Stop Hep B @ Birth

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Myanmar Liver Foundation
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Tenofovir

Criteria

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