New NIH grant project aims to improve Hepatitis C vaccine trials
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Hepatitis C transmission through shared syringes and drug paraphernalia is one of the major public health challenges of the opioid epidemic in the United States. About 4.1 million Americans are chronically impacted by this virus, and half are not aware they are living with the Hepatitis C.
While direct acting antiretrovirals control and eliminate the virus, they do not provide protection against infection or reinfection, and access to these medicines is costly. A Hepatitis C vaccine is needed to stop the spread of the virus.
SPH’s Basmattee Boodram, PhD in Epidemiology ’09 and an associate professor of community health sciences at the UIC School of Public Health, is leading a new project modeling clinical trial participation among people who use injection drugs. Funded by the National Institute of Allergy and Infectious Disease at the National Institutes of Health, Boodram is using computational modeling to address the high level of complexity in establishing representative samples of hard-to-reach populations.
“People who inject drugs in the U.S. are stigmatized, and the idea of someone even going to a doctor is a low priority for people who inject drugs,” Boodram said. “Our model is looking at all the facets related to the infection but also understanding the social level related to reinfection and transmission.”
Boodram is building an agent-based model that creates realistic profiles of people who inject drugs across healthcare access, social determinants of health, geography and more. She is using empirical data from her work with SPH’s Community Outreach Intervention Projects and two decades of her research on people who inject drugs.
In the opioid epidemic, non-urban, non-Hispanic white populations across the country are increasing use of injection drugs. In particular, young people in non-urban areas are experiencing the highest increases.
Boodram’s models will take into account the support services people who inject drugs may access. She says a clinical trial for a Hepatitis C vaccine should take into account access to and limitations of medication and the role of harm reduction services and other strategies to reduce injection drug use (e.g., medication assisted therapy). Trials need to test combinations of these factors, in particular to account for people treated for Hepatitis C who experience reinfection.
Trials also need to account for geographic variation. For example, Chicago is a low incidence location for Hepatitis C because of the current social networks of people who inject drugs. These networks are not interconnected, unlike a city like San Francisco, with a dense and connected network of people who inject drugs with high incidence of Hepatitis C.
Finally, incarceration is a social determinant of health that needs to factor into trial models. For people who use injection drugs, incarceration can be a regular part of their lives. Upon release, some may have lost their old networks and join a new network. How these networks meld and change over time is the subject of connected research from Boodram.
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“Treatment alone has never been a solution in the U.S. We’re not addressing the incidence, and more and more people are initiating drug use and sharing in the opioid epidemic. We have to address the epidemic with a vaccine, syringe exchanges and treatment.
| Associate Professor of Community Health Sciences
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Previous Hepatitis C vaccine trials in the U.S. have faced difficulties building representative samples of the population. Often, these trials have been designed by clinicians, but Boodram says introducing social epidemiology is a needed step to address lack of effectiveness in previous vaccine trials.
Co-investigators on the project include Mary Ellen Mackesy-Amiti, PhD, research associate professor of community health sciences at the UIC School of Public Health; Kimberly Page, PhD protocol chair of the first clinical trial of an experimental prophylactic vaccine against HCV; and Marian Major, PhD chief of the laboratory of hepatitis viruses at the FDA. The project is co-led by Harel Dahari, PhD, associate professor of hepatology at Loyola University Chicago and Jonathan Ozik, PhD principal computational scientist at Argonne National Laboratory.