Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

COVID-19 Clinical Trial

— SYCT  

Official title:

Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949243
• Other study ID #: Pro00108149
• Status: Completed
• Start date: April 4, 2021
• Est. completion date: November 23, 2021

Study information

• Verified date: November 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

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Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Behavioral questionaires
Behavioral surveys and questionaires

Locations

Country	Name	City	State
United States	Hamilton County	Chattanooga	Tennessee
United States	Greenville Pitt County	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection		4 months
Secondary	Number of Participants With Positive SARs-CoV-2 Antigen Test Results		4 months
Secondary	Number of Healthcare Utilization Measures		4 months