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Completed

NCT Number: NCT04797858

COVID-19 Self-Testing Through Rapid Network Distribution

COVID-19, the coronavirus disease caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has led to a global pandemic and has exacerbated existing health inequities among vulnerable populations. Despite higher rates of COVID-19 in Black and Latinx individuals compared to White individuals, rates of testing in predominately non-White, low-income communities are significantly lower than in high-income areas. Self-testing, where individuals collect their own samples, is now feasible for the detection of SARS-CoV-2. One promising approach to increase test uptake is the secondary distribution of self-testing kits, where an individual distributes tests to contacts in their social network and encourages them to self-test.

The central hypothesis of this clinical trial is that the secondary distribution of SARS-CoV-2 self-tests can significantly expand test uptake among underserved populations. To test this hypothesis, the investigators will conduct a 1:1 randomized controlled trial that will assess a self-testing intervention that promotes the secondary distribution of SARS-CoV-2 test kits compared with test referrals, with a focus on reaching underserved populations.

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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 rapidly disseminate COVID-19 testing are urgently needed, particularly to address increasing health disparities among underserved communities. One promising approach to increase test uptake is the secondary distribution of self-tests, where an individual distributes test kits to contacts in their social network and encourages them to self-test. By decentralizing testing, this approach does not require individuals to have contact with medical systems, and can lower potential barriers to obtaining testing. 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 because the testing process is decentralized.

The investigators will conduct a 1:1 randomized controlled trial randomizing individuals to receive either multiple self-test kits to distribute within their social circles, or referrals for standard clinic-based tests. All study participants will be offered testing upon enrollment. Study participants, deemed "Index Participants," will be randomized to receive multiple self-testing kits (intervention) or test referral cards and text messages (control) to encourage individuals in their social networks, deemed "network contacts" to test. Participants will complete a baseline evaluation and a follow-up evaluation at 8 weeks. We will measure network contact test uptake in both study arms. The central hypothesis of this trial is that distribution of self-test kits will increase test uptake compared with distribution of test referrals.

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

  • Younger than 18 years of age
  • Does not have a working telephone number
  • Prior COVID-19 infection in the past 90 days
  • Previously received a COVID-19 test as part of this COVID-19 research study
  • Unable or unwilling to provide informed consent

Treatment and study plan

COVID-19 self-test

Behavioral

5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.

COVID-19 test referral

Behavioral

5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.

Primary outcomes

  1. Network Contact Test Uptake

    Time frame: 8 weeks

    The primary outcome is the proportion of study participants who distributed tests/referrals to least two network contacts who completed testing. This outcome will be measured by number of participants with at least 2 unique network contacts who completed a test linked to a study participant by week 8. The investigators will test for differences in the primary outcome between the two study arms.

Secondary outcomes

  1. Network Contact Test Uptake, End of Study

    Time frame: Through study completion, up to 30 months.

    Test uptake among at least two network contacts. This outcome will be measured by the number of participants with at least two unique network contacts who completed a test linked to an index participant by end of study.

  2. Number of Contacts Tested at 8 Weeks

    Time frame: 8 weeks

    Number of unique network contacts who completed a test linked to an index participant by week 8. Participants analyzed reflects the number of network contacts only who completed a test.

  3. Number of Contacts Tested

    Time frame: Through study completion, up to 30 months

    Number of unique network contacts who completed a test linked to an index participant by end of study.

  4. Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks

    Time frame: 8 weeks

    Number of participants with at least one network contact who tested positive for COVID-19 within 8 weeks of enrollment.

  5. Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study

    Time frame: Through study completion, up to 30 months

    Number of participants with at least one network contact who tested positive for COVID-19 by the end of study

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Public Health Management Corporation

Registry information

Official study title

Secondary Distribution of COVID-19 Self-tests vs. Referrals to Increase Test Uptake in Underserved Populations

Acronym: C-STRAND

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2021
Registry last updated
May 11, 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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