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Stop Hep B @ Birth

3 de agosto de 2021 atualizado por: Khin Pyone Kyi, Myanmar Liver Foundation

Stop Hep B @ Birth: Community-Oriented Care Model for the Prevention of Mother-To-Child Transmission of Hepatitis B in Peri-Urban Yangon

Single arm, prospective open-label study of a care model consisting of two components: Component I aims to achieve high coverage of interventions to prevent maternal-to-child transmission of hepatitis B virus: antenatal tenofovir, and timely newborn administration of hepatitis B birth dose vaccine and hepatitis B immune globulin; Component II aims to achieve high coverage of screening, vaccination, and anti-viral therapy for HBV among household members of women with chronic HBV infection.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

An estimated 248 million people worldwide are chronically infected with hepatitis B virus (HBV); and 75% of them live in Asia. Mother-to-child transmission (MTCT) accounts for the majority of chronic hepatitis B infections in Southeast Asia. Elimination of MTCT of HBV is theoretically possible with a comprehensive suite of interventions that includes birth dose vaccination, hepatitis B immune globulin, and antenatal antiviral therapy (e.g., tenofovir). However, the ideal gestational age to initiate antenatal tenofovir remains undefined; and evidence is lacking for implementation strategies capable of providing cost-effective, equitable access to a comprehensive suite of interventions to prevent MTCT of HBV in low-resource settings.

Component I: Prevention of Vertical Transmission Pregnant women living in the study area will be identified and screened for hepatitis B by a network of antenatal care (ANC) providers and existing community outreach workers; HBsAg positive patients will be invited to participate in the study. Consenting participants will provide serum samples to assess eligibility for anti-viral therapy: creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelet count, HCV, HIV. Pregnant women eligible for antiviral therapy according to WHO criteria, or who have viral load (VL) >200,000 IU/mL, will be treated with tenofovir starting at 20 weeks gestation through 4 weeks postpartum. Hospital-based delivery will be encouraged. All newborns, including those delivered at home, will receive the HBV birth dose vaccine within 24 hours of delivery, and newborns of women on tenofovir treatment will also receive Hepatitis B Immunoglobulin within 24 hours after delivery. Children will be linked to routine immunization services in Myanmar to complete their HBV vaccination series (HBV is co-formulated in a pentavalent vaccine). Maternal VL will be measured at delivery; infants will be tested for hepatitis B infection at 24-28 weeks postpartum.

Component II -- Household Screening and Treatment The household members of HBsAg positive pregnant women who consent to participate in the study will be screened for HBV-related immune status and chronic HBV infection. Non-immune individuals (HBsAb/Ag negative) will be vaccinated; HBsAg positive household members will be assessed for treatment eligibility and initiated on anti-viral therapy according to World Helath Organization guidelines. Eligible household members will also be screened every six months for hepatocellular carcinoma (HCC) by liver ulatrasound and alpha-fetoprotein levels

Qualitative Study:

In-depth interviews with approximately 30 HBsAg-positive women, 30 HBVsAg-negative women, and 20 household members of study participants will be conducted to assess barriers and facilitators related to HBV testing and treatment. Approximately 15 key-informant interviews with healthcare providers and community leaders will also be conducted. Sample size will depend on data saturation and will be adjusted based on results of data analysis during the study.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

110

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Pregnant women >= 18 years of age
  • Gestational age =<34 weeks
  • Test positive for HBsAg
  • Live in study site area in South Dagon and Dagon Seikkan Townships, Yangon Region
  • Give informed consent to participate in the study
  • Newborns and household members of pregnant women enrolled in the study according to previous inclusion criteria

Exclusion Criteria:

  • Alanine aminotransferase (ALT) levels >300 IU/L

For qualitative study:

Inclusion criteria

  • Key informants (e.g., healthcare providers and community leaders in the study area) OR
  • HBsAg+ women and their household members in the study area
  • HBsAg- women and their household members in the stud area
  • Give informed consent to participate in the study
  • History of renal dysfunction
  • CrCL < 50mL/min
  • ALT>5 times the upper limit of normal (ULN)
  • Evidence of decompensated cirrhosis (e.g., jaundice, ascites, history of upper gastrointestinal bleeding/esophageal varices, and hepatic encephalopathy)
  • Any concomitant condition or treatment that, in view of the clinical site investigator, would contraindicate participation or satisfactory follow-up in the study HIV positive status unless 1) they are currently on additional ART therapy, or 2) their viral load is demonstrated to be <50 copies. Women who are newly diagnosed with HIV and referred to start a TDF-based regimen may be considered eligible once they have started the TDF-based regimen.
  • Concurrent participation in any other clinical trial without written agreement of the study team
  • Does not intend to deliver within catchment area, and/or intends to migrate before newborn follow-up is complete

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Tenofovir Disoproxil Fumerate
Pregnant women (>=20 weeks of gestation) will be treated with TDF if clinically eligible; newborns will receive birth dose vaccine (and HBIG if eligible). Non-eligible women will be treated according to normal practices; newborns will still receive birth dose vaccine.
Medicamento: Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG)
Antenatal screening for HBV, anti-viral treatment with tenofovir according to treatment eligibility criteria, and birth dose vaccination at delivery to prevent mother-to-child transmission of HBV
Outros nomes:
  • Viread
Medicamento: Regular Myanmar treatment
Treated according to normal Myanmar processes for HBV positive patients

