Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

NCT ID: NCT04949243

Last Updated: 2023-09-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-04

Study Completion Date

2021-11-23

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Behavioral questionaires

Intervention Type BEHAVIORAL

Behavioral surveys and questionaires

Interventions

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Behavioral questionaires

Behavioral surveys and questionaires

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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christoph Hornik, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Greenville Pitt County

Greenville, North Carolina, United States

Site Status

Hamilton County

Chattanooga, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00108149

Identifier Type: -

Identifier Source: org_study_id

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