SARS-CoV-2NCT04620798
Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
A study testing Immediate vs. delayed provision of antibody test results in people with SARS-CoV-2 and Serology, run by Indiana University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, Serology, Students
- What is being tested?
- Immediate vs. delayed provision of antibody test results
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,076 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 11 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Current IU undergraduate student
- Current resident of Monroe County, Indiana
Who cannot join
- Younger than 18 years old
- Current residence outside of Monroe County, Indiana
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- SARS-CoV-2, Serology, Students
- Being tested
- Immediate vs. delayed provision of antibody test results
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate vs. delayed provision of antibody test resultsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be given their results of their antibody test immediately (within 24 hours) and will be followed and surveyed to see if having this knowledge changes their engagement with SARS-CoV-2 prevention behaviors. Receives: Behavioral: Immediate vs. delayed provision of antibody test results |
| Control (Delayed) | No intervention | Participants will be given their results of their antibody test after 4 weeks. Their engagement with SARS-CoV-2 prevention behaviors will also be assessed following testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks after the baseline antibody test
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
Measured: 2 weeks after the baseline antibody test
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
Measured: 2 weeks after the baseline antibody test
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
Measured: 2 weeks after the baseline antibody test
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
Measured: 2 weeks after the baseline antibody test
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
Measured: 2 weeks after the baseline antibody test
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
Measured: 2 weeks after the baseline antibody test
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
Measured: 2 weeks after the baseline antibody test
Secondary outcomes (1)
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.
Measured: Approximately 8 weeks from baseline antibody test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start14 Sep 2020
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly Rosenberg, Indiana University
- Investigators
- Molly Rosenberg, PhD, Principal investigator, Indiana University Department of Epidemiology and Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620798
- Sponsor's protocol ID
- 2008293852
- Status last verified
- Jan 2022
- First submitted
- 4 Nov 2020
- Last updated
- 31 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will make the following documents available to the public upon completion of the study: (1) Study Protocol, (2) Statistical Analysis Plan (SAP), (3) Informed Consent Form (ICF), and (4) Clinical Study Report (CSR). The individual participant data as well as the analytic code will not be made available to the public due to privacy concerns and in order to protect participants' private health information but will be available from the Principal Investigator upon request.
Publications
Chen C, Rosenberg M, Li M, Macy JT, Ludema C. Patterns and persistence of SARS-CoV-2 seropositivity among college students at Indiana University-Bloomington. BMJ Open. 2025 Sep 22;15(9):e091418. doi: 10.1136/bmjopen-2024-091418.
PubMed 40983579Kianersi S, Luetke M, Ludema C, Valenzuela A, Rosenberg M. Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example. BMC Med Res Methodol. 2021 Aug 21;21(1):175. doi: 10.1186/s12874-021-01362-2.
PubMed 34418958
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
- ClinicalTrials.gov ID
- NCT04620798
- Acronym / sponsor ID
- 2008293852
- Conditions
- SARS-CoV-2, Serology, Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,076 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 31 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Immediate vs. delayed provision of antibody test resultsParticipants will be given their results of their antibody test immediately (within 24 hours) and will be followed and surveyed to see if having this knowledge changes their engagement with SARS-CoV-2 prevention behaviors. |
| Control (Delayed) | No intervention | –Participants will be given their results of their antibody test after 4 weeks. Their engagement with SARS-CoV-2 prevention behaviors will also be assessed following testing. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Current IU undergraduate student
- Current resident of Monroe County, Indiana
Key exclusion criteria (2 listed)
- Younger than 18 years old
- Current residence outside of Monroe County, Indiana
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate vs. delayed provision of antibody test resultsThe 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). | Behavioural | Intervention |
Primary outcome
Frequency of Handwashing
Time frame: 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
Frequency of Face Touching
Time frame: 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
Frequency of Hand Sanitizer Use
Time frame: 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
Frequency of Social Event Avoidance
Time frame: 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
Frequency of Staying Home From Work/School
Time frame: 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
Frequency of Mask Wearing
Time frame: 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
Frequency of Physical Distancing
Time frame: 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
Frequency of Avoiding People at High-risk for Severe COVID-19 Infections
Time frame: 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
1 secondary outcome
Count of Participants With SARS-CoV-2 Seroconversion Over 8 Weeks
Time frame: Approximately 8 weeks from baseline antibody test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40983579Chen C, Rosenberg M, Li M, Macy JT, Ludema C. Patterns and persistence of SARS-CoV-2 seropositivity among college students at Indiana University-Bloomington. BMJ Open. 2025 Sep 22;15(9):e091418. doi: 10.1136/bmjopen-2024-091418.
- Derived from this study: PubMed 34418958Kianersi S, Luetke M, Ludema C, Valenzuela A, Rosenberg M. Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example. BMC Med Res Methodol. 2021 Aug 21;21(1):175. doi: 10.1186/s12874-021-01362-2.
- Individual participant dataSharing planned: Yes. The study team will make the following documents available to the public upon completion of the study: (1) Study Protocol, (2) Statistical Analysis Plan (SAP), (3) Informed Consent Form (ICF), and (4) Clinical Study Report (CSR). The individual participant data as well as the analytic code will not be made available to the public due to privacy concerns and in order to protect participants' private health information but will be available from the Principal Investigator upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Molly Rosenberg, PhD principal investigator
Indiana University Department of Epidemiology and Biostatistics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate vs. delayed provision of antibody test results in people with SARS-CoV-2 and Serology, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Handwashing (time frame: 2 weeks after the baseline antibody test). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.