You and Me COVID Free

COVID-19 Clinical Trial

— YMCF  

Official title:

Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212883
• Other study ID #: Pro00108149_1
• Secondary ID: 3U24MD016258-02S
• Status: Completed
• Start date: November 15, 2021
• Est. completion date: April 19, 2022

Study information

• Verified date: May 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2778
• Est. completion date: April 19, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Behavioral questionaires
Behavioral surveys and questionnaires

Locations

Country	Name	City	State
United States	Merced County	Merced	California

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Positive COVID-19 Test Results		Baseline
Primary	Number of Participants Who Responded That They Have Received a COVID Vaccine		Baseline
Secondary	Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place		Baseline
Secondary	Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime		Baseline
Secondary	Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community		Baseline
Secondary	Number of Participants Who Report COVID Symptoms During Previous Week		Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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