ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort COVID-19 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance

COVID-19 Clinical Trial

Official title: ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort SARS-CoV-2 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance

Status Completed

Clinical Trial Summary

The purpose of this research study is to learn about the factors parents consider when deciding whether their child will go to school in-person or attend from home. Investigators are also interested in learning whether access to in-home COVID testing is of value to parents and also whether it affects decision-making about returning to school.

This study is being done at UW-Madison in partnership between the Department of Pediatrics and the Department of Industrial and Systems Engineering. A total of 50 caregivers (plus their children with medical complexity) will participate in this study. Additionally, 20 caregivers involved in the study may also be invited to participate in a one-hour, virtual visit in which the caregiver demonstrates and discusses how they perform in-home COVID testing with their child.

The results of the study may help researchers advance their understanding of in-home testing strategies for children with medical complexity.

Clinical Trial Description

During the first three months of the study, caregivers will be asked to perform the BinaxNOW Rapid Antigen test on their child twice-weekly. After the first three months of the study, the testing schedule will depend on the statewide (WI) community spread rate. If the rate of spread is above the threshold for higher risk of transmission in schools (defined by the CDC as ≥ 25 new cases per 100,000 population in past 7 days) caregivers will be asked to continue twice-weekly surveillance. If it is below the threshold, caregivers will be offered the option to continue twice-weekly testing or switch to symptomatic-only testing. The study staff will notify caregivers of changes in testing frequency during their weekly communication. Caregivers will be asked to document their testing activities, results, and any possible COVID-19 symptoms on a Parent Testing Log.

If testing produces a negative result, the caregiver will be instructed to document the test result on their testing log. While false negative tests are possible with asymptomatic individuals, there will be no change in standard mitigation measures based on the test results (mandatory masks in school, social distancing, hand hygiene, etc.).

If testing produces a positive result from an asymptomatic individual, the caregiver will be instructed to contact the study team immediately and then obtain a PCR (polymerase chain reaction) test within 48 hours. The study staff will assist the caregiver in making arrangements for this test. In the case of positive tests, children will be restricted from school activities per public health guidelines until the results of the PCR testing are known. If the PCR test returns as a negative result and the child is attending school in-person, they will be allowed to return to school the next day (or if symptomatic, once symptoms resolve). If the PCR returns as positive, the caregiver will be instructed to keep the child at home per public health guidelines. To support families and ensure these steps occur, the study staff will call families daily following positive tests. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04895085
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: N/A
• Start date: April 27, 2021
• Completion date: September 15, 2023