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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04620798
Other study ID # 2008293852
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


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.
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