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Investigating transmission of SARS-CoV-2 using novel face mask sampling: a protocol for an observational prospective study of index cases and their contacts in a congregate setting
  1. Thomas Jaenisch1,2,
  2. Molly M Lamb1,
  3. Emily N Gallichotte3,
  4. Brian Adams4,
  5. Charles Henry5,
  6. Jeannine Riess6,
  7. Joni Triantis van Sickle6,
  8. Kellie L Hawkins7,
  9. Brian T Montague8,
  10. Cody Coburn8,
  11. Leisha Conners Bauer9,
  12. Jennifer Kovarik9,
  13. Mark T Hernandez10,
  14. Amy Bronson11,
  15. Lucy Graham12,
  16. Stephanie James13,
  17. Stephanie Hanenberg14,
  18. James Kovacs15,
  19. John S Spencer3,
  20. Mark Zabel3,
  21. Philip D Fox3,
  22. Olivia Pluss4,
  23. William Windsor4,
  24. Geoffrey Winstanley4,
  25. Daniel Olson4,
  26. Michael Barer16,
  27. Stephen Berman4,
  28. Gregory Ebel3,
  29. May Chu4
  1. 1Center for Global Health and Department of Epidemiology, Colorado School of Public Health, Aurora, Colorado, USA
  2. 2Heidelberg Institute of Global Health, University Hospital Heidelberg, Heidelberg, Germany
  3. 3Department of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, Colorado, USA
  4. 4Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA
  5. 5Department of Chemical and Biological Engineering, Colorado State University, Fort Collins, Colorado, USA
  6. 6Office of Environmental Health Services, Colorado State University, Fort Collins, Colorado, USA
  7. 7Public Health Institute, Denver Health, Denver, Colorado, USA
  8. 8Occupational Health and Division of Infectious Diseases, University of Colorado School of Medicine, Denver, Colorado, USA
  9. 9Health Promotion and Collegiate Recovery Center, University of Colorado Boulder, Boulder, Colorado, USA
  10. 10Civil, Environmental and Architectural Engineering, University of Colorado Boulder, Boulder, Colorado, USA
  11. 11Office of the Vice President, Colorado Mesa University, Grand Junction, Colorado, USA
  12. 12Department of Health Sciences, Colorado Mesa University, Grand Junction, Colorado, USA
  13. 13Department of Pharmaceutical Sciences, Regis University, Denver, Colorado, USA
  14. 14Wellness Center, University of Colorado Colorado Springs, Colorado Springs, Colorado, USA
  15. 15Department of Chemistry and Biology, University of Colorado Colorado Springs, Colorado Springs, Colorado, USA
  16. 16Department of Infectious Diseases, University of Leicester, Leicester, Leicestershire, UK
  1. Correspondence to Dr Thomas Jaenisch; thomas.jaenisch{at}cuanschutz.edu

Abstract

Introduction This study aims to measure how transmission of SARS-CoV-2 occurs in communities and to identify conditions that lend to increased transmission focusing on congregate situations. We will measure SARS-CoV-2 in exhaled breath of asymptomatic and symptomatic persons using face mask sampling—a non-invasive method for SARS-CoV-2 detection in exhaled air. We aim to detect transmission clusters and identify risk factors for SARS-CoV-2 transmission in presymptomatic, asymptomatic and symptomatic individuals.

Methods and analysis In this observational prospective study with daily follow-up, index cases and their respective contacts are identified at each participating institution. Contact definitions are based on Centers for Disease Control and Prevention and local health department guidelines. Participants will wear masks with polyvinyl alcohol test strips adhered to the inside for 2 hours daily. The strips are applied to all masks used over at least 7 days. In addition, self-administered nasal swabs and (optional) finger prick blood samples are performed by participants. Samples are tested by standard PCR protocols and by novel antigen tests.

Ethics and dissemination This study was approved by the Colorado Multiple Institutional Review Board and the WHO Ethics Review Committee. From the data generated, we will analyse transmission clusters and risk factors for transmission of SARS-CoV-2 in congregate settings. The kinetics of asymptomatic transmission and the evaluation of non-invasive tools for detection of transmissibility are of crucial importance for the development of more targeted control interventions—and ultimately to assist with keeping congregate settings open that are essential for our social fabric.

Trial registration number ClinicalTrials.gov (#NCT05145803).

  • COVID-19
  • Diagnostic microbiology
  • Virology
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors TJ, MML and MC conceptualised the study. MC acquired funding. MB developed the face mask sampling method. MML and WW developed the data base, curate the data and developed the data analysis approach. MC, GE, EG, CH, MH, JSS, MZ, JKovacs and PF carry out lab investigations and developed the laboratory testing methodology. SB, TJ, GW, BA, KLH, JTvS, JR, BM, CC, LCB, JKovarik, AB, LG, SJ, SH, OP, WW and DO developed the participant recruitment strategy and conduct the recruitment. TJ and MC wrote the first draft. All authors contributed to the writing of the manuscript and approved the final version.

  • Funding The authors acknowledge that funds for the project were provided by WHO based on a grant from the German Federal Ministry of Health (BMG). In addition, the study was supported in part by Colorado State University’s Office of the Vice President for Research’s Accelerating Innovations in Pandemic Disease initiative through support from The Anschutz Foundation (to JSS).

  • Competing interests TJ, MML, WW, BA, GE and MC report grant support from WHO for this study for salaries or equipment/reagents. SB, OP, AB, CH, JR, JKovacs and MZ report grant/salary support for unrelated research without conflict of interest. EG, MH, CC, DO, SH, JKovarik, LCB, JTvS, SJ, JSS and LG report no conflict of interest. MZ reports speaker honoraria at academic institutions. BM reports industry support from Regeneron and Eli Lilly Foundation (as investigator, to the institution), MB reports support from the UK National Core Study on Transmission, and PF reports stock in Darwin Biosciences and support (equipment and reagents) from Ceres Nanosciences.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods and analysis section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.