Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Sars Cov 2
  • Serology
  • Students
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Masking Description: Because we are attempting to assess the impact of having knowledge about a participants' antibody test result on their engagement in protective behaviors to avoid SARS-CoV-2 infections, the intervention information will be masked from the participant and the investigators.Primary Purpose: Screening

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

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 deta...

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.

Tracking Information

NCT #
NCT04620798
Collaborators
Not Provided
Investigators
Principal Investigator: Molly Rosenberg, PhD Indiana University Department of Epidemiology and Biostatistics