Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic

Not Applicable

Completed

• Conditions: Hepatitis C
• Interventions: Behavioral: PREP-C

• Registration Number: NCT03831555
• Lead Sponsor: Emory University

Brief Summary

The purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis C medications.

Detailed Description

The goal of this study is to determine if a qualitative survey that assesses a patient's readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral antiviral medications. While these new medications are easier to tolerate and access than previous treatment regimens, medication adherence still remains a great barrier to cure. In this study, we will administer the Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai School of Medicine to determine psychosocial readiness for treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-06-05
• Primary Completion: 2018-05-01
• Study Completion: 2018-06-30
• Study First Submitted: 2019-01-31
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-04
• Last Update Submitted: 2019-02-04
• Study First Posted: 2019-02-06
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

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

Inclusion Criteria

• seen in the Grady Liver Clinic during the study time period
• have a confirmed chronic hepatitis C infection (hepatitis C antibody positive and detectable hepatitis C viral load)

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Exclusion Criteria

• no chronic hepatitis C infection
• co-infection with HIV or hepatitis B
• non-English speaking
• unable to consent to participate
• already started HCV therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PREP-C	PREP-C	The research assistant will complete the abbreviated PREP-C survey with the study participants either before or after their medical appointment. The PREP-C tool is accessed online at https://prepc.org/.

Primary Outcome Measures

Name	Time	Method
Number of participants keeping follow-up appointments	At 8 months	Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.
Number of participants refilling medications	At 8 months	Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.
Rapid virologic response (RVR)	At 4 weeks	The treatment outcome will be measured by analyzing the rapid virologic response (RVR) at 4 weeks after completion of treatment. Rapid virologic response (RVR) is defined as an undetectable serum hepatitis C virus (HCV) RNA. This data will be collected from chart reviews.
Number of participants who keep lab visits	At 8 months	Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.
Sustained virologic response (SVR)	At 12 weeks	The treatment outcome will be measured by analyzing the sustained virologic response (SVR) at 12 weeks after completion of treatment. SVR is defined as aviremia 12 weeks after completion of antiviral therapy. This data will be collected from chart reviews.

Trial Locations

Locations (1)

Grady Liver Clinic; 🇺🇸 Atlanta, Georgia, United States