Clinical trial NCT05589376: You and Me Healthy
Official title: You and Me Healthy Registry Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COVID-19
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 20000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The You and Me Healthy Registry will include children and adults currently living across the United States.

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.

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

Primary outcomes:
measure: Number of participants enrolled in the Virtual Community
timeFrame: Through study completion; 5 years
measure: Number of participants included in the Dataset
timeFrame: Through study completion; 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Merced
country: United States
facility: Merced County
state: California
city: Greenville
country: United States
facility: Greenville Pitt County
state: North Carolina
city: Chattanooga
country: United States
facility: Hamilton County
state: Tennessee
Study officials:
affiliation: Duke University
name: Christoph Hornik
role: PRINCIPAL_INVESTIGATOR
References: