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Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic

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ClinicalTrials.gov Identifier: NCT03831555
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Lesley Miller, 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Behavioral: PREP-C Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831555


Locations
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United States, Georgia
Grady Liver Clinic
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Lesley Miller, MD Emory University

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Responsible Party: Lesley Miller, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03831555     History of Changes
Other Study ID Numbers: IRB00093687
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lesley Miller, Emory University:
Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment tool
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections