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

Purpose

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. The outcomes in this study utilized parent/student reported data. Staff data were also collected but will not be reflected in primary outcome analyses.

Condition

  • COVID-19

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts 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 School Staff - Works at any of the participating schools from the districts the research team is working with

Exclusion Criteria

  • None

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
A Sequential Multiple Assignment Randomized Trial (SMART) design will be employed using short time frames (<1 month) and iterative evaluation cycles. The proposed trial will compare the efficacy of text messaging (TM) versus usual care in a first randomization of the study. Non-compliant participants (if no COVID-19 test is completed or no response received) will then receive their Phase 2 condition of continued TM or TM + Health Navigator (HN) to test whether "stepping up" to HN improves outcomes for those not responding to the first-line intervention of TM. All randomizations will take place on the individual level at the beginning of the study; participants will be randomized to the initial intervention (TM vs. usual care; Phase 1 Randomization), and TM participants will also be randomized to the Phase 2 condition (TM or TM+HN) which they would receive during cycles during which they are non-compliant.
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Usual Care
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.
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 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. A sub group of TM participants may be offered health navigator services (TM+HN) through a brief telephone call. These calls will be conducted using Motivation and Problem Solving (MAPS).
  • Behavioral: Text Messaging (TM)
    [see arm/group descriptions]
  • Behavioral: Text Messaging + Health Navigation (TM+HN)
    [see arm/group descriptions]

Recruiting Locations

More Details

NCT ID
NCT05112900
Status
Active, not recruiting
Sponsor
University of Utah

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 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, the 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. Phase 2 For participants in the TM condition, the Phase 2 condition will be randomly assigned upon enrollment. Participants will be randomized to 1) TM or 2) TM plus health navigator (TM+HN) Participants will receive their Phase 2 condition during the intervention cycle if they are non-compliant with the TM intervention. 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. - 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, 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 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.