COVID-19 Close Contact Self-Testing Study

Covid19 Clinical Trial

— CloseST  

Official title:

Close Contact Self-Testing Among Contacts of Individuals With COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847479
• Other study ID #: 3R01HL151292-01S1-2
• Secondary ID: 3R01HL151292-01S
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Strategies to increase testing among individuals exposed to COVID-19 are needed. One approach to increase testing and case detection is to distribute home test kits to close contacts of individuals with COVID-19. This approach decreases logistic barriers to testing, potential exposures to COVID-19, and reduces potential stigma and fear associated with facility-based COVID-19 testing.

The investigators will conduct a cohort study of individuals diagnosed with COVID-19 in the C-STRAND trial (NCT04797858), in order to determine if distribution of self-test kits to close contacts of of individuals with COVID-19 can increase case detection compared with a standard contact referral strategy among. Individuals diagnosed with COVID-19 who were randomized to the self-test (intervention) arm or received self-test kits will be assigned to receive additional self-test kits to distribute to close contacts. Individuals diagnosed with COVID-19 who were randomized to the test referral (control) arm or received test referrals will be assigned to receive text message referrals to give their close contacts to seek testing if needed. COVID-19 case detection and test uptake will be measured in both arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Has a working telephone number

• Willing and able to provide informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Behavioral:
• COVID-19 self-test
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.
• COVID-19 test referral
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.

Locations

Country	Name	City	State
United States	Public Health Management Corporation	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Public Health Management Corporation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Erratum In: JAMA Netw Open. 2020 Jul 1;3(7):e2014910. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of positive contacts	Number of close contacts who test positive for COVID-19	8 weeks
Secondary	Number of positive contacts (end of study)	Number of close contacts who test positive for COVID-19 by the end of the study	Through study completion, up to one year
Secondary	Number of contacts tested	Number of close contacts who completed a test	8 weeks
Secondary	Number of contacts tested (end of study)	Number of close contacts who completed a test by the end of the study	Through study completion, up to one year
Secondary	Number of household contacts tested	Number of household contacts who completed a test	8 weeks
Secondary	Number of household contacts tested (end of study)	Number of household contacts who completed a test by the end of the study	Through study completion, up to one year

External Links

•   C-STRAND Trial