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

behalf of the HEROS Study Team

doi:10.1093/aje/kwae077

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

behalf of the HEROS Study Team

Pediatrics

Research output: Contribution to journal › Article › peer-review

Abstract

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) Study is a prospective, multicity, 6-month incidence study conducted from May 2020 to 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 National Institutes of Health–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 5598 individuals, including 1913 principal participants (children), 1913 primary caregivers, 729 secondary caregivers, and 1043 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.

Original language	English (US)
Pages (from-to)	1329-1338
Number of pages	10
Journal	American journal of epidemiology
Volume	193
Issue number	10
DOIs	https://doi.org/10.1093/aje/kwae077
State	Published - Oct 1 2024

Funding

Study methods and findings were presented at the 2022 International Conference of the American Thoracic Society, San Francisco, California, May 13-18, 2022. A preprint version of this article was posted in medRxiv on July 9, 2022 (https://doi.org/10.1101/2022.07.09.22277457). We thank our colleagues who provided drafts of their developing Dutch COVID questionnaires for review and selection; the All of Us Data and Research Center\u2019s Pilot Research team at Vanderbilt University Medical Center for their assistance in selecting survey items for inclusion, including Brandy Mapes and Rebecca L. Johnston; Dr. Barron Patterson, our medical monitor; and our clinical sites, including investigators and staff, laboratory sites, coordination sites, and external scientific advisory group (see Appendix S3 for the full list). HEROS study activities were funded through the following: Boston Children\u2019s Hospital (grants 1UL1TR001430, 5UM1AI114271, U01 AI 110397, R01 HL 137192, K24 AI 106822, U10 HL109172), Children\u2019s Hospital Colorado (grants 3U54AI117804-06S1, 3U54AI117804-07S1, 5UM1AI114271), Children\u2019s National Health System (grant 5UM1AI114271), Cincinnati Children\u2019s Hospital Medical Center (grants 3UM1AI114271-06S1, 3UM1AI114271-07S1, 3U19AI070235-14S1, 3U54AI117804-06S1, 3U54AI117804-07S1, 5UM1AI114271), Columbia University Medical Center (grants 3UM1AI114271-06S1, 5UM1AI114271), Henry Ford Health System (grants AI024156, AI051598, UG3OD023282, UM1AI114271, 3PO1AI089473-07S1, AI089473, AI050681, AI089473), Lurie Children\u2019s Hospital (3R01AI 130348-04S1), Mass General Hospital (grant R01AI127507), National Jewish Health (grants 3UM1AI151958-02S1, 3UM1AI1519 58-01S1), Rho (grant 1UM2AI117870), St. Louis Children\u2019s Hospital (grants 3UM1AI14271-07S1, UM1 AI11427), University of Wisconsin\u2013Madison (grants U19 AI104317, PO1HL70381, UH3 OD023282), UT Southwestern Medical Center (grans 5UM1AI114271), and Vanderbilt University (grants U19 AI 095227-S2, U19 AI 095227-S1, UL1 TR002243). HEROS study activities were funded through the following: Boston Children's Hospital (grants 1UL1TR001430, 5UM1AI114271, U01 AI 110397, R01 HL 137192, K24 AI 106822, U10 HL109172), Children's Hospital Colorado (grants 3U54AI117804-06S1, 3U54AI117804-07S1, 5UM1AI114271), Children's National Health System (grant 5UM1AI114271), Cincinnati Children's Hospital Medical Center (grants 3UM1AI114271-06S1, 3UM1AI114271-07S1, 3U19AI070235-14S1, 3U54AI117804-06S1, 3U54AI117804-07S1, 5UM1AI114271), Columbia University Medical Center (grants 3UM1AI114271-06S1, 5UM1AI114271), Henry Ford Health System (grants AI024156, AI051598, UG3OD023282, UM1AI114271, 3PO1AI089473-07S1, AI089473, AI050681, AI089473), Lurie Children's Hospital (3R01AI130348-04S1), Mass General Hospital (grant R01AI127507), National Jewish Health (grants 3UM1AI151958-02S1, 3UM1AI151958-01S1), Rho (grant 1UM2AI117870), St. Louis Children's Hospital (grants 3UM1AI14271-07S1, UM1 AI11427), University of Wisconsin\u2013Madison (grants U19 AI104317, PO1HL70381, UH3 OD023282), UT Southwestern Medical Center (grans 5UM1AI114271), and Vanderbilt University (grants U19 AI 095227-S2, U19 AI 095227- S1, UL1 TR002243).

