COVID-19 Self-Testing Through Rapid Network Distribution

NCT04797858 | Completed Results DMC

• 1 other identifier: 3R01HL151292-01S1
• Study Type: interventional
• Target: 792
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 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.

  8 weeks

Secondary Outcomes (5)

• Network Contact Test Uptake, End of Study

  Through study completion, up to 30 months.

• Number of Contacts Tested at 8 Weeks

  8 weeks

• Number of Contacts Tested

  Through study completion, up to 30 months

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

  8 weeks

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

  Through study completion, up to 30 months

Study Arms (2)

Self-Test kit distribution

EXPERIMENTAL

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

Test referral distribution

ACTIVE COMPARATOR

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

Interventions

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.

Self-Test kit distribution

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.

Test referral distribution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Has a working telephone number
• Willing and able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Public Health Management Corporation: collaborator

Study Sites (1)

Public Health Management Corporation

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (8)

• Bien-Gund C, Dugosh K, Acri T, Brady K, Thirumurthy H, Fishman J, Gross R. Factors Associated With US Public Motivation to Use and Distribute COVID-19 Self-tests. JAMA Netw Open. 2021 Jan 4;4(1):e2034001. doi: 10.1001/jamanetworkopen.2020.34001.

  PMID: 33471114 BACKGROUND

• Lightfoot MA, Campbell CK, Moss N, Treves-Kagan S, Agnew E, Kang Dufour MS, Scott H, Sa'id AM, Lippman SA. Using a Social Network Strategy to Distribute HIV Self-Test Kits to African American and Latino MSM. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):38-45. doi: 10.1097/QAI.0000000000001726.

  PMID: 29771792 BACKGROUND

• Golden MR, Kerani RP, Stenger M, Hughes JP, Aubin M, Malinski C, Holmes KK. Uptake and population-level impact of expedited partner therapy (EPT) on Chlamydia trachomatis and Neisseria gonorrhoeae: the Washington State community-level randomized trial of EPT. PLoS Med. 2015 Jan 15;12(1):e1001777. doi: 10.1371/journal.pmed.1001777. eCollection 2015 Jan.

  PMID: 25590331 BACKGROUND

• Bagcchi S. Stigma during the COVID-19 pandemic. Lancet Infect Dis. 2020 Jul;20(7):782. doi: 10.1016/S1473-3099(20)30498-9. No abstract available.

  PMID: 32592670 BACKGROUND

• MacGowan RJ, Chavez PR, Borkowf CB, Owen SM, Purcell DW, Mermin JH, Sullivan PS; eSTAMP Study Group. Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):117-125. doi: 10.1001/jamainternmed.2019.5222.

  PMID: 31738378 BACKGROUND

• Altamirano J, Govindarajan P, Blomkalns AL, Kushner LE, Stevens BA, Pinsky BA, Maldonado Y. Assessment of Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for Severe Acute Respiratory Syndrome Coronavirus 2Testing. JAMA Netw Open. 2020 Jun 1;3(6):e2012005. doi: 10.1001/jamanetworkopen.2020.12005.

  PMID: 32530469 BACKGROUND

• Thirumurthy H, Masters SH, Mavedzenge SN, Maman S, Omanga E, Agot K. Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study. Lancet HIV. 2016 Jun;3(6):e266-74. doi: 10.1016/S2352-3018(16)00041-2. Epub 2016 Apr 8.

  PMID: 27240789 BACKGROUND

• Bien-Gund CH, Stephens-Shields AJ, Acri T, Dugosh K, Gross R. Provision of COVID-19 Self-Test Kits to Patients for Distribution to Social Contacts: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513708. doi: 10.1001/jamanetworkopen.2025.13708.

  PMID: 40465296 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Robert Gross
• Organization: University of Pennsylvania

grossr@pennmedicine.upenn.edu

2158982437

Study Officials

• Robert Gross, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 15, 2021
• Study Start: May 5, 2021
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)