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
COMPLETED
NA
1076 participants
2 weeks after the baseline antibody test
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
| 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
| 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
| 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 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
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 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
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 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
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 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
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 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
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 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
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 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
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 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
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
| 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)
Control (Delayed Results)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place