Trial Outcomes & Findings for Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students (NCT NCT04620798)

NCT ID: NCT04620798

Last Updated: 2022-01-31

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1076 participants

Primary outcome timeframe

2 weeks after the baseline antibody test

Results posted on

2022-01-31

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
Intervention (Immediate Results)
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
Participants will be given their results of their antibody test four weeks following the test.
Overall Study
STARTED
536
540
Overall Study
Completed Behavioral Survey
477
508
Overall Study
COMPLETED
410
402
Overall Study
NOT COMPLETED
126
138

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention (Immediate Results)
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
Participants will be given their results of their antibody test four weeks following the test.
Overall Study
Lost to Follow-up
126
138

Baseline Characteristics

Only includes participants who self-reported their age at baseline (66 participants were missing this data).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention (Immediate Results)
n=536 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=540 Participants
Participants will be given their results of their antibody test four weeks following the test.
Total
n=1076 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=508 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
0 Participants
n=502 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
0 Participants
n=1010 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
Age, Categorical
Between 18 and 65 years
508 Participants
n=508 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
502 Participants
n=502 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
1010 Participants
n=1010 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
Age, Categorical
>=65 years
0 Participants
n=508 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
0 Participants
n=502 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
0 Participants
n=1010 Participants • Only includes participants who self-reported their age at baseline (66 participants were missing this data).
Age, Customized
Age, Categorical · 18 years old
111 Participants
n=536 Participants
97 Participants
n=540 Participants
208 Participants
n=1076 Participants
Age, Customized
Age, Categorical · 19 years old
109 Participants
n=536 Participants
115 Participants
n=540 Participants
224 Participants
n=1076 Participants
Age, Customized
Age, Categorical · 20 years old
109 Participants
n=536 Participants
119 Participants
n=540 Participants
228 Participants
n=1076 Participants
Age, Customized
Age, Categorical · 21 years old
132 Participants
n=536 Participants
123 Participants
n=540 Participants
255 Participants
n=1076 Participants
Age, Customized
Age, Categorical · 22+ years old
47 Participants
n=536 Participants
48 Participants
n=540 Participants
95 Participants
n=1076 Participants
Age, Customized
Age, Categorical · Missing
28 Participants
n=536 Participants
38 Participants
n=540 Participants
66 Participants
n=1076 Participants
Sex: Female, Male
Female
333 Participants
n=534 Participants • Only includes participants who self-reported information regarding their biological sex at birth (five participants were missing this data).
356 Participants
n=537 Participants • Only includes participants who self-reported information regarding their biological sex at birth (five participants were missing this data).
689 Participants
n=1071 Participants • Only includes participants who self-reported information regarding their biological sex at birth (five participants were missing this data).
Sex: Female, Male
Male
201 Participants
n=534 Participants • Only includes participants who self-reported information regarding their biological sex at birth (five participants were missing this data).
181 Participants
n=537 Participants • Only includes participants who self-reported information regarding their biological sex at birth (five participants were missing this data).
382 Participants
n=1071 Participants • Only includes participants who self-reported information regarding their biological sex at birth (five participants were missing this data).
Ethnicity (NIH/OMB)
Hispanic or Latino
39 Participants
n=536 Participants
39 Participants
n=540 Participants
78 Participants
n=1076 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
497 Participants
n=536 Participants
501 Participants
n=540 Participants
998 Participants
n=1076 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=536 Participants
0 Participants
n=540 Participants
0 Participants
n=1076 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=536 Participants
0 Participants
n=540 Participants
0 Participants
n=1076 Participants
Race (NIH/OMB)
Asian
43 Participants
n=536 Participants
37 Participants
n=540 Participants
80 Participants
n=1076 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=536 Participants
0 Participants
n=540 Participants
0 Participants
n=1076 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=536 Participants
7 Participants
n=540 Participants
13 Participants
n=1076 Participants
Race (NIH/OMB)
White
417 Participants
n=536 Participants
430 Participants
n=540 Participants
847 Participants
n=1076 Participants
Race (NIH/OMB)
More than one race
43 Participants
n=536 Participants
42 Participants
n=540 Participants
85 Participants
n=1076 Participants
Race (NIH/OMB)
Unknown or Not Reported
27 Participants
n=536 Participants
24 Participants
n=540 Participants
51 Participants
n=1076 Participants
Region of Enrollment
United States
536 participants
n=536 Participants
540 participants
n=540 Participants
1076 participants
n=1076 Participants
Undergraduate School Year
First Year
123 Participants
n=536 Participants
113 Participants
n=540 Participants
236 Participants
n=1076 Participants
Undergraduate School Year
Second Year
119 Participants
