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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 3 Years and 72 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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

Recruiting Locations

More Details

NCT ID
NCT04887129
Status
Completed
Sponsor
University of Rochester

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.