Trial Outcomes & Findings for The Safer At School Early Alert HUB (NCT NCT05642000)

NCT ID: NCT05642000

Last Updated: 2024-12-03

Results Overview

The primary study endpoint will be student diagnostic testing uptake in the previous 14-days, measured using household surveys distributed at 2-week intervals.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1029 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2024-12-03

Participant Flow

Only parents were considered enrolled in the study. Staff who were also parents of children who attended the school were also recruited to complete the survey but they are completing the survey in their role as a parent and not as a staff of the school

Unit of analysis: schools

Participant milestones

Measure	Cluster 1 SASEA HUB intervention after 2 week baseline data collection. 12 weeks of intervention exposure.	Cluster 2 SASEA HUB intervention arm after 2 weeks of baseline data collection (district began fall term two weeks later than Cluster 1). 10 weeks of intervention exposure	Cluster 3 SASEA HUB intervention after 6 weeks of baseline data collection. 8 weeks of intervention exposure
Wave 1: Late September STARTED	67 11	38 7	39 8
Wave 1: Late September COMPLETED	67 11	38 7	39 8
Wave 1: Late September NOT COMPLETED	0 0	0 0	0 0
Wave 2: Early October STARTED	52 11	50 7	42 8
Wave 2: Early October COMPLETED	52 11	50 7	42 8
Wave 2: Early October NOT COMPLETED	0 0	0 0	0 0
Wave 3: Late October STARTED	85 11	54 7	55 8
Wave 3: Late October COMPLETED	85 11	54 7	55 8
Wave 3: Late October NOT COMPLETED	0 0	0 0	0 0
Wave 4: Early November STARTED	51 11	24 7	54 8
Wave 4: Early November COMPLETED	51 11	24 7	54 8
Wave 4: Early November NOT COMPLETED	0 0	0 0	0 0
Wave 5: Mid November STARTED	71 11	24 7	54 8
Wave 5: Mid November COMPLETED	71 11	24 7	54 8
Wave 5: Mid November NOT COMPLETED	0 0	0 0	0 0
Wave 6: Early December STARTED	70 11	93 7	33 8
Wave 6: Early December COMPLETED	70 11	93 7	33 8
Wave 6: Early December NOT COMPLETED	0 0	0 0	0 0
Wave 7: Late December STARTED	17 11	35 7	21 8
Wave 7: Late December COMPLETED	17 11	35 7	21 8
Wave 7: Late December NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	SASEA HUB n=917 Participants Access to online COVID-19 information tool hub to support testing access SASEA HUB: SASEA HUB website, an intervention tool to increase COVID-19 testing	Control School specific standard of care for COVID-19	Total n=917 Participants Total of all reporting groups
Age, Continuous	35.6 Years STANDARD_DEVIATION 6.7 • n=917 Participants	—	35.6 Years STANDARD_DEVIATION 8.6 • n=917 Participants
Sex: Female, Male Female	809 Participants n=917 Participants	—	809 Participants n=917 Participants
Sex: Female, Male Male	108 Participants n=917 Participants	—	108 Participants n=917 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	917 participants n=917 Participants	—	917 participants n=917 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Parents and staff in SASEA Hub participating schools

The primary study endpoint will be student diagnostic testing uptake in the previous 14-days, measured using household surveys distributed at 2-week intervals.

Outcome measures

Measure	SASEA HUB n=914 Participants Access to online COVID-19 information tool hub to support testing access SASEA HUB: SASEA HUB website, an intervention tool to increase COVID-19 testing	Control n=914 Participants School specific standard of COVID-19 care
Percentage of Participants Who Completed a COVID-19 Test	0.44 percentage of participants Interval 0.41 to 0.48	0.40 percentage of participants Interval 0.33 to 0.47

Adverse Events

SASEA HUB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rebecca Fielding-Miller

University of California San Diego

Phone: 8583810603

Email: rfieldingmiller@health.ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place