You and Me Healthy

• Conditions: COVID-19

• Registration Number: NCT05589376
• Lead Sponsor: Duke University

Brief Summary

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.

Study Timeline

• Study Start: 2022-09-08
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants included in the Dataset	Through study completion; 5 years	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.
Number of participants enrolled in the Virtual Community	Through study completion; 5 years	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.

Trial Locations

Locations (3)

Greenville Pitt County; 🇺🇸 Greenville, North Carolina, United States

Hamilton County; 🇺🇸 Chattanooga, Tennessee, United States

Merced County; 🇺🇸 Merced, California, United States