Editor’s note: Cook County Health responded after this article was published, when CCH clarified that they have not stopped clinical trials. While there was a pause on starting new trials due to CCH’s investigation, since CCH announced the separation from Hektoen, three new clinical trials are now in the pipeline.
By Madeline Makoul
What started as a probe into the nonprofit organization that has managed Cook County Health’s (CCH) medical research grants for decades has ended with the county severing ties with the organization.
Hektoen Institute for Medical Research, the nonprofit managing these grants, officially will stop working with the county come March 29. This decision comes nearly two years after CCH told researchers at the Ruth M. Rothstein CORE Center, a clinic on the Near West Side known for its HIV/AIDS research and care, to “pause” their new clinical trials in April 2022. The pause went into effect as CCH announced it was awaiting results of a county review into Hektoen—the results of which the county still has not shared.
In a statement CCH said a thorough review was conducted before settling on the decision to bring the functions in-house.
“For the past year, we have been developing the internal infrastructure necessary to do ethics effectively,” the statement read. “This includes the creation of a new office that is staffed with experts in research administration who provide administrative oversight of clinical research, and develop and implement new systems, policies, and procedures to support excellence in all phases of clinical research.”
Jim Pickett, a senior advisor with the AIDS Vaccine Advocacy Coalition and a longtime HIV prevention research advocate, said the lack of transparency throughout the probe “spread a lot of dust and confusion,” without any answers.
According to Pickett, CCH “never had any actual reason for investigating. What they have done is…severed an incredibly important relationship in the community that will have a real impact, and now it’s well beyond research.”
Although the investigation initially paused research, Pickett said severing the relationship with Hektoen goes far beyond, affecting care provided at the CORE Center. Hektoen manages several grants at CORE and across CCH, including managing the Ryan White CARE Act, a Public Service Act that provides grants to improve care availability and quality for those affected by HIV.
John Peller, president and CEO at the AIDS Foundation Chicago, agreed the situation has lacked transparency about the rationale for CCH cutting ties with Hektoen.
In addition, “There is not a concrete plan that Cook County Health has articulated for transitioning the programs that are funded through Hektoen and the staff in any kind of seamless way over to county employment,” Peller said. “From our perspective, this relationship with Hektoen has been working very well, and we believe getting rid of Hektoen will only result in disruption.”
CCH, however, said in the statement that this transition will allow CCH to “be best able to ensure the provision of compliant, safe, and sustainable grant and research programs for HIV care and more.
“We understand the critical important of access to care for patients living with HIV and are committed to supporting current patient services and active clinical trials through this process,” CCH said.
Changes for CORE
Within the CORE Center and throughout the HIV care system at CCH, 60% of employees are funded through grants and contracts Hektoen holds, Peller explained. This staff has unique training to provide support to the 6,000 to 7,000 patients living with HIV who get care through Cook County, and Peller shared his concern over how this transition from Hektoen to county employee will happen.
Pickett emphasized these transitions could destabilize a system that otherwise was working.
“I talk a lot about Hektoen being a pillar of services in the community, and at the end of the day, it’s about the people delivering those services,” Pickett said.
In the statement provided by CCH, it affirmed that Hektoen’s staff has “been an important extension of our team,” over the years of the partnership.
While many remain concerned about CORE continuing its services, some of the research elements transferred over to the University of Illinois Chicago in the summer, allowing Chicago’s important HIV/AIDS research to continue.
The combination of both AIDS/HIV care services and research, however, offered unique benefits at CORE, Peller explained.
“Our concern is that, over the decades, a lot of the services that were provided for people getting care at the CORE Center were funded through research grants, so that’s where a lot of the innovative work happened—where they tested a lot of models that were later incorporated into longterm service provisions,” Peller said
CCH stated that it would be working with Hektoen to make the transition as smooth as possible, with a plan for how to transition grants most successfully.
“We know that all individuals involved share the same goal of providing expert, safe, and compassionate care to our patients and of advancing the practice of medicine,” CCH said. “Due to the nature of sponsored programs, each grant project will transition over on an individual schedule to ensure compliance with grant requirements and resources to support program continuity.”
Peller emphasized that, in CORE’s 25 years of service, the center has cemented itself as one of the largest providers of HIV prevention services in the Midwest and has been home to some of the most important HIV/AIDS research. In addition, CORE long has been an important location for training infectious disease healthcare providers to improve HIV care, an influence that has much wider impacts than just in Chicago, Peller said.
CCH “is playing very rough and loose with the lives of thousands of people who live with HIV and who rely on the high quality services that CORE has delivered for decades in partnership with Hektoen,” Pickett said. “Hektoen has been a pillar of support for care, research, and prevention, and that work is important to our community, but Cook County is just dissolving it.”
The goal of ending AIDS
With decades of impactful research and care, this transition for CORE as CCH takes the grant management in house leaves many wondering how this change will affect the ultimate goal: to end the AIDS epidemic.
Pickett said the research continuing at UIC remains essential to the end goal, especially as it pertains to youth and adolescents. A focus on this population became a hallmark of CORE’s research and offers enormous benefits, he said, noting about 20% of new HIV infections every year are among those age 13 through 24, making young people a sizable group affected by the epidemic.
“Becoming infected with HIV at 18, thanks to modern medicine, you can now live 50 to 60 years, so there are huge impacts, and it’s really great that research is staying here,” Pickett said. “But now the big glaring concern is what is happening at CORE Center and CCH with the services funded through Hektoen for people with HIV. They are in a high degree of jeopardy right now.”
For these vulnerable groups, any disruption to care can have a significant effect. Peller noted any disruption in caring for those living with HIV or those looking for access to PrEP (pre-exposure prophylaxis), poses a risk of transmitting HIV or someone getting sick because they cannot access the necessary medicine.
“The question that we have to ask over and over again is how does this change help us get closer to ending the HIV epidemic by 2030,” Peller said. “No matter how I look at this, I think the answer is: it’s not.”