COVID-19 Self-Testing Through Rapid Network Distribution (C-STRAND)
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
About this trial
This is an interventional health services research trial for Covid19
Eligibility Criteria
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
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 others in their social networks.
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
Outcomes
Primary Outcome Measures
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 the number of 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.
Secondary Outcome Measures
Network contact test uptake, end of study
Test uptake among at least two network contacts. This outcome will be measured by the number of unique network contacts who completed a test linked to an index participant by end of study
Number of contacts tested at 8 weeks
Number of unique network contacts who completed a test linked to an index participant by week 8.
Number of contacts tested
Number of unique network contacts who completed a test linked to an index participant by week 8.
Number of positive contacts at 8 weeks
Number of network contacts who test positive
Number of positive contacts
Number of network contacts who test positive
Test positivity rate per index participant
Proportion of Index Participant's network contacts who tested positive
Proportion of first-time test takers
Proportion of Index Participant's network contacts who self-report their test as their first COVID-19 test.
Full Information
NCT ID
NCT04797858
First Posted
March 5, 2021
Last Updated
May 25, 2023
Sponsor
University of Pennsylvania
Collaborators
Public Health Management Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04797858
Brief Title
COVID-19 Self-Testing Through Rapid Network Distribution
Acronym
C-STRAND
Official Title
Secondary Distribution of COVID-19 Self-tests vs. Referrals to Increase Test Uptake in Underserved Populations
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 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
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.
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.
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1048 (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 others in their social networks.
Arm Title
Test referral distribution
Arm Type
Active Comparator
Arm Description
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 self-test
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 test referral
Intervention Description
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.
Primary Outcome Measure Information:
Title
Network contact test uptake
Description
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 the number of 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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Network contact test uptake, end of study
Description
Test uptake among at least two network contacts. This outcome will be measured by the number of unique network contacts who completed a test linked to an index participant by end of study
Time Frame
Through study completion, up to one year
Title
Number of contacts tested at 8 weeks
Description
Number of unique network contacts who completed a test linked to an index participant by week 8.
Time Frame
8 weeks
Title
Number of contacts tested
Description
Number of unique network contacts who completed a test linked to an index participant by week 8.
Time Frame
Through study completion, up to one year
Title
Number of positive contacts at 8 weeks
Description
Number of network contacts who test positive
Time Frame
8 weeks
Title
Number of positive contacts
Description
Number of network contacts who test positive
Time Frame
Through study completion, up to one year
Title
Test positivity rate per index participant
Description
Proportion of Index Participant's network contacts who tested positive
Time Frame
8 weeks
Title
Proportion of first-time test takers
Description
Proportion of Index Participant's network contacts who self-report their test as their first COVID-19 test.
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:
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
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
Plan to Share IPD
No
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
25590331
Citation
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.
Results Reference
background
PubMed Identifier
32592670
Citation
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.
Results Reference
background
PubMed Identifier
31738378
Citation
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. Erratum In: JAMA Intern Med. 2020 Aug 1;180(8):1134.
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
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
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COVID-19 Self-Testing Through Rapid Network Distribution
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