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

NCT ID: NCT04887129

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2024-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Students and staff at Mary Cariola Center

All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.

Group Type: EXPERIMENTAL

COVID-19 RT-PCR test

Intervention Type: DIAGNOSTIC_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.

COVID-19 Vaccine Education Campaign

Intervention Type: OTHER

Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Students:

• IDD Student of the Mary Cariola Center
• Age 3 - 18
• Have a parent/guardian who can give informed consent
• In the judgement of the Mary Cariola Medical Staff will be able to safely participate in the study procedures (nasal swab, phlebotomy)

Staff

• Age 18 - 72
• Able give informed consent
• Anticipated duration of remaining employment less than 1 month (e.g. retiring)
• Must be willing to participate in RT-PCR and antibody testing

Exclusion Criteria

Students

• Contraindication to nasal swab
• Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)

Staff

• Contraindication to nasal swab
• Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

John Foxe

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mary Cariola Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OT2HD107553-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005294

Identifier Type: -

Identifier Source: org_study_id