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).
- Diagnostic microbiology
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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.