Testing pregnant women for hepatitis B to guide antiviral treatment
Compares a quick point-of-care hepatitis B test with treating all infected pregnant women.
Plain-language title generated from the registry record
Registry title: "HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission"
Key facts
- Where
- Haiphong, VietnamSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT07054359, who can take part
Where in Vietnam
- Tien lang District Health centerHaiphong, VietnamTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ANRS, Emerging Infectious Diseases
- Trial code
- NCT07054359
- Record updated
- 8 October 2026
- Original description
To achieve global elimination of hepatitis B virus (HBV), it is crucial to eliminate HBV mother-to-child transmission (MTCT) by ensuring high coverage of birth dose vaccine and expanding the adoption of peripartum antiviral prophylaxis (PAP) by tenofovir. Current international guidelines require hepatitis B surface antigen (HBsAg)-positive pregnant women to undergo viral load (VL) quantification to identify those at high risk (VL ≥200,000 IU/mL) who should receive PAP. However, VL testing remains inaccessible in many low- and middle-income countries (LMICs), particularly in rural areas. Consequently, in the forthcoming guidelines, the WHO is going to issue a conditional recommendation for administering PAP to all HBsAg-positive women lacking access to VL testing. Although this universal strategy may appear promising for simplifying the diagnostic process, it may result in overtreating the majority of HBsAg-positive pregnant women, estimated at 85% in Africa and 70% in Asia, for whom birth dose vaccine is likely sufficient. Moreover, the real-world applicability of this strategy in LMICs has never been formally tested.Read full original descriptionShow less
"HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission"
To achieve global elimination of hepatitis B virus (HBV), it is crucial to eliminate HBV mother-to-child transmission (MTCT) by ensuring high coverage of birth dose vaccine and expanding the adoption of peripartum antiviral prophylaxis (PAP) by tenofovir. Current international guidelines require hepatitis B surface antigen (HBsAg)-positive pregnant women to undergo viral load (VL) quantification to identify those at high risk (VL ≥200,000 IU/mL) who should receive PAP. However, VL testing remains inaccessible in many low- and middle-income countries (LMICs), particularly in rural areas. Consequently, in the forthcoming guidelines, the WHO is going to issue a conditional recommendation for administering PAP to all HBsAg-positive women lacking access to VL testing. Although this universal strategy may appear promising for simplifying the diagnostic process, it may result in overtreating the majority of HBsAg-positive pregnant women, estimated at 85% in Africa and 70% in Asia, for whom birth dose vaccine is likely sufficient. Moreover, the real-world applicability of this strategy in LMICs has never been formally tested.
As an innovative alternative, the adoption of a rapid point-of-care test for hepatitis B core-related antigen (HBcrAg-RDT) is proposed to identify women eligible for PAP.This test requires only a drop of capillary blood, eliminating the need for electricity or centrifugation, and can provide a reliable result within 45 minutes. Compared to the universal strategy, HBcrAg-RDT strategy is expected to be less expensive and could prevent unnecessary tenofovir exposure for both women and their fetuses. Our aim is to establish the non-inferiority of the HBcrAg-RDT strategy, in comparison to the universal strategy, in terms of effectiveness, defined as the reduction in maternal VL at the time of childbirth, a main driver of the MTCT risk. This will be approached through a multidisciplinary framework integrating health economics, implementation science, and health policy analysis.
Inclusion: ≥18 years old, or ≥ the legal age of majority as defined by each country, on the day of inclusion; Pregnancy; Intention to attend antenatal care visits in the Primary Health Center or the Rural Hospital; Living in an area covered by the Primary Health Center or the Rural Hospital on the start date of the trial; Positive HBsAg identified during the screening phase of the study; Free, informed, and written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study.
Exclusion: Any concomitant medical condition that, according to the clinical site investigator, would contraindicate participation in the study; Concurrent participation in any other study (unless approved in writing by the Global Principal Investigators); HIV co-infection; HBV treatment ongoing on the day of inclusion; Severe gravid disease at inclusion, which poses a life-threatening risk to the mother and/or child; Having at least one of the following criteria indicatives of the third trimester of pregnancy:; Gestational Age-Based Exclusion:; The reported gestational age is ≥28 weeks, based on the last menstrual period (LMP) if known; Ultrasound-Based Exclusion:; Fetal biometry (e.g., head circumference, femur length) on ultrasound suggests a gestational age of ≥28 weeks; Fundal Height-Based Exclusion:; Symphysis-fundal height (SFH) measurement of ≥ 28 cm which corresponds to approximately 28 weeks of gestation.