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

March 27, 2024 updated by: Yelena Wu, University of Utah

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Addendum to study allocation ratio: Change of allocation for participants eligible for Phase 1 Randomization

• The study's allocation ratio was changed on 7/20/22. The original allocation ratio for Phase 1 of the study was 80% text message (TM) to 20% control. The new allocation ratio for Phase 1 was 50% TM to 50% control. The reason for the change in allocation ratio is that the study team observed low numbers of participants in TM and control groups reporting any COVID-19 testing. Thus, in order to optimize statistical power to be able to compare TM vs. control groups in end-of-study analyses, the allocation ratio was changed to the 1:1 allocation. For schools that were enrolled in the study prior to this allocation ratio change, individuals in that school who had already been assigned a study condition maintained their original assignment. To account for this change in allocation, we will adjust for the allocation ratio for when the participant was randomized, within the model.

Addendum to outcome measures timeline: Change of survey timeline of outcomes for eligible participants

• The survey distribution timeline was changed 9/27/22. The 6-month survey was not distributed (due to an electronic distribution error) and the timing of this survey was changed to 9 months post intervention enrollment. Additionally, the 1-month survey was only distributed in Year 1 of the study. Newly enrolled participants in Year 2 (as of 8/1/22) did not receive the 1-month survey. The purpose of the 1-month survey was to complete an early assessment of the intervention to determine if any changes were needed based on participant feedback, and thus was not needed in the second year of the study. Enrolled participants that did not complete the baseline survey were sent a follow up survey at the end of the study to collect demographic and other outcomes data. A final survey distributed at the end of the study was also added in order to assess accessibility, feasibility, and other outcomes.

Study Type

Interventional

Enrollment (Estimated)

20000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

School Staff

  • Works at any of the participating schools from the districts the research team is working with

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Participants will only receive public service announcement-type messaging on COVID-19 testing every 3 weeks such as recommendation to obtain COVID-19 testing if exposed or experience symptoms and information on testing options through the school or district.
Experimental: Text Messaging (TM)
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 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)
[see arm/group descriptions]
Experimental: Text Messaging + Health Navigator (TM + HN)
This arm consists of continued text messages (TM) 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.
Behavioral: Text Messaging + Health Navigation (TM+HN)
[see arm/group descriptions]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testing Uptake
Time Frame: Baseline, Monthly (up to 12-months post-baseline)
The study team will examine whether students and/or faculty and staff members tested.
Baseline, Monthly (up to 12-months post-baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Missed School Days
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
The study team will examine whether the proportion of students and/or faculty and staff members who missed school out of the total student population decreases from pre- to post-intervention.
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Intervention Acceptability assessed using Acceptability of Intervention Measures (AIM)
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
The study team will examine the acceptability of the intervention among staff and parents using the AIM.
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Intervention Appropriateness assessed using Intervention Appropriateness Measure (IAM)
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
The study team will examine the appropriateness of the intervention among staff and parents using the IAM.
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Intervention Feasibility assessed using Feasibility of Intervention Measure (FIM)
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
The study team will examine the feasibility of the intervention among staff and parents using the FIM.
Baseline, 1 Month, 3 Months, 6 Months, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Yelena Wu, PhD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00143340
  • 1OT2HD108097-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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