Covid19
Conditions
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.
Interventions
BEHAVIORALCOVID-19 self-test
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.
BEHAVIORALCOVID-19 test referral
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.
Sponsors
Public Health Management Corporation
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Network Contact Test Uptake | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Network Contact Test Uptake, End of Study | Through study completion, up to 30 months. | 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. |
| Number of Contacts Tested at 8 Weeks | 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. |
| Number of Contacts Tested | Through study completion, up to 30 months | Number of unique network contacts who completed a test linked to an index participant by end of study. |
| Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks | 8 weeks | Number of participants with at least one network contact who tested positive for COVID-19 within 8 weeks of enrollment. |
| Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study | Through study completion, up to 30 months | Number of participants with at least one network contact who tested positive for COVID-19 by the end of 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 others in their social networks.
COVID-19 self-test: 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. | 388 |
| Test Referral Distribution Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 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. | 388 |
| Total | 776 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded due to administrative error | 7 | 8 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Self-Test Kit Distribution | Total | Test Referral Distribution |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 72 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 352 Participants | 704 Participants | 352 Participants |
| Age, Continuous | 44 years | 44 years | 44 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants | 112 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 322 Participants | 640 Participants | 318 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 24 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 230 Participants | 479 Participants | 249 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 30 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 37 Participants | 77 Participants | 40 Participants |
| Race (NIH/OMB) White | 88 Participants | 157 Participants | 69 Participants |
| Region of Enrollment United States | 388 participants | 776 participants | 388 participants |
| Sex: Female, Male Female | 219 Participants | 440 Participants | 221 Participants |
| Sex: Female, Male Male | 168 Participants | 334 Participants | 166 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 388 | 0 / 388 |
| other Total, other adverse events | 0 / 388 | 0 / 388 |
| serious Total, serious adverse events | 0 / 388 | 0 / 388 |
Outcome results
Primary
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Network Contact Test Uptake | 5 Participants |
| Test Referral Distribution | Network Contact Test Uptake | 2 Participants |
p-value: 0.4595% CI: [-0.021, 0.056]Fisher Exact
Secondary
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.
Time frame: Through study completion, up to 30 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Network Contact Test Uptake, End of Study | 8 Participants |
| Test Referral Distribution | Network Contact Test Uptake, End of Study | 2 Participants |
p-value: 0.1195% CI: [-0.0004, 0.03]Fisher Exact
Secondary
Number of Contacts Tested
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 30 months
Population: Note that each participant could have up to 5 network contacts, so the denominator = 5 times the number of index participants.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Contacts Tested | 31 Network contacts |
| Test Referral Distribution | Number of Contacts Tested | 16 Network contacts |
Secondary
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.
Time frame: 8 weeks
Population: Note that each participant could have up to 5 network contacts, so the denominator = 5 times the number of index participants.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Contacts Tested at 8 Weeks | 23 Network contacts |
| Test Referral Distribution | Number of Contacts Tested at 8 Weeks | 13 Network contacts |
Secondary
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks | 3 Participants |
| Test Referral Distribution | Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks | 0 Participants |
Secondary
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
Time frame: Through study completion, up to 30 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Test Kit Distribution | Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study | 3 Participants |
| Test Referral Distribution | Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study | 0 Participants |