Relinking Diagnosed But Untreated HCV Patients Back Into Care. (Relink)

August 7, 2025 updated by: Universitair Ziekenhuis Brussel

Reintroduction of patients into a HCV infection care pathway after a positive chronic hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up.

Gaining insight in the possible reasons why patients are lost in follow-up after positive hepatitis C serology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • UZ Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Positive hepatitis C serology with positive or unknown HCV RNA.

Description

Inclusion Criteria:

  • Positive HCV serology between 2012-2022 with positive or uknown HCV RNA in UZ Brussels database
  • ≥18 years

Exclusion Criteria:

  • Positive HCV serology with negative HCV RNA
  • Previously eradicated patients in UZ Brussel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnosed-but-untreated
Diagnosed but untreated (DBU) HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.
Other: Contact the patient
Phone call, email or letter to contact the patient to relink them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective data collection
Time Frame: before contacting the patient
Prevalence of diagnosed but untreated HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.
before contacting the patient
Prospective interventional study
Time Frame: from first contact of the patient till 12 weeks after end of treatment.
To recall DBU patients by phone, e-mail or letter, trying to optimize treated and cured patients after recall
from first contact of the patient till 12 weeks after end of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reason lost in follow-up
Time Frame: from first contact of the patient till 12 weeks after end of treatment.

Understanding the different reasons why patients were lost in follow-up with the aim of improving our hospital quality in the future:

  • Unaware of positive hep C serology
  • Follow-up or treatment in other centre
  • Refusal of previously proposed therapy
  • Other?
from first contact of the patient till 12 weeks after end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RELINK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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