ADHEPTA Study: Adherence Questionnaire in Hepatitis C (ADHEPTA)
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ClinicalTrials.gov Identifier: NCT00998621 |
Recruitment Status
:
Completed
First Posted
: October 20, 2009
Last Update Posted
: October 16, 2015
|
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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 or disease | Intervention/treatment |
---|---|
Hepatitis C, Chronic HIV Infection | Other: Adherence questionnaire |
Study Type : | Observational |
Actual Enrollment : | 1120 participants |
Time Perspective: | Prospective |
Official Title: | Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | January 2013 |
Group/Cohort | Intervention/treatment |
---|---|
Hepatitis C infection |
Other: Adherence questionnaire
Adherence questionnaire
|
Hepatitis C + HIV infections |
Other: Adherence questionnaire
Adherence questionnaire
|
- 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 ]
- 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 ]

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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 |
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.

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
Spain | |
Hospital del Mar | |
Barcelona, Spain, 08003 |
Responsible Party: | Fundacion IMIM |
ClinicalTrials.gov Identifier: | NCT00998621 History of Changes |
Other Study ID Numbers: |
ADH-HEPC-2009-01 |
First Posted: | October 20, 2009 Key Record Dates |
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 |