COVID-19 Self-Testing Through Rapid Network Distribution

Not Applicable

Completed

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

• Registration Number: NCT04797858
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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.

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: 2021-03-05
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Study Start: 2021-05-05
• 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: 791

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

• 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

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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 others in their social networks.
Test referral distribution	COVID-19 test referral	Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.

Primary Outcome Measures

Name	Time	Method
Network contact test uptake	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 the number of 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 Outcome Measures

Name	Time	Method
Test positivity rate per index participant	8 weeks	Proportion of Index Participant's network contacts who tested positive
Number of positive contacts	Through study completion, up to one year	Number of network contacts who test positive
Number of contacts tested	Through study completion, up to one year	Number of unique network contacts who completed a test linked to an index participant by week 8.
Proportion of first-time test takers	Through study completion, up to one year	Proportion of Index Participant's network contacts who self-report their test as their first COVID-19 test.
Network contact test uptake, end of study	Through study completion, up to one year	Test uptake among at least two network contacts. This outcome will be measured by the number of unique network contacts who completed a test linked to an index participant by end of study
Number of contacts tested at 8 weeks	8 weeks	Number of unique network contacts who completed a test linked to an index participant by week 8.
Number of positive contacts at 8 weeks	8 weeks	Number of network contacts who test positive

Trial Locations

Locations (1)

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