ACTIV-2 Comes to Lakota Country: Introducing The American Indian Clinical Trials Research Network

ACTIV-2 Comes to Lakota Country Introducing The American Indian Clinical Trials Research Network

A new trial site organization opened its doors in response to the COVID-19 pandemic, embracing the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), program, a public-private partnership initiative launched by the National Institutes of Health (NIH) in response to the pandemic. The American Indian Clinical Trials Research Network, a trial site operation affiliated with the Black Hills Center for American Indian health in Rapid City, South Dakota, joined the ACTIV-2 program as a participating trial site, focusing on outpatient studies involving monoclonal antibodies and other therapeutics. While vaccination is part of the solution to the COVID-19 pandemic, its not the entire answer; along with protective practices therapeutic advances to treat SARS-CoV-2, the virus behind COVID-19 represents an important medicinal contribution to a path back to normalcy. Here in the Black Hills area, the clinical research as a care option movement gains momentum thanks to an innovative, forward thinking physician and Principal Investigator who also happens to be Lakota.

Welcome to Native Country

Adjacent to the Black Hills, the American Indian Clinical Trials Research Network operates in what truly can be considered a special part of America; some would consider this place sacred lands that connect to extremely proud indigenous populations (e.g. Lakota and several other groups). Despite centuries of struggle, oppression, war and strife—not to mention modern problems of poverty, alcoholism and economic stagnation—a population here possess a spark of fierce resonance, reverberating through not only the local population, but radiating outward to the rest of the society in ways many fail to understand. This pandemic, that is the pathogen called SARS-CoV-2, mobilized Indians here in ways that at times conflicted with the Governor of the State of South Dakota. But Anglo-American and Native conflict has been more the rule than the exception.

The Pandemic in Americana

While the pandemic spread throughout the land, by the end of October, tribal nations here in many cases closed their boundaries to non-residents.  For example, the Oglala Sioux and Cheyenne River Sioux established checkpoints at reservation entry points to protect local residents despite broader policies to the contrary established at the state level. At the time, South Dakota Gov. Kirsti Noem refused to mandate masks or even social distancing.

Tribal governments in South Dakota would have none of that, erecting checkpoints and establishing their own protective measures. In yet another example of Anglo-American and Indian conflict, the state of South Dakota ordered the native tribes to remove their checkpoints or deal with the legal consequences of following the government’s lead. In one documented case, the Indians refused, declaring that the protection of people’s health was more important. 

The conflict carried on during the pandemic and, in fact, according to an indigenous rights group called Cultural Survival, South Dakota government via the Governor was merely carrying out the same repressive tactics that have gone on in these parts for the past 125 years. The Cheyenne River Sioux actually sued the U.S. federal government, arguing that the move to shut down the Indian checkpoints would undermine tribal sovereignty and expose reservation residents to the life threatening pathogen.

Impact on Indians

The pandemic raised fears here as historically such contagions hit Native communities especially hard. American Indians and Alaska Natives for example faced a mortality rate four times as high as the general population during the 2009 H1n1 influenza outbreak.  

According to one scholar’s research published in The Lancet Infectious Diseases, Natives were 3.5 times more likely to be infected with SARS-CoV-2 than the white population based on data collected from the U.S. Center for Disease Control and Prevention (CDC). This same researcher reports that the Color of Coronavirus project estimated that just early in the four weeks from January to Feb 2, 2021, Native Americans experienced the deadliest stretch of the contagion while already economically depressed reservations were ravaged with the closing of tribal businesses, casinos, and the like. 

That COVID-19 threatens Native vibrancy, sustenance and cultural reproduction isn’t lost to leaders as the elderly serve such a vital function, here, teaching the youth and passing down the culture itself via storytelling for example. COVID-19 deadly march against elders here (as is with other places) threatens far more than just the loss of a life. The elderly are the custodians of the language, history and tradition to the truly indigenous way of life. Perhaps because of this special connection, the intense urgency for vaccination and interest in treatment leads to the launching of an important trial site organization.

Native Americans Embrace COVID-19 Vaccination

Vaccination programs have arrived here, and NPR reports that Native Americans are getting vaccinated at faster rates than the rest of the population. Although an Indian embrace of COVID-19 vaccination generally has led to a higher confidence more recently, that is, that things are on their way back to normal, all acknowledge that the storm hasn’t passed yet and that other treatments are still needed, reports local KOTA TV

The Program

Based out of the Black Hills Center for American Indian Health in Rapid City, the American Clinical Trials Research Network joined up with ACTIV-2 to offer local residents access to advanced therapies that could be the difference between life and death, at least for some people.   

While the local television network KOTA (part of Gray) identified ACTIV-2 as a drug, its actually a program involving multiple experimental therapies. More specifically, the ACTIV-2 program, which involves outpatient monoclonal antibodies and other therapeutics including monoclonal antibodies from Brii Biosciences as well as the long-acting dual-antibody from AstraZeneca (AZD7442), is under investigation as both prophylaxis and post-exposure therapy. 

Open to those individuals here who have been infected with COVID-19 and may experience mild to moderate symptoms, the investigational treatment represents an opportunity to not only mitigate the danger of disease progression but also contribute to the evidence that such drugs can advance to either emergency use authorization or approval. Importantly, if the study can help save more elderly lives, the culture certainly benefits as well.

The Trial Site

The Native-American run Black Hills Center for American Indian Health (BHCAIH) was actually incorporated back in 1998 to enhance the physical, mental, spiritual and cultural health of American Indians and American Indian tribes and communities.

With a vision statement “Toward Healthier Nations,” BHCAIH received approximately $11.5 million in eight National Institutes of Healthcare, Research and Quality and Indian Health Service peer-review grants in the last several years. The grants address a number of important therapeutic and/or health areas from cancer and diabetes to heart disease and tobacco use.

BHCAIH conducts a number of studies including cancer, dietary association, lifestyle risks and now COVID-19 via the ACTIV-2 program. Although BHCAIH and its new American Indian Clinical Trials Research Network focuses on Native American treatment, any and all people are welcome.

The Principal Investigator here in Lakota is Dr. Jeff Henderson who also happened to have founded and serves as president of BHCAIH. Henderson was educated at University of California, San Diego, earning his MD as well as a MPH from University of Washington. Dr. Henderson also received a certificate from CITI for Human Subjects Protections Training.

Dr. Henderson is Native himself, and his partner at BHCAIH is Dr. Patricia Nez Henderson, MH, MPH.

Dr. Henderson and his team are working on important initiatives, not only bringing the most advanced COVID-19 therapies to some of the poorest locations in the United States, but also showcasing a holistic approach that finds more engagement with the local Native community. Other programs span health training, clinical care, philanthropy and the emerging clinical research as a care option.

Lead Research/Investigator

Jeff Henderson, MD, MPH

Call to Action: Sponsors seeking to engage with Native communities should get to know Dr. Henderson and the new American Indian Clinical Trials Research Network