COVID-19NCT05150860
Communities Fighting COVID Return to School
A study testing At-home COVID-19 testing and Onsite COVID-19 testing in people with COVID-19, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- At-home COVID-19 testing and Onsite COVID-19 testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2021to 2 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- student at a Sweetwater Union High School District Middle School, staff at a Sweetwater Union High School District Middle School
Who cannot join
- <2 years of age
- Not a student or staff at a participating Sweetwater Union High School District Middle School
Trial locations and contacts
1 site in 1 country.
United States1 site
Sweetwater Union High School District
Chula Vista, California, 91911
About this study
Official title: Communities Fighting COVID!: Returning Our Kids Back to School Safely
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- At-home COVID-19 testing, Onsite COVID-19 testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-home COVID-19 testingBehavioural
At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff
Onsite COVID-19 testingBehavioural
Onsite COVID-19 testing for middle school students and staff
| Study group | Role | What they receive |
|---|---|---|
| At-home testing | Experimental | At-home COVID-19 testing model Receives: Behavioral: At-home COVID-19 testing |
| On-site testing | Active comparator | On-site COVID-19 testing model Receives: Behavioral: Onsite COVID-19 testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Weekly COVID-19 Testing Schedule
Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial
Measured: through study completion, up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start17 Oct 2021
- Primary completion2 Apr 2022
- Study completion2 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Susan M Kiene, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150860
- Sponsor's protocol ID
- HS-2021-0208
- Other IDs
- 1OT2HD108112-01
- Status last verified
- Jan 2025
- First submitted
- 3 Dec 2021
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with the NIH RADx-UP Coordination and Data Collection Center (CDCC). The CDCC is charged by the NIH with making data funded by the RADx-UP initiative available to other researchers. Data are available on the NIH COVID RADx® Data Hub.
Publications
McDaniels-Davidson C, Arechiga-Romero M, Snyder T, Chris N, Sturgis K, Moore V, Bravo R, Famania-Martinez L, Oren E, Kiene SM. Development of an At-Home COVID-19 Test Results-Reporting System for a School District Primarily Serving Underrepresented Minority Groups, San Diego, CA, 2021-2022. Am J Public Health. 2022 Nov;112(S9):S883-S886. doi: 10.2105/AJPH.2022.307073. Epub 2022 Oct 20.
PubMed 36265090Kiene SM, McDaniels-Davidson C, Lin CD, Rodriguez T, Chris N, Bravo R, Moore V, Snyder T, Arechiga-Romero M, Famania-Martinez L, Carbuccia J, Pinuelas-Morineau R, Oren E. At-Home Versus Onsite COVID-19 School-based Testing: A Randomized Noninferiority Trial. Pediatrics. 2023 Jul 1;152(Suppl 1):e2022060352F. doi: 10.1542/peds.2022-060352F.
PubMed 37394511
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communities Fighting COVID!: Returning Our Kids Back to School Safely
- ClinicalTrials.gov ID
- NCT05150860
- Acronym / sponsor ID
- HS-2021-0208
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At-home testing | Experimental | Behavioral: At-home COVID-19 testingAt-home COVID-19 testing model |
| On-site testing | Active comparator | Behavioral: Onsite COVID-19 testingOn-site COVID-19 testing model |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- student at a Sweetwater Union High School District Middle School, staff at a Sweetwater Union High School District Middle School
Key exclusion criteria (2 listed)
- <2 years of age
- Not a student or staff at a participating Sweetwater Union High School District Middle School
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-home COVID-19 testingAt-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff | Behavioural | At-home testing |
| Onsite COVID-19 testingOnsite COVID-19 testing for middle school students and staff | Behavioural | On-site testing |
Primary outcome
Adherence to the Weekly COVID-19 Testing Schedule
Time frame: through study completion, up to 21 weeks
Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36265090McDaniels-Davidson C, Arechiga-Romero M, Snyder T, Chris N, Sturgis K, Moore V, Bravo R, Famania-Martinez L, Oren E, Kiene SM. Development of an At-Home COVID-19 Test Results-Reporting System for a School District Primarily Serving Underrepresented Minority Groups, San Diego, CA, 2021-2022. Am J Public Health. 2022 Nov;112(S9):S883-S886. doi: 10.2105/AJPH.2022.307073. Epub 2022 Oct 20.
- Results publication: PubMed 37394511Kiene SM, McDaniels-Davidson C, Lin CD, Rodriguez T, Chris N, Bravo R, Moore V, Snyder T, Arechiga-Romero M, Famania-Martinez L, Carbuccia J, Pinuelas-Morineau R, Oren E. At-Home Versus Onsite COVID-19 School-based Testing: A Randomized Noninferiority Trial. Pediatrics. 2023 Jul 1;152(Suppl 1):e2022060352F. doi: 10.1542/peds.2022-060352F.
- Individual participant dataSharing planned: Yes. Data will be shared with the NIH RADx-UP Coordination and Data Collection Center (CDCC). The CDCC is charged by the NIH with making data funded by the RADx-UP initiative available to other researchers. Data are available on the NIH COVID RADx® Data Hub.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At-home COVID-19 testing and Onsite COVID-19 testing in people with COVID-19, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Weekly COVID-19 Testing Schedule (time frame: through study completion, up to 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150860, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.