Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
Condition: SARS-CoV-2; Serology; Students
Study type: Interventional

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.
    

Intervention name(s): Immediate vs. delayed provision of antibody test results
Intervention type(s): Behavioral
Intervention description(s): The primary experiment will be assessing whether provision of the antibody test results leads to behavior change with respect to personal protective behaviors. To that end, we will randomize all participants to a trial arm that immediately receive results (within 24 hours) or a trial arm with a delayed provision of results (after 4 weeks).
Intervention MeSH terms: Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary purpose: Screening