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| ID | Type | Description | Link |
|---|---|---|---|
| P30AI094189-09S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed site SOC testing | Experimental | Fixed site Standard of Care (SOC) testing |
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| Community-based testing | Experimental | Community-based, mobile van testing |
|
| Self-collected testing | Experimental | Self-collected, home-based testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed site standard of care testing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured within 30 days of randomization/consent |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Completion of SARS-CoV-2 Testing | Time (In days) to completion of SARS CoV-2 testing from randomization | Measured from randomization to testing completion (within 30 days of randomization)]. |
| Time From SARS CoV-2 Testing to Receipt of Results |
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Inclusion Criteria for households
Inclusion Criteria for Individuals
Exclusion Criteria for households:
Exclusion criteria for individuals
1. Person providing informed consent is under the influence of illicit substances
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| Name | Affiliation | Role |
|---|---|---|
| Jason E Farley, PhD, MPH, NP | Johns Hopkins University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2212 McElderry Street | Baltimore | Maryland | 21205 | United States |
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One person per household was enrolled
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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. | Posted | Count of Participants | Participants | Measured within 30 days of randomization/consent |
|
22 months
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacky Jennings,PhD, MPH; Shruti Mehta, PhD, MPH; Jason Farley, PhD, MPH, ANP-BC, FAAN | Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; Johns Hopkins University School of Nursing | 410-550-4132 | jennings@jhmi.edu; smehta@jhu.edu; jfarley1@jhu.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 | Dec 23, 2021 | May 20, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2022 | May 20, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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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).
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| Community-based, mobile van testing | Behavioral | 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. |
|
| Self-collected, home-based testing | Behavioral | 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. |
|
Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant.
| Measured from testing completion to receipt of results (within 10 days of testing) |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Households |
|
| years |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Employment | Count of Participants | Participants | Participants |
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| Essential Worker Status | Count of Participants | Participants | Participants |
|
| Educational Attainment | Count of Participants | Participants | Participants |
|
| Health Insurance | Count of Participants | Participants | Participants |
|
| History of COVID-19 Vaccination | Count of Participants | Participants | Participants |
|
| 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. |
| OG002 | 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. |
|
|
|
| Secondary | Time to Completion of SARS-CoV-2 Testing | Time (In days) to completion of SARS CoV-2 testing from randomization | Posted | Median | Inter-Quartile Range | days | Measured from randomization to testing completion (within 30 days of randomization)]. |
|
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | days | Measured from testing completion to receipt of results (within 10 days of testing) |
|
|
|
|
| 0 |
| 277 |
| 0 |
| 277 |
| 0 |
| 277 |
| EG001 | 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. | 0 | 273 | 0 | 273 | 0 | 273 |
| EG002 | 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. | 0 | 281 | 0 | 281 | 0 | 281 |
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| D007239 |
| Infections |
Models adjusted for employment |
| Times were censored at 30 days. | Accelerated Failure Time | Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment. | 0.09 | aprior significance threshold: p-value<0.05 | Time Ratio | 0.86 | 2-Sided | 95 | 0.71 | 1.03 | Equivalence | Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the self-collected testing arm to the fixed site SOC testing Alpha threshold of 0.05. | Models adjusted for employment |
Models adjusted for employment |
| Times were censored at 10 days. | Accelerated Failure Time | Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment. | 0.32 | aprior significance threshold: p-value<0.05 | Time Ratio | 0.93 | 2-Sided | 95 | 0.81 | 1.07 | Equivalence | Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the self-collected testing arm to the fixed site SOC testing. | Models adjusted for employment |