Safe and Healthy Schools
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
研究概览
简要总结
This study will target Madison Metropolitan School District (MMSD) school children ages 4-19 and staff who have not had a previous positive COVID-19 test within the past 3 months. It will enroll children and adults for 1-3 days to explore whether serial "at-home" BinaxNOW testing is feasible and non-inferior to "at school" single PCR testing for the evaluation of symptomatic individuals with a negative initial BinaxNOW. It will also explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with polymerase chain reaction (PCR) testing.
详细描述
Study Design: This is a quantitative community-based study, conducted in the K-12 setting with school children 4-19 years old, teachers, and staff.
If a participant's initial at-school BinaxNOW test is positive, then they will only complete the lollipop swab for PCR testing. They will NOT do the at-home BinaxNOW test.
If a participant's initial at-school BinaxNOW test is negative, then they will complete both the lollipop swab for PCR testing AND an at-home BinaxNOW test approximately 24 hours later.
If the participant is unwilling or unable to complete the at-home test, they will be presented with a lollipop swab only option.
Aim 1: The investigators will test the hypothesis that serial at-home BinaxNOW testing will be feasible and non-inferior to the single at-school PCR testing program. To do this, the investigators will distribute over-the-counter BinaxNOW antigen tests to volunteer families, and create a protocol to ensure families can perform and report test results accurately to the school.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •school children ages 4-19
- •MMSD staff
- •have at least one symptom of COVID-19
- •have not had a positive COVID-19 test in the past 3 months
- •will undergo nasal PCR testing at an MMSD elementary school
排除标准
- •received a positive COVID-19 test in the past 3 months
- •Criteria for inclusion in the final study sample:
- •Symptomatic participants with a negative at-school BinaxNOW test and nasal PCR results who complete both the lollipop PCR and at-home BinaxNOW tests within 72 hours will be included in the final study sample.
- •Symptomatic participants who provide a lollipop swab that is successfully resulted.
- •Criteria for exclusion in the final study sample:
- •Missing nasal PCR result
- •Do not successfully complete an at-home BinaxNOW test within 72 hours of the at-school BinaxNOW test
- •Missing nasal PCR result
- •Missing lollipop PCR result
结局指标
主要结局
Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
时间窗: up to 2 days
The primary diagnostic outcome measure will be the negative predictive value (NPV). The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the BinaxNOW at Home testing with respect to PCR nasal swab (gold standard) are reported here.
Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results
时间窗: up to 2 days
Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value.
Number of Successfully Completed At-home Tests
时间窗: up to 24 hours
Feasibility of 'at-home' BinaxNOW testing will be determined by number of successfully completed at-home tests. At-home test taking will be monitored by study team remotely (via zoom or similar).
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
时间窗: up to 2 days
The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the Lollipop Swab PCR with respect to PCR nasal swab (gold standard) are reported here.
Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs
时间窗: up to 1 day
To address the acceptability of lollipop swabs vs nasal swabs, the study team will ask participants a binary question: Are lollipop swabs more acceptable to participants when compared to nasal swabs? Yes/No.
次要结局
未报告次要终点