Communities Fighting COVID Return to School

COVID-19 Clinical Trial

Official title:

Communities Fighting COVID!: Returning Our Kids Back to School Safely

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05150860
• Other study ID #: HS-2021-0208
• Secondary ID: 1OT2HD108112-01
• Status: Completed
• Phase: N/A
• Start date: October 17, 2021
• Est. completion date: April 2, 2022

Study information

• Verified date: April 2024
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 852
• Est. completion date: April 2, 2022
• Est. primary completion date: April 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• 2 years of age or older; student at a Sweetwater Union High School District Middle School, staff at a Sweetwater Union High School District Middle School or household member of a student or staff affiliated with a Sweetwater Union High School District Middle School

Exclusion Criteria:

• <2 years of age

• No affiliation with a Sweetwater Union High School District Middle School

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• At-home COVID-19 testing
At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff
• Family-based model
Making the COVID-19 testing program available to household/family members to increase participation of students and staff in the school COVID-19 testing program
• Onsite COVID-19 testing
Onsite COVID-19 testing for middle school students and staff

Locations

Country	Name	City	State
United States	Sweetwater Union High School District	Chula Vista	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kiene 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 Tri — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rate	Percentage of students and staff who participate in testing per the testing schedule (e.g., weekly testing)	through trial completion, expected to be approximately 5 months
Primary	Adherence to the testing schedule	Percentage of scheduled tests completed	through trial completion, expected to be approximately 5 months