Trial Outcomes & Findings for Community Collaboration to Combat COVID-19 (C-FORWARD) (NCT NCT04673292)
NCT ID: NCT04673292
Last Updated: 2024-07-08
Results Overview
Uptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
831 participants
Primary outcome timeframe
Measured within 30 days of randomization/consent
Results posted on
2024-07-08
Participant Flow
One person per household was enrolled
Unit of analysis: Households
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
277 277
|
273 273
|
281 281
|
|
Overall Study
COMPLETED
|
277 277
|
273 273
|
281 281
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Community Collaboration to Combat COVID-19 (C-FORWARD)
Baseline characteristics by cohort
| Measure |
Fixed Site SOC Testing
n=277 Households
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.
|
Community-based Testing
n=273 Households
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.
|
Self-collected Testing
n=281 Households
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.
|
Total
n=831 Households
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Age, Continuous
|
55 years
n=93 Participants
|
57 years
n=4 Participants
|
56 years
n=27 Participants
|
56 years
n=483 Participants
|
|
Sex/Gender, Customized
Female
|
199 Participants
n=93 Participants
|
182 Participants
n=4 Participants
|
192 Participants
n=27 Participants
|
573 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Male
|
77 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
254 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
253 Participants
n=93 Participants
|
249 Participants
n=4 Participants
|
254 Participants
n=27 Participants
|
756 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
118 Participants
n=93 Participants
|
122 Participants
n=4 Participants
|
119 Participants
n=27 Participants
|
359 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
137 Participants
n=93 Participants
|
132 Participants
n=4 Participants
|
143 Participants
n=27 Participants
|
412 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Employment
Working now (either full or part time)
|
162 Participants
n=93 Participants
|
144 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
457 Participants
n=483 Participants
|
|
Employment
Retired/Disabled/Keeping House
|
83 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
299 Participants
n=483 Participants
|
|
Employment
Student
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Employment
Unemployed
|
19 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
|
Employment
Other
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Essential Worker Status
Essential Worker
|
67 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
194 Participants
n=483 Participants
|
|
Essential Worker Status
Not an Essential Worker
|
195 Participants
n=93 Participants
|
201 Participants
n=4 Participants
|
209 Participants
n=27 Participants
|
605 Participants
n=483 Participants
|
|
Essential Worker Status
Unknown or Not Reported
|
15 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Educational Attainment
High School Graduate or Less
|
60 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
192 Participants
n=483 Participants
|
|
Educational Attainment
Some College Level/Technical/Vocational Degree/Associate's Degree
|
62 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
188 Participants
n=483 Participants
|
|
Educational Attainment
Bachelor's Degree
|
45 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
161 Participants
n=483 Participants
|
|
Educational Attainment
Other Advanced Degree
|
109 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
285 Participants
n=483 Participants
|
|
Educational Attainment
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Health Insurance
No Health Insurance
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Health Insurance
Public (Medicare, Medicaid, Tricare)
|
101 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
315 Participants
n=483 Participants
|
|
Health Insurance
Private (purchased directly or through employer)
|
118 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
124 Participants
n=27 Participants
|
342 Participants
n=483 Participants
|
|
Health Insurance
Unknown or Not Reported
|
50 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
154 Participants
n=483 Participants
|
|
History of COVID-19 Vaccination
Any COVID-19 Vaccination
|
243 Participants
n=93 Participants
|
238 Participants
n=4 Participants
|
238 Participants
n=27 Participants
|
719 Participants
n=483 Participants
|
|
History of COVID-19 Vaccination
No COVID-19 Vaccination
|
31 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
105 Participants
n=483 Participants
|
|
History of COVID-19 Vaccination
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Measured within 30 days of randomization/consentUptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing.
Outcome measures
| Measure |
Fixed Site SOC Testing
n=277 Participants
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.
|
Community-based Testing
n=273 Participants
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.
|
Self-collected Testing
n=281 Participants
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.
|
|---|---|---|---|
|
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
|
205 Participants
|
218 Participants
|
|
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
|
68 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Measured from randomization to testing completion (within 30 days of randomization)].Time (In days) to completion of SARS CoV-2 testing from randomization
Outcome measures
| Measure |
Fixed Site SOC Testing
n=277 Participants
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.
|
Community-based Testing
n=273 Participants
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.
|
Self-collected Testing
n=281 Participants
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.
|
|---|---|---|---|
|
Time to Completion of SARS-CoV-2 Testing
|
7 days
Interval 5.0 to 11.0
|
6 days
Interval 4.0 to 10.0
|
7 days
Interval 5.0 to 12.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fixed Site SOC Testing
n=277 Participants
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.
|
Community-based Testing
n=273 Participants
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.
|
Self-collected Testing
n=281 Participants
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.
|
|---|---|---|---|
|
Time From SARS CoV-2 Testing to Receipt of Results
|
3 days
Interval 1.0 to 6.0
|
3 days
Interval 1.0 to 5.0
|
3 days
Interval 2.0 to 5.0
|
Adverse Events
Fixed Site SOC Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community-based Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-collected Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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
Phone: 410-550-4132
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place