Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing (SYCT)

November 11, 2022 updated by: Duke University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

338

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27705
        • Greenville Pitt County
    • Tennessee
      • Chattanooga, Tennessee, United States, 37341
        • Hamilton County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults and children > 8 years of age living within pre-identified communities participating in the public health intervention

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People who use the self administered SARs-CoV-2 antigen testing kits
Behavioral: Behavioral questionaires
Behavioral surveys and questionaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection
Time Frame: 4 months
4 months
Number of Participants With Positive SARs-CoV-2 Antigen Test Results
Time Frame: 4 months
4 months
Number of Healthcare Utilization Measures
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: christoph Hornik, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2021

Primary Completion (Actual)

November 23, 2021

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00108149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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