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Stop Hep B @ Birth

2021年8月3日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (预期的)

110

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：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
其他名称：
  • 威瑞德
药品：Regular Myanmar treatment
Treated according to normal Myanmar processes for HBV positive patients

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Vaccine within 24 hours
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Total screening of mothers
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)

其他结果措施

结果测量
措施说明
大体时间
Completed vaccination courses
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Myanmar Liver Foundation

调查人员

  • 首席研究员：Khin Phone Kyi, MD、Myanmar Liver Foundation
  • 首席研究员：Adam K Richards, MD、University of California, Los Angeles

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年7月1日

初级完成 (预期的)

2021年12月30日

研究完成 (预期的)

2023年6月30日

研究注册日期

首次提交

2021年1月19日

首先提交符合 QC 标准的

2021年8月3日

首次发布 (实际的)

2021年8月10日

研究记录更新

最后更新发布 (实际的)

2021年8月10日

上次提交的符合 QC 标准的更新

2021年8月3日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HBV2020

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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