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N/A N=1,076 Randomized Double-blind Screening

Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students

SARS-CoV-2 · Serology · Students

Enrolled (actual)
1,076
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Frequency of Handwashing — 412; 432; 65; 75 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Immediate vs. delayed provision of antibody test results (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Nov 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Frequency of Handwashing
412; 432; 65; 75; 0; 1
PRIMARY
Frequency of Face Touching
280; 303; 196; 204
PRIMARY
Frequency of Hand Sanitizer Use
414; 436; 60; 69; 3; 0
PRIMARY
Frequency of Social Event Avoidance
209; 236; 224; 228; 44; 43
PRIMARY
Frequency of Staying Home From Work/School
152; 185; 254; 255; 71; 66
PRIMARY
Frequency of Mask Wearing
400; 433; 76; 71
PRIMARY
Frequency of Physical Distancing
427; 452; 50; 54
PRIMARY
Frequency of Avoiding People at High-risk for Severe COVID-19 Infections
433; 466; 30; 31; 14; 10
SECONDARY
Count of Participants With SARS-CoV-2 Seroconversion Over 8 Weeks
20; 22; 386; 380

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04620798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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