Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-12 @ 12:16 PM
Study NCT ID:
NCT06349902
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Re-link HCV in Substance-Use Telemedicine Program
Sponsor:
trueNorth Medical Centres
Organization:
Study Overview
Official Title:
Re-linking People With Diagnosed But Untreated HCV to Care in a Community-based Substance-use Telemedicine Program
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This is an observational, retrospective \& prospective cohort study. The retrospective element of the study is a chart review to identify people with diagnosed but untreated HCV and re-link them to care. The observational prospective cohort element of the study will examine the HCV linkage to care, treatment initiation, treatment completion \& cure rates of these HCV clients achieved through this chart review and re-linking approach.
Detailed Description:
The study, led by trueNorth medical center in Ontario, focuses on re-linking people diagnosed with untreated Hepatitis C (HCV) to care through a community-based substance-use telemedicine program. HCV is a significant health concern in Canada, especially among people who inject drugs (PWID), who face barriers to accessing treatment. Integrating HCV treatment with substance use care may improve treatment uptake.
This observational study includes both retrospective and prospective cohorts. The retrospective aspect involves chart reviews to identify untreated HCV patients for re-linking, while the prospective cohort examines treatment outcomes such as linkage to care and cure rates. Participants include individuals over 18 with a positive HCV RNA result who have not completed a course of Direct-Acting Antiviral (DAA) treatment. Excluded are those unable to consent or with restricted access to their health records.
Study procedures involve identifying untreated HCV patients, attempting re-linkage via telecommunication, and offering treatment through the program. Outcome measures include the number of patients re-linked to care and their treatment outcomes. Data analysis will utilize IBM SPSS for logistic regression and descriptive statistics, aiming to evaluate the efficacy of this telemedicine approach in improving HCV care among PWID.
Ethical considerations include informed consent and data privacy, with oversight by the ADVARRA Canadian Institutional Review Board. The study seeks to address HCV care gaps in PWID populations by leveraging telemedicine for improved access and treatment outcomes.
This observational study includes both retrospective and prospective cohorts. The retrospective aspect involves chart reviews to identify untreated HCV patients for re-linking, while the prospective cohort examines treatment outcomes such as linkage to care and cure rates. Participants include individuals over 18 with a positive HCV RNA result who have not completed a course of Direct-Acting Antiviral (DAA) treatment. Excluded are those unable to consent or with restricted access to their health records.
Study procedures involve identifying untreated HCV patients, attempting re-linkage via telecommunication, and offering treatment through the program. Outcome measures include the number of patients re-linked to care and their treatment outcomes. Data analysis will utilize IBM SPSS for logistic regression and descriptive statistics, aiming to evaluate the efficacy of this telemedicine approach in improving HCV care among PWID.
Ethical considerations include informed consent and data privacy, with oversight by the ADVARRA Canadian Institutional Review Board. The study seeks to address HCV care gaps in PWID populations by leveraging telemedicine for improved access and treatment outcomes.
Study Oversight
Has Oversight DMC:
False
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?: