Hepatitis C, ChronicADHEPTANCT00998621
ADHEPTA Study: Adherence Questionnaire in Hepatitis C
An observational study of Hepatitis C, Chronic and HIV Infection, run by Fundacion IMIM at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, HIV Infection
- What is being tested?
- Adherence questionnaire
- How many people
- 1,120 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2009to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HCV and with HCV + HIV
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C
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.
- Conditions
- Hepatitis C, Chronic, HIV Infection
- Being tested
- Adherence questionnaire
- Keywords
- Hepatitis C, Chronic, HIV Infection, Medication Adherence, Questionnaire Design, Treatment experienced
- Medical subject headings
- Hepatitis C, Chronic, HIV Infections, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence questionnaireOther
Adherence questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis C infection | Not described Receives: Other: Adherence questionnaire | |
| Hepatitis C + HIV infections | Not described Receives: Other: Adherence questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection.
Measured: 2 years
Secondary outcomes (2)
Adherence will be measured according to 80/80/80 rule.
Measured: 2 years
Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion IMIM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998621
- Sponsor's protocol ID
- ADH-HEPC-2009-01
- Acronym
- ADHEPTA
- Status last verified
- Oct 2009
- First submitted
- 19 Oct 2009
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C
- ClinicalTrials.gov ID
- NCT00998621
- Acronym / sponsor ID
- ADHEPTA / ADH-HEPC-2009-01
- Conditions
- Hepatitis C, Chronic, HIV Infection
- Keywords
- Hepatitis C, Chronic, HIV Infection, Medication Adherence, Questionnaire Design, Treatment experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- Fundacion IMIMUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C infection | – | Other: Adherence questionnaire |
| Hepatitis C + HIV infections | – | Other: Adherence questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HCV and with HCV + HIV
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence questionnaireAdherence questionnaire | Other | Hepatitis C + HIV infections, Hepatitis C infection |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and HIV Infection, run by Fundacion IMIM at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.