Montana State University is on the rise with research expenditures hitting record highs being recently reported at $167 million for the 2019-2020 period. Now the National Institutes of Health (NIH) has awarded the Bozeman-based Montana State University Center for American Indian and Rural Health Equity (CAIRHE) to investigate COVID-19 testing strategies among the most underserved communities in Montana and Washington. A grant totaling $1,797,140 to CAIRHE is part of the NIH’s $1.4 billion Rapid Acceleration of Diagnostics initiative, or RADx, created in the early weeks of the COVID-19 pandemic to address the need for scaled up testing across the country. TrialSite has reported on RADx-UP across the country, the component of the program that funds community-engaged projects such as the one CAIRHE will embark on now in this vast, heavily rural part of the United States. Many of the communities targeted in this research are among the hardest hit in the United States, including several Native American reservations. Montana State’s CAIRHE initiative is now one of 70 across the United States and exemplifies the growth of prominence in research wielded by Fighting Bobcats. The Montana State effort is led by principal investigator Alexandra Adams, Director of CAIRHE.
Targeting underserved communities in the RADx-UP typically involves significant collaboration with various institutions and community organizations in a select community. Montana is no different in that regard—and perhaps somewhat unique compared to other communities in the sheer size of landmass covered combined with the dispersed, rural population.
This collaboration involves CAIRHE along with MSU in partnership with the University of Washington’s School of Medicine and Institute of Translational Health Science (ITHS); the Fred Hutchinson Cancer Research Center in Seattle; and Salish Kootnai College and the Confederated Salish and Kootenai Tribes on the Flathead Reservation in Montana. A local community advisory board will be involved in all stages of the research in each study location.
The Montana team — led by Adams and Selena Ahmed at CAIRHE, with Virgil Dupuis and Dr. Wendy Westbroek at Salish Kootenai College — will use CAIRHE’s existing research partnerships on the Flathead Reservation to study testing approaches among the area’s Native population.
“These communities are very similar in the rural barriers to testing that they face,” Adams said. “And they’re connected by seasonal farm workers who travel between the two areas, possibly bringing the coronavirus with them.”
The CAIRHE-led study, titled Protecting Our Community: A Pragmatic Randomized Trial of Home-Based COVID Testing with American Indian and Latino Communities, is funded by the Office of the Director of the NIH and administered by the National Institute of General Medical Sciences, which provides CAIRHE’s Centers of Biomedical Research Excellence, or COBRE, grant. In 2019 CAIRHE received a competitive renewal of its COBRE grant totaling $10.7 million through 2024.
The research hypothesis put forth involves development and distribution of test kits for targeted communities.
In each of the two locations, the project will conduct a 200-person randomized trial in the spring of 2021 that compares two approaches to home-based COVID-19 testing, Adams explained. In the “active” approach, local health educators who are trusted community members will deliver tests to study participants and provide assistance. In the “passive” approach, participants will instead receive test kits by mail or at a pick-up location. All participants will receive culturally adapted printed and video instructions, as well as a survey on their current symptoms and medical conditions.
Currently, the research team is waiting to see if tests suitable for home use, with results immediately available to the participant, will receive U.S. Food and Drug Administration approval and be commercially available in time for the study. If not, home-based sampling will be analyzed in an alternative way.
Prior to the testing trial, a series of interviews and focus groups in each study community will explore individuals’ knowledge of COVID-19 and preventive measures; beliefs about COVID-19 testing; and cultural factors that affect their testing decisions. This data will help study leaders determine the cultural, social, behavioral and economic barriers to testing that exist in those communities, Adams said.
“Using this information, we can develop the educational materials that will accompany the test kits so that they’re culturally appropriate and most effective for each community,” she added.
Montana State University Perspective
Jason Carter, MSU, vice president for research, economic development and graduate education, reported, “Montana State is committed to building strong, equitable and sustainable partnerships with tribal nations, as well as the university of Washington’s ITHS program.” He continued, “Dr. Adams and her CAIRHE team are experienced at building meaningful and impactful partnerships, and I am not at all surprised by the NIH investment in this remarkable team.”
Principal Investigator POV
Alexandra Adams, a physician and director of CAIRHE and principal investigator commented recently that, “The significant health disparities that already existed among Native and rural communities in Montana and our region have become even more pronounced with COVID-19.” Dr. Adams continued, “Because of poor access to testing in those areas and high rates of existing chronic disease, we are very concerned about the significant impact of COVID-19 in these communities.”
In the meantime, a prominent group of participants, including UW physicians Matthew Thompson and Paul Drain will provide expertise on home-based testing as part of the Seattle Coronavirus Assessment Network. While scientists from the prestigious Fred Hutchinson, Linda Ko, and her team will work with their community partners in Washington’s Yakima Valley, home to a sizable Latino population that includes migrant agricultural workers.
The project’s clinical partners in Washington, led by physician Allison Lambert of Providence Medical Group in Spokane, will consult with participants about test results. Those who test positive for COVID-19 will be referred to local public health agencies for contact tracing and clinical follow-up.
Trial Follow Up
Following the trial, the joint study team will evaluate the acceptability and feasibility of the home-based testing approaches through participant surveys. That information will allow CAIRHE and its partners to create testing protocols that could significantly increase home-based testing among Native and Latino communities nationwide, Adams said.
“At the end of the day, our goal is to decrease the devastating impact of COVID-19 in these vulnerable rural areas,” she said.
Alexandra Adams, MD, PhD, Director of CAIRHE, Principal Investigator
Virgil Dupuis, Extension Director, Salish Kootenai College
Wendy Westbroek, PhD, Salish Kootenai College
Paul Drain, MD, UW
Linda Ko, PhD, Fred Hutchinson