Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic
Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedFebruary 6, 2019
February 1, 2019
11 months
January 31, 2019
February 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
At 4 months
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.
At 8 months
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.
At 4 months
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.
At 8 months
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.
At 4 months
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.
At 8 months
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.
At 4 weeks
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.
At 12 weeks
Study Arms (2)
PREP-C
ACTIVE COMPARATORThe 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/.
Standard of care
NO INTERVENTIONParticipants will receive the standard of care (usual care) for chronic HCV infection.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- no chronic hepatitis C infection
- co-infection with HIV or hepatitis B
- non-English speaking
- unable to consent to participate
- already started HCV therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Grady Liver Clinic
Atlanta, Georgia, 30303, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lesley Miller, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 31, 2019
First Posted
February 6, 2019
Study Start
June 5, 2017
Primary Completion
May 1, 2018
Study Completion
June 30, 2018
Last Updated
February 6, 2019
Record last verified: 2019-02