Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students

NCT04620798 | Completed Results DMC

• 1 other identifier: 2008293852
• Study Type: interventional
• Target: 1,076
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2; Serology; Students

Outcome Measures

Primary Outcomes (8)

• Frequency of Handwashing

  This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response": "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?" -Frequently washed my hands with soap and water for at least 20 seconds Response options are: Always, Very Often, Sometimes, Rarely, Never

  2 weeks after the baseline antibody test

• Frequency of Face Touching

  This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. This outcome will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response": "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?" -Avoided touching my eyes, nose and mouth with unwashed hands Response options are: Always, Very Often, Sometimes, Rarely, Never

  2 weeks after the baseline antibody test

• Frequency of Hand Sanitizer Use

  This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. This outcome will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response": "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?" -Used disinfectants or hand sanitizer to clean hands when soap and water were not available Response options are: Always, Very Often, Sometimes, Rarely, Never

  2 weeks after the baseline antibody test

• Frequency of Social Event Avoidance

  This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response": "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?" -Avoided a social event I wanted to attend Response options are: Always, Very Often, Sometimes, Rarely, Never

  2 weeks after the baseline antibody test

• Frequency of Staying Home From Work/School

  This outcome is dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response": "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?" -Stayed at home from work/school Response options are: Always, Very Often, Sometimes, Rarely, Never

  2 weeks after the baseline antibody test

• Frequency of Mask Wearing

  This outcome is dichotomized into Always versus Very Often, Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response": "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?" -Wore a mask in public Response options are: Always, Very Often, Sometimes, Rarely, Never

  2 weeks after the baseline antibody test

• Frequency of Physical Distancing

  This outcome is dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. It will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response": "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?" -Ensured physical distancing in public Response options are: Always, Very Often, Sometimes, Rarely, Never

  2 weeks after the baseline antibody test

• Frequency of Avoiding People at High-risk for Severe COVID-19 Infections

  This outcome was dichotomized into Always and Very Often versus Sometimes, Rarely, and Never. This outcome will be self-reported in a web-based follow-up survey administered at 2 weeks after the baseline antibody test, with an item adapted from the WHO 2020 "Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response": "During the last 7 days, which of the following measures have you taken to prevent infection from COVID-19?" -Avoided contact with people at high-risk for severe COVID-19 infections Response options are: Always, Very Often, Sometimes, Rarely, Never

  2 weeks after the baseline antibody test

Secondary Outcomes (1)

• Count of Participants With SARS-CoV-2 Seroconversion Over 8 Weeks

  Approximately 8 weeks from baseline antibody test.

Study Arms (2)

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.

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.

Interventions

Immediate vs. delayed provision of antibody test results BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Current IU undergraduate student
• Current resident of Monroe County, Indiana

You may not qualify if:

• Younger than 18 years old
• Current residence outside of Monroe County, Indiana

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

Related Publications (2)

• 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.

  PMID: 40983579 DERIVED

• Kianersi 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.

  PMID: 34418958 DERIVED

Limitations and Caveats

As results were disseminated by email, we cannot confirm that everyone in each treatment condition received their results on the expected schedule, or at all. However, operational and survey data we collected indicated that participants received their test results at similar rates in both arms, alleviating concerns of differential intervention uptake.

Results Point of Contact

• Title: Molly Rosenberg, MPH, PhD
• Organization: Indiana University Bloomington School of Public Health

rosenmol@indiana.edu

(812) 856-2509

Study Officials

• Molly Rosenberg, PhD

  Indiana University Department of Epidemiology and Biostatistics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Public Health

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: September 14, 2020
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: January 31, 2022
• Results First Posted: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: These study protocol documents will be made available upon completion of the study and the analyses. A de-identified, limited data set and analytic code will be available from the Principal Investigator upon request.
• Access Criteria: Protocol will be available on clinicaltrials.gov while the other documents, data, and analytic code from the Principal Investigator upon request.

Locations

US (1)