Recruiting

HCV

Sponsor:

trueNorth Medical Centres

Code:

NCT06349902

Conditions

Hepatitis C

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Re-Link

Study Details

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.

Conditions

Hepatitis C

Study ID

NCT06349902

Start date

Mar 12, 2024

Status verified date

Mar, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • number of patients identified as having diagnosed but untreated HCV [ Time Frame: March 2024 - August 2024 ]
  • percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care [ Time Frame: March 2024 - December 2024 ]

Central Contacts and Locations

Locations

trueNorth Medical Centre

Recruiting

Toronto, Ontario, Canada, M5B 2A5

Contacts

Principal Investigator:

Chris Cavacuiti, BA, MD, MHSc

More Information

Sponsor

trueNorth Medical Centres

Last update posted

Apr 5, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by trueNorth Medical Centres on 2024-04-05.