COVID-19SASEA HUBNCT05642000
The Safer At School Early Alert HUB
A study testing SASEA HUB in people with COVID-19, run by University of California, San Diego at 1 site in United States.
Trial summary
Schools serve important community roles beyond academic education. In historically marginalized communities they are trusted providers for a range of support services for families in need. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- SASEA HUB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,029 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 17 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals ages 18 and above affiliated with students attending the 3 school districts participating in the SASEA study
Who cannot join
- Children under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Schools serve important community roles beyond academic education. In historically marginalized communities they are trusted providers for a range of support services for families in need. The tradeoff between these crucial benefits of in-person learning against the risk of SARS-CoV-2 transmission in school settings has been hotly debated throughout much of 2020 and 2021. The stakes are particularly high in historically marginalized communities which rely most heavily on school services, but have also been hit the hardest by COVID-19 primarily due to structural issues. The Safer at School Early Alert (SASEA) program was co-developed by the University of California, San Diego, the County of San Diego, and 15 partner schools serving socially vulnerable students in 5 school districts across San Diego County. SASEA utilizes daily wastewater and surface (floor) environmental monitoring to detect asymptomatic SARS-CoV-2 infections among students and staff on campus. Positive environmental signals are immediately followed by targeted responsive testing for a whole school (in the case of wastewater) or classroom (for a positive surface sample). In this project, we will develop the Safer at School Early Alert HUB (SASEA HUB), an online school environmental monitoring report dashboard with resources to address structural barriers to COVID-19 diagnostic testing in historically marginalized communities (Aim 1). We will also create a toolkit to allow any school to rapidly adapt the template to their specific setting. In Aims 2 and 3, we will use a randomized stepped wedge trial to compare SASEA (control) vs SASEA HUB (intervention) in 26 schools across 3 diverse school clusters in San Diego County. Our primary outcome (Aim 2) is higher rates of diagnostic testing in intervention schools. Our secondary outcome (Aim 3) is increased risk mitigation behaviors in school community members when environmental surveillance data suggests a potential case on campus. In Aim 4, we will use parent-child narrative interviews with 40 parent-student pairs to understand how children perceive COVID-19 risk at school, assess differences in perceptions of testing barriers between intervention and control sites, and better understand how children understand the process of environmental surveillance and responsive testing.
- Conditions
- COVID-19
- Being tested
- SASEA HUB
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SASEA HUBBehavioural
SASEA HUB website, an intervention tool to increase COVID-19 testing
| Study group | Role | What they receive |
|---|---|---|
| SASEA HUB | Experimental | Access to online COVID-19 information tool hub to support testing access Receives: Behavioral: SASEA HUB |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Completed a COVID-19 Test
The primary study endpoint will be student diagnostic testing uptake in the previous 14-days, measured using household surveys distributed at 2-week intervals.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start19 Sep 2022
- Primary completion17 Dec 2022
- Study completion17 Dec 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.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Fielding-Miller, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642000
- Sponsor's protocol ID
- 1U01HD108787-01
- Acronym
- SASEA HUB
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2022
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safer At School Early Alert HUB
- ClinicalTrials.gov ID
- NCT05642000
- Acronym / sponsor ID
- SASEA HUB / 1U01HD108787-01
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schools serve important community roles beyond academic education. In historically marginalized communities they are trusted providers for a range of support services for families in need. The tradeoff between these crucial benefits of in-person learning against the risk of SARS-CoV-2 transmission in school settings has been hotly debated throughout much of 2020 and 2021. The stakes are particularly high in historically marginalized communities which rely most heavily on school services, but have also been hit the hardest by COVID-19 primarily due to structural issues. The Safer at School Early Alert (SASEA) program was co-developed by the University of California, San Diego, the County of San Diego, and 15 partner schools serving socially vulnerable students in 5 school districts across San Diego County. SASEA utilizes daily wastewater and surface (floor) environmental monitoring to detect asymptomatic SARS-CoV-2 infections among students and staff on campus. Positive environmental signals are immediately followed by targeted responsive testing for a whole school (in the case of wastewater) or classroom (for a positive surface sample). In this project, we will develop the Safer at School Early Alert HUB (SASEA HUB), an online school environmental monitoring report dashboard with resources to address structural barriers to COVID-19 diagnostic testing in historically marginalized communities (Aim 1). We will also create a toolkit to allow any school to rapidly adapt the template to their specific setting. In Aims 2 and 3, we will use a randomized stepped wedge trial to compare SASEA (control) vs SASEA HUB (intervention) in 26 schools across 3 diverse school clusters in San Diego County. Our primary outcome (Aim 2) is higher rates of diagnostic testing in intervention schools. Our secondary outcome (Aim 3) is increased risk mitigation behaviors in school community members when environmental surveillance data suggests a potential case on campus. In Aim 4, we will use parent-child narrative interviews with 40 parent-student pairs to understand how children perceive COVID-19 risk at school, assess differences in perceptions of testing barriers between intervention and control sites, and better understand how children understand the process of environmental surveillance and responsive testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SASEA HUB | Experimental | Behavioral: SASEA HUBAccess to online COVID-19 information tool hub to support testing access |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals ages 18 and above affiliated with students attending the 3 school districts participating in the SASEA study
Key exclusion criteria (1 listed)
- Children under the age of 18
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 |
|---|---|---|
| SASEA HUBSASEA HUB website, an intervention tool to increase COVID-19 testing | Behavioural | SASEA HUB |
Primary outcome
Percentage of Participants Who Completed a COVID-19 Test
Time frame: 14 days
The primary study endpoint will be student diagnostic testing uptake in the previous 14-days, measured using household surveys distributed at 2-week intervals.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 SASEA HUB in people with COVID-19, run by University of California, San Diego 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 1 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 3 Dec 2024. 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 3 Dec 2024). 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?
Percentage of Participants Who Completed a COVID-19 Test (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2024.