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NCT Number: NCT06579313

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

Exclusion criteria

  • HBV/HCV Co-infection
  • HIV
  • 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.

Treatment and study plan

Primary outcomes

  1. Treatment Rate in male in HBV cohort

    Time frame: from July 2020 to December 2023

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

  2. Treatment Rate in female in HBV cohort

    Time frame: from July 2020 to December 2023

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

  3. Treatment Rate in male in HCV cohort

    Time frame: from July 2016 to December 2019

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

  4. Treatment Rate in female in HCV cohort

    Time frame: from July 2016 to December 2019

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

Secondary outcomes

  1. Distribution of Income levels among male in HBV cohort

    Time frame: from July 2020 to December 2023

    categorize into 3 levels - low income (less than 50,000 CNY/year), medium income (50,000-300,000 CNY/year), high income (more than 300,000 CNY/year), in male populations infected with HBV

  2. Distribution of Income levels among female in HBV cohort

    Time frame: from July 2020 to December 2023

    categorize into 3 levels - low income (less than 50,000 CNY/year), medium income (50,000-300,000 CNY/year), high income (more than 300,000 CNY/year), in female populations infected with HBV

  3. Distribution of medical insurance type in male in HCV cohort

    Time frame: from July 2016 to December 2019

    categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV

  4. Distribution of medical insurance type in female in HCV cohort

    Time frame: from July 2016 to December 2019

    categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV

Study contacts

Contact information is provided by the study sponsor or research team.

Honglian Gui

CONTACT

[email protected]

+8613564725017

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

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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