Hepatitis C
Conditions
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.
Interventions
BEHAVIORALRe-Link
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.
Sponsors
Gilead Sciences
trueNorth Medical Centres
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
For the retrospective chart review element of the study, inclusion criteria includes anyone who had a telemedicine visit at the community based substance use telemedicine program between January 1st 2023 and December 31st 2024. For the prospective cohort element of the study, the inclusion criteria are listed below: 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.
Exclusion criteria
For the retrospective chart review element of the study,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients identified as having diagnosed but untreated HCV | March 2024 - August 2024 | number of patients identified as having diagnosed but untreated HCV |
| percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care | March 2024 - December 2024 | percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment initiation rates | March 2024 - December 2024 | treatment initiation rates |
| treatment completion dates | March 2024 - December 2024 | treatment completion dates |
| cure rates | March 2024 - December 2024 | cure rates |
Countries
Canada
Contacts
Primary ContactHannah O'Reilly
Backup ContactChris Cavacuiti
Outcome results
None listed