Coronavirus Infection
Conditions
Brief summary
This is randomized trial where households will be randomized to identify the optimal SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of households in Baltimore City, Maryland. 1,386 households in Baltimore City will be randomized 1:1:1 to one of three testing modalities: 1) fixed-site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing.
Detailed description
The target population will include English- and Spanish-speaking families residing in Baltimore City households (N=238,427). The sample size goal is 1,386 households (0.44% of households) or 3,000 individual household members. Households will be sampled using a multi-stage approach with 1) selection of 105 of 653 census block groups (CBGs) with probabilities proportional to the estimated number of occupied households selected from 9 strata of CBGs defined by socioeconomic status and race/ethnicity with over-sampling of CBGs with harder-to-reach populations (e.g., Latinos/x, low-income whites); 2) selection of residential addresses within each of the strata via non-linear optimization; and finally, 3) screening of individuals selected for eligibility (e.g., household occupied vs. not, English/Spanish speaking). After completion of brief surveys, individuals will be asked to enroll other willing household members. One adult member of the household will be randomized 1:1:1 using a stratified, blocked approach with varying block sizes of 3, to one of three testing modalities: 1) fixed site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing. Randomization will be stratified by geography (n=12 zones) and race/ethnicity (non-hispanic white/other, non-hispanic black and hispanic/latinx). Arm 1 includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Arm 2 includes a convenient, accessible mobile van option which will be located in the center of each of 12 geographic zones. Arm 3 includes a home-based testing kit which will be delivered by courier service. Outcomes related to testing will be measured within 30 days of the initial randomization. Participants will be followed with weekly symptom pulses and monthly follow-up visits to ascertain subsequent testing need/COVID-19 symptoms. Testing during follow-up will be on-demand and participants can use either the fixed site or the home-based testing kits. The investigators will measure the impact of the time to receipt of SARS CoV-2 testing results.
Interventions
BEHAVIORALFixed site standard of care testing
This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.
BEHAVIORALCommunity-based, mobile van testing
This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.
BEHAVIORALSelf-collected, home-based testing
Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Each household will be randomized to one of three arms in the study: Fixed site SOC testing (Arm 1), community-based, mobile van testing (Arm 2), or self-collected, home-based testing (Arm 3).
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for households 1. Selected address within Baltimore City 2. At least one member of the household \>18 years of age who speaks English and/or Spanish 3. At least one member of the household provides informed consent 4. At least one member of the household psychologically fit to complete survey Inclusion Criteria for Individuals 1. Reports primary residence within the sampled household 2. Provides informed consent 3. For children (12 years of age or older), with child assent.
Exclusion criteria
for households: 1. Adult member of the household is under the influence of illicit substances, in the opinion of the phone interviewer 2. Residents of nursing homes, half-ways houses or shelters 3. Psychologically unfit to complete the survey 4. Not a selected household address
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing | Measured within 30 days of randomization/consent | Uptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Completion of SARS-CoV-2 Testing | Measured from randomization to testing completion (within 30 days of randomization)]. | Time (In days) to completion of SARS CoV-2 testing from randomization |
| Time From SARS CoV-2 Testing to Receipt of Results | Measured from testing completion to receipt of results (within 10 days of testing) | Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant. |
Countries
United States
Participant flow
Recruitment details
One person per household was enrolled
Participants by arm
| Arm | Count |
|---|---|
| Fixed Site SOC Testing Fixed site Standard of Care (SOC) testing
Fixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule. | 277 |
| Fixed Site SOC Testing Fixed site Standard of Care (SOC) testing
Fixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule. | 277 |
| Community-based Testing Community-based, mobile van testing
Community-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them. | 273 |
| Community-based Testing Community-based, mobile van testing
Community-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them. | 273 |
| Self-collected Testing Self-collected, home-based testing
Self-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available. | 281 |
| Self-collected Testing Self-collected, home-based testing
Self-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available. | 281 |
| Total | 1,662 |
Baseline characteristics
| Characteristic | Community-based Testing | Total | Self-collected Testing | Fixed Site SOC Testing |
|---|---|---|---|---|
| Age, Continuous | 57 years | 56 years | 56 years | 55 years |
| Educational Attainment Bachelor's Degree | 62 Participants | 161 Participants | 54 Participants | 45 Participants |
| Educational Attainment High School Graduate or Less | 69 Participants | 192 Participants | 63 Participants | 60 Participants |
| Educational Attainment Other Advanced Degree | 80 Participants | 285 Participants | 96 Participants | 109 Participants |
