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

NCT ID: NCT02933970

Last Updated: 2024-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2022-11-01

Brief Summary

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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.

Detailed Description

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The study is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, referral to an offsite hepatitis specialist (Referral). The arm assignment is at the cluster (clinic) level. After an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the Usual Care arm to the Telemedicine arm. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients cured of HCV are followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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)

Group Type OTHER

Telemedicine

Intervention Type OTHER

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

Interventions

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Telemedicine

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

Intervention Type OTHER

Other Intervention Names

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Two way video conferencing

Eligibility Criteria

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Inclusion Criteria

1. HCV antibody detected
2. Ability and willingness of subject or legal representative to provide written informed consent.
3. 18 years of age
4. A minimum of 12-month enrollment in the opiate agonist treatment program
5. Likely to be adherent to the therapeutic regimen
6. Covered by medical insurance

Exclusion Criteria

1. Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
2. \<18 years of age
3. \< 12 months enrolled in an opiate agonist treatment program.
4. 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.
5. Lack of medical insurance coverage
6. Ineligibility for HCV treatment
7. Active treatment for HCV at the time of the study enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Andrew Talal

OTHER

Sponsor Role lead

Responsible Party

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Andrew Talal

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrew H Talal, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Locations

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Andrew H Talal

Buffalo, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41094463 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38865703 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38568601 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37252770 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35925809 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.who.int/mediacentre/factsheets/fs164/en/.

Related Info

http://www.cdnetwork.org/teamc

Related Info

Other Identifiers

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Telemedicine vs. Usual Care

Identifier Type: -

Identifier Source: org_study_id