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Vaccine within 24 hours
Prazo: Within 24 hours of birth
Proportion of newborns of HBsAg positive mothers receiving HBV vaccine within 24 hours of birth
Within 24 hours of birth
Effective treatment of pregnant women
Prazo: During pregnancy (until delivery) of each woman, average of 9 months

Proportions of pregnant women with chronic HBV (HBsAg positive) who are (a) linked to care (attend BK Kee Clinic for assessment of treatment eligibility); (b) complete TDF eligibility testing; (c) initiate tenofovir treatment (TDF, among those eligible); (d) adhere to TDF treatment until delivery and (e) continue treatment until 4 weeks post-partum

o Low/medium/high high medication adherence are defined, respectively, as ≤6, 6-7 or 8 points on the Morisky Medication Adherence Scale (MMAS-8)
During pregnancy (until delivery) of each woman, average of 9 months
Household contact screening
Prazo: Upon identification of participating women, until the end of the project, average of 1 year
Proportions of adult household contacts who (a) are screened for chronic HBV infection and immunity (HBsAg/Ab); (b) are linked to care (among HBsAg positive) or vaccinated (if HBsAb negative); (c) complete appropriate testing for hepatocellular carcinoma (HCC) screening, (d) eligible for TDF treatment; (e) initiate chronic HBV treatment with TDF
Upon identification of participating women, until the end of the project, average of 1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Total screening of mothers
Prazo: During pregnancy (until delivery) of each woman, average of 9 months

Proportion of pregnant women in the target population who are:

  • screened for HBsAg (denominator estimated from population census counts and crude birth rate)
  • HBsAg positive (chronic HBV prevalence among women attending ANC)
During pregnancy (until delivery) of each woman, average of 9 months
Antenatal care for HBV positive pregnant mothers
Prazo: During pregnancy (until delivery) of each woman, average of 9 months

Proportions of pregnant women with chronic HBV who:

  • attend their first antenatal care (ANC) visit prior to 20, 24, 28 and 32 weeks gestation
  • are eligible for TDF (HBV VL >200,00 IU/mL or WHO criteria)
  • are HBeAg positive
  • deliver at home
During pregnancy (until delivery) of each woman, average of 9 months
Vaccination of HBV negative pregnant mothers
Prazo: During pregnancy (until delivery) of each woman, average of 9 months
Proportion of women who tested negative for HBsAg and HBsAb at baseline who complete the HBV vaccination schedule
During pregnancy (until delivery) of each woman, average of 9 months
Treatment of high viral load pregnant mothers
Prazo: At delivery; during antenatal care testing; at 4 months postpartum, throughout the project, average of 12 months

Among women who had VL>200,000 IU/mL at baseline and were eligible for TDF treatment:

  • the proportion that achieve viral suppression (HBV DNA <200,000 IU/mL) at delivery
  • the proportion who are HBeAg positive
  • proportion with HBV flare 4 months postpartum (ALT >300 IU/L)
At delivery; during antenatal care testing; at 4 months postpartum, throughout the project, average of 12 months
Viral suppression
Prazo: At delivery, throughout the project (one off)
Associations of maternal viral suppression (VL <200,000 at delivery and: baseline HBV VL, duration of exposure to TDF, and TDF adherence
At delivery, throughout the project (one off)
Mother-to-child transmission
Prazo: At 28 weeks postpartum, throughout the project (one off)

Proportion of infants born to HBsAg positive mothers who

  • complete the HBV vaccination series within the recommended intervals
  • are HBsAg positive or with measurable HBV VL at 28 weeks postpartum (rate of mother-to-child transmission of HBV)
At 28 weeks postpartum, throughout the project (one off)
Household screening
Prazo: At household screening, throughout the project (one off)

Among household members screened for HBsAg and HBsAb:

o Prevalence of chronic infection (% HBsAg positive); and immune status (% HBsAb positive and HBsAg negative)
At household screening, throughout the project (one off)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Completed vaccination courses
Prazo: Before age 1, average of 1 year
Proportion of infants of HBsAg positive mothers who complete HBV vaccination prior to study termination, before and after coronavirus- and coup- related delays in public vaccination program
Before age 1, average of 1 year
Proportion of pregnant women with HBsAg identified by surveillance team members
Prazo: During pregnancy, average of 9 months
Proportion of pregnant women with HBsAg identified by surveillance team members
During pregnancy, average of 9 months
Timeliness of pregnancy surveillance
Prazo: During pregnancy, average of 9 months

Among pregnant women identified by surveillance team members:

  • Proportion who are linked to care and screened for HBsAg
  • Proportions identified prior to gestational age of 20, 24, 28 and 32 weeks
During pregnancy, average of 9 months
Equity of intervention
Prazo: During pregnancy and in first year after delivery, average of 16 months
Distributions of select outcomes according to age, sex and axes of social disadvantage: household wealth; educational attainment; occupation; and ethnic/religious affiliation
During pregnancy and in first year after delivery, average of 16 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Myanmar Liver Foundation

Investigadores

  • Investigador principal: Khin Phone Kyi, MD, Myanmar Liver Foundation
  • Investigador principal: Adam K Richards, MD, University of California, Los Angeles

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de julho de 2018

Conclusão Primária (Antecipado)

30 de dezembro de 2021

Conclusão do estudo (Antecipado)

30 de junho de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

19 de janeiro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de agosto de 2021

Primeira postagem (Real)

10 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de agosto de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2021

Última verificação

1 de agosto de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • HBV2020

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

The investigators are currently developing an individual participant data (IPD) sharing plan.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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