NCT00998621

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,120

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2009

Enrollment Period

11 months

First QC Date

October 19, 2009

Last Update Submit

October 14, 2015

Conditions

Hepatitis C, ChronicHIV Infection

Keywords

Hepatitis C, ChronicHIV InfectionMedication AdherenceQuestionnaire DesignTreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection.

    2 years

Secondary Outcomes (2)

  • Adherence will be measured according to 80/80/80 rule.

    2 years

  • Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR).

    2 years

Study Arms (2)

Hepatitis C infection

Other: Adherence questionnaire

Hepatitis C + HIV infections

Other: Adherence questionnaire

Interventions

Adherence questionnaireOTHER

Adherence questionnaire

Hepatitis C + HIV infectionsHepatitis C infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with HCV and with HCV + HIV

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHIV InfectionsMedication Adherence

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 20, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

January 1, 2013

Last Updated

October 16, 2015

Record last verified: 2009-10

Locations

ES(1)