NCT06349902|Unknown
Re-link HCV in Substance-Use Telemedicine Program
Re-linking People With Diagnosed But Untreated HCV to Care in a Community-based Substance-use Telemedicine Program
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Re-linking People With Diagnosed But Untreated HCV to Care in a Community-based Substance-use Telemedicine Program
Sponsor study identifier
observational
5,000
1 country
1
Study Start
March 12, 2024
Actual (reported)Primary Completion
August 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2024
Actual (reported)March 31, 2024
Actual (reported)April 5, 2024
Actual (reported)August 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
number of patients identified as having diagnosed but untreated HCV
number of patients identified as having diagnosed but untreated HCV
March 2024 - August 2024
percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care
percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care
March 2024 - December 2024
treatment initiation rates
March 2024 - December 2024
treatment completion dates
March 2024 - December 2024
cure rates
March 2024 - December 2024
Having a positive HCV RNA laboratory result and lacking a sufficient previous course of DAA treatment.
The HCV nurse will attempt to contact the PWDU HCV via phone call and text. If unable to connect with a client via phone, an alert is added to the client's chart in the electronic medical record. When the client presents to the CBSUTP for their regular substance use follow up appointment, the chart alert is flagged by the administrative team and the client is connected with the HCV nurse via telemedicine. Clients who are connected to the HCV team are considered re-linked. The HCV nurse will provide an HCV intake as per program guidelines. Clients who would prefer to pursue treatment elsewhere will be supported with a referral to their family doctor or an alternative HCV program in the community. Clients who choose to be treated at the CBSUTP will receive a HCV consultation, DAA treatment and follow-up from the HCV clinical team onsite as per existing program guidelines.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population for this research comprises individuals diagnosed with Hepatitis C Virus (HCV) who have not yet received treatment. Key characteristics of the study population include: Age: Participants are aged 18 years or older. Health Condition: All individuals have a confirmed positive HCV RNA laboratory result, indicating an active HCV infection but lack a sufficient previous course of treatment with Direct-Acting Antivirals (DAAs). Telemedicine Engagement: They have had at least one telemedicine visit with the community-based substance use telemedicine program (CBSUTP) between January 1st, 2023, and December 31st, 2024. Informed Consent: Participants possess the ability and willingness to provide informed consent to participate in the study.
trueNorth Medical Centre
Toronto, Ontario, M5B 2A5, Canada
Hannah O'Reilly
trueNorth Medical
First Submitted
March 31, 2024
First Posted
April 5, 2024
Study Start
March 12, 2024
Actual (reported)Primary Completion
August 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The National Australian HCV Point-of-Care Testing Program - Minimal Dataset
Contact the study team to confirm eligibility.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 5, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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