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

University of Rochester

Status: Completed

Conditions: Covid19

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04887129

OT2HD107553-01 (U.S. NIH Grant/Contract)

STUDY00005294

Details and patient eligibility

About

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.

Enrollment: 392 patients

Sex: All

Ages: 3 to 72 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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392 participants in 1 patient group

Students and staff at Mary Cariola Center

Experimental group

Description:

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

Treatment:

Other: COVID-19 Vaccine Education Campaign

Diagnostic Test: COVID-19 RT-PCR test