Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students

SARS-CoV-2 Clinical Trial

Official title:

Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620798
• Other study ID #: 2008293852
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: November 11, 2020

Study information

• Verified date: January 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1076
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2
• Serology
• Students

Intervention

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).

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Handwashing	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 weeks after the baseline antibody test
Primary	Frequency of Face Touching	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	2 weeks after the baseline antibody test
Primary	Frequency of Hand Sanitizer Use	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	2 weeks after the baseline antibody test
Primary	Frequency of Social Event Avoidance	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	2 weeks after the baseline antibody test
Primary	Frequency of Staying Home From Work/School	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	2 weeks after the baseline antibody test
Primary	Frequency of Mask Wearing	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	2 weeks after the baseline antibody test
Primary	Frequency of Physical Distancing	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	2 weeks after the baseline antibody test
Primary	Frequency of Avoiding People at High-risk for Severe COVID-19 Infections	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	2 weeks after the baseline antibody test
Secondary	Count of Participants With SARS-CoV-2 Seroconversion Over 8 Weeks	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.	Approximately 8 weeks from baseline antibody test.