| Educational Attainment Some College Level/Technical/Vocational Degree/Associate's Degree | 60 Participants | 188 Participants | 66 Participants | 62 Participants |
| Educational Attainment Unknown or Not Reported | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| Employment Other | 5 Participants | 12 Participants | 0 Participants | 7 Participants |
| Employment Retired/Disabled/Keeping House | 110 Participants | 299 Participants | 106 Participants | 83 Participants |
| Employment Student | 5 Participants | 16 Participants | 5 Participants | 6 Participants |
| Employment Unemployed | 9 Participants | 47 Participants | 19 Participants | 19 Participants |
| Employment Working now (either full or part time) | 144 Participants | 457 Participants | 151 Participants | 162 Participants |
| Essential Worker Status Essential Worker | 64 Participants | 194 Participants | 63 Participants | 67 Participants |
| Essential Worker Status Not an Essential Worker | 201 Participants | 605 Participants | 209 Participants | 195 Participants |
| Essential Worker Status Unknown or Not Reported | 8 Participants | 32 Participants | 9 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 37 Participants | 13 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 249 Participants | 756 Participants | 254 Participants | 253 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 38 Participants | 14 Participants | 11 Participants |
| Health Insurance No Health Insurance | 10 Participants | 20 Participants | 2 Participants | 8 Participants |
| Health Insurance Private (purchased directly or through employer) | 100 Participants | 342 Participants | 124 Participants | 118 Participants |
| Health Insurance Public (Medicare, Medicaid, Tricare) | 111 Participants | 315 Participants | 103 Participants | 101 Participants |
| Health Insurance Unknown or Not Reported | 52 Participants | 154 Participants | 52 Participants | 50 Participants |
| History of COVID-19 Vaccination Any COVID-19 Vaccination | 238 Participants | 719 Participants | 238 Participants | 243 Participants |
| History of COVID-19 Vaccination No COVID-19 Vaccination | 33 Participants | 105 Participants | 41 Participants | 31 Participants |
| History of COVID-19 Vaccination Unknown or Not Reported | 2 Participants | 7 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 22 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 122 Participants | 359 Participants | 119 Participants | 118 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 18 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 20 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) White | 132 Participants | 412 Participants | 143 Participants | 137 Participants |
| Sex/Gender, Customized Female | 182 Participants | 573 Participants | 192 Participants | 199 Participants |
| Sex/Gender, Customized Male | 90 Participants | 254 Participants | 87 Participants | 77 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 277 | 0 / 273 | 0 / 281 |
| other Total, other adverse events | 0 / 277 | 0 / 273 | 0 / 281 |
| serious Total, serious adverse events | 0 / 277 | 0 / 273 | 0 / 281 |
Outcome results
Primary
Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing
Uptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing.
Time frame: Measured within 30 days of randomization/consent
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Site SOC Testing | Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing | Completed PCR testing within 30 days of study randomization | 199 Participants |
| Fixed Site SOC Testing | Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing | Did not complete PCR testing within 30 days of randomization | 78 Participants |
| Community-based Testing | Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing | Completed PCR testing within 30 days of study randomization | 205 Participants |
| Community-based Testing | Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing | Did not complete PCR testing within 30 days of randomization | 68 Participants |
| Self-collected Testing | Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing | Completed PCR testing within 30 days of study randomization | 218 Participants |
| Self-collected Testing | Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing | Did not complete PCR testing within 30 days of randomization | 63 Participants |
p-value: 0.6795% CI: [0.86, 1.27]Poisson Regression
p-value: 0.4395% CI: [0.89, 1.31]Poisson Regression
Secondary
Time From SARS CoV-2 Testing to Receipt of Results
Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant.
Time frame: Measured from testing completion to receipt of results (within 10 days of testing)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fixed Site SOC Testing | Time From SARS CoV-2 Testing to Receipt of Results | 3 days |
| Community-based Testing | Time From SARS CoV-2 Testing to Receipt of Results | 3 days |
| Self-collected Testing | Time From SARS CoV-2 Testing to Receipt of Results | 3 days |
Comparison: Times were censored at 10 days.p-value: 0.5695% CI: [0.83, 1.1]Accelerated Failure Time
Comparison: Times were censored at 10 days.p-value: 0.3295% CI: [0.81, 1.07]Accelerated Failure Time
Secondary
Time to Completion of SARS-CoV-2 Testing
Time (In days) to completion of SARS CoV-2 testing from randomization
Time frame: Measured from randomization to testing completion (within 30 days of randomization)].
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fixed Site SOC Testing | Time to Completion of SARS-CoV-2 Testing | 7 days |
| Community-based Testing | Time to Completion of SARS-CoV-2 Testing | 6 days |
| Self-collected Testing | Time to Completion of SARS-CoV-2 Testing | 7 days |
Comparison: Times were censored at 30 days.p-value: 0.1495% CI: [0.73, 1.05]Accelerated Failure Time
Comparison: Times were censored at 30 days.p-value: 0.0995% CI: [0.71, 1.03]Accelerated Failure Time