TY  - JOUR
AU  - Burns, Joy
AU  - Rivers, Patrick
AU  - LeClair, Lindsay B
AU  - Jovel, Krystal S
AU  - Rai, Ramona P
AU  - Lowe, Ashley A
AU  - Edwards, Laura J
AU  - Khan, Sana M
AU  - Mathenge, Clare
AU  - Ferraris, Maria
AU  - Kuntz, Jennifer L
AU  - Lamberte, Julie Mayo
AU  - Hegmann, Kurt T
AU  - Odean, Marilyn J
AU  - McLeland-Wieser, Hilary
AU  - Beitel, Shawn
AU  - Odame-Bamfo, Leah
AU  - Schaefer Solle, Natasha
AU  - Mak, Josephine
AU  - Phillips, Andrew L
AU  - Sokol, Brian E
AU  - Hollister, James
AU  - Ochoa, Jezahel S
AU  - Grant, Lauren
AU  - Thiese, Matthew S
AU  - Jacoby, Keya B
AU  - Lutrick, Karen
AU  - Pubillones, Felipe A
AU  - Yoo, Young M
AU  - Rentz Hunt, Danielle
AU  - Ellingson, Katherine
AU  - Berry, Mark C
AU  - Gerald, Joe K
AU  - Lopez, Joanna
AU  - Gerald, Lynn B
AU  - Wesley, Meredith G
AU  - Krupp, Karl
AU  - Herring, Meghan K
AU  - Madhivanan, Purnima
AU  - Caban-Martinez, Alberto J
AU  - Tyner, Harmony L
AU  - Meece, Jennifer K
AU  - Yoon, Sarang K
AU  - Fowlkes, Ashley L
AU  - Naleway, Allison L
AU  - Gwynn, Lisa
AU  - Burgess, Jefferey L
AU  - Thompson, Mark G
AU  - Olsho, Lauren EW
AU  - Gaglani, Manjusha
PY  - 2022
DA  - 2022/7/28
TI  - Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study
JO  - JMIR Res Protoc
SP  - e37929
VL  - 11
IS  - 7
KW  - COVID-19
KW  - SARS-CoV-2
KW  - vaccine effectiveness
KW  - vaccine
KW  - efficacy
KW  - effectiveness
KW  - cohort study
KW  - pediatric
KW  - child
KW  - inoculation
KW  - vaccination
KW  - public health
KW  - children
KW  - health care professional
KW  - health care
KW  - caregiver
KW  - health data
KW  - online survey
KW  - incidence
AB  - Background: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2. Objective: This report describes the objectives and methods for conducting the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study. PROTECT is a longitudinal prospective pediatric cohort study designed to estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) against infection among children aged 6 months to 17 years, as well as differences in SARS-CoV-2 infection and vaccine response between children and adolescents. Methods: The PROTECT multisite network was initiated in July 2021, which aims to enroll approximately 2305 children across four US locations and collect data over a 2-year surveillance period. The enrollment target was based on prospective power calculations and accounts for expected attrition and nonresponse. Study sites recruit parents and legal guardians of age-eligible children participating in the existing Arizona Healthcare, Emergency Response, and Other Essential Workers Surveillance (HEROES)-Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) network as well as from surrounding communities. Child demographics, medical history, COVID-19 exposure, vaccination history, and parents/legal guardians’ knowledge and attitudes about COVID-19 are collected at baseline and throughout the study. Mid-turbinate nasal specimens are self-collected or collected by parents/legal guardians weekly, regardless of symptoms, for SARS-CoV-2 and influenza testing via reverse transcription-polymerase chain reaction (RT-PCR) assay, and the presence of COVID-like illness (CLI) is reported. Children who test positive for SARS-CoV-2 or influenza, or report CLI are monitored weekly by online surveys to report exposure and medical utilization until no longer ill. Children, with permission of their parents/legal guardians, may elect to contribute blood at enrollment, following SARS-CoV-2 infection, following COVID-19 vaccination, and at the end of the study period. PROTECT uses electronic medical record (EMR) linkages where available, and verifies COVID-19 and influenza vaccinations through EMR or state vaccine registries. Results: Data collection began in July 2021 and is expected to continue through the spring of 2023. As of April 13, 2022, 2371 children are enrolled in PROTECT. Enrollment is ongoing at all study sites. Conclusions: As COVID-19 vaccine products are authorized for use in pediatric populations, PROTECT study data will provide real-world estimates of VE in preventing infection. In addition, this prospective cohort provides a unique opportunity to further understand SARS-CoV-2 incidence, clinical course, and key knowledge gaps that may inform public health. International Registered Report Identifier (IRRID): RR1-10.2196/37929 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2022/7/e37929
UR  - https://doi.org/10.2196/37929
UR  - http://www.ncbi.nlm.nih.gov/pubmed/35635842
DO  - 10.2196/37929
ID  - info:doi/10.2196/37929
ER  -