ADHEPTA Study: Adherence Questionnaire in Hepatitis C

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Fundacion IMIM.
Recruitment status was  Recruiting
Information provided by:
Fundacion IMIM Identifier:
First received: October 19, 2009
Last updated: April 13, 2011
Last verified: October 2009

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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence will be measured according to 80/80/80 rule. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1120
Study Start Date: October 2009
Groups/Cohorts Assigned Interventions
Hepatitis C infection Other: Adherence questionnaire
Adherence questionnaire
Other Name: Adherence questionnaire
Hepatitis C + HIV infections Other: Adherence questionnaire
Adherence questionnaire
Other Name: Adherence questionnaire


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with HCV and with HCV + HIV


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00998621

Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Esther Alcampel    +34937496300   
Sponsors and Collaborators
Fundacion IMIM
  More Information

No publications provided

Responsible Party: Ricard Solà Lamoglia, Fundacion IMIM Identifier: NCT00998621     History of Changes
Other Study ID Numbers: ADH-HEPC-2009-01
Study First Received: October 19, 2009
Last Updated: April 13, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion IMIM:
Hepatitis C, Chronic
HIV Infection
Medication Adherence
Questionnaire Design
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases processed this record on October 02, 2015