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Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students

Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04620798
Enrollment
1076
Registered
2020-11-09
Start date
2020-09-14
Completion date
2020-11-11
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2, Serology, Students

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.

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.

Interventions

BEHAVIORALImmediate 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).

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, 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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Avoiding People at High-risk for Severe COVID-19 Infections2 weeks after the baseline antibody testThis 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
Frequency of Handwashing2 weeks after the baseline antibody testThis 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
Frequency of Face Touching2 weeks after the baseline antibody testThis 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
Frequency of Hand Sanitizer Use2 weeks after the baseline antibody testThis 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
Frequency of Social Event Avoidance2 weeks after the baseline antibody testThis 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
Frequency of Staying Home From Work/School2 weeks after the baseline antibody testThis 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
Frequency of Mask Wearing2 weeks after the baseline antibody testThis 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
Frequency of Physical Distancing2 weeks after the baseline antibody testThis 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

Secondary

MeasureTime frameDescription
Count of Participants With SARS-CoV-2 Seroconversion Over 8 WeeksApproximately 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.

Countries

United States

Participant flow

Recruitment details

We randomly sampled 7,499 students from the sampling frame of all IU Bloomington undergraduates enrolled at the beginning of the Fall 2020 semester. Students in the sample were eligible to participate if they were (1) aged 18 years or older, (2) a current IU Bloomington undergraduate student, and (3) currently residing in Monroe County, Indiana. Of those sampled, 4,069 potential participants met the inclusion criteria for the study and were contacted by email with a study invitation.

Pre-assignment details

Following the study invitation, 1076 of the 4069 eligible sampled students were enrolled in the study and received randomization. 2651 students tacitly refused participation, 21 students explicitly refused participation or withdrew from the study, and 321 students missed the baseline study visit.

Participants by arm

ArmCount
Intervention (Immediate Results)
Participants will be given their results of their antibody test immediately (within 24 hours).
536
Control (Delayed Results)
Participants will be given their results of their antibody test four weeks following the test.
540
Total1,076

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up126138

Baseline characteristics

CharacteristicControl (Delayed Results)Intervention (Immediate Results)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
502 Participants508 Participants1010 Participants
Age, Customized
Age, Categorical
18 years old
97 Participants111 Participants208 Participants
Age, Customized
Age, Categorical
19 years old
115 Participants109 Participants224 Participants
Age, Customized
Age, Categorical
20 years old
119 Participants109 Participants228 Participants
Age, Customized
Age, Categorical
21 years old
123 Participants132 Participants255 Participants
Age, Customized
Age, Categorical
22+ years old
48 Participants47 Participants95 Participants
Age, Customized
Age, Categorical
Missing
38 Participants28 Participants66 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
39 Participants39 Participants78 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
501 Participants497 Participants998 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Greek Affiliation Status
Missing
2 Participants4 Participants6 Participants
Greek Affiliation Status
No
409 Participants403 Participants812 Participants
Greek Affiliation Status
Yes
129 Participants129 Participants258 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
37 Participants43 Participants80 Participants
Race (NIH/OMB)
Black or African American
7 Participants6 Participants13 Participants
Race (NIH/OMB)
More than one race
42 Participants43 Participants85 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
24 Participants27 Participants51 Participants
Race (NIH/OMB)
White
430 Participants417 Participants847 Participants
Region of Enrollment
United States
540 participants536 participants1076 participants
Residence
Missing
3 Participants2 Participants5 Participants
Residence
Off-Campus
375 Participants358 Participants733 Participants
Residence
On-Campus
162 Participants176 Participants338 Participants
Sex: Female, Male
Female
356 Participants333 Participants689 Participants
Sex: Female, Male
Male
181 Participants201 Participants382 Participants
Undergraduate School Year
Fifth Year or More
17 Participants10 Participants27 Participants
Undergraduate School Year
First Year
113 Participants123 Participants236 Participants
Undergraduate School Year
Fourth Year
143 Participants154 Participants297 Participants
Undergraduate School Year
Missing
3 Participants3 Participants6 Participants
Undergraduate School Year
Second Year
127 Participants119 Participants246 Participants
Undergraduate School Year
Third Year
137 Participants127 Participants264 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 5360 / 540
other
Total, other adverse events
0 / 5360 / 540
serious
Total, serious adverse events
0 / 5360 / 540

Outcome results

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

Time frame: 2 weeks after the baseline antibody test

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Frequency of Avoiding People at High-risk for Severe COVID-19 InfectionsAlways or Very Often433 Participants
Intervention (Immediate Results)Frequency of Avoiding People at High-risk for Severe COVID-19 InfectionsNever, Sometimes, or Rarely30 Participants
Intervention (Immediate Results)Frequency of Avoiding People at High-risk for Severe COVID-19 InfectionsNot Applicable14 Participants
Control (Delayed Results)Frequency of Avoiding People at High-risk for Severe COVID-19 InfectionsAlways or Very Often466 Participants
Control (Delayed Results)Frequency of Avoiding People at High-risk for Severe COVID-19 InfectionsNever, Sometimes, or Rarely31 Participants
Control (Delayed Results)Frequency of Avoiding People at High-risk for Severe COVID-19 InfectionsNot Applicable10 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.97, 1.04]
Comparison: This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.74, 1.12]
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

