You and Me Healthy

NCT ID: NCT05589376

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-08

Study Completion Date

2027-12-31

Brief Summary

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The You and Me Healthy Registry provides a resource for collecting information on people currently living in the United States. The overall goal of the Registry is to create and engage a community of people who may be eligible for participation in future research studies aiming to answer research questions about COVID-19 and other conditions.

Detailed Description

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus responsible for the COVID-19 pandemic. In the United States (US) up until January 2022, \> 60 million people have been infected with the SARS-CoV-2 virus and \>800,000 died, with infections and deaths disproportionally affecting populations that have been historically marginalized1. Wide disparities also persist by race/ethnicity and age with COVID-19 testing and vaccine uptake related to social and structural factors, resulting in adverse health consequences.

As public health measures have scaled up, mitigation strategies are increasingly being considered to reduce community spread of infection. These measures include rapid-result at-home tests, protective measures (masking, social distancing, increased hygiene), treatments, and contact-tracing and isolation. As the pandemic evolves, new discoveries, technologies, and strategies to combat COVID-19 are being implemented with limited backing of research data. To address this continued unmet public health need, the You and Me Healthy registry is being created to engage community members and serve as a way to provide and collect information from all people who are interested in engaging in upcoming research studies, including those related to COVID-19.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Currently residing in the United States
* Age ≥ 2 (for minors, parents/legal guardian will be the primary point of contact)
* Able to speak and read in the language used in the surveys/assessments available
Minimum Eligible Age

2 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

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Merced County

Merced, California, United States

Site Status

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

References

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D'Agostino EM, Granados I, Abbott-Grimes P, Brown-Lowery C, Damman A, Fadika T, Ward M, Cooper M, Sato J, Kasper J, Vizcaino T, Gray W, Swart A, Sparling A, Corchado CG, Hornik CP. Community partnership lessons learned from the You & Me: Test and Treat study. BMC Public Health. 2025 Jun 6;25(1):2115. doi: 10.1186/s12889-025-23216-y.

Reference Type DERIVED
PMID: 40481451 (View on PubMed)

Other Identifiers

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Pro00110716

Identifier Type: -

Identifier Source: org_study_id

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