Trial Outcomes & Findings for Health Information Technology for COVID-19 Testing in Schools (SCALE-UP Counts) (NCT NCT05112900)
NCT ID: NCT05112900
Last Updated: 2024-12-31
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7122 participants
Primary outcome timeframe
Monthly (up to 16-months post-baseline)
Results posted on
2024-12-31
Participant Flow
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.
1. Randomization Error- Multiple records per phone number, randomized more than once 2. Excluded for other reasons- No home address, Opt-out before randomization
Participant milestones
| Measure |
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.
|
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.
|
Text Messaging and 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2588
|
2270
|
2264
|
|
Overall Study
COMPLETED
|
1628
|
1349
|
1296
|
|
Overall Study
NOT COMPLETED
|
960
|
921
|
968
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Text Messaging and 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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
960
|
921
|
968
|
Baseline Characteristics
Health Information Technology for COVID-19 Testing in Schools (SCALE-UP Counts)
Baseline characteristics by cohort
| Measure |
Usual Care
n=2367 Participants
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.
|
Text Messaging (TM)
n=2187 Participants
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.
|
Text Messaging + Health Navigation (TM+HN)
n=2166 Participants
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.
|
Total
n=6720 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2367 Participants
n=5 Participants
|
2187 Participants
n=7 Participants
|
2166 Participants
n=5 Participants
|
6720 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
1166 Participants
n=5 Participants
|
1092 Participants
n=7 Participants
|
1066 Participants
n=5 Participants
|
3324 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
1197 Participants
n=5 Participants
|
1092 Participants
n=7 Participants
|
1099 Participants
n=5 Participants
|
3388 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Unknown
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian/NA
|
17 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
108 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
360 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian or Pacific Islander
|
69 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
89 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
1329 Participants
n=5 Participants
|
1277 Participants
n=7 Participants
|
1316 Participants
n=5 Participants
|
3922 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
752 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
558 Participants
n=5 Participants
|
1899 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Free/Reduced Lunch of students
|
51.70 percent
n=5 Participants
|
52.86 percent
n=7 Participants
|
52.20 percent
n=5 Participants
|
52.25 percent
n=4 Participants
|
PRIMARY outcome
Timeframe: Monthly (up to 16-months post-baseline)Population: Unique participants that responded to text messages on COVID-19 testing completion.
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
Outcome measures
| Measure |
Usual Care
n=966 Participants
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.
|
Text Messaging (TM)
n=789 Participants
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
n=770 Participants
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.
|
|---|---|---|---|
|
Testing Uptake- The Number of Valid Responses That Confirmed COVID-19 Testing Was Completed by Households
|
.1603 Valid response to message on testing
Standard Deviation .3669
|
.2552 Valid response to message on testing
Standard Deviation .4361
|
.2484 Valid response to message on testing
Standard Deviation .4322
|
SECONDARY outcome
Timeframe: 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.
The study team will examine the number of missed school days enrolled students missed due to COVID-19 related reasons (e.g., exposure, testing).
Outcome measures
| Measure |
Usual Care
n=797 Participants
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.
|
Text Messaging (TM)
n=803 Participants
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
n=968 Participants
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.
|
|---|---|---|---|
|
Missed School Days
|
.25 Number of missed school days
Standard Deviation 1.11
|
.37 Number of missed school days
Standard Deviation 1.27
|
.38 Number of missed school days
Standard Deviation 1.17
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Messaging (TM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Messaging + Health Navigation (TM+HN)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yelena Wu
Huntsman Cancer Institute at the University of Utah
Phone: 801-213-5653
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place