Assocation Between In-person Instruction and COVID-19 Risk

Study Overview
=================
Brief Summary
-----------------
Whether university teaching on campus with infection control measures in place is associated with higher risk of COVID-19 than online instruction, is unknown. The investigators will assess this by conducting repeated surveys among students at universities and university colleges in Norway, where some instruction is given in-person, and some is provided online (hybrid model). The investigators will ask about the students' COVID-19 status, and how much in-person and online instruction the students are getting. The investigators will estimate the association between in-person instruction and COVID-19-risk using multivariate regression, controlling for likely confounders. The investigators will also assess whether type of instruction is associated with how satisfied the students are with the instruction the students are offered, their quality of life, and learning outcomes.

Detailed Description
-----------------
The investigators are inviting all universities and university colleges in Norway to take part. All students at institutions that agree to participate will receive an SMS (alternatively an e-mail) inviting them to take part in the study. The invitation includes a link that directs participants to a web-based informed consent-form and questionnaire. The investigators will use the University of Oslo's solutions for online consent form, web-based survey (Nettskjema), and secure storage of research data (TSD). The investigators will ask the participants if the participants have been tested for COVID-19, the results of such a test, how much in-person instruction the students have been offered, and how much online instruction the students have been offered. The investigators will also inquire about other risk factors for COVID-19 and background variables that may be included as potential adjustment factors (confounders) in the analyses (see Attachment 1 - Questionnaire). The investigators will survey the students every two weeks by new invitations by SMS or e-mail. The study period will last as long as the universities maintain their arrangement with in-person instruction for only select groups of students. The investigators plan for a study period that lasts for the remainder of 2020. The investigators will ask for the participants consent to link the survey results to information on study programme, basis for admission, study status, academic results, sex and age from the Common Student System. The investigators will run multivariate regressions to test whether there is an association between in-person instruction and the outcomes. In-person instruction is a continuous variable, defined as (Number of days offered in-person instruction) / (Number of days offered in-person instruction + Number of days offered online instruction) The investigators will control for potentially confounding variables, including year of study program, field of study, age, and gender. The investigators plan for separate analyses for each participating university/university college, and a pooled analysis across institutions.

Official Title
-----------------
Relationship Between In-person Instruction and COVID-19 Incidence Among University Students: A Prospective Cohort Study

Conditions
-----------------
Infection Control, Infection

Intervention / Treatment
-----------------
* Behavioral: Online instruction
* Behavioral: In-person instruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Student in first, second, or third year at university or university college Agrees to participate (signed consent form) Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Students, Higher Education Institution 1<br>All first, second, and third year students at Higher Education Institution 1 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 2<br>All first, second, and third year students at Higher Education Institution 2 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 3<br>All first, second, and third year students at Higher Education Institution 3 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 4<br>All first, second, and third year students at Higher Education Institution 4 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 5<br>All first, second, and third year students atHigher Education Institution 5 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 6<br>All first, second, and third year students at Higher Education Institution 6 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 7<br>All first, second, and third year students at Higher Education Institution 7 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 8<br>All first, second, and third year students at Higher Education Institution 8 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 9<br>All first, second, and third year students at Higher Education Institution 9 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 10<br>All first, second, and third year students at Higher Education Institution 10 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 11<br>All first, second, and third year students at Higher Education Institution 11 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 12<br>All first, second, and third year students at Higher Education Institution 12 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 13<br>All first, second, and third year students at Higher Education Institution 13 who agree to take part in study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|
| Students, Higher Education Institution 14<br>All first, second, and third year students at Higer Education Institution 14 who agree to take part in the study. | Behavioral: Online instruction<br>* For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.<br>Behavioral: In-person instruction<br>* For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 incidence | Self-reported positive test results | Through study completion, i.e. 4 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Self-reported (Overall, how satisfied are you with life right now?) | Through study completion, i.e. 4 months. | 
| Satisfaction with teaching | Self-reported (Overall, how satisfied have you been with the teaching you have received in the past 14 days?) | Through study completion, i.e. 4 months. | 
| COVID-19 testing incidence | Self-reported | Through study completion, i.e. 4 months. | 
| Learning outcome | Exam results from Common Student System | End of term, December 2020. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Campus, Social distancing, Digital instruction, In-person instruction, University, College, Higher education institutions, COVID-19