Keywords

COVID-19
public health
remote methods
surveillance

ASJC Scopus subject areas

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/aje/kwae077

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title = "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",

abstract = "The Human Epidemiology and Response to SARS-CoV-2 (HEROS) Study is a prospective, multicity, 6-month incidence study conducted from May 2020 to 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 National Institutes of Health–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 5598 individuals, including 1913 principal participants (children), 1913 primary caregivers, 729 secondary caregivers, and 1043 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.",

keywords = "COVID-19, public health, remote methods, surveillance",

author = "{behalf of the HEROS Study Team} and Fulkerson, {Patricia C.} and Lussier, {Stephanie J.} and Bendixsen, {Casper G.} and Castina, {Sharon M.} and Tebeb Gebretsadik and Marlin, {Jessica S.} and Russell, {Patty B.} and Seibold, {Max A.} and Everman, {Jamie L.} and Moore, {Camille M.} and Snyder, {Brittney M.} and Kathy Thompson and Tregoning, {George S.} and Stephanie Wellford and Arbes, {Samuel J.} and Bacharier, {Leonard B.} and Agustin Calatroni and Camargo, {Carlos A.} and Dupont, {William D.} and Furuta, {Glenn T.} and Gruchalla, {Rebecca S.} and Gupta, {Ruchi S.} and Hershey, {Gurjit Khurana} and Jackson, {Daniel J.} and Johnson, {Christine C.} and Meyer Kattan and Liu, {Andrew H.} and Liza Murrison and O{\textquoteright}Connor, {George T.} and Wanda Phipatanakul and Katherine Rivera-Spoljaric and Rothenberg, {Marc E.} and Seroogy, {Christine M.} and Teach, {Stephen J.} and Zoratti, {Edward M.} and Alkis Togias and Hartert, {Tina V.}",

year = "2024",

month = oct,

day = "1",

doi = "10.1093/aje/kwae077",

language = "English (US)",

volume = "193",

pages = "1329--1338",

journal = "American journal of epidemiology",

issn = "0002-9262",

publisher = "Oxford University Press",

number = "10",

}

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. / behalf of the HEROS Study Team.
In: American journal of epidemiology, Vol. 193, No. 10, 01.10.2024, p. 1329-1338.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Human Epidemiology and Response to SARS-CoV-2 (HEROS)

T2 - objectives, design, and enrollment results of a 12-city remote observational surveillance study of households with children, using direct-to-participant methods

AU - behalf of the HEROS Study Team

AU - Fulkerson, Patricia C.

AU - Lussier, Stephanie J.

AU - Bendixsen, Casper G.

AU - Castina, Sharon M.

AU - Gebretsadik, Tebeb

AU - Marlin, Jessica S.

AU - Russell, Patty B.

AU - Seibold, Max A.

AU - Everman, Jamie L.

AU - Moore, Camille M.

AU - Snyder, Brittney M.

AU - Thompson, Kathy

AU - Tregoning, George S.

AU - Wellford, Stephanie

AU - Arbes, Samuel J.

AU - Bacharier, Leonard B.

AU - Calatroni, Agustin

AU - Camargo, Carlos A.

AU - Dupont, William D.

AU - Furuta, Glenn T.

AU - Gruchalla, Rebecca S.

AU - Gupta, Ruchi S.

AU - Hershey, Gurjit Khurana

AU - Jackson, Daniel J.

AU - Johnson, Christine C.

AU - Kattan, Meyer

AU - Liu, Andrew H.

AU - Murrison, Liza

AU - O’Connor, George T.

AU - Phipatanakul, Wanda

AU - Rivera-Spoljaric, Katherine

AU - Rothenberg, Marc E.

AU - Seroogy, Christine M.

AU - Teach, Stephen J.

AU - Zoratti, Edward M.

AU - Togias, Alkis

AU - Hartert, Tina V.

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KW - COVID-19

KW - public health

KW - remote methods

KW - surveillance

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UR - http://www.scopus.com/inward/citedby.url?scp=85206018270&partnerID=8YFLogxK

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M3 - Article

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AN - SCOPUS:85206018270

SN - 0002-9262

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SP - 1329

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JO - American journal of epidemiology

JF - American journal of epidemiology

IS - 10

ER -

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

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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