Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Self-Test kit distribution
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
    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.
Active Comparator
Test referral distribution
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
    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.

Recruiting Locations

More Details

NCT ID
NCT04797858
Status
Completed
Sponsor
University of Pennsylvania

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.