COVID-19 Close Contact Self-Testing Study

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Behavioral: COVID-19 self-test; Behavioral: COVID-19 test referral

• Registration Number: NCT04847479
• Lead Sponsor: University of Pennsylvania

Brief Summary

Widespread testing and contact tracing are critical to controlling the COVID-19 epidemic. Distribution of COVID-19 self-test kits can augment public health contact tracing efforts, as individuals with COVID-19 can distribute self-testing to close contacts. This approach can increase case detection by facilitating testing among exposed individuals, and potentially ameliorate stigma, fear, and medical mistrust associated with COVID-19 among vulnerable populations.

The central hypothesis of this study is that distribution of SARS-CoV-2 self-tests to close contacts of among individuals with COVID-19 infection can increase case detection compared with a standard contact referral strategy.

Detailed Description

Strategies to increase testing among individuals exposed to COVID-19 are needed. One approach to increase testing and case detection is to distribute home test kits to close contacts of individuals with COVID-19. This approach decreases logistic barriers to testing, potential exposures to COVID-19, and reduces potential stigma and fear associated with facility-based COVID-19 testing.

The investigators will conduct a cohort study of individuals diagnosed with COVID-19 in the C-STRAND trial (NCT04797858), in order to determine if distribution of self-test kits to close contacts of of individuals with COVID-19 can increase case detection compared with a standard contact referral strategy among. Individuals diagnosed with COVID-19 who were randomized to the self-test (intervention) arm or received self-test kits will be assigned to receive additional self-test kits to distribute to close contacts. Individuals diagnosed with COVID-19 who were randomized to the test referral (control) arm or received test referrals will be assigned to receive text message referrals to give their close contacts to seek testing if needed. COVID-19 case detection and test uptake will be measured in both arms.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Study Start: 2021-05-06
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• 18 years of age or older
• Has a working telephone number
• Willing and able to provide informed consent

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Exclusion Criteria

• Severe symptoms requiring immediate medical attention
• Younger than 18 years of age
• Does not have a working telephone number
• Unable or unwilling to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Test kit distribution	COVID-19 self-test	Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
Test referral distribution	COVID-19 test referral	Participants in the test referral arm receive text messages providing testing information to send to their close contacts.

Primary Outcome Measures

Name	Time	Method
Number of positive contacts	8 weeks	Number of close contacts who test positive for COVID-19

Secondary Outcome Measures

Name	Time	Method
Number of contacts tested	8 weeks	Number of close contacts who completed a test
Number of household contacts tested	8 weeks	Number of household contacts who completed a test
Number of contacts tested (end of study)	Through study completion, up to one year	Number of close contacts who completed a test by the end of the study
Number of positive contacts (end of study)	Through study completion, up to one year	Number of close contacts who test positive for COVID-19 by the end of the study
Number of household contacts tested (end of study)	Through study completion, up to one year	Number of household contacts who completed a test by the end of the study

Trial Locations

Locations (1)

Public Health Management Corporation; 🇺🇸 Philadelphia, Pennsylvania, United States