Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Hepatitis C Virus Infection Clinical Trial

— Relink  

Official title:

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975216
• Other study ID #: Relink
• Status: Recruiting
• Start date: July 6, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: July 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Silke François, Dr.
• Phone: +32 2 477
• Email: silke.francois[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection

Intervention

Other:
• Contact the patient
Phone call, email or letter to contact the patient to relink them.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective data collection	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
Primary	Prospective interventional study	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	Reason lost in follow-up	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.