Expanding Hepatitis B Screening with Point-of-Care Rapid Testing in Primary Care: An Implementation Science Study

Abstract Background Vietnam faces a significant burden of hepatitis B virus (HBV) with around 10% of the population living with HBV and up to 80% unaware of their infection status. This study implemented a strategy using point-of-care rapid testing (POC-RT) for early HBV detection and linkage to care in primary care settings. The EPIS frameworks guided implementation, assessing barriers, enablers, feasibility, and acceptability. Method The implementation plan integrated insights from participating site’s authorities, local policies, practices, and patient pathways. A mixed-methods approach was employed at three primary care clinics in North Vietnam. Each site received 200-300 POC-RT test kits for use within 10 weeks. Patients received pre- and post-screening consultations for HBV using POC-RT, followed by referrals. Quantitative and qualitative data was collected to assess barriers, enablers, feasibility, and acceptability. Results Out of 600 POC-RT tests, 24 HBV positive cases were identified. Nine cases from public clinics received follow-up testing and specialist referrals within two weeks. Patients favored POC-RT for its simplicity, minimal blood requirement, and no cost. Physicians found POC-RT feasible for mass screenings, but noted challenges related to older adults’ skin thickness and blood volume accuracy. Linkage to care was satisfactory, but patients desired more health information during treatment. Conclusion Implementing POC-RT at primary care settings with comprehensive consultation and linkage to care is feasible and well-received. Patient feedback underscores the need for ongoing health information during treatment and follow-up, which is vital for retention in care. Enhancing the test kit design could further enhance POC-RT uptake in the population. Research in Context Evidence before this study As of May 1, 2024, a comprehensive search on PubMed and Google Scholar using the terms (“HBV” or “viral hepatitis B” or “hepatitis B virus”) AND “point-of-care” AND “screening” AND “Vietnam” revealed no relevant studies specifically investigating the use of lateral capillary blood flow point-of-care rapid tests (POC-RT) for HBV screening in Vietnam. This highlights a significant gap in the literature regarding the implementation of POC-RT for HBV in this region. Added value of this study This study is pioneering in its application of the Exploration-Preparation-Implementation-Sustainment (EPIS) framework to incorporate POC-RT for HBV screening at the primary care level in Vietnam. It adopts a universal screening approach, recommending HBV screening for all patients irrespective of their risk profiles. This is a paradigm shift in HBV testing strategy in Vietnam. Until now, HBV testing is typically based on clinical signs and symptoms of HBV related end stage liver disease in Vietnam. As a result, only an estimated 20-30% of people living with HBV are diagnosed and thus 1.32% of the eligible are on anti-viral therapies. Our proposed study suggested shifting from a model of HBsAg testing based on clinical indication to a public health model of routine community wide HBsAg testing to achieve greater absolute and more equitable reach of HBV diagnosis across demographic characteristics. Additionally, the study documents how local authorities and healthcare workers have adapted to using POC-RT and the universal screening approach in both public and private primary care facilities at central and provincial levels. Furthermore, it identifies challenges related to test selection and patient linkage to care, while also considering patient perspectives on mass screening feasibility and acceptability. Implications of all the available evidence Given the high prevalence of HBV and the significant proportion of individuals unaware of their infection status and unscreened for HBV, Vietnam would benefit from a proactive universal screening strategy. Decentralizing screening services using POC-RT at the primary care level is strategically essential toward this universal premise. Future research should focus on broader implementation and dissemination of POC-RT in primary care and other resource-limited settings, with an emphasis on effective methods for ensuring linkage to care. Taken together, this study’s novelty lies in its systematic approach to integrating POC-RT in Vietnam’s healthcare infrastructure, potentially setting a precedent for similar interventions in other regions with high HBV prevalence and limited resources