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Tenofovir disoproxil fumarate (TDF) treatment can reduce MTCT of HBV although the optimal timing to attain undetectable HBV DNA concentrations at delivery is unknown. This protocol describes the procedures following early initiation of maternal TDF prior to 20 weeks gestation to determine efficacy, safety and feasibility of this approach in a limited-resource setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analyses<\/jats:title>\n                    <jats:p>One hundred and seventy pregnant women from the Thailand\u2013Myanmar border between 12 and &lt;20 weeks gestational age will be enrolled into a one-arm, open-label, TDF treatment study with cessation of TDF 1\u2009month after delivery. Sampling occurs monthly prenatal, at birth and at 1, 2, 4 and 6 months post partum. Measurement of tenofovir concentrations in maternal and cord plasma is anticipated in 10\u201315 women who have detectable HBV DNA at delivery and matched to 20\u201330 women with no detectable HBV DNA. Infant HBsAg status will be determined at 2\u2009months of age and HBV DNA confirmed in HBsAg positive cases. Adverse events including risk of flare and adherence, based on pill count and questionnaire, will be monitored. Infants will receive HBV vaccinations at birth, 2, 4 and 6 months and hepatitis B immunoglobulin at birth if the mother is hepatitis B e antigen positive. Infant growth and neurodevelopment at 6\u2009months will be compared with established local norms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has ethical approval by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University (FTM ECF-019-06), Johns Hopkins University (IRB no: 00007432), Chiang Mai University (FAM-2559-04227), Oxford Tropical Research Ethics Committee (OxTREC Reference: 49-16) and by the local Tak Community Advisory Board (TCAB-02\/REV\/2016). The article will be published as an open-access publication.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT02995005\">NCT02995005<\/jats:ext-link>\n                      , Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-038123","type":"journal-article","created":{"date-parts":[[2020,9,14]],"date-time":"2020-09-14T05:47:15Z","timestamp":1600062435000},"page":"e038123","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Prevention of mother-to-child transmission of hepatitis B virus: protocol for a one-arm, open-label intervention study to estimate the optimal timing of tenofovir in pregnancy"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct02995005","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2585-1066","authenticated-orcid":false,"given":"Marieke","family":"Bierhoff","sequence":"first","affiliation":[{"name":"Department of Maternal and Child health, Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand"},{"name":"Amsterdam UMC, Internal Medicine, Department of Infectious Diseases, Centre of Tropical Medicine and Travel Medicine, location AMC, University of Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenrad E","family":"Nelson","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nan","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuanxi","family":"Jia","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chaisiri","family":"Angkurawaranon","sequence":"additional","affiliation":[{"name":"Department of Family Medicine, Chiang Mai University, Suthep, Chiang Mai, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Podjanee","family":"Jittamala","sequence":"additional","affiliation":[{"name":"Department of Maternal and Child health, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 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