n=536 Participants
127 Participants
n=540 Participants
246 Participants
n=1076 Participants
Undergraduate School Year
Third Year
127 Participants
n=536 Participants
137 Participants
n=540 Participants
264 Participants
n=1076 Participants
Undergraduate School Year
Fourth Year
154 Participants
n=536 Participants
143 Participants
n=540 Participants
297 Participants
n=1076 Participants
Undergraduate School Year
Fifth Year or More
10 Participants
n=536 Participants
17 Participants
n=540 Participants
27 Participants
n=1076 Participants
Undergraduate School Year
Missing
3 Participants
n=536 Participants
3 Participants
n=540 Participants
6 Participants
n=1076 Participants
Residence
On-Campus
176 Participants
n=536 Participants
162 Participants
n=540 Participants
338 Participants
n=1076 Participants
Residence
Off-Campus
358 Participants
n=536 Participants
375 Participants
n=540 Participants
733 Participants
n=1076 Participants
Residence
Missing
2 Participants
n=536 Participants
3 Participants
n=540 Participants
5 Participants
n=1076 Participants
Greek Affiliation Status
Yes
129 Participants
n=536 Participants
129 Participants
n=540 Participants
258 Participants
n=1076 Participants
Greek Affiliation Status
No
403 Participants
n=536 Participants
409 Participants
n=540 Participants
812 Participants
n=1076 Participants
Greek Affiliation Status
Missing
4 Participants
n=536 Participants
2 Participants
n=540 Participants
6 Participants
n=1076 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=477 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=508 Participants
Participants will be given their results of their antibody test four weeks following the test.
Frequency of Handwashing
Always or Very Often
412 Participants
432 Participants
Frequency of Handwashing
Never, Sometimes, or Rarely
65 Participants
75 Participants
Frequency of Handwashing
Not Applicable
0 Participants
1 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=476 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=507 Participants
Participants will be given their results of their antibody test four weeks following the test.
Frequency of Face Touching
Always or Very Often
280 Participants
303 Participants
Frequency of Face Touching
Never, Sometimes, or Rarely
196 Participants
204 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=477 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=505 Participants
Participants will be given their results of their antibody test four weeks following the test.
Frequency of Hand Sanitizer Use
Always or Very Often
414 Participants
436 Participants
Frequency of Hand Sanitizer Use
Never, Sometimes, or Rarely
60 Participants
69 Participants
Frequency of Hand Sanitizer Use
Not Applicable
3 Participants
0 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=477 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=507 Participants
Participants will be given their results of their antibody test four weeks following the test.
Frequency of Social Event Avoidance
Always or Very Often
209 Participants
236 Participants
Frequency of Social Event Avoidance
Never, Rarely, or Sometimes
224 Participants
228 Participants
Frequency of Social Event Avoidance
Not Applicable
44 Participants
43 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=477 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=506 Participants
Participants will be given their results of their antibody test four weeks following the test.
Frequency of Staying Home From Work/School
Always or Very Often
152 Participants
185 Participants
Frequency of Staying Home From Work/School
Never, Rarely, or Sometimes
254 Participants
255 Participants
Frequency of Staying Home From Work/School
Not Applicable
71 Participants
66 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=476 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=504 Participants
Participants will be given their results of their antibody test four weeks following the test.
Frequency of Mask Wearing
Always
400 Participants
433 Participants
Frequency of Mask Wearing
Never, Rarely, Sometimes, or Very Often
76 Participants
71 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=477 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=506 Participants
Participants will be given their results of their antibody test four weeks following the test.
Frequency of Physical Distancing
Always or Very Often
427 Participants
452 Participants
Frequency of Physical Distancing
Never, Rarely, or Sometimes
50 Participants
54 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=477 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=507 Participants
Participants will be given their results of their antibody test four weeks following the test.
Frequency of Avoiding People at High-risk for Severe COVID-19 Infections
Always or Very Often
433 Participants
466 Participants
Frequency of Avoiding People at High-risk for Severe COVID-19 Infections
Never, Sometimes, or Rarely
30 Participants
31 Participants
Frequency of Avoiding People at High-risk for Severe COVID-19 Infections
Not Applicable
14 Participants
10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention (Immediate Results)
n=406 Participants
Participants will be given their results of their antibody test immediately (within 24 hours).
Control (Delayed Results)
n=402 Participants
Participants will be given their results of their antibody test four weeks following the test.
Count of Participants With SARS-CoV-2 Seroconversion Over 8 Weeks
Yes
20 Participants
22 Participants
Count of Participants With SARS-CoV-2 Seroconversion Over 8 Weeks
No
386 Participants
380 Participants

Adverse Events

Intervention (Immediate Results)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control (Delayed Results)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Molly Rosenberg, MPH, PhD

Indiana University Bloomington School of Public Health

Phone: (812) 856-2509

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place