NCT06483451

Brief Summary

Hepatitis C virus is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. We aim to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System. This study is a chart review data analysis to evaluate outcomes of facilitated telemedicine integrated into opioid treatment programs and to evaluate the number of individuals who initiate and complete treatment for hepatitis C virus infection.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

June 14, 2024

Last Update Submit

February 3, 2026

Conditions

HCV

Keywords

telemedicine

Outcome Measures

Primary Outcomes (2)

  • HCV Treatment Initiation

    The time point that HCV treatment is initiated

    1 year

  • HCV Sustained Virologic Response

    The time point that HCV cure (sustained virologic response) is achieved

    1 year

Study Arms (1)

Individuals with active HCV infection

Individuals with active HCV infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals enrolled in the opioid treatment programs of Catholic Health System

You may qualify if:

  • evidence of active HCV infection

You may not qualify if:

  • no evidence of active HCV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 38568601BACKGROUND

Study Officials

  • Andrew H Talal, MD, MPH

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew H Talal, MD, MPH

CONTACT

7168293101ahtalal@buffalo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 14, 2024

First Posted

July 3, 2024

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02