NEW YORK – As one of seven projects funded by the US National Institutes of Health to address the COVID-19 pandemic, Vibrent Health's COVID-CARE program will soon be rolling out nationwide to provide screening and testing for COVID-19.
The digital health company, with a stated focus on furthering precision medicine and research through digital tools, received its initial grant from NIH in September as part of the institute's effort to support digital health solutions to address the pandemic. The National Cancer Institute and National Institute of Biomedical Imaging and Bioengineering selected the projects out of nearly 200 applications.
Fairfax, Virginia-based Vibrent Health then received the second grant, with both grants totaling $4 million, in June after completing phase one of its NIH project, which required organizations to demonstrate feasibility of the project. It is now finishing up its phase two stage, aiming for commercial launch in the fall, Vibrent CEO Praduman Jain said.
The COVID-CARE program, once rolled out, will comprise multiple parts. Consisting of both a web and mobile application, users will be asked a series of questions related to symptoms, location, and demographics. "The approach is to look at the human as a whole," Jain said.
The answers are then inputted into an algorithm that determines the likelihood of the user having COVID-19. If a user is flagged as likely having the virus, a QuickVue At-Home test distributed by either Quidel or Everlywell is shipped so that the patient can administer it at home. Jain said test kits can be delivered "within a few hours" in a surrounding geographic area and results are delivered within 10 minutes.
Results will be entered into the app, and the data can be used by health departments to pinpoint outbreaks or track infections.
"It starts to close the loop between screening and the test kit," Jain said.
The program resulted after a year of strategy conversations with NIH, looking at the market and the need for infectious disease detection, he said. It is intended to help reduce unnecessary testing for patients who likely don't have the virus.
"When you rely only on test kits, somebody has to make the test kits. You have to get a production capacity, you have to ship them," Jain said. "Somebody has to receive them. They have to know how to make it work — it's a long lead time."
As software has become more sophisticated, a software-enabled approach to screening, testing, and tracing became a viable option, he said.
He added that the firm decided to work with Quidel and Everlywell because their tests have received Emergency Use Authorization from the US Food and Drug Administration and have shown good performance. Whether Quidel's or Everlywell's test is sent to a consumer is based on the supply chain and which test is available, Jain said.
Jain said that the platform could also ship laboratory-based PCR tests, although Vibrent's focus upon commercial launch of its platform is on at-home kits. For testing using more complex specimens, such as blood, Jain said the program could also send kits to individuals who would then take their samples to local laboratories.
The company traditionally has worked with partners rather than distributing its products directly to consumers and is talking to a variety of potential distributors for the commercial launch, he said.
Both NIH and Vibrent have been focused on using the tool for COVID-19, but Jain said it's "going to evolve" to help the nation "get ready for the next pandemic." The proprietary algorithm Vibrent uses was kept easily programmable to be used for other diseases, including influenza, he said. The app also collects data each day from different zip codes to monitor hot spots and infection trends, Jain added.
"The technology was designed to be flexible and accommodate … infectious diseases," Jain said.
The machine learning algorithm relies on prevalence data from the NIH and US Centers for Disease Control and Prevention, combined with symptom data from other data sets, including electronic health record, or EHR, data from EPIC Systems and Cerner's networks and insurance claim data, to determine the likelihood of COVID-19, Jain said.
This data is de-identified and shared by public and government sources, he added.
NIH's guidance was invaluable in developing the program, and the agency helped the company design the app's workflow. In the first phase of the project, Vibrent had to demonstrate that both the algorithm and application worked in a proof-of-concept showing, in addition to providing a prototype.
For phase one of the project, the company used CDC and NIH data to develop 45 models based on different scenarios for COVID-19, influenza, and influenza-like illness spread in a patient's region. The company randomly sampled 10,000 cases from NIH and the CDC so that the prevalence of diseases reflected one of the 45 scenarios, which were then organized by prevalence of COVID-19, influenza, and influenza-like illnesses.
In December, most regions in the US were in the scenario with a 2 percent prevalence of COVID-19, .01 percent prevalence of influenza, and 3.5 percent prevalence of influenza-like illnesses, Jain said.
