ADHEPTA Study: Adherence Questionnaire in Hepatitis C

HIV Infection Clinical Trial

— ADHEPTA  

Official title:

Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998621
• Other study ID #: ADH-HEPC-2009-01
• Status: Completed
• Phase: N/A
• First received: October 19, 2009
• Last updated: October 14, 2015
• Start date: October 2009
• Est. completion date: January 2013

Study information

• Verified date: October 2009
• Source: Fundacion IMIM
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1120
• Est. completion date: January 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• HIV Infection
• HIV Infections

Intervention

Other:
• Adherence questionnaire
Adherence questionnaire

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion IMIM

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection.		2 years	No
Secondary	Adherence will be measured according to 80/80/80 rule.		2 years	No
Secondary	Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR).		2 years	No