MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo
Starting soon
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT07388979
- Run by
- Gardiens de Vies
- People needed
- 7500
- Starts
- 2026-03-01
- Expected to finish
- 2027-12-21
- Last updated by the study team
- 2026-02-05
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Women in labor or who refuse to give their consent.
Full record on ClinicalTrials.gov
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