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[Preprint]. 2022 Jul 10:2022.07.09.22277457.

doi: 10.1101/2022.07.09.22277457.

Human Epidemiology and RespOnse to SARS-CoV-2 (HEROS): Objectives, Design and Enrollment Results of a 12-City Remote Observational Surveillance Study of Households with Children using Direct-to-Participant Methods

Patricia C Fulkerson¹, Stephanie J Lussier², Casper G Bendixsen³, Sharon M Castina², Tebeb Gebretsadik⁴, Jessica S Marlin⁵, Patty B Russell⁶, Max A Seibold^{7

8

9}, Jamie L Everman⁷, Camille M Moore^{7

10

11}, Brittney M Snyder⁶, Kathy Thompson¹, George S Tregoning⁵, Stephanie Wellford², Samuel J Arbes², Leonard B Bacharier⁶, Agustin Calatroni², Carlos A Camargo Jr¹², William D Dupont⁴, Glenn T Furuta¹³, Rebecca S Gruchalla¹⁴, Ruchi S Gupta¹⁵, Gurjit Khurana Hershey¹⁶, Daniel J Jackson¹⁷, Christine C Johnson¹⁸, Meyer Kattan¹⁹, Andrew H Liu²⁰, Liza Murrison¹⁶, George T O'Connor²¹, Wanda Phipatanakul²², Katherine Rivera-Spoljaric²³, Marc E Rothenberg²⁴, Christine M Seroogy¹⁷, Stephen J Teach²⁵, Edward M Zoratti¹⁸, Alkis Togias¹, Tina V Hartert^{4

26}

Affiliations

¹ National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
² Rho, Inc., Chapel Hill, NC, USA.
³ Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, WI, USA.
⁴ Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
⁵ Vanderbilt Coordinating Center, Vanderbilt University Medical Center, Nashville, TN, USA.
⁶ Department of Medicine, Center for Asthma Research, Vanderbilt University Medical Center, Nashville, TN, USA.
⁷ Center for Genes, Environment, and Health, National Jewish Health, Denver, CO, USA.
⁸ Department of Pediatrics, National Jewish Health, Denver, CO, USA.
⁹ Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine; Aurora, CO, USA.
¹⁰ Department of Biomedical Research, National Jewish Health; Denver, CO, USA.
¹¹ Department of Biostatistics and Informatics, University of Colorado; Denver, CO, USA.
¹² Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
¹³ Digestive Health Institute, Children's Hospital Colorado and Section of Pediatric Gastroenterology, Hepatology and Nutrition, Gastrointestinal Eosinophilic Diseases Program, University of Colorado School of Medicine, Aurora, CO, USA.
¹⁴ University of Texas Southwestern Medical Center, Dallas, TX, USA.
¹⁵ Ann & Robert H. Lurie Hospital of Chicago & Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
¹⁶ Division of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
¹⁷ University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
¹⁸ Henry Ford Health System, Detroit, MI, USA.
¹⁹ Columbia University Medical Center, New York, NY, USA.
²⁰ Breathing Institute, Children's Hospital Colorado and Section of Pediatric Pulmonary & Sleep Medicine, University of Colorado School of Medicine, Aurora CO, USA.
²¹ Pulmonary Center, Boston University School of Medicine, Boston, MA, USA.
²² Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
²³ Washington University School of Medicine, St. Louis, MO, USA.
²⁴ Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
²⁵ Children's National Hospital, Washington, DC, USA.
²⁶ Center for Asthma Research, Vanderbilt University Medical Center, Nashville, TN, USA.

PMID: 35860216
PMCID: PMC9298141
DOI: 10.1101/2022.07.09.22277457

Human Epidemiology and RespOnse to SARS-CoV-2 (HEROS): Objectives, Design and Enrollment Results of a 12-City Remote Observational Surveillance Study of Households with Children using Direct-to-Participant Methods

Patricia C Fulkerson et al. medRxiv. 2022.

[Preprint]. 2022 Jul 10:2022.07.09.22277457.

doi: 10.1101/2022.07.09.22277457.

Authors

Affiliations

¹ National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
² Rho, Inc., Chapel Hill, NC, USA.
³ Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, WI, USA.
⁴ Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
⁵ Vanderbilt Coordinating Center, Vanderbilt University Medical Center, Nashville, TN, USA.
⁶ Department of Medicine, Center for Asthma Research, Vanderbilt University Medical Center, Nashville, TN, USA.
⁷ Center for Genes, Environment, and Health, National Jewish Health, Denver, CO, USA.
⁸ Department of Pediatrics, National Jewish Health, Denver, CO, USA.
⁹ Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine; Aurora, CO, USA.
¹⁰ Department of Biomedical Research, National Jewish Health; Denver, CO, USA.
¹¹ Department of Biostatistics and Informatics, University of Colorado; Denver, CO, USA.
¹² Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
¹³ Digestive Health Institute, Children's Hospital Colorado and Section of Pediatric Gastroenterology, Hepatology and Nutrition, Gastrointestinal Eosinophilic Diseases Program, University of Colorado School of Medicine, Aurora, CO, USA.
¹⁴ University of Texas Southwestern Medical Center, Dallas, TX, USA.
¹⁵ Ann & Robert H. Lurie Hospital of Chicago & Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
¹⁶ Division of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
¹⁷ University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
¹⁸ Henry Ford Health System, Detroit, MI, USA.
¹⁹ Columbia University Medical Center, New York, NY, USA.
²⁰ Breathing Institute, Children's Hospital Colorado and Section of Pediatric Pulmonary & Sleep Medicine, University of Colorado School of Medicine, Aurora CO, USA.
²¹ Pulmonary Center, Boston University School of Medicine, Boston, MA, USA.
²² Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
²³ Washington University School of Medicine, St. Louis, MO, USA.
²⁴ Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
²⁵ Children's National Hospital, Washington, DC, USA.
²⁶ Center for Asthma Research, Vanderbilt University Medical Center, Nashville, TN, USA.

