Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students

• ClinicalTrials.gov Identifier: NCT04620798
• Recruitment Status: Completed
• First Posted: November 9, 2020
• Results First Posted: January 31, 2022
• Last Update Posted: January 31, 2022
• Sponsor: Indiana University
• Information provided by (Responsible Party): Molly Rosenberg, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
SARS-CoV-2; Serology; Students	Behavioral: Immediate vs. delayed provision of antibody test results	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1076 participants
• 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)
• 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
• Official Title: Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
• Actual Study Start Date: September 14, 2020
• Actual Primary Completion Date: November 11, 2020
• Actual Study Completion Date: November 11, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Participants will be given their results of their antibody test immediately (within 24 hours) and will be followed and surveyed to see if having this knowledge changes their engagement with SARS-CoV-2 prevention behaviors.	Behavioral: Immediate vs. delayed provision of antibody test results; 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).
No Intervention: Control (Delayed); Participants will be given their results of their antibody test after 4 weeks. Their engagement with SARS-CoV-2 prevention behaviors will also be assessed following testing.

Outcome Measures

Primary Outcome Measures :

1. Frequency of Handwashing [ Time Frame: 2 weeks after the baseline antibody test ]

   This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response":

   "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?"

   -Frequently washed my hands with soap and water for at least 20 seconds

   Response options are: Always, Very Often, Sometimes, Rarely, Never

2. Frequency of Face Touching [ Time Frame: 2 weeks after the baseline antibody test ]

   This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. This outcome will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response":

   "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?"

   -Avoided touching my eyes, nose and mouth with unwashed hands

   Response options are: Always, Very Often, Sometimes, Rarely, Never

3. Frequency of Hand Sanitizer Use [ Time Frame: 2 weeks after the baseline antibody test ]

   This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. This outcome will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response":

   "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?"

   -Used disinfectants or hand sanitizer to clean hands when soap and water were not available

   Response options are: Always, Very Often, Sometimes, Rarely, Never

4. Frequency of Social Event Avoidance [ Time Frame: 2 weeks after the baseline antibody test ]

   This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response":

   "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?"

   -Avoided a social event I wanted to attend

   Response options are: Always, Very Often, Sometimes, Rarely, Never

5. Frequency of Staying Home From Work/School [ Time Frame: 2 weeks after the baseline antibody test ]

   This outcome is dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response":

   "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?"

   -Stayed at home from work/school

   Response options are: Always, Very Often, Sometimes, Rarely, Never

6. Frequency of Mask Wearing [ Time Frame: 2 weeks after the baseline antibody test ]

   This outcome is dichotomized into Always versus Very Often, Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response":

   "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?"

   -Wore a mask in public

   Response options are: Always, Very Often, Sometimes, Rarely, Never

7. Frequency of Physical Distancing [ Time Frame: 2 weeks after the baseline antibody test ]

   This outcome is dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response":

   "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?"

   -Ensured physical distancing in public

   Response options are: Always, Very Often, Sometimes, Rarely, Never

8. Frequency of Avoiding People at High-risk for Severe COVID-19 Infections [ Time Frame: 2 weeks after the baseline antibody test ]

   This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. This outcome will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response":

   "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?"

   -Avoided contact with people at high-risk for severe COVID-19 infections

   Response options are: Always, Very Often, Sometimes, Rarely, Never

Secondary Outcome Measures :

1. Count of Participants With SARS-CoV-2 Seroconversion Over 8 Weeks [ Time Frame: Approximately 8 weeks from baseline antibody test. ]
   This outcome will be assessed by comparing SARS-CoV-2 serostatus at baseline (September 2020) and endline (November 2020). Those who were antibody negative at baseline but antibody positive at endline will be considered seroconverters in this study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Indiana

Indiana University

Bloomington, Indiana, United States, 47405

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: Molly Rosenberg, PhD; Indiana University Department of Epidemiology and Biostatistics

  Study Documents (Full-Text)

Documents provided by Molly Rosenberg, Indiana University:

Study Protocol and Statistical Analysis Plan  [PDF] September 1, 2020

Informed Consent Form  [PDF] September 1, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Molly Rosenberg, Assistant Professor Public Health, Indiana University
• ClinicalTrials.gov Identifier: NCT04620798
• Other Study ID Numbers: 2008293852
• First Posted: November 9, 2020
• Results First Posted: January 31, 2022
• Last Update Posted: January 31, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The study team will make the following documents available to the public upon completion of the study: (1) Study Protocol, (2) Statistical Analysis Plan (SAP), (3) Informed Consent Form (ICF), and (4) Clinical Study Report (CSR). The individual participant data as well as the analytic code will not be made available to the public due to privacy concerns and in order to protect participants' private health information but will be available from the Principal Investigator upon request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: These study protocol documents will be made available upon completion of the study and the analyses. A de-identified, limited data set and analytic code will be available from the Principal Investigator upon request.
• Access Criteria: Protocol will be available on clinicaltrials.gov while the other documents, data, and analytic code from the Principal Investigator upon request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Antibodies; Immunologic Factors; Physiological Effects of Drugs