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

NCT04887129 | Completed Results DMC

• 2 other identifiers: STUDY00005294OT2HD107553-01
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Number Infected With COVID-19

  Number of students or staff who test positive for COVID-19 at least once using a nasal swab test.

  16 months

• Change in the Percentage of Participants Reporting Anxiety

  Anxiety will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having anxiety if they were moderate or severe.

  baseline to 16 months

• Change in the Percentage of Participants Classified as Depressed

  Depression was measured using the PROMIS-29 assessment. Students or staff were classified within normal range, mild, moderate or severe. They were counted as having depression if they were moderate or severe.

  baseline to 16 months

• Change in the Percentage of Participants Classified With Fatigue

  Fatigue will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having fatigue if they were moderate or severe.

  baseline to 16 months

• Change in Percentage of Participants With Deficits in Social Functioning

  Social functioning will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having social functioning deficits if they were moderate or severe.

  baseline to 16 months

Study Arms (1)

Students and staff at Mary Cariola Center

EXPERIMENTAL

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

Diagnostic Test: COVID-19 RT-PCR test; Other: COVID-19 Vaccine Education Campaign

Interventions

COVID-19 RT-PCR test 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.

Students and staff at Mary Cariola Center

COVID-19 Vaccine Education Campaign OTHER

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

Students and staff at Mary Cariola Center

Eligibility Criteria

• Age: 3 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rochester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Mary Cariola Center

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: John Foxe, Phd
• Organization: University of Rochester

John_foxe@urmc.rochester.edu

585 - 275 - 2591

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 14, 2021
• Study Start: May 3, 2021
• Primary Completion: August 31, 2023
• Study Completion: March 31, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Locations

US (1)