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NIH RADx-UP Program Aims to Address COVID-19 Testing Disparities in Underserved Communities


NEW YORK – Not long after the start of COVID-19 pandemic, communities of color as well as underserved communities, in general, complained about their lack of access to testing for SARS-CoV-2.

More than a year later, some diagnostic companies say they are seeing a decline in COVID-19 testing as more tests are being made available. Yet for those in neighborhoods where access to tests were limited, challenges to getting a SARS-CoV-2 test remains. 

To try to address this, the US National Institutes of Health's Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) initiative has provided funding for projects that aim to implement ways to widen access to testing and fill in healthcare gaps for these communities. Monica Webb Hooper, deputy director of NIH's National Institute on Minority Health and Health disparities, said the goal for RADx, a larger NIH program under whose purview RADx-UP falls, is to speed innovation. The RADx programs she noted can "help us understand COVID-19 testing patterns," strengthen data on health disparities, and help health officials develop strategies to increase testing.

Broadly, healthcare disparities had been widespread pre-pandemic throughout the US even as insurance coverage and access to care have improved. According to the 2019 National Healthcare Quality and Disparities Report from the Agency for Healthcare Research and Quality, while some disparities have gotten smaller from 2000 to 2018, many have worsened, particularly for poor and uninsured people. Social determinants of health, such as the neighborhoods people live in, the jobs they have, their education levels, and their income, contribute to these gaps in care. 

Those issues have been exacerbated by COVID-19. APM Research Lab's Color of Coronavirus project found that Pacific Islander, Latino, Indigenous, and Black Americans all have a COVID-19 death rate of double or higher than that of white and Asian Americans. 

Similarly, according to the US Centers for Disease Control and Prevention's guidance on racial and ethnic health disparities in COVID-19, the numbers of deaths among Hispanic/Latino, non-Hispanic Black, non-Hispanic American Indian, and Alaska Native Americans from COVID-19 are disproportionately high, relative to their population figures. 

The disparities related to COVID-19 aren't just prevalent in racial and ethnic minority groups, however. An analysis from Surgo Ventures in November found that 64 percent of all rural counties in the US do not have a COVID-19 testing site.

Meanwhile, a report published in the Journal of Rural Health in February found that nonmetropolitan COVID-19 incidence and mortality trends steadily increased and surpassed those in metropolitan areas starting last August. Researchers for the JRH study said rural areas "have an equal need for testing, healthcare personnel, and mitigation resources," despite the fewer amount of people living there.  

Webb Hooper noted that there's "consistent evidence" that COVID-19 has had a disproportionate impact on people with comorbidities, elderly people, and people from different social groups. There are also "known hurdles" in getting these groups tested, including an overall level of distrust and unrest in some of these communities and "economic and contextual factors that could impact testing." 

Ensuring equity in COVID-19 testing and care has been a major focus of the Biden administration, which created the COVID-19 Health Equity Task Force in January with one of its mission to provide specific recommendations to President Biden to mitigate disparities in care caused or exacerbated by the COVID-19 pandemic, as well as for preventing the inequities in the future. Last month, the CDC announced it will provide $2.25 billion over two years to address disparities in COVID-19 testing in high-risk and underserved communities. 

The CDC and NIH also announced last month a community health initiative called "Say Yes! COVID Test" to provide a free month-long supply of rapid antigen tests that can be administered at home. The initiative has been rolled out in Pitt County, North Carolina, and is being rolled out to Hamilton County, Tennessee, and as many as 160,000 residents will have access to the tests, supplied through RADx, to use three times per week over the course of a month. NIH will evaluate the effectiveness of the program as it tries to determine if frequent, self-administered testing can help residents reduce community transmission of SARS-CoV-2.

The two communities were selected based on local infection rates, public availability of accurate COVID-19 tracking data, existing community relationships through RADx-UP, and local infrastructure to support the project. 

