Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

NCT04949243 | Completed Results

• 1 other identifier: Pro00108149
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  2 weeks

• Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection

  4 months

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

  4 months

• Number of Healthcare Utilization Measures

  4 months

Study Arms (1)

People who use the self administered SARs-CoV-2 antigen testing kits

Behavioral: Behavioral questionaires

Interventions

Behavioral questionaires BEHAVIORAL

Behavioral surveys and questionaires

People who use the self administered SARs-CoV-2 antigen testing kits

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Greenville Pitt County

Greenville, North Carolina, 27705, United States

Location

Hamilton County

Chattanooga, Tennessee, 37341, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Saira Siddiqui, MPH
• Organization: Duke University

saira.siddiqui@duke.edu

919-688-8464

Study Officials

• christoph Hornik, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 2, 2021
• Study Start: April 4, 2021
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: September 22, 2023
• Results First Posted: September 22, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)