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Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PREP-C
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis C focused on measuring Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment tool

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grady Liver Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

PREP-C

Standard of care

Arm Description

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/.

Participants will receive the standard of care (usual care) for chronic HCV infection.

Outcomes

Primary Outcome Measures

Number of participants keeping follow-up appointments
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 keeping follow-up appointments
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
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.
Number of participants refilling medications
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.
Number of participants who keep lab visits
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.
Number of participants who keep lab visits
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.
Rapid virologic response (RVR)
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.
Sustained virologic response (SVR)
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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2019
Last Updated
February 4, 2019
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03831555
Brief Title
Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic
Official Title
Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment tool

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PREP-C
Arm Type
Active Comparator
Arm Description
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/.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Participants will receive the standard of care (usual care) for chronic HCV infection.
Intervention Type
Behavioral
Intervention Name(s)
PREP-C
Intervention Description
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: Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment Information: knowledge about HCV treatment and one's own HCV disease status Medication Adherence: current prescribed medications and adherence to them in the prior month Self-efficacy: self-confidence about adhering to HCV treatment Social Support and Stability: stability of financial, housing, and social support resources Alcohol and substance use: alcohol and substance use behaviors and current treatment Psychiatric Stability: current psychiatric status, previous and current treatment Energy Level: sleep and fatigue Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory.
Primary Outcome Measure Information:
Title
Number of participants keeping follow-up appointments
Description
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.
Time Frame
At 4 months
Title
Number of participants keeping follow-up appointments
Description
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.
Time Frame
At 8 months
Title
Number of participants refilling medications
Description
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.
Time Frame
At 4 months
Title
Number of participants refilling medications
Description
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.
Time Frame
At 8 months
Title
Number of participants who keep lab visits
Description
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.
Time Frame
At 4 months
Title
Number of participants who keep lab visits
Description
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.
Time Frame
At 8 months
Title
Rapid virologic response (RVR)
Description
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.
Time Frame
At 4 weeks
Title
Sustained virologic response (SVR)
Description
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.
Time Frame
At 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley Miller, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Liver Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic

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