Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

Completed

• Conditions: COVID-19

• Registration Number: NCT04949243
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-04
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-07-02
• Primary Completion: 2021-11-23
• Study Completion: 2021-11-23
• Status Verified: 2022-11
• Results First Submitted: 2022-11-11
• Results First Submitted QC: 2022-11-11
• Last Update Submitted: 2022-11-11
• Results First Posted: 2023-09-22
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Not Following Social Distancing Guidelines	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection	4 months
Number of Healthcare Utilization Measures	4 months
Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure	2 weeks	Number of participants who reported at their first follow-up assessment as having avoided public spaces, gatherings, or crowds as a prevention measure.
Number of Participants With Positive SARs-CoV-2 Antigen Test Results	4 months

Trial Locations

Locations (2)

Greenville Pitt County; 🇺🇸 Greenville, North Carolina, United States

Hamilton County; 🇺🇸 Chattanooga, Tennessee, United States