Facilitated Telemedicine in the Catholic Health System

Not yet recruiting

• Conditions: HCV

• Registration Number: NCT06483451
• Lead Sponsor: State University of New York at Buffalo

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.

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Study Start: 2025-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• evidence of active HCV infection

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Exclusion Criteria

• no evidence of active HCV infection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCV Sustained Virologic Response	1 year	The time point that HCV cure (sustained virologic response) is achieved
HCV Treatment Initiation	1 year	The time point that HCV treatment is initiated