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Completed

NCT Number: NCT03000023

Anticipated and Perceived Benefits Following Hepatitis C Treatment

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2016
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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