COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Schools and colleges are stratified by size (<500 of =500 students on register), type (maintained, independent, residential, special provision), presence of a sixth form, and proportion of students e
Sponsors
Department of Health and Social Care
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Secondary school/further education college 2. Willing and able to follow the study protocol 3. Willing and able to undertake PCR testing of contacts in the event the school is allocated to the control group 4. Commits to maintaining contact management in line with national standards 5. Willing and able to provide regular data of test results to Test and Trace and to allow members of an index case’s contact group to be flagged in a database. 6. Willing and able to support baseline data collection requirements (e.g., provision of school register, bubble allocation data, etc.) 7. Willing to communicate regularly to Participants via Participant Information Sheets and other communication materials 8. Willing and able to provide a dedicated DHSC-funded Research Assistant to support data collection Inclusion criteria for DCT (in the intervention arm): Staff (including temporary or contract staff) and students in secondary schools/further education colleges/year 7 and above in all-through schools’ individuals, who are: 1. Contact of a positive case related to school 2. Asymptomatic 3. Onsite i.e. not self-isolating or shielding 4. Contact of an index case in the school’s population i.e. a staff member or student who has tested positive
Exclusion criteria
Exclusion criteria: 1. The school’s contact management policy does not conform to national standards 2. Inability to support in-school LFD testing (i.e. not part of the NHS Test and Trace Asymptomatic Testing Site network) Exclusion criteria for DCT (in the intervention arm): 1. Contact of a non-school index case 2. Household contact of a diagnosed COVID-19 positive individual 3. Symptomatic individuals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-Primary End-Points: 1. Number of school days missed among those eligible to be in school during the 9-week period of the study. Daily school attendances will be obtained from the school register and absences recorded with reconciliation with COVID-19 associated absences. This will be compared between study arms, to historic schools’ data, and to national schools’ benchmark data collected via a survey of non-participating schools. 2. Estimated number of in-school COVID-19 transmission events during the 9-week period of the study: the number of positive cases will be obtained from the following sources: 2.1. Weekly LFD active case finding (control and intervention arms) during the 9-week period of the study 2.2. Symptomatic individuals’ NHS Test and Trace results obtained from Community Testing routine data (control and intervention arms) during the 9-week period of the study 2.3. In-school LFD DCT testing (intervention arm) during the 9-week period of the study Positivity rates will be reported for each source separately to facilitate like-for-like comparison between arms Epidemiological links between cases will be obtained from the NHS Test & Trace Contact Tracing and Advice Service database. Additional links will be obtained by membership of school-reported contact groups. Onward transmission from the index case will be determined by the following: 1. Genomic sequence of virus: the additional PCR swab collected from positive individuals will be used to determine the whole genomic sequence of isolates. A sample of apparent links will be assessed with comparisons of whole-genome sequencing. The diversity of genetic sequences both in the schools and the community (routinely determined by COG) will be used to help interpret the results. Preliminary work currently undertaken will determine the appropriate genetic distance to be used to excl | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of positive first-order contacts missed by daily LFD testing during the 9-week period of the study (intervention arm only). Routine qPCR of first-order contacts will be used to determine the performance of DCT testing with LFDs. Comparisons of PCR with the same day LFD will allow comparison between CT values and LFD results in a ‘real world setting’ These comparisons can also be used to compare the relative performance between assisted school-based testing and home/self-testing. 2. Number of COVID-19 cases transmitted to the first-order contacts of index cases during the 9-week period of the study (“primary attack rate”). The first-order close contacts of all index cases will be identified by the school based on their existing close contact management policy. LFD DCT testing and (for symptomatic individuals) routine NHS Test and Trace PCR testing will be used to calculate the primary attack rate. As above, genomic sequencing will be used, wherever possible, to exclude non-direct transmission events. 3. Number of COVID-19 cases transmitted to the second-order contacts of index cases during the 9-week period of the study (“secondary attack rate”). The second-order contacts of all index cases will be identified (regardless of the COVID-19 status of the DCT-contacts) as described in Section 3.7. The COVID-19 status of these second-order contacts will be measured in two ways: 3.1. Where the second-order contact is a consented participant in this study their COVID-19 status will be assessed by weekly LFD active case finding during the 9-week period of the study, and records kept by the school of any participants who become symptomatic and test positive via standard NHS Test and Trace community testing. 3.2. Where the second-order contact is not a consented participant in this study (e.g., household contact of the first-order contact), analysis of routine NHS Test and Trace data recorded during the | — |
Countries
England, United Kingdom
Contacts
Public ContactSaroj Kendrick
Outcome results
None listed