Time frame: 2 weeks after the baseline antibody test

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Frequency of Face TouchingAlways or Very Often280 Participants
Intervention (Immediate Results)Frequency of Face TouchingNever, Sometimes, or Rarely196 Participants
Control (Delayed Results)Frequency of Face TouchingAlways or Very Often303 Participants
Control (Delayed Results)Frequency of Face TouchingNever, Sometimes, or Rarely204 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.89, 1.1]
Comparison: This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.5, 1.62]
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

Time frame: 2 weeks after the baseline antibody test

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Frequency of Hand Sanitizer UseAlways or Very Often414 Participants
Intervention (Immediate Results)Frequency of Hand Sanitizer UseNever, Sometimes, or Rarely60 Participants
Intervention (Immediate Results)Frequency of Hand Sanitizer UseNot Applicable3 Participants
Control (Delayed Results)Frequency of Hand Sanitizer UseAlways or Very Often436 Participants
Control (Delayed Results)Frequency of Hand Sanitizer UseNever, Sometimes, or Rarely69 Participants
Control (Delayed Results)Frequency of Hand Sanitizer UseNot Applicable0 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.96, 1.06]
Comparison: This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.74, 1.31]
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

Time frame: 2 weeks after the baseline antibody test

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Frequency of HandwashingAlways or Very Often412 Participants
Intervention (Immediate Results)Frequency of HandwashingNever, Sometimes, or Rarely65 Participants
Intervention (Immediate Results)Frequency of HandwashingNot Applicable0 Participants
Control (Delayed Results)Frequency of HandwashingAlways or Very Often432 Participants
Control (Delayed Results)Frequency of HandwashingNever, Sometimes, or Rarely75 Participants
Control (Delayed Results)Frequency of HandwashingNot Applicable1 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.96, 1.07]
Comparison: This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.77, 1.44]
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

Time frame: 2 weeks after the baseline antibody test

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Frequency of Mask WearingAlways400 Participants
Intervention (Immediate Results)Frequency of Mask WearingNever, Rarely, Sometimes, or Very Often76 Participants
Control (Delayed Results)Frequency of Mask WearingAlways433 Participants
Control (Delayed Results)Frequency of Mask WearingNever, Rarely, Sometimes, or Very Often71 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.99, 1.03]
Comparison: This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.77, 1.21]
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

Time frame: 2 weeks after the baseline antibody test

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Frequency of Physical DistancingAlways or Very Often427 Participants
Intervention (Immediate Results)Frequency of Physical DistancingNever, Rarely, or Sometimes50 Participants
Control (Delayed Results)Frequency of Physical DistancingAlways or Very Often452 Participants
Control (Delayed Results)Frequency of Physical DistancingNever, Rarely, or Sometimes54 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.97, 1.06]
Comparison: This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.6, 1.11]
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

Time frame: 2 weeks after the baseline antibody test

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Frequency of Social Event AvoidanceAlways or Very Often209 Participants
Intervention (Immediate Results)Frequency of Social Event AvoidanceNever, Rarely, or Sometimes224 Participants
Intervention (Immediate Results)Frequency of Social Event AvoidanceNot Applicable44 Participants
Control (Delayed Results)Frequency of Social Event AvoidanceAlways or Very Often236 Participants
Control (Delayed Results)Frequency of Social Event AvoidanceNever, Rarely, or Sometimes228 Participants
Control (Delayed Results)Frequency of Social Event AvoidanceNot Applicable43 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.84, 1.09]
Comparison: This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.33, 1.72]
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

Time frame: 2 weeks after the baseline antibody test

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Frequency of Staying Home From Work/SchoolAlways or Very Often152 Participants
Intervention (Immediate Results)Frequency of Staying Home From Work/SchoolNever, Rarely, or Sometimes254 Participants
Intervention (Immediate Results)Frequency of Staying Home From Work/SchoolNot Applicable71 Participants
Control (Delayed Results)Frequency of Staying Home From Work/SchoolAlways or Very Often185 Participants
Control (Delayed Results)Frequency of Staying Home From Work/SchoolNever, Rarely, or Sometimes255 Participants
Control (Delayed Results)Frequency of Staying Home From Work/SchoolNot Applicable66 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.74, 1.04]
Comparison: This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.95% CI: [0.6, 3.25]
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.

Time frame: Approximately 8 weeks from baseline antibody test.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Immediate Results)Count of Participants With SARS-CoV-2 Seroconversion Over 8 WeeksYes20 Participants
Intervention (Immediate Results)Count of Participants With SARS-CoV-2 Seroconversion Over 8 WeeksNo386 Participants
Control (Delayed Results)Count of Participants With SARS-CoV-2 Seroconversion Over 8 WeeksYes22 Participants
Control (Delayed Results)Count of Participants With SARS-CoV-2 Seroconversion Over 8 WeeksNo380 Participants
Comparison: This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and seroconversion. The reference group for this analysis was the control (delayed results) group.95% CI: [0.52, 1.71]

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026