Re-link HCV in Substance-Use Telemedicine Program

Hepatitis C Clinical Trial

Official title:

Re-linking People With Diagnosed But Untreated HCV to Care in a Community-based Substance-use Telemedicine Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06349902
• Other study ID #: Pro00077561
• Status: Recruiting
• Start date: March 12, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: trueNorth Medical Centres
• Contact: Hannah O'Reilly
• Phone: 8888783563
• Email: hannah.oreilly[@]truenorthmedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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, exclusion criteria is: a consent directive to restrict access to their OLIS record.

For the prospective cohort study, exclusion criteria is an inability or unwillingness of the participant to provide informed consent.

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Related Conditions & MeSH terms

• Hepatitis C
• Substance-Related Disorders

Intervention

Behavioral:
• Re-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.

Locations

Country	Name	City	State
Canada	trueNorth Medical Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
trueNorth Medical Centres	Gilead Sciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients identified as having diagnosed but untreated HCV	number of patients identified as having diagnosed but untreated HCV	March 2024 - August 2024
Primary	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	treatment initiation rates	treatment initiation rates	March 2024 - December 2024
Secondary	treatment completion dates	treatment completion dates	March 2024 - December 2024
Secondary	cure rates	cure rates	March 2024 - December 2024