Background
Methods/design
Partnerships
Institution | Role |
---|---|
NIH | Study funder; provided test kits, approved protocol, and implementation plans, led SYCT launch, and coordinated study activities among stakeholders |
CDC | Assisted with protocol development and selection of SYCT communities, engaged local and state health departments |
RADx-UP Coordination and Data Collection Center (Duke Clinical Research Institute and the UNC Center for Health Equity Research) | Led design of SYCT intervention and ecological analysis, consulted on public health intervention protocol development, implementation of community-based distribution; created, designed, and implemented marketing campaign for public health intervention; consulted on design and implementation of community engagement plan; tracked kit distribution from local distribution partners; performed data integration and analysis, and manuscript preparation; responsible for all elements of SYCT substudy design, survey development, data management and analysis, and reporting |
NCCU | Assisted with design and implementation of community engagement strategy and identification of local distribution partners |
CCPH | Led design and implementation of community engagement plan for SYCT; led engagement and relationship building efforts with local distribution partners |
University of Massachusetts | Data management partner for the SYCT substudy |
Pitt County (NC) Health Department | Coordinated test distribution and local distribution partner engagement for SYCT in Pitt County, NC |
Chattanooga (TN) Health Department | Coordinated test distribution and local distribution partner engagement for SYCT in Chattanooga, TN |
Quidel | Manufactured at-home tests; applied for and received emergency use authorization from FDA |
CareEvo | Designed the study mobile application; coordinated online ordering portal and distribution of kits via Amazon |
Amazon | Distributed test kits requested through an online ordering system |
DataRobot | Conducted simulations during planning for the public health intervention to guide community selection |
Noble Laboratory (UNC) | Processed and tested wastewater samples from North Carolina |
Biobot Analytics, Inc. | Processed and tested wastewater samples from Tennessee |
Study design
Setting and population
Study sites
SYCT intervention and ecological analysis
Study population
SARS-CoV-2 test
Test distribution
Community engagement strategy
Communications and micromarketing campaign
Testing protocol
Participant support
Statistical considerations and data analysis
Outcome Measures | Endpoints | Data source | Unit of observation | Frequency of data collection | Maximum geographic granularity |
---|---|---|---|---|---|
Primary | |||||
SARS-CoV-2 test results | Community prevalence point estimate and 95% confidence interval; community incidence rate | Local health departments | County | Daily | County |
Secondary | |||||
SARS-CoV-2 viral copies per liter | Community transmission | Wastewater | Wastewater treatment plant sewer shed | Twice weekly | Wastewater treatment plant sewer shed |
Number of new hospitalizations for COVID-19 disease per day | Hospitalizations | Local health departments | County | Daily | Center |
Hospital census | Hospital capacity/Health care utilization | Local health departments | County | Daily | County/ Healthcare center |
GPS location and length of stay; requests for driving directions; requests for walking directions | Mobility | Mobile phones (Google and Apple Maps) | County | Daily | City |
SARS-CoV-2-positive patients admitted to the ICU | Number of ICU admissions | Local health department | Individual | Daily | Health care Center |
Behavioral substudy
Study population
Study questionnaires
Questionnaire distribution
Statistical considerations and data analysis
Outcome Measures | Endpoint |
---|---|
Primary | |
Self-reported data on social distancing, quarantine, social connectedness, healthcare utilization, well-being | The proportion of respondents who report adhering to social distancing guidelines after a test result for the entire study cohort and stratified by participant demographics (e.g., gender) of interest; comparison of proportion adherent after positive vs. negative test result |
Secondary | |
Self-reported data on awareness of the issue, engagement, decisions to act, action, and maintenance | The proportion of respondents who decide to act on precautionary behaviors after a test result for the entire study cohort and stratified by participant demographics (e.g., gender) of interest |
Self-reported emergency department visits, hospitalizations, and intensive care unit admission, for SARS CoV-2 evaluation or treatment | Point estimate and 95% confidence interval for each healthcare utilization measure and composite measure for the entire study cohort and stratified by participant demographics (e.g., gender) of interest |
Self-reported data on perceptions and prevention of risks of contracting SARS CoV-2 infection | The proportion of respondents who are knowledgeable of precautionary measures to prevent infection for the entire study cohort and stratified by participant demographics (e.g., gender) of interest |
Reported results of self-administered SARS CoV-2 antigen test | Prevalence of positive test results with 95% confidence intervals for the entire study cohort and stratified by participant demographic variables of interest |
Exploratory | |
Self-reported data on acceptability, practicality, integration, penetration, and demand of at-home self-administered antigen test | The proportion of respondents who find at-home self-administered antigen test acceptable for the entire study cohort and stratified by participant demographics (e.g., gender) of interest |
Mobility patterns as captured by surrogates, including activity trackers | Distribution of individual mobility data in response to positive vs. negative SARS CoV-2 test results |
Self-reported data on perceived susceptibility, severity, benefits, barriers, and cues to action related to SARS CoV-2 vaccination | Distribution of respondent’s perception about SARS CoV-2 vaccination for the entire study cohort and stratified by participant demographics (e.g., gender) of interest |