MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo

Performance study to evaluate the clinical performance of the In-Vitro Diagnostic Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from pregnant women attending antenatal care (ANC) services in the Democratic Republic of the Congo. This study aligns with the WHO 2022-2030 strategy for the integrated elimination of mother-to-child transmission of HIV, HBV, HCV, and syphilis.

NCT Number	NCT07388979
Lead Sponsor	Gardiens de Vies Collaborators: Institut Pasteur, MagIA Diagnostics
Conditions	HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV), Syphilis, Mother-to-Child Transmission, Performance, Point of Care STI Testing, TREAT B
Enrollment	7,500 participants
Start Date	2026-03-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-12-21 (estimated)
Updated on ClinicalTrials.gov	2026-02-05