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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 5/8/22 | Other Identifier | UW Madison | |
| A536756 | Other Identifier | UW Madison |
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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.
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.
Two key questions will be addressed:
Aim 2: The investigators will test the hypothesis that lollipop swabs are more acceptable to individuals and PCR testing is non-inferior to performing PCR on nasal swabs. To test this hypothesis, the investigators will work with MMSD schools to incorporate a lollipop swab for PCR at the time a symptomatic student or staff receives a nasal swab for PCR that is part of the Department of Health Services (DHS) program.
Two key questions will be addressed:
Hypotheses to be tested:
Protocol Amendment 2/4/22 to expand the upper eligible age for children from 14 to 19 years and to recognize the potential supply chain limitations of BinaxNOW tests. If the study team does not have any BinaxNOW tests due to a supply shortage, the BinaxNOW procedures will be dropped and only the lollipop swab will be collected.
Protocol Amendment 5/16/22 extends the study timeline and adds a lollipop swab only option.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BinaxNOW Test + Lollipop PCR | Experimental | If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for PCR testing. If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later. For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BinaxNOW Test | Diagnostic Test | diagnostic test for SARS-CoV-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR | 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. | up to 2 days |
| Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results | Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value. | up to 2 days |
| Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR | 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. | up to 2 days |
| Number of Successfully Completed At-home Tests | 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). | up to 24 hours |
| Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs | 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. | up to 1 day |
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Inclusion Criteria:
Exclusion Criteria:
Criteria for inclusion in the final study sample:
Criteria for exclusion in the final study sample:
Aim 1
Aim 2
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| Name | Affiliation | Role |
|---|---|---|
| Ellen R Wald, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Locations | Madison | Wisconsin | 53705 | United States |
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Participants were recruited from Madison Metropolitan School District from October 2021 to May 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 Tests | If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for polymerase chain reaction (PCR) testing. If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later. For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit. BinaxNOW Test: diagnostic test for SARS-CoV-2 "Lollipop" swab: A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds. All participants took the gold-standard Nasal Swab PCR test at school. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Tests | If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for PCR testing. If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later. For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit. BinaxNOW Test: diagnostic test for SARS-CoV-2 "Lollipop" swab: A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds. All participants took the gold-standard Nasal Swab PCR test at school. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR | 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. | Posted | Number | 95% Confidence Interval | kappa value in percentage | up to 2 days | At-home Binax tests | At-home Binax tests |
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Adverse events were collected after consent was signed and until they completed study procedures during the school visit or during the Binax Now visit (up to 5 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVID-19 Tests | If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for PCR testing. If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later. For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit. BinaxNOW Test: diagnostic test for SARS-CoV-2 "Lollipop" swab: A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds. |
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Some limitations and caveats of this study include:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Wald, MD | UW School of Medicine and Public Health | (608) 263-8558 | erwald@pediatrics.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2022 | Mar 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| "Lollipop" swab | Diagnostic Test | A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds. |
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| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
|---|
| Participants |
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| At-home Binax tests |
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| Primary | Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results | Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value. | 1 device did not function properly, 99 participants had data from both test to analyze | Posted | Count of Units | COVID-19 tests | No | up to 2 days | COVID-19 tests | COVID-19 tests |
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| Primary | Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR | 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. | 1 device did not function properly, 99 participants had data from both test to analyze | Posted | Number | 95% Confidence Interval | kappa value in percentage | up to 2 days | COVID-19 tests | COVID-19 tests |
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|
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| Primary | Number of Successfully Completed At-home Tests | 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). | Posted | Count of Units | at home COVID-19 tests | No | up to 24 hours | at home COVID-19 tests | at home COVID-19 tests |
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|
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| Primary | Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs | 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. | Posted | Count of Participants | Participants | up to 1 day |
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Negative Predictive Value |
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| one-sample binomial test |
| 0.0705 |
| Non-Inferiority |
non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99% |