NCT04887129

Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)

COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 3 Years – 72 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to understand how to prevent COVID-19 spread in a school like the Mary Cariola Center (MCC) in Rochester, NY by answering questions like these: how do activities in the school alter chances of infection? Are there people infected with the COVID-19 virus who have no symptoms? How is spread of COVID-19 affected by vaccination rates? Is there any hesitancy to get the vaccine and what are the reasons? This information will be used to help keep the school open and the students and staff safe. Eligible participants are those that work at the Mary Cariola Center (MCC) and interact with the students at MCC who have a high risk of infection from COVID-19. The study lasts for up to 16 months.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	COVID-19 RT-PCR test	Participating individuals (students and employees) will be tested for COVID-19 (RT-PCR) using a specimen collected using a mid-turbinate swab. This asymptomatic testing regime starts on or after (if scheduling testing requires this to begin on a different day) enrollment and is repeated every 5-14 days for up to 16 months . Anyone testing positive is followed up as described below for symptomatic individuals. Those presenting with symptoms will be also tested for COVID-19 (RT-PCR). Those with negative test results will return to the asymptomatic testing protocol. Students who test positive are retested then 3 days until two negative tests. Employees who test positive also be tested every 3 days until two negative tests.
OTHER	COVID-19 Vaccine Education Campaign	Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health

Timeline

• Start date: 2021-05-03
• Primary completion: 2023-08-31
• Completion: 2024-03-31
• First posted: 2021-05-14
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

1 site across 1 country: United States