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
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,...
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2024-12-01
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| Online Access: | https://doi.org/10.1186/s12889-024-20946-3 |
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| author | Leila Bell Aleesha Kalulu Kali Ameara Nicole Allard Sereana Natuman Zeshi Fisher Caroline SE Homer Annie Taissets Kathy Jackson Navin Karan Kaylene Kalmos Emily Deed Leiwia Dick Leias Obed Florita Toa Harriet Obed Ben John Taura Philippe Guyant Jessica Howell Jason Iopa Junior George Pakoa Minado Paul Harriet Sam Tim Spelman Jenny Stephens Sale Vurobaravu Margaret Hellard Caroline van Gemert |
| author_facet | Leila Bell Aleesha Kalulu Kali Ameara Nicole Allard Sereana Natuman Zeshi Fisher Caroline SE Homer Annie Taissets Kathy Jackson Navin Karan Kaylene Kalmos Emily Deed Leiwia Dick Leias Obed Florita Toa Harriet Obed Ben John Taura Philippe Guyant Jessica Howell Jason Iopa Junior George Pakoa Minado Paul Harriet Sam Tim Spelman Jenny Stephens Sale Vurobaravu Margaret Hellard Caroline van Gemert |
| author_sort | Leila Bell |
| collection | DOAJ |
| 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. |
| format | Article |
| id | doaj-art-6a0aed4a3bca47aa9380efffe31904e1 |
| institution | DOAJ |
| issn | 1471-2458 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
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| spelling | doaj-art-6a0aed4a3bca47aa9380efffe31904e12025-08-20T02:40:18ZengBMCBMC Public Health1471-24582024-12-012411810.1186/s12889-024-20946-3Protektem 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, 2024–2025Leila Bell0Aleesha Kalulu1Kali Ameara2Nicole Allard3Sereana Natuman4Zeshi Fisher5Caroline SE Homer6Annie Taissets7Kathy Jackson8Navin Karan9Kaylene Kalmos10Emily Deed11Leiwia Dick12Leias Obed13Florita Toa14Harriet Obed15Ben John Taura16Philippe Guyant17Jessica Howell18Jason Iopa19Junior George Pakoa20Minado Paul21Harriet Sam22Tim Spelman23Jenny Stephens24Sale Vurobaravu25Margaret Hellard26Caroline van Gemert27Burnet InstituteBurnet InstituteBurnet InstituteDepartment of Infectious Diseases, University of MelbourneMinistry of HealthBurnet InstituteBurnet InstituteMinistry of HealthVictorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and ImmunityVictorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and ImmunityMinistry of HealthLondon School of Hygiene and Tropical MedicineLaboratory Department, Vila Central HospitalVanuatu Family Health AssociationMinistry of HealthMinistry of HealthMinistry of HealthWorld Health OrganizationBurnet InstituteMinistry of HealthLaboratory Department, Vila Central HospitalVila Central Hospital General MedicineMinistry of HealthBurnet InstituteMinistry of HealthVila Central Hospital General MedicineBurnet InstituteBurnet InstituteAbstract 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.https://doi.org/10.1186/s12889-024-20946-3Hepatitis BPregnancyMother-to-child transmissionUniversal peripartum antiviral prophylaxisTenofovir disoproxil fumarateVanuatu |
| spellingShingle | Leila Bell Aleesha Kalulu Kali Ameara Nicole Allard Sereana Natuman Zeshi Fisher Caroline SE Homer Annie Taissets Kathy Jackson Navin Karan Kaylene Kalmos Emily Deed Leiwia Dick Leias Obed Florita Toa Harriet Obed Ben John Taura Philippe Guyant Jessica Howell Jason Iopa Junior George Pakoa Minado Paul Harriet Sam Tim Spelman Jenny Stephens Sale Vurobaravu Margaret Hellard Caroline van Gemert 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 BMC Public Health Hepatitis B Pregnancy Mother-to-child transmission Universal peripartum antiviral prophylaxis Tenofovir disoproxil fumarate Vanuatu |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Hepatitis B Pregnancy Mother-to-child transmission Universal peripartum antiviral prophylaxis Tenofovir disoproxil fumarate Vanuatu |
| url | https://doi.org/10.1186/s12889-024-20946-3 |
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