An interventional study of Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG) and Regular Myanmar treatment in Hepatitis B, sponsored by Myanmar Liver Foundation. Status unknown at 1 site in Myanmar. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by Myanmar Liver Foundation · Not applicable, Interventional, and Prevention
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.
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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 110 is below the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →This is the only study on the registry with Myanmar Liver Foundation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
For qualitative study:
Inclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG) · Drug: Regular Myanmar treatment
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
Also known as: Viread
Treated according to normal Myanmar processes for HBV positive patients
Vaccine within 24 hours
Proportion of newborns of HBsAg positive mothers receiving HBV vaccine within 24 hours of birth
Time frame: Within 24 hours of birth
Effective treatment of pregnant women
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)
Time frame: During pregnancy (until delivery) of each woman, average of 9 months
Household contact screening
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
Time frame: Upon identification of participating women, until the end of the project, average of 1 year
Total screening of mothers
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)
Time frame: During pregnancy (until delivery) of each woman, average of 9 months
Antenatal care for HBV positive pregnant mothers
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
Time frame: During pregnancy (until delivery) of each woman, average of 9 months
Vaccination of HBV negative pregnant mothers
Proportion of women who tested negative for HBsAg and HBsAb at baseline who complete the HBV vaccination schedule
Time frame: During pregnancy (until delivery) of each woman, average of 9 months
Treatment of high viral load pregnant mothers
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)
Time frame: At delivery; during antenatal care testing; at 4 months postpartum, throughout the project, average of 12 months
Viral suppression
Associations of maternal viral suppression (VL \<200,000 at delivery and: baseline HBV VL, duration of exposure to TDF, and TDF adherence
Time frame: At delivery, throughout the project (one off)
Mother-to-child transmission
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)
Time frame: At 28 weeks postpartum, throughout the project (one off)
Household screening
Among household members screened for HBsAg and HBsAb: o Prevalence of chronic infection (% HBsAg positive); and immune status (% HBsAb positive and HBsAg negative)
Time frame: At household screening, throughout the project (one off)
Completed vaccination courses
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
Time frame: Before age 1, average of 1 year
Proportion of pregnant women with HBsAg identified by surveillance team members
Proportion of pregnant women with HBsAg identified by surveillance team members
Time frame: During pregnancy, average of 9 months
Timeliness of pregnancy surveillance
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
Time frame: During pregnancy, average of 9 months
Equity of intervention
Distributions of select outcomes according to age, sex and axes of social disadvantage: household wealth; educational attainment; occupation; and ethnic/religious affiliation
Time frame: During pregnancy and in first year after delivery, average of 16 months
Plan to share: Undecided — The investigators are currently developing an individual participant data (IPD) sharing plan.
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenofovir