COVID-19 Close Contact Self-Testing Study

NCT04847479 | Completed Results DMC

• 2 other identifiers: 3R01HL151292-01S1-23R01HL151292-01S1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Widespread testing and contact tracing are critical to controlling the COVID-19 epidemic. Distribution of COVID-19 self-test kits can augment public health contact tracing efforts, as individuals with COVID-19 can distribute self-testing to close contacts. 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. The central hypothesis of this study is that distribution of SARS-CoV-2 self-tests to close contacts of among individuals with COVID-19 infection can increase case detection compared with a standard contact referral strategy.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Number of Positive Contacts

  Number of close contacts who test positive for COVID-19

  8 weeks

Secondary Outcomes (5)

• Number of Positive Contacts (End of Study)

  Through study completion, up to one year

• Number of Contacts Tested

  8 weeks

• Number of Contacts Tested (End of Study)

  Through study completion, up to one year

• Number of Household Contacts Tested

  8 weeks

• Number of Household Contacts Tested (End of Study)

  Through study completion, up to one year

Study Arms (2)

Self-Test kit distribution

EXPERIMENTAL

Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.

Behavioral: COVID-19 self-test

Test referral distribution

ACTIVE COMPARATOR

Participants in the test referral arm receive text messages providing testing information to send to their close contacts.

Behavioral: COVID-19 test referral

Interventions

COVID-19 self-test BEHAVIORAL

Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.

Self-Test kit distribution

COVID-19 test referral BEHAVIORAL

Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.

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:

• Severe symptoms requiring immediate medical attention
• Younger than 18 years of age
• Does not have a working telephone number
• 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 (4)

• 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

• 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

• 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

Related Links

• C-STRAND Trial

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

215-898-2437

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: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 19, 2021
• Study Start: May 6, 2021
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Locations

US (1)