Covid19
Conditions
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.
Interventions
BEHAVIORALCOVID-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.
BEHAVIORALCOVID-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.
Sponsors
Public Health Management Corporation
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Positive Contacts | 8 weeks | Number of close contacts who test positive for COVID-19 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Contacts Tested | 8 weeks | Number of close contacts who completed a test |
| Number of Positive Contacts (End of Study) | Through study completion, up to one year | Number of close contacts who test positive for COVID-19 by the end of the study |
| Number of Contacts Tested (End of Study) | Through study completion, up to one year | Number of close contacts who completed a test by the end of the study |
| Number of Household Contacts Tested | 8 weeks | Number of household contacts who completed a test |
| Number of Household Contacts Tested (End of Study) | Through study completion, up to one year | Number of household contacts who completed a test by the end of the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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 |
| Total | 3 |
Baseline characteristics
| Characteristic | Self-Test Kit Distribution | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants |
| Age, Continuous | 33 years | 33 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
Number of Positive Contacts
Number of close contacts who test positive for COVID-19
Time frame: 8 weeks
Population: We were unable to recruit any participants in the test referral arm who tested positive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Positive Contacts | 0 Participants |
| Test Referral Distribution | Number of Positive Contacts | 0 Participants |
Secondary
Number of Contacts Tested
Number of close contacts who completed a test
Time frame: 8 weeks
Population: We were unable to recruit any participants in the test referral arm who tested positive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Contacts Tested | 2 Participants |
Secondary
Number of Contacts Tested (End of Study)
Number of close contacts who completed a test by the end of the study
Time frame: Through study completion, up to one year
Population: We were unable to recruit any participants in the test referral arm who tested positive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Contacts Tested (End of Study) | 0 Participants |
| Test Referral Distribution | Number of Contacts Tested (End of Study) | 0 Participants |
Secondary
Number of Household Contacts Tested
Number of household contacts who completed a test
Time frame: 8 weeks
Population: We were unable to recruit any participants in the test referral arm who tested positive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Household Contacts Tested | 0 Participants |
| Test Referral Distribution | Number of Household Contacts Tested | 0 Participants |
Secondary
Number of Household Contacts Tested (End of Study)
Number of household contacts who completed a test by the end of the study
Time frame: Through study completion, up to one year
Population: We were unable to recruit any participants in the test referral arm who tested positive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Household Contacts Tested (End of Study) | 0 Participants |
| Test Referral Distribution | Number of Household Contacts Tested (End of Study) | 0 Participants |
Secondary
Number of Positive Contacts (End of Study)
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
Population: We were unable to recruit any participants in the test referral arm who tested positive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Positive Contacts (End of Study) | 0 Participants |
| Test Referral Distribution | Number of Positive Contacts (End of Study) | 0 Participants |