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YMCF: You and Me Covid Free

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT05212883
Collaborator
National Institutes of Health (NIH) (NIH), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
1,275
Enrollment
2
Locations
5.1
Actual Duration (Months)
637.5
Patients Per Site
125.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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, we 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. Our central hypothesis is that focused community intervention will reduce COVID-19 transmission. Our 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 Design

Study Type:
Observational
Actual Enrollment :
1275 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
Actual Study Start Date :
Nov 15, 2021
Actual Primary Completion Date :
Mar 8, 2022
Actual Study Completion Date :
Apr 19, 2022

Outcome Measures

Primary Outcome Measures

  1. Number of participants who test after obtaining kits [Baseline]

Secondary Outcome Measures

  1. Number of participants who act on precautionary behaviors after test result [Baseline]

  2. Number of participants who are knowledgeable of precautionary measures to prevent infection [Baseline]

  3. Number of positive test results [Baseline]

  4. Number of healthcare utilization measures [Baseline]

  5. Number of participants who report adhering to social distancing guidelines after a test [Baseline]

  6. Number of participants who report vaccination status [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Greenville Pitt County Greenville North Carolina United States 27705
2 Hamilton County Chattanooga Tennessee United States 37341

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Christoph Hornik, Duke University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05212883
Other Study ID Numbers:
  • Pro00108149_1
  • 3U24MD016258-02S1
First Posted:
Jan 28, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
Rapid test
Covid-19
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jun 10, 2022