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
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2024
CompletedFirst Submitted
Initial submission to the registry
March 31, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 5, 2024
March 1, 2024
6 months
March 31, 2024
April 4, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
treatment initiation rates
March 2024 - December 2024
treatment completion dates
March 2024 - December 2024
cure rates
March 2024 - December 2024
Study Arms (1)
Positive HCV RNA, no sufficient previous course of DAA treatment.
Having a positive HCV RNA laboratory result and lacking a sufficient previous course of DAA treatment.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Aged ≥18. Ability and willingness of the participant to provide informed consent. Having a positive HCV RNA laboratory result and lacking a sufficient previous course of DAA treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- trueNorth Medical Centreslead
- Gilead Sciencescollaborator
Study Sites (1)
trueNorth Medical Centre
Toronto, Ontario, M5B 2A5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hannah O'Reilly
trueNorth Medical
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2024
First Posted
April 5, 2024
Study Start
March 12, 2024
Primary Completion
August 31, 2024
Study Completion
December 31, 2024
Last Updated
April 5, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share