Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT04797858
Status:
COMPLETED
Last Update Posted:
2025-05-11
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
COVID-19 Self-Testing Through Rapid Network Distribution
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Secondary Distribution of COVID-19 Self-tests vs. Referrals to Increase Test Uptake in Underserved Populations
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C-STRAND
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: