Relinking Diagnosed But Untreated HCV Patients Back Into Care.

• Sponsor: Universitair Ziekenhuis Brussel (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05975216
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 12.8
• Patients Per Site Per Month: 46.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection	Other: Contact the patient

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Relinking Diagnosed But Untreated HCV Patients Back Into Care.
• Actual Study Start Date: Jul 6, 2023
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Retrospective data collection [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.

2. Prospective interventional study [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

Secondary Outcome Measures

1. Reason lost in follow-up [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?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussel	Brussel		Belgium	1090

Sponsors and Collaborators

• Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT05975216
• Other Study ID Numbers: Relink
• First Posted: Aug 3, 2023
• Last Update Posted: Aug 3, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis C

Study Results

No Results Posted as of Aug 3, 2023