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OpenTrials
Completed

NCT Number: NCT04847479

COVID-19 Close Contact Self-Testing Study

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Management Corporation

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 self-test

Behavioral

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.

COVID-19 test referral

Behavioral

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.

Primary outcomes

  1. Number of Positive Contacts

    Time frame: 8 weeks

    Number of close contacts who test positive for COVID-19

Secondary outcomes

  1. Number of Positive Contacts (End of Study)

    Time frame: Through study completion, up to one year

    Number of close contacts who test positive for COVID-19 by the end of the study

  2. Number of Contacts Tested

    Time frame: 8 weeks

    Number of close contacts who completed a test

  3. Number of Contacts Tested (End of Study)

    Time frame: Through study completion, up to one year

    Number of close contacts who completed a test by the end of the study

  4. Number of Household Contacts Tested

    Time frame: 8 weeks

    Number of household contacts who completed a test

  5. Number of Household Contacts Tested (End of Study)

    Time frame: Through study completion, up to one year

    Number of household contacts who completed a test by the end of the study

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Public Health Management Corporation

Registry information

Official study title

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

Acronym: CloseST

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2021
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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