Faculty members in the Clemson University College of Behavioral, Social and Health Sciences (CBSHS) have received $3.4 million in funding from the Patient-Centered Outcomes Research Institute (PCORI) to implement research findings from a previous PCORI-funded research project into clinical practice.
This effort is co-led by Alain Litwin, MD, MPH, professor of practice in the Department of Psychology and Clemson University School of Health Research, co-director of the Clemson University Center for Addiction and Mental Health Research and vice chair of academics and research in the Department of Medicine at Prisma Health and University of South Carolina School of Medicine, and John Ward, MD, director of the Coalition for Global Hepatitis Elimination and adjunct professor with the Rollins School of Public Health of Emory University. Moonseong Heo, Ph.D., professor in the Department of Public Health Sciences at Clemson University, has led the parent HERO data team and will oversee the Hero in Practice implementation efforts.
The new PCORI funding (HERO in Practice) will support the implementation of research findings from the completed HERO randomized controlled trial, a comparative effectiveness study examining two models of hepatitis c (HCV) care in people who inject drugs (PWID).
“I am grateful to PCORI for this support as it allows us to move beyond discovery and into implementation,” said Litwin. “Our previous PCORI-funded study generated promising evidence that will meaningfully improve patient outcomes, and this funding provides the infrastructure to translate those findings directly into clinical practice. It is an opportunity to bridge the gap between research and real-world care and ensure that what we learn in controlled settings truly benefits people who inject drugs living with hepatitis c virus.”
The original study compared two patient-centered models of HCV care in people with active drug use. This was a randomized, controlled trial conducted at ten opioid treatment programs and 15 community health centers in eight cities nationwide. During the study, 755 people actively injecting drugs within three months of the study were randomly selected to participate in one of two interventions, patient navigation (PN) or modified directly observed therapy (mDOT). All participants received a fixed-dose combination tablet (sofosbuvir 400 mg/velpatasvir 100 mg) once daily for 12 weeks.
The primary outcome was sustained virologic response (SVR) – or the inability to detect HCV genetic material in the blood 12 or more weeks after completing interventions. The results demonstrated that people who actively inject drugs can achieve high SVR in diverse settings with either mDOT or PN support. The findings were significant because no study has directly compared models of mDOT and PN in active PWID.
Based on these findings, the new project, HERO in Practice, will implement on-site HCV treatment programs at 21 clinical sites and networks that serve people who inject drugs across the United States. These on-site programs are designed to increase diagnosis and intervention initiation and completion, cure HCV-infected PWID and minimize reinfection.
The project team will apply evidence from the previous study to facilitate implementation of patient-centered models nationwide. They will work with opioid treatment programs, rural clinics, mobile health clinics and correctional facilities and collaborate with states’ Department of Health, offices of rural health and regional networks of opioid treatment programs to leverage established training, technical assistance and real-time clinical expertise mechanisms and deliver user-friendly evidence-based guides for diverse stakeholders.
“In addition to funding patient-centered comparative clinical effectiveness research, PCORI funds dissemination and implementation projects like this one to support the uptake of findings into clinical practice,” said PCORI Executive Director Nakela L. Cook, M.D., MPH. “Implementing evidence addressing a key gap in care for hepatitis C virus, this project has the potential to improve health care practice and patient outcomes.”
Litwin’s funding award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent nonprofit with a mission to fund research designed to provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.
The Departments of Psychology and Public Health Sciences are part of the College of Behavioral, Social and Health Sciences. Established in July 2016, CBSHS is a 21st-century, land-grant college that combines work in nine disciplines – communication; nursing; parks, recreation and tourism management; political science; psychology; public health sciences; sociology, anthropology and criminal justice – to further its mission of “building people and communities” in South Carolina and beyond.
