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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04949243
Collaborator
(none)
256
2
7.7
128
16.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral questionaires

Study Design

Study Type:
Observational
Actual Enrollment :
256 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
Actual Study Start Date :
Apr 4, 2021
Actual Primary Completion Date :
Nov 23, 2021
Actual Study Completion Date :
Nov 23, 2021

Arms and Interventions

Arm Intervention/Treatment
People who use the self administered SARs-CoV-2 antigen testing kits

Behavioral: Behavioral questionaires
Behavioral surveys and questionaires

Outcome Measures

Primary Outcome Measures

  1. Number of participants that report adhering to social distancing guidelines after a test [4 months]

Secondary Outcome Measures

  1. Number of participants that act on precautionary behaviors after test result [4 months]

  2. Number of participants who are knowledgeable of precautionary measures to prevent infection [4 months]

  3. Number of positive test results [4 months]

  4. Number of healthcare utilization measures [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Greenville Pitt County Greenville North Carolina United States 27705
2 Hamilton County Chattanooga Tennessee United States 37341

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: christoph Hornik, MD, Duke University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04949243
Other Study ID Numbers:
  • Pro00108149
First Posted:
Jul 2, 2021
Last Update Posted:
Feb 10, 2022
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 10, 2022