Hepatitis CNCT03000023
Anticipated and Perceived Benefits Following Hepatitis C Treatment
An observational study of Hepatitis C and Hepatitis C, Chronic, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The study is both qualitative and quantitative, gathering patient's perceptions of HCV treatment benefits before and after HCV treatment by administering surveys and conducting in-depth qualitative patient interviews. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hepatitis C, Hepatitis C, Chronic
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jul 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Hepatitis C
Who may be able to join
- Age 21 or older
- English-speaking
- Any genotype
- Any treatment duration (e.g. 8, 12, or 24 weeks)
- Has been written a prescription for a sofosbuvir (SOF)-containing regimen.
Who cannot join
- Currently listed for liver transplant; post-liver transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: A Qualitative and Quantitative Evaluation of Patients' Anticipated and Perceived Treatment Benefits Following HCV Viral Eradication
The study is both qualitative and quantitative, gathering patient's perceptions of HCV treatment benefits before and after HCV treatment by administering surveys and conducting in-depth qualitative patient interviews. The study seeks to understand all anticipated and actual benefits patients perceive before and after viral eradication.
Read the detailed description
This study employs a mixed methods (qualitative and quantitative) pre-post study design utilizing in-depth qualitative interviews and patient reported outcome surveys. Pre-treatment surveys and interviews will be conducted before HCV therapy commences to understand all potential psychological, social, physical and medical consequences perceived to be related to HCV and the patients' anticipation (hope for) of improvements in these factors after viral eradication. Post-treatment surveys and interviews will occur 4 to 8 months after treatment ends to examine long-term treatment benefits, i.e., changes in HCV-related factors, such as symptoms, functioning, and health status.
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Keywords
- Hepatitis C, Patient-Reported Outcomes, DAA Treatment, Qualitative, Mixed methods
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment.
To conduct a pre-post qualitative analysis that will evaluate changes in a broad range of patients' perceptions of psychological, social, and physical effects associated with HCV and viral cure collected through qualitative interviews.
Measured: 1 Year
Evaluate pre-post survey change in patient reported HCV symptoms and other factors.
To conduct a pre-post survey evaluation of change in patient-reported HCV symptoms, functioning, and health perceptions associated with HCV and viral cure.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Donna Evon, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000023
- Sponsor's protocol ID
- 15-2081
- Status last verified
- Oct 2018
- First submitted
- 6 Dec 2016
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative and Quantitative Evaluation of Patients' Anticipated and Perceived Treatment Benefits Following HCV Viral Eradication
- ClinicalTrials.gov ID
- NCT03000023
- Acronym / sponsor ID
- 15-2081
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Keywords
- Hepatitis C, Patient-Reported Outcomes, DAA Treatment, Qualitative, Mixed methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Oct 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 21 Dec 2016 (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.
The study is both qualitative and quantitative, gathering patient's perceptions of HCV treatment benefits before and after HCV treatment by administering surveys and conducting in-depth qualitative patient interviews. The study seeks to understand all anticipated and actual benefits patients perceive before and after viral eradication.
Detailed description
This study employs a mixed methods (qualitative and quantitative) pre-post study design utilizing in-depth qualitative interviews and patient reported outcome surveys. Pre-treatment surveys and interviews will be conducted before HCV therapy commences to understand all potential psychological, social, physical and medical consequences perceived to be related to HCV and the patients' anticipation (hope for) of improvements in these factors after viral eradication. Post-treatment surveys and interviews will occur 4 to 8 months after treatment ends to examine long-term treatment benefits, i.e., changes in HCV-related factors, such as symptoms, functioning, and health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Hepatitis C
Key inclusion criteria (5 listed)
- Age 21 or older
- English-speaking
- Any genotype
- Any treatment duration (e.g. 8, 12, or 24 weeks)
- Has been written a prescription for a sofosbuvir (SOF)-containing regimen.
Key exclusion criteria (1 listed)
- Currently listed for liver transplant; post-liver transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment.
Time frame: 1 Year
To conduct a pre-post qualitative analysis that will evaluate changes in a broad range of patients' perceptions of psychological, social, and physical effects associated with HCV and viral cure collected through qualitative interviews.
Evaluate pre-post survey change in patient reported HCV symptoms and other factors.
Time frame: 1 Year
To conduct a pre-post survey evaluation of change in patient-reported HCV symptoms, functioning, and health perceptions associated with HCV and viral cure.
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 24 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Donna Evon, PhD principal investigator
University of North Carolina, Chapel Hill
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 and Hepatitis C, Chronic, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 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 24 Oct 2018. 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 United States. 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?
Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment. (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 24 Oct 2018.