Protektem pikinini blong yu trial: protocol for a single arm field trial to assess the effectiveness of treating-all pregnant women with hepatitis B infection with tenofovir prophylaxis to prevent mother-to-child transmission in Vanuatu, 2024-2025.

Bell, L; Kalulu, A; Ameara, K; Allard, N; Natuman, S; Fisher, Z; Homer, CS; Taissets, A; Jackson, K; Karan, N; Kalmos, K; Deed, E; Dick, L; Obed, L; Toa, F; Obed, H; Taura, BJ; Guyant, P; Howell, J; Iopa, J; Pakoa, JG; Paul, M; Sam, H; Spelman, T; Stephens, J; Vurobaravu, S; Hellard, M; van Gemert, C

Protektem pikinini blong yu trial: protocol for a single arm field trial to assess the effectiveness of treating-all pregnant women with hepatitis B infection with tenofovir prophylaxis to prevent mother-to-child transmission in Vanuatu, 2024-2025.

Bell, L Kalulu, A Ameara, K Allard, N Natuman, S Fisher, Z Homer, CS Taissets, A Jackson, K Karan, N Kalmos, K Deed, E Dick, L Obed, L Toa, F Obed, H Taura, BJ Guyant, P Howell, J Iopa, J Pakoa, JG Paul, M Sam, H Spelman, T Stephens, J Vurobaravu, S Hellard, M van Gemert, C

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Publisher:: Springer Nature
Publication Type:: Journal Article
Citation:: BMC Public Health, 2024, 24, (1), pp. 3457
Issue Date:: 2024-12-18

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Field	Value	Language
dc.contributor.author	Bell, L
dc.contributor.author	Kalulu, A
dc.contributor.author	Ameara, K
dc.contributor.author	Allard, N
dc.contributor.author	Natuman, S
dc.contributor.author	Fisher, Z
dc.contributor.author	Homer, CS
dc.contributor.author	Taissets, A
dc.contributor.author	Jackson, K
dc.contributor.author	Karan, N
dc.contributor.author	Kalmos, K
dc.contributor.author	Deed, E
dc.contributor.author	Dick, L
dc.contributor.author	Obed, L
dc.contributor.author	Toa, F
dc.contributor.author	Obed, H
dc.contributor.author	Taura, BJ
dc.contributor.author	Guyant, P
dc.contributor.author	Howell, J
dc.contributor.author	Iopa, J
dc.contributor.author	Pakoa, JG
dc.contributor.author	Paul, M
dc.contributor.author	Sam, H
dc.contributor.author	Spelman, T
dc.contributor.author	Stephens, J
dc.contributor.author	Vurobaravu, S
dc.contributor.author	Hellard, M
dc.contributor.author	van Gemert, C
dc.date.accessioned	2025-01-14T02:31:57Z
dc.date.available	2024-12-03
dc.date.available	2025-01-14T02:31:57Z
dc.date.issued	2024-12-18
dc.identifier.citation	BMC Public Health, 2024, 24, (1), pp. 3457
dc.identifier.issn	1471-2458
dc.identifier.issn	1471-2458
dc.identifier.uri	http://hdl.handle.net/10453/183435
dc.description.abstract	BACKGROUND: Hepatitis B infection is a major public health concern in Vanuatu, with approximately 9% of the general population estimated to be living with chronic hepatitis B. Most new infections are due to mother-to-child transmission (MTCT). Hepatitis B vaccination is available in Vanuatu, but coverage rates for first dose within 24 h of birth and third dose are suboptimal. While treatment of chronic hepatitis B infection with tenofovir disoproxil fumarate (TDF) is available in country, there is no capacity to test hepatitis B e antigen and limited capacity to test hepatitis B virus (HBV) DNA viral load, which is a current eligibility requirement for women in pregnancy to access hepatitis B prophylaxis for MTCT per National guidelines. Recently, the World Health Organization guidelines have been updated to recommend universal peripartum antiviral prophylaxis (PAP) of pregnant women living with hepatitis B to prevent MTCT of HBV, without assessment of viral load in places without access to testing. However, these recommendations are conditional based on low-certainty evidence. The aim of this trial is to evaluate the effectiveness and safety of universal PAP and provide evidence for the global guidelines. METHODS: A single arm field trial compared to real world control sites will be conducted in Vanuatu involving pregnant women attending antenatal care services with positive HBsAg rapid tests. Participants at the control sites will undergo routine care. Participants at the intervention sites will all receive oral TDF prophylaxis from second trimester to completion of infant primary hepatitis B vaccination schedule. Primary data analysis will be by intention-to-treat. Initial analyses will be unadjusted comparisons of the intervention sites and control sites. Adjusted analyses will be performed, as needed, and presented in addition to unadjusted comparisons. DISCUSSION: This study will provide evidence of acceptability, effectiveness and cost-effectiveness of prophylaxis for all women with hepatitis B during pregnancy, as per the updated WHO guidelines, compared with current practice. The outcome of this trial will provide critical information to inform national and global guidelines around universal peripartum antiviral prophylaxis for hepatitis B during pregnancy. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12623001202651p. Registered 21 November 2023.
dc.format	Electronic
dc.language	eng
dc.publisher	Springer Nature
dc.relation.ispartof	BMC Public Health
dc.relation.isbasedon	10.1186/s12889-024-20946-3
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1117 Public Health and Health Services
dc.subject.classification	Public Health
dc.subject.classification	4202 Epidemiology
dc.subject.classification	4203 Health services and systems
dc.subject.classification	4206 Public health
dc.subject.mesh	Humans
dc.subject.mesh	Female
dc.subject.mesh	Pregnancy
dc.subject.mesh	Infectious Disease Transmission, Vertical
dc.subject.mesh	Tenofovir
dc.subject.mesh	Antiviral Agents
dc.subject.mesh	Pregnancy Complications, Infectious
dc.subject.mesh	Hepatitis B
dc.subject.mesh	Adult
dc.subject.mesh	Hepatitis B, Chronic
dc.subject.mesh	Humans
dc.subject.mesh	Pregnancy Complications, Infectious
dc.subject.mesh	Hepatitis B
dc.subject.mesh	Hepatitis B, Chronic
dc.subject.mesh	Antiviral Agents
dc.subject.mesh	Pregnancy
dc.subject.mesh	Adult
dc.subject.mesh	Female
dc.subject.mesh	Infectious Disease Transmission, Vertical
dc.subject.mesh	Tenofovir
dc.subject.mesh	Humans
dc.subject.mesh	Female
dc.subject.mesh	Pregnancy
dc.subject.mesh	Infectious Disease Transmission, Vertical
dc.subject.mesh	Tenofovir
dc.subject.mesh	Antiviral Agents
dc.subject.mesh	Pregnancy Complications, Infectious
dc.subject.mesh	Hepatitis B
dc.subject.mesh	Adult
dc.subject.mesh	Hepatitis B, Chronic
dc.title	Protektem pikinini blong yu trial: protocol for a single arm field trial to assess the effectiveness of treating-all pregnant women with hepatitis B infection with tenofovir prophylaxis to prevent mother-to-child transmission in Vanuatu, 2024-2025.
dc.type	Journal Article
utslib.citation.volume	24
utslib.location.activity	England
utslib.for	1117 Public Health and Health Services
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.date.updated	2025-01-14T02:31:56Z
pubs.issue	1
pubs.publication-status	Published online
pubs.volume	24
utslib.citation.issue	1

