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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 monthly (up to 16-months post-baseline)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 ~ monthly (up to 16-months post-baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly (up to 16-months post-baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly (up to 16-months post-baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Testing Uptake

Secondary study objectives

Missed School Days

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Text Messaging (TM)Experimental Treatment2 Interventions

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).

Group II: Usual CareActive Control1 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.

Do I qualify?Apply below to find out