Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants keeping follow-up appointments
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •no chronic hepatitis C infection
- •co-infection with HIV or hepatitis B
- •non-English speaking
- •unable to consent to participate
- •already started HCV therapy
结局指标
主要结局
Number of participants keeping follow-up appointments
时间窗: 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.
Number of participants refilling medications
时间窗: 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.
Rapid virologic response (RVR)
时间窗: 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.
Number of participants who keep lab visits
时间窗: 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.
Sustained virologic response (SVR)
时间窗: 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.
次要结局
未报告次要终点
研究者
Lesley Miller
Associate Professor
Emory University