N/A
Completed N=338
Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
Source: ClinicalTrials.gov NCT04949243 ↗Enrolled (actual)
338
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Number of Participants Who Reported Not Following Social Distancing Guidelines — 164 Participants
Summary
This observational, cohort sub-studyis embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communitiesthrough the CDC.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. The study hypothesis is that positive at-home test results will be associated withaltered self-reported social interactions and altered health behaviors compared to negative test results. Surveys and questionnaires will be completed by participants through the smartphone app or via call center phone calls according to the schedule of events.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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Reported Not Following Social Distancing Guidelines |
164 | — |
| SECONDARY Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure |
84 | — |
| SECONDARY Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection |
— | — |
| SECONDARY Number of Participants With Positive SARs-CoV-2 Antigen Test Results |
7 | — |
| SECONDARY Number of Healthcare Utilization Measures |
— | — |
Eligibility Criteria
Inclusion Criteria
- Self-reported primary residence within the pre-identified communities
- Age> 8 years at enrollment
- Provision of signed and dated informed consent form
Exclusion Criteria: None if above are met
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Data sourced from ClinicalTrials.gov (NCT04949243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.