COVID-19 Close Contact Self-Testing Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Close Contact Self-Testing Among Contacts of Individuals With COVID-19 Infection

Conditions
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Covid19

Intervention / Treatment
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* Behavioral: COVID-19 self-test
* Behavioral: COVID-19 test referral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Has a working telephone number Willing and able to provide informed consent 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Test kit distribution<br>Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts. | Behavioral: COVID-19 self-test<br>* Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.<br>|
| Active Comparator: Test referral distribution<br>Participants in the test referral arm receive text messages providing testing information to send to their close contacts. | Behavioral: COVID-19 test referral<br>* Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive contacts | Number of close contacts who test positive for COVID-19 | 8 weeks | 

Secondary Outcome Measures

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