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

Not Yet RecruitingN/A

Sponsor: Gardiens de Vies

Conditions: HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV), Syphilis, Mother-to-Child Transmission

Interventions: MAGIA H3S

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.

Eligibility overview

Sex: FEMALE

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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.