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临床试验/NCT06579313
NCT06579313尚未招募不适用

Current Situation of Health Care in Women With HBV or HCV Infection

Ruijin Hospital0 个研究点目标入组 2,500 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,500
主要终点
Treatment Rate in female in HBV cohort

研究概览

简要总结

A multicenter, retrospective study conducted in male and female population infected with HBV or HCV in east China. HCV part, study will enroll 500 HCV antibody positive and HCV RNA positive patients during 2020.7-2023.12 and then observe the characteristics, duration from diagnosis to treatment, treatment rate and sustained virologic response (SVR12) among eligible female and male patients. HBV part, study will enroll 2000 HBsAg positive patients during 2016.7-2019.12 and then observe the clinical characteristics, natural history, duration from diagnosis to treatment, treatment rate and adherence among eligible female and male patients.

详细描述

Some of the sociocultural factors may prevent women infected with HBV or HCV benefiting from quality health care. Limited articles have ever reported the situation of health care in women with viral hepatitis. A previous study found that low HCV knowledge was observed in females, which was related to a lower willingness to be treated for HCV. Besides that, in other disease areas like hypertension, studies found that females have less awareness of their disease but have higher control over it compared with males. These findings might reflect the differences in health literacy levels which might influence disease outcomes, healthcare-seeking and adherence to treatment. This research aims to fill the data gaps of the gender differences in cascade of care in HBV and HCV, to facilitate patient activation, especially for women.

So far, data on the current health care status in HBV-infected women is scarce. With the expansion of treatment indications recommended by China CHB guidelines, more female patients will have the opportunity to gain timely and necessary treatment. This study will analyze the cascade of care by observing the duration from diagnosis to treatment and treatment adherence for women. And this knowledge will serve as a guide for interventions for the management of viral hepatitis, as well as effectively finding and activating patients who meet treatment criteria but are not being treated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HBV Cohort -
  • ≥18 years old
  • serum HBsAg positive for >6 months
  • Treatment naïve or,
  • Patients who had been previously treated for HBV but discontinued for at least 1 year before enrollment
  • HCV Cohort -
  • ≥18 years old
  • HCV-Ab positive
  • HCV RNA positive
  • Treatment naïve or,
  • Patients who had been previously treated for HCV with a regimen containing interferon and not had a sustained virologic response.

排除标准

  • HBV/HCV Co-infection
  • History of hepatic decompensation or hepatocellular carcinoma
  • Other carcinoma
  • Other severe liver disease
  • Severe Comorbidity like cardiovascular disease, diabetes etc.
  • Patients who had discontinued previous HCV treatment because of an adverse event.
  • Patients who had previously received any nucleotide analogue HCV NS5B inhibitor or any NS5A inhibitor
  • Patients who had discontinued previous HBV treatment because of an adverse event.

结局指标

主要结局

Treatment Rate in female in HBV cohort

时间窗: from July 2020 to December 2023

The treatment rate in female populations who meet treatment criteria recommended by China CHB guideline

Treatment Rate in male in HBV cohort

时间窗: from July 2020 to December 2023

The treatment rate in male populations who meet treatment criteria recommended by China CHB guideline

Treatment Rate in male in HCV cohort

时间窗: from July 2016 to December 2019

The treatment rate in male populations who meet treatment criteria recommended by China CHC guideline

Treatment Rate in female in HCV cohort

时间窗: from July 2016 to December 2019

The treatment rate in female populations who meet treatment criteria recommended by China CHC guideline

次要结局

  • Distribution of Income levels among male in HBV cohort(from July 2020 to December 2023)
  • Distribution of Income levels among female in HBV cohort(from July 2020 to December 2023)
  • Distribution of medical insurance type in male in HCV cohort(from July 2016 to December 2019)
  • Distribution of medical insurance type in female in HCV cohort(from July 2016 to December 2019)

研究者

申办方类型
Other
责任方
Sponsor

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