Covid19C-STRANDNCT04797858
COVID-19 Self-Testing Through Rapid Network Distribution
A study testing COVID-19 self-test and COVID-19 test referral in people with Covid19, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 self-test and COVID-19 test referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Has a working telephone number
- Willing and able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Management Corporation
Philadelphia, Pennsylvania, 19102
About this study
Official title: Secondary Distribution of COVID-19 Self-tests vs. Referrals to Increase Test Uptake in Underserved Populations
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- COVID-19 self-test, COVID-19 test referral
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 self-testBehavioural
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.
COVID-19 test referralBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Test kit distribution | Experimental | Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks. Receives: Behavioral: COVID-19 self-test |
| Test referral distribution | Active comparator | Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks. Receives: Behavioral: COVID-19 test referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 number of participants with at least 2 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.
Measured: 8 weeks
Secondary outcomes (5)
Network Contact Test Uptake, End of Study
Test uptake among at least two network contacts. This outcome will be measured by the number of participants with at least two unique network contacts who completed a test linked to an index participant by end of study.
Measured: Through study completion, up to 30 months.
Number of Contacts Tested at 8 Weeks
Number of unique network contacts who completed a test linked to an index participant by week 8. Participants analyzed reflects the number of network contacts only who completed a test.
Measured: 8 weeks
Number of Contacts Tested
Number of unique network contacts who completed a test linked to an index participant by end of study.
Measured: Through study completion, up to 30 months
Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks
Number of participants with at least one network contact who tested positive for COVID-19 within 8 weeks of enrollment.
Measured: 8 weeks
Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study
Number of participants with at least one network contact who tested positive for COVID-19 by the end of study
Measured: Through study completion, up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start5 May 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Management Corporation
- Responsible party
- Principal investigator, Robert Gross, University of Pennsylvania
- Investigators
- Robert Gross, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797858
- Sponsor's protocol ID
- 3R01HL151292-01S1
- Acronym
- C-STRAND
- Status last verified
- May 2025
- First submitted
- 5 Mar 2021
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33471114Lightfoot 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.
PubMed 29771792Golden 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.
PubMed 25590331Bagcchi 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.
PubMed 32592670MacGowan 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.
PubMed 31738378Altamirano 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.
PubMed 32530469Thirumurthy 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.
PubMed 27240789Bien-Gund CH, Stephens-Shields AJ, Acri T, Dugosh K, Gross R. Provision of COVID-19 Self-Test Kits to Patients for Distribution to Social Contacts: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513708. doi: 10.1001/jamanetworkopen.2025.13708.
PubMed 40465296
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Distribution of COVID-19 Self-tests vs. Referrals to Increase Test Uptake in Underserved Populations
- ClinicalTrials.gov ID
- NCT04797858
- Acronym / sponsor ID
- C-STRAND / 3R01HL151292-01S1
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Public Health Management Corporation
- Study start
- 5 May 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Test kit distribution | Experimental | Behavioral: COVID-19 self-testParticipants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks. |
| Test referral distribution | Active comparator | Behavioral: COVID-19 test referralParticipants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Has a working telephone number
- Willing and able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 self-test5 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. | Behavioural | Self-Test kit distribution |
| COVID-19 test referral5 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. | Behavioural | Test referral distribution |
Primary outcome
Network Contact Test Uptake
Time frame: 8 weeks
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 number of participants with at least 2 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.
5 secondary outcomes
Network Contact Test Uptake, End of Study
Time frame: Through study completion, up to 30 months.
Number of Contacts Tested at 8 Weeks
Time frame: 8 weeks
Number of Contacts Tested
Time frame: Through study completion, up to 30 months
Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks
Time frame: 8 weeks
Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study
Time frame: Through study completion, up to 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33471114Bien-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.
- Background: PubMed 29771792Lightfoot 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.
- Background: PubMed 25590331Golden 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.
- Background: PubMed 32592670Bagcchi 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.
- Background: PubMed 31738378MacGowan 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.
- Background: PubMed 32530469Altamirano 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.
- Background: PubMed 27240789Thirumurthy 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.
- Derived from this study: PubMed 40465296Bien-Gund CH, Stephens-Shields AJ, Acri T, Dugosh K, Gross R. Provision of COVID-19 Self-Test Kits to Patients for Distribution to Social Contacts: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513708. doi: 10.1001/jamanetworkopen.2025.13708.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Gross, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 self-test and COVID-19 test referral in people with Covid19, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Network Contact Test Uptake (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797858, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.