Covid19
Conditions
Keywords
SARS-CoV-2, Screening testing, School-based COVID-19 Transmission
Brief summary
The primary goal of this study is to determine the most effective SARS-CoV-2 testing strategy for successful return of in-person school in the under-served communities of St. Louis. Regular screening testing has been recommended by the CDC as an additive mitigation strategy for in-person schools in areas of high community transmission. We will compare the effectiveness and acceptance of two different school-based testing strategies among students and school staff (symptomatic testing only versus weekly surveillance testing plus symptomatic testing), measuring school-based SARS-CoV-2 transmission through a cluster randomized trial.
Detailed description
We will complete a cluster randomized trial to compare the incidence of school-based SARS-CoV-2 transmission between weekly screening testing of students and school staff versus testing only symptomatic students and staff. In this proposal, 16 middle and high schools from five school districts in the St. Louis metropolitan area will be cluster randomized to screening testing plus symptomatic testing versus symptomatic testing alone. The symptomatic testing will be provided to the entire school community as well as household members of students and staff. The second Aim will evaluate existing mitigation strategies utilized in schools and the rate of school-based SARS-CoV-2 transmission by defining the mitigation strategies utilized in participating schools through survey tools developed with CDC and their impact on school-based COVID-19 transmission and quantifying the rate of COVID-19 transmission in schools and the impact of this transmission on households through extensive interviews and testing of contacts and household members. Our 3rd Aim involves partnering with community-based organizations to specify and address the social, ethical, and behavioral implications of in-person schooling during the COVID-19 pandemic and the impact of SARS-CoV-2 testing on the school and community. Listening sessions will be utilized to understand barriers and facilitators to testing, ethical concerns of the community in research participation, and the behavioral health impact of lack of in-person schooling.
Interventions
OTHERScreening testing strategy
The intervention we are evaluating is the use of weekly screening testing among students and staff.
OTHERNo screening testing strategy
a group of schools will not receive screening testing.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A student or staff in one of the five school districts. * Household members of a student or staff member in the five school districts.
Exclusion criteria
* People not affiliated with the school.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Rate of All COVID-19 Cases in Schools. | Up to one year. | The rate of all new COVID-19 cases of student/staff in schools per randomization group. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason G. Newland, MD
Washington University School of Medicine
Participant flow
Recruitment details
All students, staff, and family members from 16 middle and high schools were eligible to participate.
Pre-assignment details
1390 individuals from 16 middle and high schools were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Weekly Screening Testing Plus Symptomatic Testing Among 16 middle and high schools, 8 will be randomized to offer students and staff weekly SARS-CoV-2 testing. Additionally, these schools will offer testing for symptomatic students, staff, household members in all age groups.
Screening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff. | 894 |
| Symptomatic Testing All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.
No screening testing strategy: a group of schools will not receive screening testing. | 496 |
| Total | 1,390 |
Baseline characteristics
| Characteristic | Weekly Screening Testing Plus Symptomatic Testing | Symptomatic Testing | Total |
|---|---|---|---|
| Age, Continuous | 36 years | 30 years | 35 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 7 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 771 Participants | 413 Participants | 1184 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 93 Participants | 76 Participants | 169 Participants |
| Participant Type Household | 290 Participants | 83 Participants | 373 Participants |
| Participant Type Staff | 353 Participants | 203 Participants | 556 Participants |
| Participant Type Student | 200 Participants | 183 Participants | 383 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 323 Participants | 282 Participants | 605 Participants |
| Race (NIH/OMB) More than one race | 47 Participants | 31 Participants | 78 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 79 Participants | 36 Participants | 115 Participants |
| Race (NIH/OMB) White | 431 Participants | 144 Participants | 575 Participants |
| Received COVID-19 Vaccine No | 170 Participants | 142 Participants | 312 Participants |
| Received COVID-19 Vaccine Other | 215 Participants | 102 Participants | 317 Participants |
| Received COVID-19 Vaccine Yes | 509 Participants | 252 Participants | 761 Participants |
| Sex/Gender, Customized Gender Female | 530 Participants | 299 Participants | 829 Participants |
| Sex/Gender, Customized Gender Male | 310 Participants | 175 Participants | 485 Participants |
| Sex/Gender, Customized Gender Other | 54 Participants | 22 Participants | 76 Participants |
| Social Vulnerability Index High | 123 Participants | 107 Participants | 230 Participants |
| Social Vulnerability Index Low | 293 Participants | 120 Participants | 413 Participants |
| Social Vulnerability Index Low-Medium | 128 Participants | 67 Participants | 195 Participants |
| Social Vulnerability Index Medium - High | 331 Participants | 197 Participants | 528 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Rate of All COVID-19 Cases in Schools.
The rate of all new COVID-19 cases of student/staff in schools per randomization group.
Time frame: Up to one year.
Population: The unit analyzed were the number of the tests completed overall during the study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Weekly Screening Testing Plus Symptomatic Testing | Overall Rate of All COVID-19 Cases in Schools. | 453 Completed tests |
| Symptomatic Testing | Overall Rate of All COVID-19 Cases in Schools. | 297 Completed tests |
p-value: 0.2595% CI: [-0.04981, 0.01292]generalized estimating equations