Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China

Study Overview
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Brief Summary
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China has the world's largest burden of hepatitis B virus (HBV) infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. One of the main issues in the management of patients with chronic HBV infection (CHB) is to maximize the individuals who need the treatment engaged and retained in care. However, our investigation revealed that 21.1% patients were treatment eligible but not treated based on Chinese 2019 CHB treatment guidelines, while only 213 (13.9%) patients were indicated-but-not-treated according to AASLD 2018 Hepatitis B guidance in a real-life cohort study. To maximize the individuals who need the treatment engaged and retained in care, integrated intervention strategies to address these treatment barriers are urgently needed. Therefore, we aim to propose a study to narrow the gap between in accordance with guidelines and consent to treat CHB population in EAST of China.

Official Title
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Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Other: Integrated intervention strategies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive HBV surface antigen (HBsAg) for 6 months or more; Elevated ALT levels (>1×ULN) and detectable HBV DNA; Treatment-naïve; Willing to attend this study and able to provide the written informed consent. Exclusion Criteria: Co-infection with other viral hepatitis and human immunodeficiency virus; Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease; Patients with liver cirrhosis; Coexistence of hepatocellular carcinoma and other malignant tumor; Underwent liver transplantation before the enrollment; Severe cardiac, renal, respiratory, hematological, or psychiatric illness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated intervention strategies<br> | Other: Integrated intervention strategies<br>* Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of indicated-but-not-treated CHB patients. | The proportion of indicated-but-not-treated CHB patients. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of lost to follow-up in CHB patients. |  | 18 months | 
| The frequency of follow-up visit in CHB patients. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis b, Antiviral treatment