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Enrolling by invitation NCT05589376

You and Me Healthy

Observational COVID-19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: COVID-19. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

You and Me Healthy Registry Study

Overview

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

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.

Primary outcome measures

  • Number of participants enrolled in the Virtual Community [Time frame: Through study completion; 5 years]
  • Number of participants included in the Dataset [Time frame: Through study completion; 5 years]

Eligibility criteria

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

Exclusion criteria

There are no specific exclusion criteria for this registry

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Merced County — Merced
  • Greenville Pitt County — Greenville
  • Hamilton County — Chattanooga

Publications

  • 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. PMID 40481451

Identifiers

NCT: NCT05589376 · Pro00110716

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