Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals

NCT02933970 | Completed Results DMC

• 1 other identifier: Telemedicine vs. Usual Care
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication

  Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)

  12 weeks post treatment cessation

Secondary Outcomes (3)

• Comparison of Treatment Initiation Percentages

  Up to 160 weeks

• Comparison of Treatment Completion Rates

  Up to 210 weeks

• Comparison of Patient Satisfaction

  Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).

Study Arms (2)

Control

NO INTERVENTION

Referral-HCV seropositive subjects enrolled for at least 12 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist

Intervention

OTHER

Telemedicine - HCV seropositive subjects enrolled for at least 12 months in an OAT program will be treated on site by a liver specialist via two-way video conferencing. (telemedicine)

Other: Telemedicine

Interventions

Telemedicine OTHER

Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member

Also known as: Two way video conferencing

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV antibody detected
• Ability and willingness of subject or legal representative to provide written informed consent.
• years of age
• A minimum of 12-month enrollment in the opiate agonist treatment program
• Likely to be adherent to the therapeutic regimen
• Covered by medical insurance

You may not qualify if:

• Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
• \<18 years of age
• \< 12 months enrolled in an opiate agonist treatment program.
• Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.
• Lack of medical insurance coverage
• Ineligibility for HCV treatment
• Active treatment for HCV at the time of the study enrollment

Sponsors & Collaborators

• Andrew Talal: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Andrew H Talal

Buffalo, New York, 14216, United States

Location

Related Publications (5)

• Talal AH, Markatou M, Zeremski M, Liu A, Dharia A, George SG, Taylor M, Davis K, Silber A, Brown LS, Tobin JN. Opioid treatment program-integrated facilitated telemedicine for hepatitis C treatment: a hybrid effectiveness-implementation analysis. BMC Complement Med Ther. 2025 Oct 15;25(1):377. doi: 10.1186/s12906-025-05138-9.

  PMID: 41094463 DERIVED

• Dickerson SS, George SJ, Ventuneac A, Dharia A, Talal AH. Care Integration for Hepatitis C Virus Treatment Through Facilitated Telemedicine Within Opioid Treatment Programs: Qualitative Study. J Med Internet Res. 2024 Jun 12;26:e53049. doi: 10.2196/53049.

  PMID: 38865703 DERIVED

• Talal AH, Markatou M, Liu A, Perumalswami PV, Dinani AM, Tobin JN, Brown LS. Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial. JAMA. 2024 Apr 23;331(16):1369-1378. doi: 10.1001/jama.2024.2452.

  PMID: 38568601 DERIVED

• Ventuneac A, Dickerson SS, Dharia A, George SJ, Talal AH. Scaling and Sustaining Facilitated Telemedicine to Expand Treatment Access Among Underserved Populations: A Qualitative Study. Telemed J E Health. 2023 Dec;29(12):1862-1869. doi: 10.1089/tmj.2022.0534. Epub 2023 May 26.

  PMID: 37252770 DERIVED

• Talal AH, Sofikitou EM, Wang K, Dickerson S, Jaanimagi U, Markatou M. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study. Telemed J E Health. 2023 Mar;29(3):395-407. doi: 10.1089/tmj.2022.0189. Epub 2022 Aug 4.

  PMID: 35925809 DERIVED

Related Links

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MeSH Terms

Conditions

Hepatitis C

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Andrew Talal
• Organization: University at Buffalo

AHTALAL@BUFFALO.EDU

7168884737

Study Officials

• Andrew H Talal, MD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: October 14, 2016
• Study Start: February 28, 2017
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2022
• Last Updated: December 20, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)