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

NCT05112900 | Completed Phase 3 Results DMC

• 2 other identifiers: IRB_001433401OT2HD108097-01
• Study Type: interventional
• Target: 7,122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

Adolescents; Behavioral Research; Screening

Outcome Measures

Primary Outcomes (1)

• Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households

  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

  Monthly (up to 16-months post-baseline)

Secondary Outcomes (1)

• Missed School Days

  Monthly (up to 16-months post-baseline)

Study Arms (3)

Usual Care

NO INTERVENTION

Participants will only receive unidirectional public service announcement-type text messaging on COVID-19 testing every 3 weeks such as recommendation to obtain COVID-19 testing if exposed, experience symptoms, or have an interest in preemptive testing and information on testing options through the school or district.

Text Messaging (TM)

EXPERIMENTAL

This arm consists of a text message (TM) prompt asking if a participant has COVID-19 symptoms or if a participant has been exposed to a person who 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 also be asked if they have an interest in preemptive testing, regardless of symptoms or exposure Participants will be provided with information on testing options. After 24 hours, the participant will receive another TM that asks if they tested and what their results are. After 3 days, participants will be prompted to re-test.

Behavioral: Text Messaging (TM)

Text Messaging plus Health Navigation (TM+HN)

EXPERIMENTAL

TM+HN consists of the same intervention as TM with the addition of health navigation services based on non-compliance. Participants will be evaluated as non-compliant if they had reported symptoms, contact, or interest in testing and then stop responding to text messages or respond that they did not test. Health navigator (HN) calls will be conducted using Motivation and Problem Solving (MAPS).

Behavioral: Text Messaging + Health Navigation (TM+HN)

Interventions

Text Messaging (TM) BEHAVIORAL

\[see arm/group descriptions\]

Text Messaging (TM)

Text Messaging + Health Navigation (TM+HN) BEHAVIORAL

\[see arm/group descriptions\]

Text Messaging plus Health Navigation (TM+HN)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Utah: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Wu YP, Chipman JJ, Kolp L, Stump TK, Kuzmenko TV, Del Fiol G, Haaland B, Kaphingst KA, Brooks R, Hersh AL, Brady HL, Lundberg KJ, Wan N, Carroll C, Orleans B, Wirth J, Wetter DW. Mobile Intervention for Increasing COVID-19 Testing in K-12 Schools Serving Disadvantaged Communities: Randomized Controlled Trial of SCALE-UP Counts. J Med Internet Res. 2025 Nov 11;27:e79775. doi: 10.2196/79775.

  PMID: 41217804 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Yelena Wu
• Organization: Huntsman Cancer Institute at the University of Utah

yelena.wu@utah.edu

801-213-5653

Study Officials

• Yelena Wu, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Investigator

Model Details: A Parallel study using short time frames (\<1 month) and iterative evaluation cycles. The proposed trial will compare the efficacy of text messaging (TM) and text messaging plus health navigation (TM+HN) versus usual care. All randomizations will take place on the individual level at the beginning of the study.

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 9, 2021
• Study Start: January 11, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2024
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-12

Locations

US (1)