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Observational Study
. 2024 Oct 7;193(10):1329-1338.
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

Patricia C Fulkerson  1 , Stephanie J Lussier  2 , Casper G Bendixsen  3 , Sharon M Castina  2 , Tebeb Gebretsadik  4 , Jessica S Marlin  5 , Patty B Russell  6 , Max A Seibold  7   8   9 , Jamie L Everman  7 , Camille M Moore  7   10   11 , Brittney M Snyder  6 , Kathy Thompson  1 , George S Tregoning  5 , Stephanie Wellford  2 , Samuel J Arbes  2 , Leonard B Bacharier  6 , Agustin Calatroni  2 , Carlos A Camargo Jr  12 , William D Dupont  4 , Glenn T Furuta  13 , Rebecca S Gruchalla  14 , Ruchi S Gupta  15 , Gurjit Khurana Hershey  16 , Daniel J Jackson  17 , Christine C Johnson  18 , Meyer Kattan  19 , Andrew H Liu  20 , Liza Murrison  16 , George T O'Connor  21 , Wanda Phipatanakul  22 , Katherine Rivera-Spoljaric  23 , Marc E Rothenberg  24 , Christine M Seroogy  17 , Stephen J Teach  25 , Edward M Zoratti  18 , Alkis Togias  1 , Tina V Hartert  4   26 , On Behalf Of The Heros Study Team
Affiliations
Observational Study

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. Am J Epidemiol. .

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. Trial registration: ClinicalTrials.gov. Identifier: NCT04375761.

Keywords: COVID-19; public health; remote methods; surveillance.

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Conflict of interest statement

The authors declare no relevant conflicts of interest.

Figures

Figure 1
Figure 1
Human Epidemiology and Response to SARS-CoV-2 study clinical, laboratory, and coordinating sites. The map depicts the clinical, laboratory, and coordinating study sites (the number of participants is indicated below the site location). The chart summarizes the enrolled households, numbers of adults and children, and their age distribution.
Figure 2
Figure 2
Human Epidemiology and Response to SARS-CoV-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
Figure 3
Human Epidemiology and Response to SARS-CoV-2 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

Update of

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