Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic

February 4, 2019 updated by: Lesley Miller, Emory University

Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Liver Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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/.
Behavioral: PREP-C

The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey:

  1. Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment
  2. Information: knowledge about HCV treatment and one's own HCV disease status
  3. Medication Adherence: current prescribed medications and adherence to them in the prior month
  4. Self-efficacy: self-confidence about adhering to HCV treatment
  5. Social Support and Stability: stability of financial, housing, and social support resources
  6. Alcohol and substance use: alcohol and substance use behaviors and current treatment
  7. Psychiatric Stability: current psychiatric status, previous and current treatment
  8. Energy Level: sleep and fatigue
  9. Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory.
No Intervention: Standard of care
Participants will receive the standard of care (usual care) for chronic HCV infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants keeping follow-up appointments
Time Frame: At 4 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.
At 4 months
Number of participants keeping follow-up appointments
Time Frame: 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.
At 8 months
Number of participants refilling medications
Time Frame: At 4 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.
At 4 months
Number of participants refilling medications
Time Frame: 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.
At 8 months
Number of participants who keep lab visits
Time Frame: At 4 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.
At 4 months
Number of participants who keep lab visits
Time Frame: 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.
At 8 months
Rapid virologic response (RVR)
Time Frame: 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.
At 4 weeks
Sustained virologic response (SVR)
Time Frame: 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.
At 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Lesley Miller, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00093687

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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