dbGaP Study Accession: phs002800

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

DOI: 10.60773/q8pd-9n90

Release Date: 08/30/2023

Study Description: Project Goals: 1) Virological Testing: This study aimed to establish a nasal-swab FDA-approved testing regimen to monitor and identify disease outbreaks in a specialized school setting serving 450 children with moderate-to-severe IDD and the 500 staff supporting them, a setting at ultra-high risk for COVID-19 disease transmission. This study rapidly identified infections and developed approaches for isolating and contact-tracing to stem virus spread. 2) Serological Testing: Serology established background immunity levels in students and staff, from infection or vaccination, and followed those who are antibody-positive longitudinally to quantify temporal decay of IgG and neutralizing antibody levels. This study examined whether protective immunity in children with IDD, a population with prevalent immunological dysfunction, wanes at an accelerated rate compared to the population-at-large; by doing so this study addressed an important knowledge gap, and provided key data to inform public health policy. 3) Modeling to Optimize Testing: This study used network models and agent based simulation models (or hybrid approaches) to guide testing strategies and interventions at MCC. Simulations were conducted interactively and iteratively, to assist in planning and implementation of testing procedures, exploring the dynamic interplay between school operations and personnel interactions, potential infection risks and disease dynamics (including variant strains), and implementation of control measures (e.g. quarantine, isolation, contact-tracing and vaccination rates). 4) Mobile Unit Testing: This study built on a successful mobile approach to delivering mobile dental care to the IDD students of MCC (the SMILEmobile), by staffing, equipping and deploying a customized, disability-enabled, mobile testing unit, which was used to directly deliver rapid flexible testing to MCC. 5) Overcoming Testing & Vaccine Anxiety/Hesitancy: The study conducted focus group interviews at MCC to identify key community concerns, myths and misconceptions about vaccination, and then built on success in reducing vaccine hesitancy among URMC staff, to create a multimodal educational campaign that addressed these concerns. Strategies included a speakers' bureau, group discussions, and "table talk" conversations, combined with innovative visual approaches that communicated complex information in a readily accessible manner (via graphic medicine) and that promoted vaccine uptake (via narrative portraits of trusted peers and coworkers who have chosen to be vaccinated). Finally, this study assessed the impact of this program by deploying a validated, electronic patient reported outcome scale (PROMIS-29) already in widespread use across the UR health system and at Rochesters East High School, to collect longitudinal data from staff, parents/guardians and children (by proxy reporting) across multiple health domains (including anxiety, depression, sleep disturbance, and social functioning). This scalable approach revealed the full impact of the interventions and approaches undertaken, and is readily compatible with extension to other sites in the RADx network.

Updated Date: 04/17/2024

Principal Investigator: Foxe, John J

Has Data Files: Yes

Study Domain: COVID in School Settings; Diagnostic Testing; Mobile Unit Testing; Pandemic Perceptions or Decision-Making; Serological or Antibody Testing; Testing Rate or Uptake; Vaccination Rate or Uptake; Virological Testing

Data Collection Method: Antibody or Adaptive Immune Response Testing; Interview or Focus Group; Molecular Nucleic Acid or PCR Testing Device; Survey

Keywords: COVID Education; Children with Intellectual or Developmental Disabilities; Families/Legal Guardians of School-aged Children/Young Adults; Individual-Level Data; School Staff/Stakeholders; School-aged Children/Young Adults; Vaccine Hesitancies

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Clinical; Immunological; Psychological; Questionnaire or Survey

Study Start Date: 05/11/2021

Study End Date: 03/31/2023

Species: Human

Sample Size: 392

Study Population Focus: Adults; Children; Intellectual or Developmental Disabilities; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Racial or Ethnic Minorities; School Communities; Underserved or Vulnerable Populations

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04887129

Publication URL: https://pubmed.ncbi.nlm.nih.gov/34737170/; https://pubmed.ncbi.nlm.nih.gov/34737171/; https://pubmed.ncbi.nlm.nih.gov/34737172/; https://pubmed.ncbi.nlm.nih.gov/34737173/; https://pubmed.ncbi.nlm.nih.gov/34737175/; https://pubmed.ncbi.nlm.nih.gov/34737176/; https://pubmed.ncbi.nlm.nih.gov/34737177/; https://pubmed.ncbi.nlm.nih.gov/34737178/; https://pubmed.ncbi.nlm.nih.gov/34737179/; https://pubmed.ncbi.nlm.nih.gov/34737180/; https://pubmed.ncbi.nlm.nih.gov/34737181/; https://pubmed.ncbi.nlm.nih.gov/35260896/; https://pubmed.ncbi.nlm.nih.gov/37394501/; https://pubmed.ncbi.nlm.nih.gov/37394501/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394504/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8926067/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647737/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647738/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647774/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647775/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647777/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647778/

Acknowledgement Statement: This study was supported through funding, 3OT2HD107553-01S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. Approved users should acknowledge the provision of data access by dbGaP for accession phs002800.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

NIH Grant or Contract Number(s): 3OT2HD107553-01S1

Consent/Data Use Limitations: General Research Use