Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic

Emory University

Status: Completed

Conditions: Hepatitis C

Treatments: Behavioral: PREP-C

Study type: Interventional

Funder types: Other

Identifiers

NCT03831555

IRB00093687

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

PREP-C

Active Comparator group

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/.

Treatment:

Behavioral: PREP-C

Standard of care

No Intervention group

Description:

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