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OpenTrials
Completed

NCT Number: NCT04949243

Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Greenville Pitt County, Greenville, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-reported primary residence within the pre-identified communities
  • Age> 8 years at enrollment
  • Provision of signed and dated informed consent form

Exclusion criteria

None if above are met

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Treatment and study plan

Behavioral questionaires

Behavioral

Behavioral surveys and questionaires

Primary outcomes

  1. Number of Participants Who Reported Not Following Social Distancing Guidelines

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 4 months

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

    Time frame: 4 months

  4. Number of Healthcare Utilization Measures

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: SYCT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2021
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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