ADHEPTA Study: Adherence Questionnaire in Hepatitis C (ADHEPTA)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00998621

First Posted: October 20, 2009

Last Update Posted: October 16, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Fundacion IMIM

Purpose

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.

Condition	Intervention
Hepatitis C, Chronic HIV Infection	Other: Adherence questionnaire


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:

Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection. [ Time Frame: 2 years ]

Secondary Outcome Measures:

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


Enrollment:	1120
Study Start Date:	October 2009
Study Completion Date:	January 2013
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Hepatitis C infection	Other: Adherence questionnaire Adherence questionnaire
Hepatitis C + HIV infections	Other: Adherence questionnaire Adherence questionnaire

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with HCV and with HCV + HIV

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998621

Locations


Spain
Hospital del Mar
Barcelona, Spain, 08003

Sponsors and Collaborators

Fundacion IMIM

More Information


Responsible Party:	Fundacion IMIM
ClinicalTrials.gov Identifier:	NCT00998621 History of Changes
Other Study ID Numbers:	ADH-HEPC-2009-01
First Submitted:	October 19, 2009
First Posted:	October 20, 2009
Last Update Posted:	October 16, 2015
Last Verified:	October 2009

Keywords provided by Fundacion IMIM:


Hepatitis C, Chronic HIV Infection Medication Adherence Questionnaire Design Treatment experienced

Additional relevant MeSH terms:


Hepatitis Hepatitis A Hepatitis C HIV Infections Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections	Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hepatitis, Chronic

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