Anticipated and Perceived Benefits Following Hepatitis C Treatment

Completed

• Conditions: Hepatitis C; Hepatitis C, Chronic

• Registration Number: NCT03000023
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-18
• Study First Posted: 2016-12-21
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States