Field trial in Vanuatu to assess the effectivess of treating-all pregnant women with hepatitis B with tenofovir prophylaxis to prevent mother-to-child transmission compared to guideline-based care

Burnet Institute0 个研究点目标入组 234 人开始时间: 2023年11月21日最近更新: 2023年11月27日

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•Eligible participants include pregnant women aged 18 years and older, 14-28 weeks gestation at their first ANC appointment, that have a positive HBsAg test result during routine antenatal care, and able and willing to provide written informed consent prior to study-related procedures being performed. Infants born to eligible HBsAg-positive pregnant women are also considered participants.

•Exclusion criteria includes women coinfected with either HIV or hepatitis C, evidence of cirrhosis or if already receiving hepatitis B antiviral therapy prior to pregnancy. Women not planning on delivering or living in Vanuatu in the 12 months after delivery (and therefore not available for follow-up) will also be excluded. Pregnant women with evidence of cirrhosis (indicated through calculation of the APRI score ([aspartate aminotransferase ratio index], which is calculated based on AST and platelet counts, as per the Vanuatu Hepatitis B Guidelines)) will be referred to separate clinics for hepatitis B treatment assessment but will not be eligible for inclusion in the study.

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