Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

Duke University338 enrolled

Overview

This observational, cohort sub-studyis embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communitiesthrough the CDC.Within this sub-study, we will evaluate the socio-behavioral mechanisms of SARS-CoV-2 community transmission, including social interactions, health behaviors, healthcare utilization, knowledge, disease burden, and feasibility of at-home testing. The study hypothesis is that positive at-home test results will be associated withaltered self-reported social interactions and altered health behaviors compared to negative test results. Surveys and questionnaires will be completed by participants through the smartphone app or via call center phone calls according to the schedule of events.Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.

Study Type

OBSERVATIONAL

Enrollment

338

Conditions

COVID-19

Interventions

Behavioral questionairesBEHAVIORAL

Eligibility

Sex: ALLMin age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Self-reported primary residence within the pre-identified communities 2. Age\> 8 years at enrollment 3. Provision of signed and dated informed consent form Exclusion Criteria: None if above are met \-

Locations (2)

Greenville Pitt County

Greenville, North Carolina, United States

Hamilton County

Chattanooga, Tennessee, United States

Outcomes

Primary Outcomes

Number of Participants Who Reported Not Following Social Distancing Guidelines

Number of participants who reported at their first follow-up assessment as having close contact (within 6 feet) with people who do not live with them.

Time frame: 2 weeks

Secondary Outcomes

Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure

Number of participants who reported at their first follow-up assessment as having avoided public spaces, gatherings, or crowds as a prevention measure.

Time frame: 2 weeks

Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection

Time frame: 4 months

Number of Participants With Positive SARs-CoV-2 Antigen Test Results

Time frame: 4 months

Number of Healthcare Utilization Measures

Time frame: 4 months