COVID-19 Self-Testing Through Rapid Network Distribution

Study Overview
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Brief Summary
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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
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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.

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

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: 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

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


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 others in their social networks. | Behavioral: COVID-19 self-test<br>* 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.<br>|
| Active Comparator: Test referral distribution<br>Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks. | Behavioral: COVID-19 test referral<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Network contact test uptake | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Network contact test uptake, end of study | 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 | Through study completion, up to one year | 
| Number of contacts tested at 8 weeks | Number of unique network contacts who completed a test linked to an index participant by week 8. | 8 weeks | 
| Number of contacts tested | Number of unique network contacts who completed a test linked to an index participant by week 8. | Through study completion, up to one year | 
| Number of positive contacts at 8 weeks | Number of network contacts who test positive | 8 weeks | 
| Number of positive contacts | Number of network contacts who test positive | Through study completion, up to one year | 
| Test positivity rate per index participant | Proportion of Index Participant's network contacts who tested positive | 8 weeks | 
| Proportion of first-time test takers | Proportion of Index Participant's network contacts who self-report their test as their first COVID-19 test. | Through study completion, up to one year |