ADHEPTA Study: Adherence Questionnaire in Hepatitis C

Fundacion IMIM

Status: Completed

Conditions: Hepatitis C, Chronic; HIV Infection

Treatments: Other: Adherence questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT00998621

ADH-HEPC-2009-01

Details and patient eligibility

About

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.

Enrollment: 1,120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,120 participants in 2 patient groups

Hepatitis C infection

Treatment:

Other: Adherence questionnaire

Hepatitis C + HIV infections

Treatment:

Other: Adherence questionnaire