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Completed

NCT Number: NCT03831555

Tool to Improve Treatment Adherence and Outcomes at 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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Liver Clinic

Atlanta, Georgia, 30303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PREP-C

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2019
Registry last updated
Feb 6, 2019

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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