- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05589376
You and Me Healthy (YMH)
You and Me Healthy Registry Study
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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California
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Merced, California, United States, 95340
- Merced County
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North Carolina
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Greenville, North Carolina, United States, 27705
- Greenville Pitt County
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Tennessee
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Chattanooga, Tennessee, United States, 37341
- Hamilton County
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants enrolled in the Virtual Community
Time Frame: Through study completion; 5 years
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Create a virtual community of people in the United States interested in engaging in upcoming research studies, including those related to COVID-19; By asking them to sign -up and join the registry- they provide their email address and through that they will receive information on upcoming research and information on health issues occurring in their community.
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Through study completion; 5 years
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Number of participants included in the Dataset
Time Frame: Through study completion; 5 years
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Create a dataset of health-related measurements, risk factors, and outcomes for future; analysis and in support of upcoming research studies; through collecting survey responses via questioners.
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Through study completion; 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christoph Hornik, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00110716
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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