized Controlled Trial of SCALE-UP Counts.
   Wu YP, Chipman JJ, Kolp L, Stump TK, et al · · 2025 · PMID 41217804 · DOI 10.2196/79775