Community Collaboration to Combat COVID-19 (C-FORWARD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community Collaboration to Combat COVID-19

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Behavioral: Fixed site standard of care testing
* Behavioral: Community-based, mobile van testing
* Behavioral: Self-collected, home-based testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for households Selected address within Baltimore City At least one member of the household >18 years of age who speaks English and/or Spanish At least one member of the household provides informed consent At least one member of the household psychologically fit to complete survey Inclusion Criteria for Individuals Reports primary residence within the sampled household Provides informed consent For children (12 years of age or older), with child assent. Exclusion Criteria for households: Adult member of the household is under the influence of illicit substances, in the opinion of the phone interviewer Residents of nursing homes, half-ways houses or shelters Psychologically unfit to complete the survey Not a selected household address Exclusion criteria for individuals 1. Person providing informed consent is under the influence of illicit substances

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed site SOC testing<br>Fixed site Standard of Care (SOC) testing | Behavioral: Fixed site standard of care testing<br>* 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.<br>|
| Experimental: Community-based testing<br>Community-based, mobile van testing | Behavioral: Community-based, mobile van testing<br>* 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.<br>|
| Experimental: Self-collected testing<br>Self-collected, home-based testing | Behavioral: Self-collected, home-based testing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of SARS-CoV-2 testing results | Proportion of those who complete a survey who agree to be randomized to a SARS-CoV-2 testing modality. | Measured from baseline survey completion to enrollment within 30 days of completion of baseline survey | 
| 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 from randomization to testing completion (within 30 days of randomization) | 
| 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 20 days of randomization) | 
| 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. | Measured from testing completion to receipt of results (within 10 days of testing) |