Covid19
Conditions
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.
Interventions
DIAGNOSTIC_TESTCOVID-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.
OTHERCOVID-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
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 72 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Infected With COVID-19 | 16 months | Number of students or staff who test positive for COVID-19 at least once using a nasal swab test. |
| Change in the Percentage of Participants Reporting Anxiety | baseline to 16 months | 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. |
| Change in the Percentage of Participants Classified as Depressed | baseline to 16 months | 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. |
| Change in the Percentage of Participants Classified With Fatigue | baseline to 16 months | 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. |
| Change in Percentage of Participants With Deficits in Social Functioning | baseline to 16 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Students All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY. | 59 |
| Staff All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY. | 333 |
| Total | 392 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 24 |
| Overall Study | Other | 2 | 9 |
| Overall Study | Withdrawal by Subject | 9 | 57 |
Baseline characteristics
| Characteristic | Students | Total | Staff |
|---|---|---|---|
| Age, Continuous | 10 years | NA years | 33 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 17 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 315 Participants | 274 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 60 Participants | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 9 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 46 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 66 Participants | 52 Participants |
| Race (NIH/OMB) White | 32 Participants | 257 Participants | 225 Participants |
| Region of Enrollment United States | 59 participants | 392 participants | 333 participants |
| Sex: Female, Male Female | 14 Participants | 267 Participants | 253 Participants |
| Sex: Female, Male Male | 31 Participants | 67 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 333 |
| other Total, other adverse events | 0 / 59 | 5 / 333 |
| serious Total, serious adverse events | 0 / 59 | 0 / 333 |
Outcome results
Primary
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.
Time frame: baseline to 16 months
Population: 29 students did not have data collected at 16 months. 165 adults did not have data collected at 16 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Students | Change in Percentage of Participants With Deficits in Social Functioning | 1.7 percentage of participants |
| Staff | Change in Percentage of Participants With Deficits in Social Functioning | 1.2 percentage of participants |
Primary
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.
Time frame: baseline to 16 months
Population: 29 students did not have data collected at 16 months. 165 adults did not have data collected at 16 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Students | Change in the Percentage of Participants Classified as Depressed | -0.8 percentage of participants |
| Staff | Change in the Percentage of Participants Classified as Depressed | 3.5 percentage of participants |
Primary
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.
Time frame: baseline to 16 months
Population: 29 students did not have data collected at 16 months. 165 adults did not have data collected at 16 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Students | Change in the Percentage of Participants Classified With Fatigue | 2.3 percentage of participants |
| Staff | Change in the Percentage of Participants Classified With Fatigue | 11.8 percentage of participants |
Primary
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.
Time frame: baseline to 16 months
Population: 29 students did not have data collected at 16 months. 165 adults did not have data collected at 16 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Students | Change in the Percentage of Participants Reporting Anxiety | 11.7 percentage of participants |
| Staff | Change in the Percentage of Participants Reporting Anxiety | -0.7 percentage of participants |
Primary
Number Infected With COVID-19
Number of students or staff who test positive for COVID-19 at least once using a nasal swab test.
Time frame: 16 months
Population: 12 staff members did not have a valid test for COVID
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Students | Number Infected With COVID-19 | 29 Participants |
| Staff | Number Infected With COVID-19 | 141 Participants |