NCT07054359Recruiting
"HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission"
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3200 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 10 Aug 2026
- Primary completion date
- 10 Nov 2028
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- Hepatitis B
- NCT number
- NCT07054359
What you commit to
- Study type: Interventional
- Planned participants: 3200
- From 10 Aug 2026 to the primary completion date, 10 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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
Age
- 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.
Who the study is looking for
- ≥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.
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tien lang District Health center Coordinator of this site? Confirm its status | Haiphong | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.