Coordinating investigators
- Olivier SegeralGeneva University Hospital, Geneva, Switzerland
- Yusuke ShimakawaInstitut Pasteur, Paris, France
- Didier EkoueviUniversity of Lomé, Lomé, Togo
Site project · Hepatitis B
HIPOCAMP
HBV unIversal vs Point Of Care-based Antiviral treatMent to Prevent mother-to-child transmission: a multi-country cluster-randomized controlled trial
Project overview
Comparing universal and point-of-care-guided antiviral prophylaxis for pregnant women with hepatitis B in Vietnam, Cameroon, Côte d’Ivoire and Togo.
Objective
Assess whether a targeted strategy using an innovative hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) for pregnant women with HBV infection followed at primary healthcare level is non-inferior to universal tenofovir disoproxil fumarate (TDF) prophylaxis for all HBV-infected pregnant women, in terms of retention in care and reduction in maternal HBV DNA levels at childbirth.
Study design
Two-arm, cluster-randomized non-inferiority trial across Vietnam, Cameroon, Côte d’Ivoire and Togo. Eighty primary health centres or rural hospitals are randomized 1:1 to universal or selective prophylaxis, with stratification by country. Each cluster will recruit approximately 40 HBsAg-positive pregnant women, for a total of 3,200 participants. Women are followed during pregnancy, at childbirth, and at 3 and 9 months postpartum. The multidisciplinary study integrates health economics, social sciences, implementation science and health policy analysis.
ANRS-MIE Vietnam site involvement
Support for regulatory procedures.
Consortium
Project leadership and partner institutions
Country investigators · Vietnam
- Pham Minh KhueHai Phong University of Medicine and Pharmacy, Vietnam
- Hoang Thi GiangHai Phong University of Medicine and Pharmacy, Vietnam
- Vu Hai VinhViet Tiep Hospital, Hai Phong, Vietnam
Partner institutions
- Hai Phong University of Medicine and Pharmacy, Vietnam
- Viet Tiep Hospital, Hai Phong, Vietnam
- Japan Institute for Health Security
- Country partners in Cameroon, Côte d’Ivoire and Togo
Project news
Latest updates from HIPOCAMP
HIPOCAMP project launch in Hai Phong
The project launch meeting brought together the study teams in Hai Phong, marking the operational launch in Vietnam.
Funding, ethics approval and study preparation
ANRS funding was approved on 30 April 2025. HPMU ethics approval was obtained on 10 June 2025, and the ANRS–HPMU financial agreement was signed in August 2025. At the March 2026 Scientific Board meeting, standard operating procedures were under development; receipt of the Vietnam budget and procurement of tests and medicines were still pending. Cluster randomization and international training were planned for June 2026, followed by local training in July.