You and Me COVID Free

NCT ID: NCT05212883

Last Updated: 2023-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2778 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-04-19

Brief Summary

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Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities.

Detailed Description

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This observational, cohort sub-study is embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities through the CCPH. Within this sub-study, the investigators 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 central hypothesis is that focused community intervention will reduce COVID-19 transmission. The secondary hypothesis is that this intervention will increase vaccine uptake. Surveys and questionnaires will be completed by participants via a QR code from the test kits that directs participants to a link. 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

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Behavioral questionaires

Behavioral surveys and questionnaires

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self- reported primary residence within the pre-identified communities
* Age \>12 years at enrollment
* Provision of signed and dated informed consent form

Exclusion Criteria

-None if above are met
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Hornik, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Merced County

Merced, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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3U24MD016258-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00108149_1

Identifier Type: -

Identifier Source: org_study_id

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