Clinical trial NCT04673292: Community Collaboration to Combat COVID-19 (C-FORWARD)
Official title: Community Collaboration to Combat COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-12-17
Enrollment: 831
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Exclusion criteria for individuals

1. Person providing informed consent is under the influence of illicit substances

Primary outcomes:
measure: Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing
timeFrame: Measured within 30 days of randomization/consent
Secondary outcomes:
measure: Time to Completion of SARS-CoV-2 Testing
timeFrame: Measured from randomization to testing completion (within 30 days of randomization)].
measure: Time From SARS CoV-2 Testing to Receipt of Results
timeFrame: Measured from testing completion to receipt of results (within 10 days of testing)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: 2212 McElderry Street
state: Maryland
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Jason E Farley, PhD, MPH, NP
role: PRINCIPAL_INVESTIGATOR
References: