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

NCT04887129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2025-02-03

Study results available
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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

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Rochester

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2023-08-31
Completion
2024-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04887129 on ClinicalTrials.gov