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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
Sponsor:
Information provided by:
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT00998621
First received: October 19, 2009
Last updated: April 13, 2011
Last verified: October 2009
History of Changes
  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:

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 ] [ 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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998621

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Esther Alcampel     +34937496300     ealcampel@es.imshealth.com    
Sponsors and Collaborators
Fundacion IMIM
  More Information

No publications provided

Responsible Party: Ricard Solà Lamoglia, Fundacion IMIM
ClinicalTrials.gov 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
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on March 03, 2013