Stop Hep B @ Birth

NCT04998838 | Unknown

• 1 other identifier: HBV2020
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (3)

• Vaccine within 24 hours

  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

  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

  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

Secondary Outcomes (7)

• Total screening of mothers

  During pregnancy (until delivery) of each woman, average of 9 months

• Antenatal care for HBV positive pregnant mothers

  During pregnancy (until delivery) of each woman, average of 9 months

• Vaccination of HBV negative pregnant mothers

  During pregnancy (until delivery) of each woman, average of 9 months

• Treatment of high viral load pregnant mothers

  At delivery; during antenatal care testing; at 4 months postpartum, throughout the project, average of 12 months

• Viral suppression

  At delivery, throughout the project (one off)

Other Outcomes (4)

• Completed vaccination courses

  Before age 1, average of 1 year

• Proportion of pregnant women with HBsAg identified by surveillance team members

  During pregnancy, average of 9 months

• Timeliness of pregnancy surveillance

  During pregnancy, average of 9 months

Study Arms (1)

Tenofovir Disoproxil Fumerate

EXPERIMENTAL

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

Interventions

Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG) DRUG

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

Tenofovir Disoproxil Fumerate

Regular Myanmar treatment DRUG

Treated according to normal Myanmar processes for HBV positive patients

Tenofovir Disoproxil Fumerate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Alanine aminotransferase (ALT) levels \>300 IU/L
• For qualitative study:
• 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

Sponsors & Collaborators

• Myanmar Liver Foundation: lead

Study Sites (1)

BK Kee Clinic

Yangon, Burma

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Interventions

Tenofovir; hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Khin Phone Kyi, MD

  Myanmar Liver Foundation

  PRINCIPAL INVESTIGATOR

• Adam K Richards, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khin Pyone Kyi, MD

CONTACT

+95 9 250 022 398; pmcthbv2018kpk@gmail.com

Eindra Htoo, MD

CONTACT

+95 9 975 477 478; eindrahtoo@cpintl.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: 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

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: August 10, 2021
• Study Start: July 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: June 30, 2023
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

BU (1)