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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01HL151292-01S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Public Health Management Corporation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Test kit distribution | Experimental | Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts. |
|
| Test referral distribution | Active Comparator | Participants in the test referral arm receive text messages providing testing information to send to their close contacts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 self-test | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Positive Contacts | Number of close contacts who test positive for COVID-19 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Contacts Tested |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gross, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Management Corporation | Philadelphia | Pennsylvania | 19102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33471114 | Background | 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. | |
| 29771792 | Background | 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. |
| Label | URL |
|---|---|
| C-STRAND Trial | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-Test Kit Distribution | Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts. 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. |
| FG001 | Test Referral Distribution | Participants in the test referral arm receive text messages providing testing information to send to their close contacts. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We were unable to recruit participants in the test referral distribution arm since there were no patients in that arm that tested positive.
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-Test Kit Distribution | Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Positive Contacts | Number of close contacts who test positive for COVID-19 | We were unable to recruit any participants in the test referral arm who tested positive. | Posted | Count of Participants | Participants | 8 weeks |
|
Subjects were considered enrolled in our study for 8 weeks. 8 weeks after enrollment, they completed a follow-up survey and were then considered to have completed the study.
We were unable to recruit any participants in the test referral arm who tested positive.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-Test Kit Distribution | Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to their close contacts. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Gross | University of Pennsylvania | 215-898-2437 | grossr@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2022 | Nov 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| COVID-19 test referral | Behavioral | 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. |
|
Number of close contacts who completed a test
| 8 weeks |
| 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 |
| Number of Household Contacts Tested | Number of household contacts who completed a test | 8 weeks |
| 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 |
| 27240789 | Background | 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. |
| 32530469 | Background | 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. |
| BG001 |
| Test Referral Distribution |
Participants in the test referral arm receive text messages providing testing information to send to their close contacts. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants in the test referral arm receive text messages providing testing information to send to their close contacts.
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.
|
|
| Secondary | Number of Positive Contacts (End of Study) | Number of close contacts who test positive for COVID-19 by the end of the study | We were unable to recruit any participants in the test referral arm who tested positive. | Posted | Count of Participants | Participants | Through study completion, up to one year |
|
|
|
| Secondary | Number of Contacts Tested | Number of close contacts who completed a test | We were unable to recruit any participants in the test referral arm who tested positive. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Number of Contacts Tested (End of Study) | Number of close contacts who completed a test by the end of the study | We were unable to recruit any participants in the test referral arm who tested positive. | Posted | Count of Participants | Participants | Through study completion, up to one year |
|
|
|
| Secondary | Number of Household Contacts Tested | Number of household contacts who completed a test | We were unable to recruit any participants in the test referral arm who tested positive. | Posted | Count of Participants | Participants | 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 | We were unable to recruit any participants in the test referral arm who tested positive. | Posted | Count of Participants | Participants | Through study completion, up to one year |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Test Referral Distribution | Participants in the test referral arm receive text messages providing testing information to send to their close contacts. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |