CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7,122 enrolled
Drug / intervention
Text Messaging (TM) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05112900
NCT05112900Phase 3Completed

SCALE-UP Counts: A Health Information Technology Approach to Increasing COVID-19 Testing in Elementary and Middle Schools Serving Disadvantaged Communities

University of Utah·interventional·Posted Nov 9, 2021·Updated Dec 31, 2024

In Brief

A Phase 3 clinical trial evaluating Text Messaging (TM) and Text Messaging + Health Navigation (TM+HN) for COVID-19. Completed, enrolled 7,122 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedNov 9, 2021
Enrollment StartJan 11, 2022
Primary CompletionJul 31, 2023
Study CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.6 years ago

Interventions

Text Messaging (TM)behavioral

\[see arm/group descriptions\]

Text Messaging + Health Navigation (TM+HN)behavioral

\[see arm/group descriptions\]