COVID-19 Close Contact Self-Testing Study (CloseST)

University of Pennsylvania

Status: Completed

Conditions: Covid19

Treatments: Behavioral: COVID-19 test referral; Behavioral: COVID-19 self-test

Study type: Interventional

Funder types: Other

Identifiers

NCT04847479

3R01HL151292-01S1

3R01HL151292-01S1-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3 participants in 2 patient groups

Self-Test kit distribution

Experimental group

Description:

Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.

Treatment:

Behavioral: COVID-19 self-test

Test referral distribution

Active Comparator group

Description:

Participants in the test referral arm receive text messages providing testing information to send to their close contacts.

Treatment:

Behavioral: COVID-19 test referral