You and Me COVID Free (YMCF)

Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: Behavioral questionaires

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.

• Study Type: Observational
• Enrollment (Actual): 2778

Contacts and Locations

Study Locations

• United States
  • California
    • Merced, California, United States, 95340
      • Merced County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Reason for Testing for COVID-19	Those that used a test from a kit were asked to provide the reason why they were doing a test. The possible answers are: "I wanted to be sure I/my child did not have COVID-19 before being around others", "I/my child had COVID-19 like symptoms", "I/my child was in close contact with someone who might have COVID-19", "I/my child was in close contact with someone who tested positive for COVID-19", "Someone in my household might have COVID-19", "Someone in my household tested positive for COVID-19", "Other"	Baseline
Number of Positive COVID-19 Test Results		Baseline
Number of Participants Who Responded That They Have Received a COVID Vaccine		Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place		Baseline
Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime		Baseline
Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community		Baseline
Number of Participants Who Report COVID Symptoms During Previous Week		Baseline
Likelihood of Future COVID-19 Vaccination	Number of participants with front door survey entries indicating various levels of the likelihood the responder will get vaccinated in the future. Available options: "Very likely", "Somewhat likely", "Not very likely", "Not at all likely", and "Prefer not to answer".	Baseline
Reasons for Not Getting a COVID-19 Vaccine	Number of participants indicating various reasons for why they have not received a COVID-19 vaccine on the baseline survey. Available options: "I'm allergic to vaccines", "I don't like needles", "I'm not concerned about getting really sick from COVID-19", "I'm concerned about side effects from the vaccines", "I don't think vaccines work very well", "I don't trust that the vaccines will be safe", "I don't believe the COVID-19 pandemic is as bad as some people say it is", "I don't want to pay for it", and "I don't know enough about how well a COVID-19 vaccine works".	Baseline
Reasons for Getting a COVID-19 Vaccine	Number of participants indicating various reasons for why they have received a COVID-19 vaccine on the baseline survey. Available options: "I want to keep my family safe", "I want to keep my community safe", "I want to keep myself safe", "I have a chronic health problem, like asthma or diabetes", "My doctor told me to get a COVID-19 vaccine", "I don't want to get really sick from COVID-19", "I want to feel safe around other people", "I believe life won't go back to normal until most people get a COVID-19 vaccine", "Required by my school or workplace", and "Required for travel".	Baseline
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications	Number of front door survey entries indicating various ways in which participants would find it easy to get free COVID-19 oral medications. Available options: "An urgent care center". "A doctor's or other health professional's office", "A mobile health unit", "A drug store / pharmacy", "A grocery store", "A community center", "A place of worship", "A community park", "A neighborhood school", or "other". More than one answer can be selected by an individual participant.	Baseline
Method Used to Test for COVID-19	Number of participants indicating the method used to test for COVID-19 on the baseline survey. Available options: "Nasal swab", "Throat swab", "Blood sample", and "Saliva".	Baseline

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Christoph Hornik, MD, PhD, MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): March 8, 2022
• Study Completion (Actual): April 19, 2022

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Rapid test
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00108149_1; 3U24MD016258-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No