TeamC

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.

Image used with permission from SLACK Incorporated

[CLICK HERE FOR PROJECT FACT SHEET]

Timeline

Participating Sites

Usual Care Arm

Patient Flow Diagram [PDF]

Telemedicine Care Arm

Patient Flow Diagram [PDF]

 

HCV Telemedicine simulation

HCV Telemedicine simulation in Spanish

NATAP HCV Webinar

Key Considerations for HCV Elimination in the U.S.

Andrew H. Talal MD, MPH
Professor of Medicine
SUNY University at Buffalo

Link to archived webcast
Download the Slide Set Here
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Webcasts

Rigorous Clinical Trials in Real World Settings

Speaker:
Marianthi Markatou, PhD
Professor of Biostatistics, Associate Chair of Research and Healthcare Informatics, Department of Biostatistics, School of Public Health and Health Professions, Assistant Director, Institute of Healthcare Informatics, Adjunct Professor, Department of Computer Science and Engineering, University of Buffalo, New York

Sponsor:
Clinical Directors Network Inc, (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)

Date:
Monday, June 28, 2021, 12:00 PM – 1:30 PM ET

Treating Substance Users for HCV via Telemedicine: Implementation and Engagement Considerations

Speaker:
Andrew Talal, MD MPH

Professor and Director, Center for Research and Clinical Care in Liver Disease
University at Buffalo

Sponsor:
Clinical Directors Network Inc, (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)

Date:
Wednesday, May 12, 2021, 12:00 PM to 1:30 PM ET

Innovative Strategies to Eliminate HCV

Speaker:
Andrew Talal, MD MPH
Professor and Director, Center for Research and Clinical Care in Liver Disease
University at Buffalo

Sponsor:
Clinical Directors Network Inc, (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)

Date:
Friday June 7, 2019; 1:00 PM to 2:30 PM ET

Triple E for HCV- Engagement, Education and Eradication of HCV Among Patients with Substance Use Disorders

Speaker:
Andrew Talal, MD MPH
Professor and Director, Center for Research and Clinical Care in Liver Disease
University at Buffalo

Sponsor:
Clinical Directors Network, Inc. (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)

Date:
Tuesday, November 15th, 2016, 12:00 – 1:30 PM EST

HCV Clinical Provider Trainings 

 Click Here for Trainings

Opportunities to Improve Opioid Use Disorder and Infectious Disease Services:
Integrating Responses to a Dual Epidemic (2020) CLICK HERE TO LEARN MORE!

Publications

  1. Talal AH, Jaanimägi U, Davis K, Bailey J, Bauer BM, Dharia A, George S, McLeod A, Morton K, Nugent A, Zeremski M. Facilitating engagement of persons with opioid use disorder in treatment for hepatitis C virus infection via telemedicine: Stories of onsite case managers. Journal of Substance Abuse Treatment. 2021 Apr 21:108421. [LINK]
  2. Talal AH, Sofikitou EM, Jaanimägi U, Zeremski M, Tobin JN, Markatou M. A Framework for Patient-Centered Telemedicine: Application and Lessons Learned from Vulnerable Populations. J Biomed Inform. 2020 Nov 10:103622. doi: 10.1016/j.jbi.2020.103622. Epub ahead of print. PMID: 33186707
  3. Talal AH, Andrews P, Mcleod A, Chen Y, Sylvester C, Markatou M, Brown LS. Integrated, Co-located, Telemedicine-based Treatment Approaches for Hepatitis C Virus (HCV) Management in Opioid Use Disorder Patients on Methadone. Clinical Infectious Diseases. 2018 Oct 17. PMID: 30329042 
  4. 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
  5. 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
  6. 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 
  7. 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]
  8. 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 
Please CONTACT US to request a copy of any of the reprints listed.

Additional Resources

  • “Hepatitis C Expert Applauds New Recommendation for HCV Screening” [CLICK HERE FOR MORE]
  • “Attacking a Medical Quandary” [CLICK HERE FOR MORE]
  • “Telemedicine Takes Focus in Study of HCV Treatment in Methadone Centers” [CLICK HERE FOR MORE]
  • “Telehealth Project Expands to Tackle HCV, Substance Abuse Treatment” [CLICK HERE FOR MORE]
  • “Buffalo-launched Opioid Treatment Aims to Thwart Deadly Related Virus” [CLICK HERE FOR MORE]
  • “Treating Substance Use and Hep C Through Telemedicine” [CLICK HERE FOR MORE]
  • “COMPA Members Help Researchers Study Benefits of Telemedicine in Treating Opioid Use Disorder and Hepatitis C” [CLICK HERE FOR MORE]
  • “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
    • Speakers: Dr. Andrew Talal and Patient Representatives
      Produced by: The University at Buffalo and START Treatment and Recovery Centers
  • Patient Testimonials on Telemedicine-based Treatment: Living with Hepatitis C [CLICK HERE FOR VIDEO]
  • 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
  • SAMHSA’s Take Action Against Hepatitis C – For People in Recovery from Mental Illness or Addiction  [PDF]
    • This booklet is intended for use with clients who:
      • Are at risk for infection with the hepatitis C virus (HCV)
      • Have been identified as HCV antibody positive
      • Have been diagnosed with hepatitis C

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