You and Me Healthy

COVID-19 Clinical Trial

— YMH  

Official title:

You and Me Healthy Registry Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05589376
• Other study ID #: Pro00110716
• Status: Enrolling by invitation
• Start date: September 8, 2022
• Est. completion date: September 8, 2024

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20000
• Est. completion date: September 8, 2024
• Est. primary completion date: September 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
United States	Hamilton County	Chattanooga	Tennessee
United States	Greenville Pitt County	Greenville	North Carolina
United States	Merced County	Merced	California

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants enrolled in the Virtual Community	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.	Through study completion; 5 years
Primary	Number of participants included in the Dataset	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.	Through study completion; 5 years