Optimizing Healthcare Access Through Policy Innovation: An Implementation Evaluation Framework for Hepatitis C Elimination Program in Malaysia

Author(s)

Noor Syahireen Mohammed, MSc1, Huan Keat Chan, PhD2, Ibtisam Ismail, Bachelor of Health Science1, Muhammad Radzi Abu Hassan, FRGS1.
1Clinical Research Centre, Hospital Sultanah Bahiyah, Institute for Clinical Research, National Institute for Health, Ministry of Health Malaysia, Kedah, Malaysia, 2Institute for Clinical Research, National Institute for Health, Ministry of Health Malaysia, Selangor, Malaysia.
OBJECTIVES: Malaysia is advancing hepatitis C elimination through compulsory licensing of direct-acting antivirals, aiming for key targets with innovative policies like treatment decentralization and intersectoral collaboration. The EASE trial showed that an 8-week regimen of ravidasvir/sofosbuvir achieves over 90% sustained virological response, SVR12 and has over 97% adherence among vulnerable populations, proving non-inferior to the 12-week standard. Following regulatory approval, this study evaluates the translation of these evidence-based interventions into routine practice to enhance Malaysia's elimination strategy.
METHODS: This mixed-methods implementation evaluation employs the Consolidated Framework for Implementation Research (CFIR) within a convergent parallel design following StaRI guidelines. Quantitative assessment utilizes routine health system data (2019-2025) from decentralized facilities examining Proctor's implementation outcomes: acceptability, appropriateness, feasibility, fidelity, penetration, and sustainability. Facility-level comparisons employ descriptive statistics adjusted for contextual factors. Qualitative investigation conducts CFIR-informed semi-structured interviews with purposively sampled stakeholders (n=60) across multiple organizational levels. Thematic analysis identifies implementation barriers and facilitators. Data integration employs systematic convergent design procedures linking quantitative outcomes to qualitative themes using Expert Recommendations for Implementing Change (ERIC) taxonomy.
RESULTS: The study will identify multi-level implementation determinants, contextual factors influencing strategy effectiveness, and optimization opportunities for sustained hepatitis C elimination program scale-up across diverse healthcare settings in resource-constrained environments.
CONCLUSIONS: This implementation science evaluation seeks to generate actionable evidence for enhancing Malaysia's hepatitis C elimination model and to provide innovative methodologies relevant to health system interventions in low- and middle-income countries. By yielding findings that inform evidence-based policy decisions, this study facilitates replication in similar contexts aiming for equitable hepatitis C elimination. The resulting framework effectively bridges the gap between policy, evidence, and frontline healthcare delivery, offering a sustainable model for other nations pursuing their HCV elimination goals.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

HSD78

Topic

Health Policy & Regulatory, Health Service Delivery & Process of Care, Real World Data & Information Systems

Disease

Gastrointestinal Disorders, Infectious Disease (non-vaccine), No Additional Disease & Conditions/Specialized Treatment Areas

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