Facilitated Telemedicine in the Catholic Health System | NCT06483451

Studies
Facilitated Telemedicine in the Catholic Health System

NCT06483451

Sponsor

State University of New York at Buffalo

Status

Not yet recruiting

Last Update Posted

Feb 5, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jun 14, 2024

First Submission Date that Met QC Criteria

Jun 25, 2024

First Posted Date

Jul 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2026

Last Update Posted Date

Feb 5, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew Talal, Professor of Medicine, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Hepatitis C virus (HCV) is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. In 2013, direct-acting antivirals were introduced for HCV treatment: all oral medications with minimal side effects and excellent efficacy when taken for 2-3 months. However, only 34% of eligible individuals received direct-acting antivirals between 2013 and 2022. Moreover, HCV treatment with direct-acting antivirals was substantially lower among people with opioid use disorder. Access to highly effective HCV treatment by the populations with the greatest need remains inadequate.

To address this issue, we propose that facilitated telemedicine could be a bridge to integrate HCV treatment into opioid treatment programs. In our model, telemedicine encounters are facilitated by a case manager who is also a patient advocate and an educator. We recently completed a randomized clinical trial that compared facilitated telemedicine integrated into opioid treatment programs for HCV treatment compared to offsite referral. The HCV cure rate was 90.3% in facilitated telemedicine compared to 39.4% in offsite referral.

In the proposed project, we seek to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Individuals with active HCV infection		Individuals with active HCV infection

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

evidence of active HCV infection

Exclusion Criteria:

no evidence of active HCV infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals enrolled in the opioid treatment programs of Catholic Health System

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrew H Talal, MD, MPH	Contact	7168293101		ahtalal@buffalo.edu

Overall Officials

Name	Affiliation	Role
Andrew H Talal, MD, MPH	University at Buffalo	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38568601	Background	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.