COVID-19Phase 3NCT05112900
Health Information Technology for COVID-19 Testing in Schools (SCALE-UP Counts)
A Phase 3 study testing Text Messaging (TM) and Text Messaging + Health Navigation (TM+HN) in people with COVID-19, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Text Messaging (TM) and Text Messaging + Health Navigation (TM+HN)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,122 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2022to 31 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: 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 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Text Messaging (TM), Text Messaging + Health Navigation (TM+HN)
- Keywords
- Adolescents, Behavioral Research, Screening
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging (TM)Behavioural
[see arm/group descriptions]
Text Messaging + Health Navigation (TM+HN)Behavioural
[see arm/group descriptions]
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Text Messaging + Health Navigation (TM+HN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Monthly (up to 16-months post-baseline)
Secondary outcomes (1)
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).
Measured: Monthly (up to 16-months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start11 Jan 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 7,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Yelena Wu, University of Utah
- Investigators
- Yelena Wu, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112900
- Sponsor's protocol ID
- IRB_00143340
- Other IDs
- 1OT2HD108097-01
- Status last verified
- Dec 2024
- First submitted
- 1 Nov 2021
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41217804
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCALE-UP Counts: A Health Information Technology Approach to Increasing COVID-19 Testing in Elementary and Middle Schools Serving Disadvantaged Communities
- ClinicalTrials.gov ID
- NCT05112900
- Acronym / sponsor ID
- IRB_00143340
- Conditions
- COVID-19
- Keywords
- Adolescents, Behavioral Research, Screening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,122 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Posted 31 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: 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. |
| Text Messaging plus Health Navigation (TM+HN) | Experimental | Behavioral: Text Messaging + Health Navigation (TM+HN)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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Messaging (TM)[see arm/group descriptions] | Behavioural | Text Messaging (TM) |
| Text Messaging + Health Navigation (TM+HN)[see arm/group descriptions] | Behavioural | Text Messaging plus Health Navigation (TM+HN) |
Primary outcome
Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households
Time frame: 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
1 secondary outcome
Missed School Days
Time frame: Monthly (up to 16-months post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41217804Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelena Wu, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Text Messaging (TM) and Text Messaging + Health Navigation (TM+HN) in people with COVID-19, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households (time frame: Monthly (up to 16-months post-baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05112900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.