Social isolation and restrictions on access to healthcare providers may have reduced the number of influenza and similar illnesses that were reported to the CDC, he added.
One challenge during development of the program was the timeline for recruiting people, because the volume of COVID-19 cases fluctuated throughout the pandemic, requiring the company to expand community recruitment efforts and hire additional research staff, he said.
When the concept and prototype met NIH's feasibility and acceptability criteria, the company moved on to phase two — finalizing the product and integrating it with the test kit process, figuring out how the kits would be shipped and what the workflow would look like, Jain said.
Vibrent is currently completing the final steps before launch, including putting marketing materials together and making minor tweaks to the application, Jain said.
NIH also asked Vibrent to demonstrate that its product could improve access to screening and testing in underrepresented populations.
The issues Vibrent is looking to address in these populations include trust in the system, convenience, the digital divide, and digital inequities of mobile technologies, healthcare information, and access to care, Jain said. The platform works both in self-supported and staff-supported settings, with options for virtual healthcare visits for users who request them.
To address issues with access and familiarity with technology, Vibrent purposefully designed the program to work across devices and software — it has so far been used by more than 400,000 people, 80 percent of whom "are from backgrounds underrepresented in biomedical research," Jain said.
One of those groups involved several hundred Black participants in Richmond, Virginia, and the company is integrating feedback from that cohort to improve the program, Jain said.
Multiple languages are also included in the product, with an emphasis on straightforward language and quizzes provided to gauge understanding, he said.
The program will be rolling out nationwide in the fall. Although the current focus is on launching the program in the US, Jain noted that the firm has done some initial testing in India and would like to scale the program up for use internationally. The challenge, however, is finding the resources to reach that scale, he said. "Something like this … to deploy, it needs funding."
Vibrent is talking with a variety of federal agencies, including the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority and the US Department of Defense to figure out how to expand the platform while asking, "Where should this go from here?" Jain said.
A spokesperson from NIH's National Cancer Institute added that the agency would facilitate the availability of the data collected, as well as associated analysis, from the studies that were funded under the contract.
Diverse product uses
The company offers tools, all of which are hosted in the cloud, beyond its COVID-CARE program, including products for data collection and research, Jain said. One of its tools can be used to recruit and enroll patients for clinical trials and to integrate the data with EHRs and claims systems to link data across a hospital or health system, Jain said.
Using mobile apps and wearable devices from Vibrent, research teams can monitor how study participants are doing and whether they're meeting the aims of their studies, Jain said.
Sunita Dodani, founding director of the Healthcare Analytics and Delivery Science Institute, or HADSI, at Eastern Virginia Medical School, worked on a statewide study with Vibrent and George Mason University to determine the long-term impacts of COVID-19 on individuals and communities. She said that Vibrent appealed to her because it offered a method for reaching out to different communities and was user-friendly and easy to access.
Using Vibrent to conduct surveys for the project, Dodani said the tools helped patients access healthcare who may not have been able to do so previously, since the products were available through computers, cell phones, and iPads.
It can often be hard to follow patients throughout a study, especially one that requires data collection once a month for six months as the COVIDsmart study did, she said. But with Vibrent's ability to integrate with wearable devices and EHRs, researchers were able to connect with patients and address any access issues, Dodani said.
However, there were some issues with follow-up data analysis, she said. Vibrent's tools had difficulty determining which data points matched with the month they were taken, leading to issues when patients missed a month. She noted that the study was a test run for both Vibrent and HADSI and that it was a "great platform for research."
As for use in a clinical setting, Dodani said Vibrent would need to address multiple requirements for use with a health system, including ensuring the platform is HIPAA-compliant.
In addition to the COVIDsmart study, Vibrent has signed on to work on further COVID-19 projects, including a partnership with Virginia Commonwealth University's Long-Haul COVID Clinic to study the virus across twins to determine genetic and environmental factors associated with long-haul COVID-19.
It is also working with Children's National Hospital to use remote monitoring to collect long-term COVID-19 data in children and with NIH in its All of Us research program to study COVID-19 and its effects in underserved populations.
"The work … is not just for COVID," Jain noted. "It is building technology, scientific basis, for the future of health research and to protect all of us in the future."