RADx-UP programs address disparities

In light of these issues, RADx-UP has provided millions of dollars in funding to organizations expanding COVID-19 testing for underserved and vulnerable populations, including a project led by Jesse Nodora, an associate professor in the Herbert Wertheim School of Public Health and Human Longevity at the University of California, San Diego. Nodora's project addresses

COVID-19 testing in underserved and vulnerable populations receiving care in San Diego community health centers, and it has been awarded nearly $1.7 million over two years by the RADx-UP program. 

As part of the funding, UCSD is partnering with three federally qualified healthcare centers (FQHCs), also called community health centers, to test 3,000 patients in each center over five to six months, Nodora said. These centers are "where poor people in this country go to get their primary care," he added. The two priority groups for the study will be asymptomatic people 65 and older and those with existing conditions, such as diabetes, cancer, and heart disease, he said.

Additionally, the partners are studying the best, most sustainable ways to scale up future COVID-19 testing sustainability and vaccination with an emphasis on underserved and vulnerable populations. The researchers are working with a CLIA-certified laboratory at UCSD to provide PCR testing from self-collected samples, although Nodora said they were open to other modalities "as they come along," including saliva tests.  He added that most of the testing will be done within the first year of the project. 

An advantage of working directly with FQHCs, Nodora noted, is that the centers already have population management tools and electronic health records in place to identify how many patients have existing conditions. His team has also worked with FQHCs previously for colorectal cancer screening, so "all of the moving pieces were kind of already there." 

One question Nodora's group is looking into is whether the FQHCs can set up this testing infrastructure in a way that can be maintained, he said. Another question is whether these people will come in for testing at all if they don't have COVID-19 symptoms. Because many of the patients live in multigenerational households, they are being asked if there are any essential workers in their households and to share their information so they can be referred for testing as well.

Many of these patients haven't been seen in person at an FQHC since March of last year, unless they had a procedure. "We do anticipate that there'll be a significant number that have never been tested before," Nodora said. 

There are three main challenges Nodora said his team will face throughout the project: communication, supply chain, and data. Communication may be a particular issue since many of the patients at these centers aren't fluent in English.

Most of the people in underserved communities have access to technology, specifically smartphones, Nodora said – that's not the issue. "The issue is the message, the language and cultural concordance," he said. The larger concern is about providing follow-up care and information, he said. Getting someone in for an initial test may be easy but getting them to come back after a positive result is often more difficult. And scheduling for vaccinations, particularly the Moderna and Pfizer vaccines that require a second dose, will likely also be a problem. 

Supply chain challenges have continued throughout the pandemic, and there is always a question of getting enough personal protective equipment and supplies to provide these tests, as well as enough of the tests themselves.

As for data, he said that the data and assessment need to be granular, complete, and to encompass social determinants of health. If problems aren't getting adequately measured, it's harder to address them.

"COVID is just basically showing us that we have a huge public health and clinical issue or shortcoming within our infrastructure," Nodora said. For the populations with less resources, "it just exemplifies the lack of infrastructure, the lack of attention, the lack of information, detailed information, and data.

"All these systems are scrambling to try to go to where the problem is and where the real needs are," he added.

Another RADx-UP project, spearheaded by Dedra Buchwald – a professor at the Elson S. Floyd College of Medicine and director of the Institute for Research and Education to Advance Community Health at Washington State University – aims to advance testing for Native American communities. The project has been awarded $4.3 million over two years.

Her team is partnering with Urban Indian Health Programs to eliminate barriers to SARS-CoV-2 testing, first by analyzing data from the UIHPs to see current testing figures, then surveying administrators, providers, and 600 patients to understand the barriers and preferred testing options. Once those surveys are complete, the UIHPs will implement clinic-associated and outreach-based strategies, such as drive-through testing, mobile unit-based testing, and COVID-19 navigators, to increase testing. The testing rates will be re-examined after a year and then Buchwald's team and the UIHPs will produce a list of sustainable practices for future pandemics and vaccination programs.

Buchwald said the initial data analysis, as well as surveying at three of the sites, has already occurred and the team is just starting to take the information and making documents for the lessons learned during the study, although the final analysis hasn't been done yet. A benefit of working with the UIHPs is that patients already know the clinics and the providers and trust them, which helps increase testing rates, she added.

