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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05112900
Enrollment
7122
Registered
2021-11-09
Start date
2022-01-11
Completion date
2024-07-31
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Adolescents, Behavioral Research, Screening

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.

Detailed description

Intervention: Randomization of parent/student participants will take place upon enrollment in the study. Participants are assigned to either usual care (UC), text messaging (TM), or text messaging plus health navigation (TM+HN). Participants included are those who did not opt-out of the study. Participants eligible for Randomization will either be assigned to 1) Usual Care (control, approximately 20% of participants), 2) Text Message (TM, approximately 40% of participants), or 3) Text Message plus Health Navigation (TM+HN, approximately 40% of participants). Usual Care participants will only receive unidirectional and fixed public service announcement-type text 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 more intensive, bidirectional 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, or if the participant has interest in preemptive testing. 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. If a participant had interest in preemptive testing, they will be asked if testing was completed after 7 days. Testing and re-testing prompts will be adjusted through the study to mirror public health guidance on testing strategies. TM+HN consists of the same intervention as TM with the addition of health navigation services based on participant 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). 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, have been exposed to someone that has tested positive for COVID-19, or reported interest in preemptive testing. Assessments: The study team will collect survey data from 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 Randomization • The study's allocation ratio was changed on 7/20/22. The original allocation ratio for the study was 20% usual care with the remaining 80% randomly assigned equally to the TM and TM+HN groups. The new allocation ratio was 50% randomly assigned to control with the remaining 50% randomly assigned equally to the TM and TM+HN groups. The reason for the change in allocation ratio is that the study team observed low numbers of participants reporting any COVID-19 testing. Thus, in order to optimize statistical power to be able to compare the control group to both experimental groups (TM and TM+HN) together in end-of-study analyses, the allocation ratio was changed. 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.

Interventions

\[see arm/group descriptions\]

BEHAVIORALText Messaging + Health Navigation (TM+HN)

\[see arm/group descriptions\]

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by HouseholdsMonthly (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

Secondary

MeasureTime frameDescription
Missed School DaysMonthly (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).

Countries

United States

Participant flow

Recruitment details

Utah K-12 schools were recruited between October 2021 and March 2023. Recruitment focused on Title 1 schools and schools in underserved communities. Parents were eligible to participate if they had a functioning cell phone that could receive/send text messages. This study used an opt-out design. Schools provided parent telephone numbers who were contacted by text with an initial opportunity to opt-out. Those who did not opt out within 24 hours of the initial message were automatically enrolled.

Pre-assignment details

1. Randomization Error- Multiple records per phone number, randomized more than once 2. Excluded for other reasons- No home address, Opt-out before randomization

Participants by arm

ArmCount
Usual Care
Participants will only receive unidirectional, static, 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. Participants were informed on how to access test kits through the participating school and were provided with an email address to request test kits by direct mail from the study team.
2,367
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 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. Participants were informed on how to access test kits by pick up from the participating school and provided an email address to request test kits by direct mail from the study team through text messaging.
2,187
Text Messaging + Health Navigation (TM+HN)
This arm consists of the same text message prompts as the TM group with the addition of health navigator services (TM+HN) through a brief telephone call. These calls will be conducted using Motivation and Problem Solving (MAPS). Participants in this arm that interacted with the text messaging system by indicating an interest in testing but did not report test completion were deemed non-responders. Non-responders in this group received the phone call from a health navigator to assess testing barriers. Participants were informed on how to access test kits by pick up from the participating school and provided an email address to request test kits by direct mail from the study team through text messaging.
2,166
Total6,720

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyWithdrawal by Subject960921968

Baseline characteristics

CharacteristicTotalUsual CareText Messaging (TM)Text Messaging + Health Navigation (TM+HN)
Age, Categorical
<=18 years
6720 Participants2367 Participants2187 Participants2166 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Free/Reduced Lunch of students52.25 percent51.70 percent52.86 percent52.20 percent
Race/Ethnicity, Customized
Race/Ethnicity
American Indian/NA
76 Participants17 Participants29 Participants30 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Asian
360 Participants108 Participants128 Participants124 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black or African American
245 Participants89 Participants85 Participants71 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic or Latino
1899 Participants752 Participants589 Participants558 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Native Hawaiian or Pacific Islander
212 Participants69 Participants77 Participants66 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Unknown or Not Reported
6 Participants3 Participants2 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
3922 Participants1329 Participants1277 Participants1316 Participants
Sex/Gender, Customized
Sex/Gender
Female
3324 Participants1166 Participants1092 Participants1066 Participants
Sex/Gender, Customized
Sex/Gender
Male
3388 Participants1197 Participants1092 Participants1099 Participants
Sex/Gender, Customized
Sex/Gender
Unknown
8 Participants4 Participants3 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 2,3670 / 2,1870 / 2,166
other
Total, other adverse events
0 / 2,3670 / 2,1870 / 2,166
serious
Total, serious adverse events
0 / 2,3670 / 2,1870 / 2,166

Outcome results

Primary

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

Time frame: Monthly (up to 16-months post-baseline)

Population: Unique participants that responded to text messages on COVID-19 testing completion.

ArmMeasureValue (MEAN)Dispersion
Usual CareTesting Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households.1603 Valid response to message on testingStandard Deviation 0.3669
Text Messaging (TM)Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households.2552 Valid response to message on testingStandard Deviation 0.4361
Text Messaging Plus Health NavigationTesting Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households.2484 Valid response to message on testingStandard Deviation 0.4322
Secondary

Missed School Days

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

Time frame: Monthly (up to 16-months post-baseline)

Population: The population analyzed are participants that responded to the surveys assessing for missed school days. Not all participants responded to this survey.

ArmMeasureValue (MEAN)Dispersion
Usual CareMissed School Days.25 Number of missed school daysStandard Deviation 1.11
Text Messaging (TM)Missed School Days.37 Number of missed school daysStandard Deviation 1.27
Text Messaging Plus Health NavigationMissed School Days.38 Number of missed school daysStandard Deviation 1.17

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026