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Health Information Technology for COVID-19 Testing
Phase 3
Waitlist Available
Led By Yelena Wu, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months, 6 months, 12 months
Awards & highlights
Study Summary
This trial will help figure out how best to use technology to remind students & staff to get coronavirus tests, & will offer in-home serial testing if needed.
Who is the study for?
This trial is for school staff, parents who are legal guardians of a student and have a working cell phone, and students attending participating schools in Utah. There are no specific exclusion criteria mentioned.Check my eligibility
What is being tested?
The trial tests two methods to increase COVID-19 testing in schools: automated text messages (TM) alone or combined with follow-up from a health navigator (HN). It also offers at-home testing if in-person testing is difficult.See study design
What are the potential side effects?
Since the interventions involve information technology approaches like text messaging and health navigation, there aren't direct medical side effects. However, privacy concerns or stress related to frequent communication about COVID-19 could be potential issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 months, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, 6 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Testing Uptake
Secondary outcome measures
Change in Missed School Days
Intervention Acceptability assessed using Acceptability of Intervention Measures (AIM)
Intervention Appropriateness assessed using Intervention Appropriateness Measure (IAM)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Text Messaging + Health Navigator (TM + HN)Experimental Treatment1 Intervention
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.
Group II: Text Messaging (TM)Experimental Treatment1 Intervention
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.
Group III: Usual CareActive Control1 Intervention
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.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,102 Previous Clinical Trials
1,759,261 Total Patients Enrolled
14 Trials studying COVID-19
460,646 Patients Enrolled for COVID-19
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,970 Previous Clinical Trials
2,657,647 Total Patients Enrolled
12 Trials studying COVID-19
40,880 Patients Enrolled for COVID-19
Yelena Wu, PhDPrincipal InvestigatorUniversity of Utah
5 Previous Clinical Trials
11,614 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with patients using Text Messaging + Health Navigation (TM+HN)?
"There is prior clinical data supporting the safety of Text Messaging + Health Navigation (TM+HN), so it received a score of 3."
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