NCT03000023

Brief 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. The study seeks to understand all anticipated and actual benefits patients perceive before and after viral eradication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

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, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

December 6, 2016

Last Update Submit

October 22, 2018

Conditions

Hepatitis CHepatitis C, Chronic

Keywords

Hepatitis CPatient-Reported OutcomesDAA TreatmentQualitativeMixed methods

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 Year

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Hepatitis C

You may qualify if:

  • 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.

You may not qualify if:

  • Currently listed for liver transplant; post-liver transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Donna Evon, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 21, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)