dbGaP Study Accession: phs002800

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/q8pd-9n90

Updated Date: 04/17/2024

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.

Principal Investigator: Foxe, John J

Has Data Files: Yes

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

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

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

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Psychological; Immunological; Clinical; Questionnaires/Surveys

Study Start Date: 05/11/2021

Study End Date: 03/31/2023

Species: Human Data

Estimated Cohort Size: 450

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

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

Publication URL: 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/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/PMC9647777/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647778/; 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/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394504/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647775/

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