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Not yet recruiting NCT06579313

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

— Observational HBV HCV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: HBV, HCV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Primary outcome measures

  • Treatment Rate in male in HBV cohort [Time frame: from July 2020 to December 2023]
  • Treatment Rate in female in HBV cohort [Time frame: from July 2020 to December 2023]
  • Treatment Rate in male in HCV cohort [Time frame: from July 2016 to December 2019]
  • Treatment Rate in female in HCV cohort [Time frame: from July 2016 to December 2019]
Secondary outcome measures (4)
  • Distribution of Income levels among male in HBV cohort [Time frame: from July 2020 to December 2023]
  • Distribution of Income levels among female in HBV cohort [Time frame: from July 2020 to December 2023]
  • Distribution of medical insurance type in male in HCV cohort [Time frame: from July 2016 to December 2019]
  • Distribution of medical insurance type in female in HCV cohort [Time frame: from July 2016 to December 2019]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06579313 · IN-US-987-7219

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