Viewing Study NCT02933970



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Last Modification Date: 2024-10-26 @ 12:11 PM
Study NCT ID: NCT02933970
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2022-11-03
First Post: 2016-09-24

Brief Title: Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals
Sponsor: Andrew Talal
Organization: State University of New York at Buffalo

Study Overview

Official Title: Stepped-Wedge Randomized Control Trial to Compare Integrated Co-located Telemedicine-based HCV Management for Individuals on Opiate Agonist Treatment Versus Usual Care Treatment of HCV of Individuals on Opiate Agonist Treatment
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: The study will be conducted as a non-blinded stepped wedge cluster randomized controlled trial with two arms onsite HCV management through telemedicine versus HCV management through usual care which in most cases will be referral to an offsite liver specialist Referral The arm assignment will be at the cluster clinic level After an initial period 6 months in which all clinics implement the control intervention usual care at regular intervals ie the steps of 6 months duration each one group of clinics will be randomized to cross over from the Usual Care arm to the Telemedicine arm In this way there will be enough time for implementation and assessment of the intervention within each time period The process continues until all clinics have crossed over to implement telemedicine and thus all clinics contribute data to both interventions In addition patients will be followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None