PMID: 35860216
PMCID: PMC9298141
DOI: 10.1101/2022.07.09.22277457

Update in

Human Epidemiology and Response to SARS-CoV-2 (HEROS): objectives, design, and enrollment results of a 12-city remote observational surveillance study of households with children, using direct-to-participant methods.
Fulkerson PC, Lussier SJ, Bendixsen CG, Castina SM, Gebretsadik T, Marlin JS, Russell PB, Seibold MA, Everman JL, Moore CM, Snyder BM, Thompson K, Tregoning GS, Wellford S, Arbes SJ, Bacharier LB, Calatroni A, Camargo CA Jr, Dupont WD, Furuta GT, Gruchalla RS, Gupta RS, Hershey GK, Jackson DJ, Johnson CC, Kattan M, Liu AH, Murrison L, O'Connor GT, Phipatanakul W, Rivera-Spoljaric K, Rothenberg ME, Seroogy CM, Teach SJ, Zoratti EM, Togias A, Hartert TV, Heros Study Team OBOT. Fulkerson PC, et al. Am J Epidemiol. 2024 Oct 7;193(10):1329-1338. doi: 10.1093/aje/kwae077. Am J Epidemiol. 2024. PMID: 38775275 Free PMC article.

Abstract

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) is a prospective multi-city 6-month incidence study which was conducted from May 2020-February 2021. The objectives were to identify risk factors for SARS-CoV-2 infection and household transmission among children and people with asthma and allergic diseases, and to use the host nasal transcriptome sampled longitudinally to understand infection risk and sequelae at the molecular level. To overcome challenges of clinical study implementation due to the coronavirus pandemic, this surveillance study used direct-to-participant methods to remotely enroll and prospectively follow eligible children who are participants in other NIH-funded pediatric research studies and their household members. Households participated in weekly surveys and biweekly nasal sampling regardless of symptoms. The aim of this report is to widely share the methods and study instruments and to describe the rationale, design, execution, logistics and characteristics of a large, observational, household-based, remote cohort study of SARS-CoV-2 infection and transmission in households with children. The study enrolled a total of 5,598 individuals, including 1,913 principal participants (children), 1,913 primary caregivers, 729 secondary caregivers and 1,043 other household children. This study was successfully implemented without necessitating any in-person research visits and provides an approach for rapid execution of clinical research.

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Conflict of interest statement

Conflict of interest statement The authors declare no relevant conflicts of interest.

Figures

**Figure 1.. HEROS clinical, laboratory and coordinating sites.**
The left panel depicts the clinical, laboratory and coordinating study sites. The right panel summarizes the enrolled households, numbers of adults and children, and their age distribution.

**Figure 2.. HEROS study survey and sample collection timetable and study enrollment of households, adults and children.**
The schematic of the HEROS study design depicts the timeline of events with enrollment data and biospecimen collection, weekly surveys, biweekly nasal swabs, and additional illness visits triggered by an automated algorithm based on clinical symptom survey responses.

**Figure 3.**
HEROS study flow diagram of parent cohort participants, and household and individual participant enrollment through 6-month study completion.

See this image and copyright information in PMC

References

1. Madewell ZJ, Yang Y, Longini IM Jr., et al. Factors Associated With Household Transmission of SARS-CoV-2: An Updated Systematic Review and Meta-analysis. JAMA Netw Open 2021;4(8):e2122240. - PMC - PubMed
1. Gao YD, Ding M, Dong X, et al. Risk factors for severe and critically ill COVID-19 patients: A review. Allergy 2021;76(2):428–55. - PubMed
1. 2020 Census Operational Plan. A New Design for the 21st Century. 2015. https://www2.census.gov/programs-surveys/decennial/2020/program-manageme.... U.S. Census Bureau, U.S. Department of Commerce.
1. Seibold MA, Moore CM, Everman JL et al. Risk factors for SARS-CoV-2 infection and transmission in households with children with asthma and allergy: A prospective surveillance study. J Allergy Clin Immunol 2022; S0091–6749(22)00752–7. - PMC - PubMed
1. Yount SE, Cella D, Blozis S. PROMIS(R): Standardizing the patient voice in health psychology research and practice. Health Psychol 2019;38(5):343–6. - PubMed

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This is a preprint.

Human Epidemiology and RespOnse to SARS-CoV-2 (HEROS): Objectives, Design and Enrollment Results of a 12-City Remote Observational Surveillance Study of Households with Children using Direct-to-Participant Methods

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Human Epidemiology and RespOnse to SARS-CoV-2 (HEROS): Objectives, Design and Enrollment Results of a 12-City Remote Observational Surveillance Study of Households with Children using Direct-to-Participant Methods

Authors

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Update in

Abstract

Conflict of interest statement

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