Evidence map›Paper›PMID 39695524›Full record

ArticleBMC public health2024

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.

Leila Bell, Aleesha Kalulu, Kali Ameara, Nicole Allard, Sereana Natuman, Zeshi Fisher, Caroline Se Homer, Annie Taissets, Kathy Jackson, Navin Karan and 18 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC public health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Leila BellBurnet Institute, Melbourne, Australia. leila.bell@burnet.edu.au.
Aleesha KaluluBurnet Institute, Melbourne, Australia.
Kali AmearaBurnet Institute, Melbourne, Australia.
Nicole AllardDepartment of Infectious Diseases, University of Melbourne, Melbourne, Australia.
Sereana NatumanMinistry of Health, Port Vila, Vanuatu.
Zeshi FisherBurnet Institute, Melbourne, Australia.
Caroline Se HomerBurnet Institute, Melbourne, Australia.
Annie TaissetsMinistry of Health, Port Vila, Vanuatu.
Kathy JacksonVictorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia.
Navin KaranVictorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia.
Kaylene KalmosMinistry of Health, Port Vila, Vanuatu.
Emily DeedLondon School of Hygiene and Tropical Medicine, London, UK.
Leiwia DickLaboratory Department, Vila Central Hospital, Port Vila, Vanuatu.
Leias ObedVanuatu Family Health Association, Port Vila, Vanuatu.
Florita ToaMinistry of Health, Port Vila, Vanuatu.
Harriet ObedMinistry of Health, Port Vila, Vanuatu.
Ben John TauraMinistry of Health, Port Vila, Vanuatu.
Philippe GuyantWorld Health Organization, Port Vila, Vanuatu.
Jessica HowellBurnet Institute, Melbourne, Australia.
Jason IopaMinistry of Health, Port Vila, Vanuatu.
Junior George PakoaLaboratory Department, Vila Central Hospital, Port Vila, Vanuatu.
Minado PaulVila Central Hospital General Medicine, Port Vila, Vanuatu.
Harriet SamMinistry of Health, Port Vila, Vanuatu.
Tim SpelmanBurnet Institute, Melbourne, Australia.
Jenny StephensMinistry of Health, Port Vila, Vanuatu.
Sale VurobaravuVila Central Hospital General Medicine, Port Vila, Vanuatu.
Margaret HellardBurnet Institute, Melbourne, Australia.
Caroline van GemertBurnet Institute, Melbourne, Australia.

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundHepatitis 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.

methodsA 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 registrationAustralian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12623001202651p. Registered 21 November 2023.

Indexed as

Antiviral AgentsInfectious Disease Transmission, VerticalPregnancy Complications, InfectiousTenofovirAdultFemaleHepatitis BHepatitis B, ChronicHumansPregnancyAntiviral AgentsTenofovirHepatitis BMother-to-child transmissionPacificPregnancyTenofovir disoproxil fumarateUniversal peripartum antiviral prophylaxisVanuatuWestern Pacific Region

Identifiers

PMID39695524
PMCPMC11657636

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.