ADHEPTA Study: Adherence Questionnaire in Hepatitis C - Full Text View

Sponsor:	IMS Health
Information provided by:	IMS Health
ClinicalTrials.gov Identifier:	NCT00998621

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:	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: AIDS Hepatitis Hepatitis C

U.S. FDA Resources

Further study details as provided by IMS Health:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1120
Study Start Date:	October 2009

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

IMS Health

More Information

No publications provided

Responsible Party:	Fundacion IMIM ( Ricard Solà Lamoglia )
Study ID Numbers:	ADH-HEPC-2009-01
Study First Received:	October 19, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00998621 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by IMS Health:

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

Additional relevant MeSH terms:

Communicable Diseases
Liver Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Hepatitis, Chronic
Flaviviridae Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Infection

Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Hepatitis C
Hepatitis C, Chronic
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010