Protektem Pikinini Blong Yu: Preventing mother-to-child transmission of hepatitis B in Vanuatu

WHO recommends pregnant women with a high hepatitis B viral load receive tenofovir during pregnancy to prevent mother-to-child transmission, however there is limited access to viral load testing across Vanuatu and other Pacific Island Countries. This field trial compares the effectiveness of WHO-based guidelines to an alternative model of care, in which all hepatitis B-infected pregnant women receive tenofovir without requiring viral load testing, to prevent mother-to-child transmission of hepatitis B.

Objective

The project aims to:

• evaluate if the treat-all approach to managing hepatitis B-infected pregnant women leads to a reduction in hepatitis B among infants compared to a guideline-based care approach
• evaluate and compare the acceptability, cost-effectiveness and safety of the treat-all and guideline-based care approaches to management of hepatitis B-infected pregnant women. 

Timeline

2023–2025.

Approach

A two-arm, parallel group, randomised trial with hepatitis B-infected pregnant women attending antenatal clinics in Port Vila, Vanuatu. Infants will be tested 6-12 months after birth. 

Community impact

The treat-all approach is highly novel and will facilitate a major paradigm shift in prevention of mother-to-child transmission of hepatitis B in low and low-middle income countries including Pacific Island Countries. 

Pacific regional stakeholders will be consulted to determine the best strategy for regional roll-out of updated guidance. 

The impact of the intervention will be immediate in terms of averting hepatitis B infections in infants in Vanuatu. Scale-up of the intervention across the Pacific could avert hundreds of infections each year.