Patient-Centered HCV Care via Telemedicine for Individuals on Opiate Substitution Therapy: A Stepped Wedge Cluster Randomized Controlled Trial
Hepatitis C virus (HCV) affects almost 5 million people in the United States and is a major cause of chronic liver disease leading to liver fibrosis, cirrhosis, liver cancer and death. Persons with substance use disorders (PWSUD), specifically injection drug users, have the highest HCV prevalence and incidence rates but only a small minority is treated for the infection. Referral to an HCV specialist is the current standard HCV management strategy for PWSUD. However, while the majority of PWSUD express willingness to be treated for HCV, only a very small percentage has actually received HCV treatment. Therefore, novel models for HCV care in this population are needed as current approaches for HCV treatment of PWSUD are limited in their reach and effectiveness.
The primary aim of this study is to compare the effectiveness of patient-centered delivery of HCV care through telemedicine with referral to an offsite liver or infectious diseases specialist, which is the current standard of care. The study is conducted as a non-blinded stepped-wedge cluster randomized controlled trial with two arms in twelve geographically distinct opiate substitutions treatment programs (OSTPs) from throughout New York State over a five year period. All sites will start with applying their standard of care and at regular 9 months intervals a group of 4 OSTPs will switch in random order to the telemedicine intervention. The primary outcome will be assessed at week 12 post-treatment to establish sustained virologic response. Patients will be followed for 24 months post treatment completion to assess for reinfection. We aim to recruit a total of 624 patients in the study, with 52 patients recruited per OSTP.
HCV Telemedicine simulation
Triple E for HCV- Engagement, Education and Eradication of HCV Among Patients with Substance Use Disorders
Andrew Talal, MD MPH
Professor and Director, Center for Research and Clinical Care in Liver Disease
University at Buffalo
Clinical Directors Network (CDN), and the Patient Centered Outcomes Research Institute project on Patient-Centered HCV Care via Telemedicine for Individuals on Opiate Substitution Therapy (PCORI Grant # 1507-31640)
Tuesday, November 15th, 2016, 12:00 – 1:30 PM EST
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- Talal AH, McLeod A, Andrews P, Nieves-McGrath H, Chen Y, Reynolds A, Sylvester C, Dickerson SS, Markatou M, Brown LS. Patient Reaction to Telemedicine for Clinical Management of Hepatitis C Virus Integrated into an Opioid Treatment Program. Telemedicine and e-Health. 2018 Oct 16. PMID: 30325701
- Talal AH, Chen Y, Zeremski M, Zavala R, Sylvester C, Kuhns M, et al. Hepatitis C virus core antigen: A potential alternative to HCV RNA testing among persons with substance use disorders. J Subst Abuse Treat. 2017;78:37–42. PMID: 28554601
- Alemayehu D, Chen Y, Markatou M. A comparative study of subgroup identification methods for differential treatment effect: Performance metrics and recommendations. Stat Methods Med Res. 2017 Jun 20;96228021771057. PMID: 28629264
- Gonzalez SA, Fierer DS, Talal AH. Medical and Behavioral Approaches to Engage People Who Inject Drugs Into Care for Hepatitis C Virus Infection. Addict Disord Their Treat. 2017 Jun;16:S1–23. [LINK]
- Talal AH, Thomas DL, Reynolds JL, Khalsa JH, JP B, M P, et al. Toward Optimal Control of Hepatitis C Virus Infection in Persons With Substance Use Disorders. Ann Intern Med]. 2017 Jun 20;166(12):897. PMID: 28437796
- “Gov. Cuomo names UB expert to statewide task force on hepatitis C virus” [CLICK HERE FOR MORE]
- Akuffo, Rachelle. “Dr. Andrew H. Talal discusses World Hepatitis Day.” China Global Television Network. Web. [CLICK HERE FOR VIDEO]
- Scanlon, Scott. “Hepatitis C can be cured: Should you get tested?” The Buffalo News, 7 Jul, 2017. Web. [CLICK HERE FOR MORE]
- “UB research receives $7 million award to study telemedicine as a way to treat HCV-infected drug users.” University at Buffalo News Releases. 26 May, 2016. Web. [CLICK HERE FOR MORE]
- “Solving the Hepatitis C Epidemic Among Population of Drug Users.” Jacobs School of Medicine and Biomedical Sciences – University at Buffalo. 3 May, 2017. Web. [CLICK HERE FOR MORE] [CLICK FOR VIDEO]
- Talal, Andrew. “Telemedicine Aids Treatment of Patients with HCV, Substance Use Disorders.” Healio. SLACK Incorporated, 23 Apr. 2017. Web. [CLICK HERE FOR MORE]
- Andrew Talal discusses integrating substance use and Hepatitis C care through telehealth. This allows health care providers in different locations to collaborate and treat patients who are in need of both services through the use of technology.
- Volanski, Rob. “Telemedicine Programs Flourish in the DAA Era.“ HCV Next (2017). Healio. SLACK Incorporated, 15 Mar. 2017. Web. [CLICK HERE FOR MORE]
- Telemedicine programs, with the rise of technology, are expanding rapidly where video is used to train primary care clinicians in locations that have shortages of HCV through a program called ECHO. Also, telemedicine patient visits made it so more people can be treated without compromising patient-satisfaction and increasing cost effectiveness and compliance.
- Tan, Sandra. “Opioid epidemic leads to revival of hepatitis cases.” Buffalo News, 6 Feb. 2017. Web. [CLICK HERE FOR MORE]
- University at Buffalo professor leads the battle for treating hepatitis C cases in needle-users.
- Altersitz, Katrina. “Collaboration in Buffalo: How Liver Care Is Changing the Face of a City.“ HCV Next (2015). Healio. SLACK Incorporated, Oct. 2015. Web. [CLICK HERE FOR MORE]
- Andrew Talal and Anthony Martinez collaborated in Buffalo to create liver centers where the no show rate is minimized and a telemedicine based approach to HCV care is integrated in the practice. In addition, research is being performed on improving HCV screening and a liver biorepository is being developed in Buffalo.
- Patient Testimonials on Telemedicine-based Treatment: Living with Hepatitis C [CLICK HERE FOR VIDEO]
- Speakers: Dr. Andrew Talal and Patient Representatives
Produced by: The University at Buffalo and START Treatment and Recovery Centers
- Speakers: Dr. Andrew Talal and Patient Representatives
- Case Study in Hepatitis C: Managing Chronic HCV in a Patient on Opioid Substitution Treatment.
- Contributing Editors: Andrew H. Talal, MD, MPH, Phyllis Andres, RPA-C, and Heidi Nieves-Mcgrath, BSN
- Medical Writer: Kirstin Bass, MD, PhD