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OpenTrials
Completed

NCT Number: NCT05212883

You and Me COVID Free

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

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Merced County

Merced, California, 95340, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral questionaires

Behavioral

Behavioral surveys and questionnaires

Primary outcomes

  1. Main Reason for Testing for COVID-19

    Time frame: Baseline

    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"

  2. Number of Positive COVID-19 Test Results

    Time frame: Baseline

  3. Number of Participants Who Responded That They Have Received a COVID Vaccine

    Time frame: Baseline

Secondary outcomes

  1. Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place

    Time frame: Baseline

  2. Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime

    Time frame: Baseline

  3. Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community

    Time frame: Baseline

  4. Number of Participants Who Report COVID Symptoms During Previous Week

    Time frame: Baseline

  5. Likelihood of Future COVID-19 Vaccination

    Time frame: Baseline

    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".

  6. Reasons for Not Getting a COVID-19 Vaccine

    Time frame: Baseline

    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".

  7. Reasons for Getting a COVID-19 Vaccine

    Time frame: Baseline

    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".

  8. Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications

    Time frame: Baseline

    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.

  9. Method Used to Test for COVID-19

    Time frame: Baseline

    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".

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

Acronym: YMCF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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