Clinical trial NCT04620798: Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
Official title: Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV-2
Serology
Students
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 1076
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive their antibody test results either within a day of the test or after a four-week waiting period in order to assess whether receiving the results of an antibody test changes protective behavior to avoid SARS-CoV-2 infections.
Primary purpose: SCREENING

Brief summary: The primary goal for this study is to assess whether receiving the results of an antibody test changes protective behavior to avoid SARS-CoV-2 infections (i.e., mask-wearing, physical distancing, limiting close contacts/avoiding crowds, hand-washing, avoiding contact with high-risk individuals). While studies have been published on the cross-sectional relationship between risk perception and other demographic characteristics and health behaviors that are protective for SARS-CoV-2 infection (see citations), there have been no studies showing the effect of receiving information about antibody positivity on protective behavior. Not only can results from this study be used to better model transmission, a better understanding of college student's risk perception around SARS-CoV-2 infections has implications for future vaccination strategies as well. There are concerns that a desire to return to "normal" life in combination with reduced perception of risk could have negative consequences for uptake of vaccination (Johns Hopkins Center for Health Security 2020 report, The Public's Role in COVID-19 Vaccination: Planning Recommendations Informed by Design Thinking and the Social, Behavioral, and Communication Sciences).

The antibody test used in this study is named 'SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold)'. It provides a fast, on-site, and accurate detection of IgM/IgG antibodies against SARS-CoV-2, with positive results of IgM antibodies indicating a recent infection, while positive results of IgG antibodies signaling a longer or previous infection. It can detect IgM and IgG antibodies against SARS-CoV-2 in human specimens of serum, plasma, or venous whole blood.

Detailed description: This study will take place between September - November, 2020, and will ask participants to participate in: a web-based baseline survey, two rounds of SARS-CoV-2 serological testing (September and November), and bi-weekly web-based behavioral surveys (4 total surveys). Each is described in more detail below:

Web-based baseline survey: The baseline survey is designed to collect data on participant demographics, SARS-CoV-2 protective behaviors, alcohol drinking habits, nicotine use, and personality profile and should take less than 30 minutes to fill out. Participants who provide informed consent will be provided the link to the survey which they can fill out at a time convenient to them prior to first round of serological testing.

SARS-CoV-2 serological testing: There will be two rounds of SARS-CoV-2 serological testing, once at baseline (September 14-23) and once at endline (November 9-11). The serological testing visits will involve in-person laboratory testing for SARS-CoV-2 antibodies. The laboratory test involves a fingerstick to provide a small blood sample for the antibody test kits.

Antibody test results will eventually be provided to all study participants via secure link sent by email. With this message, we will include a clearly written information sheet about the chance for inaccurate test results and how it is still unknown whether previous infections confer immunity to future infections. We will clearly counsel participants to not use the results of the tests as proof of a previous SARS-CoV-2 infection, nor as a reason to change their behaviors. If participants wish to participate in the study, but do not wish to be provided with their antibody test results, they will be able to opt out of the results provision. If any participants opt out of receiving their test results, these participants would essentially create a third category of respondents: those who do not receive their results at all. However, these participants will still be analyzed with the trial arm to which they were randomized (intent to treat analysis).

The primary experiment will assess whether provision of the antibody test results leads to behavior change with respect to personal protective behaviors. To that end, all participants will be randomized to a trial arm that immediately receive results (within 24 hours) or a trial arm with a delayed provision of results (after 4 weeks). So as to not incentivize early drop-out, if a participant in the delayed results arm drops out early, they will still be provided their test results at the regularly scheduled time, not earlier. All other procedures between arms are identical. The endline laboratory test results will be delivered to all participants in the same timeframe - within 24-72 hours. The early and delayed test result intervention will have completed after the first round of testing.

Web-based behavioral surveys: To assess whether or not the provision of antibody test results changes behaviors, participants will self-reported behaviors in a short web-based survey every two weeks under observation. Links to these surveys will be sent to participants at regular bi-weekly intervals. Participants will fill out these short follow-up surveys on their computers or mobile devices. They are designed to take about 5 minutes or less to complete for each survey.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Current IU undergraduate student
* Current resident of Monroe County, Indiana

Exclusion Criteria:

* Younger than 18 years old
* Current residence outside of Monroe County, Indiana

Primary outcomes:
measure: Frequency of Handwashing
timeFrame: 2 weeks after the baseline antibody test
measure: Frequency of Face Touching
timeFrame: 2 weeks after the baseline antibody test
measure: Frequency of Hand Sanitizer Use
timeFrame: 2 weeks after the baseline antibody test
measure: Frequency of Social Event Avoidance
timeFrame: 2 weeks after the baseline antibody test
measure: Frequency of Staying Home From Work/School
timeFrame: 2 weeks after the baseline antibody test
measure: Frequency of Mask Wearing
timeFrame: 2 weeks after the baseline antibody test
measure: Frequency of Physical Distancing
timeFrame: 2 weeks after the baseline antibody test
measure: Frequency of Avoiding People at High-risk for Severe COVID-19 Infections
timeFrame: 2 weeks after the baseline antibody test
Secondary outcomes:
measure: Count of Participants With SARS-CoV-2 Seroconversion Over 8 Weeks
timeFrame: Approximately 8 weeks from baseline antibody test.
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University Department of Epidemiology and Biostatistics
name: Molly Rosenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kianersi S, Luetke M, Ludema C, Valenzuela A, Rosenberg M. Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example. BMC Med Res Methodol. 2021 Aug 21;21(1):175. doi: 10.1186/s12874-021-01362-2.