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COVID-19 Close Contact Self-Testing Study (CloseST)

Primary Purpose

Covid19

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID-19 self-test
COVID-19 test referral
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Public Health Management CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-Test kit distribution

Test referral distribution

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of positive contacts
Number of close contacts who test positive for COVID-19

Secondary Outcome Measures

Number of positive contacts (end of study)
Number of close contacts who test positive for COVID-19 by the end of the study
Number of contacts tested
Number of close contacts who completed a test
Number of contacts tested (end of study)
Number of close contacts who completed a test by the end of the study
Number of household contacts tested
Number of household contacts who completed a test
Number of household contacts tested (end of study)
Number of household contacts who completed a test by the end of the study

Full Information

First Posted
April 14, 2021
Last Updated
August 2, 2023
Sponsor
University of Pennsylvania
Collaborators
Public Health Management Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04847479
Brief Title
COVID-19 Close Contact Self-Testing Study
Acronym
CloseST
Official Title
Close Contact Self-Testing Among Contacts of Individuals With COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Public Health Management Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-Test kit distribution
Arm Type
Experimental
Arm Description
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts.
Arm Title
Test referral distribution
Arm Type
Active Comparator
Arm Description
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 self-test
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 test referral
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of positive contacts
Description
Number of close contacts who test positive for COVID-19
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of positive contacts (end of study)
Description
Number of close contacts who test positive for COVID-19 by the end of the study
Time Frame
Through study completion, up to one year
Title
Number of contacts tested
Description
Number of close contacts who completed a test
Time Frame
8 weeks
Title
Number of contacts tested (end of study)
Description
Number of close contacts who completed a test by the end of the study
Time Frame
Through study completion, up to one year
Title
Number of household contacts tested
Description
Number of household contacts who completed a test
Time Frame
8 weeks
Title
Number of household contacts tested (end of study)
Description
Number of household contacts who completed a test by the end of the study
Time Frame
Through study completion, up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Gross, MD
Phone
2158982437
Email
grossr@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Gross, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health Management Corporation
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Dugosh, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33471114
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.
Results Reference
background
PubMed Identifier
29771792
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.
Results Reference
background
PubMed Identifier
27240789
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.
Results Reference
background
PubMed Identifier
32530469
Citation
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.
Results Reference
background
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT04797858
Description
C-STRAND Trial

Learn more about this trial

COVID-19 Close Contact Self-Testing Study

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