Abstract:

BACKGROUND: Hepatitis B infection is a major public health concern in Vanuatu, with approximately 9% of the general population estimated to be living with chronic hepatitis B. Most new infections are due to mother-to-child transmission (MTCT). Hepatitis B vaccination is available in Vanuatu, but coverage rates for first dose within 24 h of birth and third dose are suboptimal. While treatment of chronic hepatitis B infection with tenofovir disoproxil fumarate (TDF) is available in country, there is no capacity to test hepatitis B e antigen and limited capacity to test hepatitis B virus (HBV) DNA viral load, which is a current eligibility requirement for women in pregnancy to access hepatitis B prophylaxis for MTCT per National guidelines. Recently, the World Health Organization guidelines have been updated to recommend universal peripartum antiviral prophylaxis (PAP) of pregnant women living with hepatitis B to prevent MTCT of HBV, without assessment of viral load in places without access to testing. However, these recommendations are conditional based on low-certainty evidence. The aim of this trial is to evaluate the effectiveness and safety of universal PAP and provide evidence for the global guidelines. METHODS: A single arm field trial compared to real world control sites will be conducted in Vanuatu involving pregnant women attending antenatal care services with positive HBsAg rapid tests. Participants at the control sites will undergo routine care. Participants at the intervention sites will all receive oral TDF prophylaxis from second trimester to completion of infant primary hepatitis B vaccination schedule. Primary data analysis will be by intention-to-treat. Initial analyses will be unadjusted comparisons of the intervention sites and control sites. Adjusted analyses will be performed, as needed, and presented in addition to unadjusted comparisons. DISCUSSION: This study will provide evidence of acceptability, effectiveness and cost-effectiveness of prophylaxis for all women with hepatitis B during pregnancy, as per the updated WHO guidelines, compared with current practice. The outcome of this trial will provide critical information to inform national and global guidelines around universal peripartum antiviral prophylaxis for hepatitis B during pregnancy. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12623001202651p. Registered 21 November 2023.

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