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

Gardiens de Vies

Status: Begins enrollment this month

Conditions: Performance; Hepatitis C Virus (HCV); Mother-to-Child Transmission; Syphilis; HIV - Human Immunodeficiency Virus; HBV (Hepatitis B Virus); Point of Care STI Testing; TREAT B

Treatments: Diagnostic Test: MAGIA H3S

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07388979

101159665 (Other Grant/Funding Number)

676/CNES/BN/PMMF/2025

Details and patient eligibility

About

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.

Enrollment: 7,500 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being pregnant, regardless of age or stage of pregnancy (prenatal period);
• Having signed an informed consent form at the start of prenatal care (CPN) to participate in the study.

Note: for pregnant minors, the consent of a parent or legal guardian is required;

• Have chosen to attend prenatal care at the healthcare facility selected for the study;
• Plan to give birth at the same healthcare facility where they were included in the study;
• Plan to attend postnatal care (PNC) and preschool consultations (PSC) at the same healthcare facility where they were included in the study.
• Plan to give birth at the same health facility where they were enrolled;
• Plan to attend postnatal consultations (PNC) and preschool consultations (PSC) at the same facility

Exclusion criteria

• Women in labor or who refuse to give their consent.