Clinical trial NCT06349902: Re-link HCV in Substance-Use Telemedicine Program
Official title: Re-linking People With Diagnosed But Untreated HCV to Care in a Community-based Substance-use Telemedicine Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C
Lead sponsor: trueNorth Medical Centres
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2024-04-05
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: number of patients identified as having diagnosed but untreated HCV
timeFrame: March 2024 - August 2024
measure: percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care
timeFrame: March 2024 - December 2024
Secondary outcomes:
measure: treatment initiation rates
timeFrame: March 2024 - December 2024
measure: treatment completion dates
timeFrame: March 2024 - December 2024
measure: cure rates
timeFrame: March 2024 - December 2024
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: trueNorth Medical Centre
state: Ontario
Study officials:
affiliation: trueNorth Medical
name: Hannah O'Reilly
role: STUDY_DIRECTOR
References: