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

Study Overview
=================
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.

Official Title
-----------------
COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: COVID-19 RT-PCR test
* Other: COVID-19 Vaccine Education Campaign


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 72 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Students and staff at Mary Cariola Center<br>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<br>* 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.<br>Other: COVID-19 Vaccine Education Campaign<br>* Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of students infected with COVID-19 | Number of students who test positive for COVID-19 at least once using a nasal swab test. | 16 months | 
| Number of staff infected with COVID-19 | Number of staff who test positive for COVID-19 at least once using a nasal swab test. | 16 months | 
| Mean change in anxiety in students | Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety. | baseline to 16 months | 
| Mean change in anxiety in staff | Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety. | baseline to 16 months | 
| Mean change in depression in students | Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression. | baseline to 16 months | 
| Mean change in depression in staff | Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression. | baseline to 16 months | 
| Mean change in fatigue in students | Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue. | baseline to 16 months | 
| Mean change in fatigue in staff | Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue. | baseline to 16 months | 
| Mean change in social functioning in students | Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction. | baseline to 16 months | 
| Mean change in social functioning in staff | Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction. | baseline to 16 months |