Study to assess the effectiveness of the treatment in chronic hepatitis patients with low viremia and evaluate strategies to optimize intervention

This is a single arm hybrid Type II effectiveness implementation protocol conducted in two public sector facilities in western India one tertiary hospital and one district hospital serving a predominantly tribal population. Adults aged 18 years and above with chronic hepatitis B defined as HBsAg positive for more than six months HBV DNA between 2000 and 20000 IU per mL and elevated ALT will receive guideline based antiviral therapy with tenofovir or entecavir along with structured adherence support. Participants will be followed for 24 months. The primary effectiveness outcome is change in quantitative HBsAg at 12 and 24 months. Secondary outcomes include HBV DNA suppression ALT normalization fibrosis progression assessed by transient elastography HBeAg seroconversion safety outcomes and health related quality of life measured by EQ 5D. Implementation outcomes guided by Proctor framework include acceptability feasibility adoption fidelity and determinants of treatment initiation and adherence. Quantitative tools include Acceptability of Intervention Measure and Feasibility of Intervention Measure. Qualitative data from interviews and focus group discussions with patients providers and policymakers will be analyzed using the Consolidated Framework for Implementation Research CFIR 2 0. Determinants will be mapped to tailored strategies using the CFIR ERIC matching tool. Mixed methods integration will use joint displays to link biological and implementation findings.