ADHEPTA Study: Adherence Questionnaire in Hepatitis C

Completed

• Conditions: Hepatitis C, Chronic; HIV Infection
• Interventions: Other: Adherence questionnaire

• Registration Number: NCT00998621
• Lead Sponsor: Fundacion IMIM

Brief Summary

Main objective: To study and validate a questionnaire measuring treatment adherence in patients with Hepatitis C virus (HCV) infection.

Design of the study: Multicentric, prospective, epidemiological study in the field of usual clinical practice.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study Start: 2009-10
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Primary Completion: 2010-09
• Study Completion: 2013-01
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1120

Inclusion Criteria

• Ambulatory patient infected by HCV according to diagnosis criteria used en usual clinical practice.
• Patient no treated previously and beginning a treatment for HCV.
• Patient that signed the informed consent to participate in the study.
• Group A: patient with HCV monoinfection.
• Group B: patient with HCV and HCV co-infection (according to diagnosis criteria used en usual clinical practice).

Exclusion Criteria

• Patient that received previous treatment for HCV.
• Patient that is going to participate in a clinical trial Turing the HCV treatment period.
• Patient with cognitive impairment or patient unable to understand and answer the auto-administered questionnaire.
• Patient unable to read or write Spanish.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatitis C + HIV infections	Adherence questionnaire	-
Hepatitis C infection	Adherence questionnaire	-

Primary Outcome Measures

Name	Time	Method
Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection.	2 years

Secondary Outcome Measures

Name	Time	Method
Adherence will be measured according to 80/80/80 rule.	2 years
Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR).	2 years

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain