Anticipated and Perceived Benefits Following Hepatitis C Treatment

A Qualitative and Quantitative Evaluation of Patients' Anticipated and Perceived Treatment Benefits Following HCV Viral Eradication

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03000023

Enrollment

100

Registered

2016-12-21

Start date

2016-10-31

Completion date

2018-07-31

Last updated

2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Hepatitis C, Chronic

Keywords

Hepatitis C, Patient-Reported Outcomes, DAA Treatment, Qualitative, Mixed methods

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Currently listed for liver transplant; post-liver transplant

Design outcomes

Primary

Measure	Time frame	Description
Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment.	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.	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.

Countries

United States

Outcome results