She also said options for at-home testing, which have been another major emphasis of the Biden administration, are dependent on the specific Native populations. For those with access to broadband internet connections and a computer, at-home testing is easier because they can order the test online. However, not all patients served by UIHPs have broadband internet, and people in those communities must rely on clinic-based testing.

Another issue she raised echoed Nodora's comments about comprehensive data getting collected. For some grant proposals to the NIH, the turnaround time for finding out about the grant and completing and submitting a proposal is just a few weeks, making it impossible to partner with a Native community or clinic, write the grant, and get it submitted.

"Just by the structure and the timeline of those opportunities, you automatically exclude Native people," she said. 

Another initiative funded by RADx-UP called the SCALE-UP Utah project and led by researchers at the University of Utah, is investigating the most efficient way to offer testing at community health centers. It is looking at clinic and population health management interventions to increase the uptake of COVID-19 testing and examining their effectiveness.

The clinics are offering a variety of testing, both PCR and rapid antigen tests, and the program is looking into rolling out at-home testing, said Jennifer Wirth, the project's manager and the program manager at the Center for Health Outcomes and Population Equity at the University of Utah. The project is targeting people who receive care from CHCs, mostly poor and under-insured patients. 

Kellie Morrow, director of operations at Mountainlands Community Health Center, one of the CHCs involved in SCALE-UP, said there are multiple barriers for underserved people trying to access testing. Just trying to get to the clinics where testing occurs can be a challenge due to limited hours of service, and limited access to transportation. To alleviate those issues, Morrow said the clinic offered testing every weekday afternoon and on Saturdays, and it worked with the Utah Transit Authority to offer homeless people free 24-hour bus passes, so they could access testing at the clinics and pharmacies if they needed prescriptions.

Morrow said her clinic also does testing at homeless sites sometimes, via a mobile testing site.

The sheer volume of people who need testing can also complicate logistics, as Morrow said that on some days early in the pandemic the clinics reached full capacity for the day within 20 minutes of opening, although that demand has tapered off, and the clinic is only offering testing three days a week right now.

Another concern is the issue of patient trust in the healthcare system. Morrow said that people aren't comfortable receiving care from sites they don't know, such as those provided by government departments of health or other organizations. In addition, 68 percent of the Mountainlands patient population identifies as an ethnic or racial minority, with 50 percent to 60 percent of the population speaking a language other than English, according to Morrow. Many of the places to get testing weren't offering services in Spanish or other languages, which also contributed to the lack of trust in the institutions.

The distrust is magnified with vaccines, Morrow said. With a test someone can decide to "take or leave" the result and choose what they want to do with it. A vaccine, on the other hand, requires an injection that "can have potentially a negative outcome."

One of the interventions the study is assessing is the use of text messages only versus texts and a one-on-one navigation call to determine which is more effective in getting patients tested. The hypothesis, Wirth said, is that patients who receive the personalized call from a healthcare worker will lead to more testing and vaccinations.

The other key intervention is the implementation of a customizable population health management tool that would make it easier to contact patients and allow for risk stratification, which could have long-term impacts on the patient population. CHCs would have access to their own data through the tool, but also be able to compare their data with other CHCs, said Courtney Pariera Dinkins, associate director of the Association for Utah Community Health.

Morrow said that existing population health management tools aren't very customizable or easy to pull data from. "I could sit here and probably list 100 different healthcare gaps that are there right now … that we're not fulfilling that this project could help us be able to fill that gap in," she said. One example is using the system to get home screening kits for colorectal cancer returned, which is a major issue for her clinic. 

Despite the difficulties of providing COVID-19 testing and figuring out what works during the height of a pandemic, the improvements being made and tools being implemented through the NIH programs are intended to last beyond this outbreak and address the underlying disparities in US healthcare.

"My sincerest hope … is that the lessons that we learn through this do not just have an application for COVID-19, but [that] they emphasize the importance of addressing and fixing all these problems that we have in both our clinical and public health infrastructure in how we meet the needs of poor and underserved communities," Nodora said.