COVID-19
Conditions
Brief summary
San Diego State University (SDSU), a designated Hispanic-serving institution, is partnering with Sweetwater Union High School District, an independent public school district serving 90% ethnic minority and a high proportion of socioeconomically disadvantaged students, and other community partners, to generate evidence for effective and feasible COVID-19 testing for unvaccinated and medically vulnerable middle school students and staff as part of broader COVID mitigation strategies including vaccination to return students back to school safely.
Detailed description
Equitable access to coronavirus 2019 (COVID-19) screening is important to reduce transmission and maintain in-person learning for middle school communities, particularly in disadvantaged schools. Rapid antigen testing, and at-home testing in particular, could offer substantial advantages over onsite testing from a school district's perspective, but it is unknown if engagement in at-home testing can be initiated and sustained. The investigators hypothesized that an at-home COVID-19 school testing program would be non-inferior to an onsite school COVID-19 testing program with regard to school participation rates and adherence to a weekly screening testing schedule. The study enrolled 3 middle schools within a large, predominantly Latinx-serving, independent school district into a noninferiority trial from October 2021 to March 2022. Two schools were randomized to onsite and 1 school to at-home COVID-19 testing programs. All students and staff were eligible to participate.
Interventions
BEHAVIORALAt-home COVID-19 testing
At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff
BEHAVIORALOnsite COVID-19 testing
Onsite COVID-19 testing for middle school students and staff
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
San Diego State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* student at a Sweetwater Union High School District Middle School, staff at a Sweetwater Union High School District Middle School
Exclusion criteria
* \<2 years of age * Not a student or staff at a participating Sweetwater Union High School District Middle School
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Weekly COVID-19 Testing Schedule | through study completion, up to 21 weeks | Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial |
Countries
United States
Participant flow
Recruitment details
Trial enrollment of participants occurred from mid-October 2021 through late March 2022, with COVID-19 testing occurring from November 7, 2021 to March 27, 2022; the length of possible trial participation varied from 2 to 21 weeks. Participants were recruited from the three participating middle school populations. All students and school staff at the participating schools were eligible to enroll in the trial.
Pre-assignment details
Schools were excluded if they had a lower proportion of students from households receiving SNAP Program benefits and a lower proportion of underrepresented minority students compared with other schools (3 schools); had ongoing school-wide testing programs with a commercial provider (2 schools); had larger (1 school) or smaller (1 school) student populations (for matching purposes) than the remaining schools; or were geographically closer to the remaining schools (1 school).
Participants by arm
| Arm | Count |
|---|---|
| At-home COVID-19 Testing Weekly COVID-19 screening testing using at-home rapid antigen tests | 264 |
| Onsite COVID-19 Testing Weekly COVID-19 screening testing onsite at school with rapid antigen tests | 588 |
| Total | 852 |
Baseline characteristics
| Characteristic | At-home COVID-19 Testing | Onsite COVID-19 Testing | Total |
|---|---|---|---|
| Age, Continuous | 20.04 years STANDARD_DEVIATION 14.18 | 17.10 years STANDARD_DEVIATION 11.55 | 18.01 years STANDARD_DEVIATION 12.49 |
| Primary language spoken at home English | 198 Participants | 481 Participants | 679 Participants |
| Primary language spoken at home Spanish | 66 Participants | 107 Participants | 173 Participants |
| Race/Ethnicity, Customized Race and ethnicity African American/Black | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Race and ethnicity Another race or ethnicity | 14 Participants | 10 Participants | 24 Participants |
| Race/Ethnicity, Customized Race and ethnicity Filipino, Asian, or Asian Pacific Islander | 9 Participants | 45 Participants | 54 Participants |
| Race/Ethnicity, Customized Race and ethnicity Latinx | 218 Participants | 500 Participants | 718 Participants |
| Race/Ethnicity, Customized Race and ethnicity Non-Hispanic white | 20 Participants | 27 Participants | 47 Participants |
| Region of Enrollment United States | 264 participants | 588 participants | 852 participants |
| Sex/Gender, Customized Gender Identity Another category (transgender, genderqueer, bigender, agender) | 4 Participants | 12 Participants | 16 Participants |
| Sex/Gender, Customized Gender Identity Man | 95 Participants | 251 Participants | 346 Participants |
| Sex/Gender, Customized Gender Identity Woman | 165 Participants | 325 Participants | 490 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 264 | 0 / 588 |
| other Total, other adverse events | 0 / 264 | 0 / 588 |
| serious Total, serious adverse events | 0 / 264 | 0 / 588 |
Outcome results
Primary
Adherence to the Weekly COVID-19 Testing Schedule
Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial
Time frame: through study completion, up to 21 weeks
Population: Student and school staff participants enrolled in the trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| At-home COVID-19 Testing | Adherence to the Weekly COVID-19 Testing Schedule | 0.394 proportion of scheduled tests completed | Standard Error 0.038 |
| Onsite COVID-19 Testing | Adherence to the Weekly COVID-19 Testing Schedule | 0.352 proportion of scheduled tests completed | Standard Error 0.032 |