Clinical trial NCT05212883: You and Me COVID Free
Official title: Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Rapid test
COVID-19
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-01-28
Enrollment: 2778
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children \>12 years of age living within pre-identified communities participating in the public health intervention

Brief summary: Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities.

Detailed description: This observational, cohort sub-study is embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities through the CCPH. Within this sub-study, the investigators will evaluate the socio-behavioral mechanisms of SARS-CoV-2 community transmission, including social interactions, health behaviors, healthcare utilization, knowledge, disease burden, and feasibility of at-home testing. The central hypothesis is that focused community intervention will reduce COVID-19 transmission. The secondary hypothesis is that this intervention will increase vaccine uptake. Surveys and questionnaires will be completed by participants via a QR code from the test kits that directs participants to a link. Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.

Eligibility criteria: Inclusion Criteria:

* Self- reported primary residence within the pre-identified communities
* Age \>12 years at enrollment
* Provision of signed and dated informed consent form

Exclusion Criteria:

-None if above are met

Primary outcomes:
measure: Main Reason for Testing for COVID-19
timeFrame: Baseline
measure: Number of Positive COVID-19 Test Results
timeFrame: Baseline
measure: Number of Participants Who Responded That They Have Received a COVID Vaccine
timeFrame: Baseline
Secondary outcomes:
measure: Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place
timeFrame: Baseline
measure: Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime
timeFrame: Baseline
measure: Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community
timeFrame: Baseline
measure: Number of Participants Who Report COVID Symptoms During Previous Week
timeFrame: Baseline
measure: Likelihood of Future COVID-19 Vaccination
timeFrame: Baseline
measure: Reasons for Not Getting a COVID-19 Vaccine
timeFrame: Baseline
measure: Reasons for Getting a COVID-19 Vaccine
timeFrame: Baseline
measure: Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications
timeFrame: Baseline
measure: Method Used to Test for COVID-19
timeFrame: Baseline
Other outcomes:
Locations:
city: Merced
country: United States
facility: Merced County
state: California
Study officials:
affiliation: Duke University
name: Christoph Hornik, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: