NCT07388979Not yet recruiting
MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo
MAGIa In-vitro- Diagnostics Medical Device Dedicated to Combined Screening of HIV, HBV, HCV and Syphilis and HBV Reflective Panels aMong Congolese pregnAnt woMen Attending to Ante Natal Care Consultations
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 7500 (estimated)
- First submitted
- 7 Jan 2026
- Start date
- Mar 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Gardiens de Vies
- Diseases
- Hepatitis B, HIV
- NCT number
- NCT07388979
What you commit to
- Study type: Observational
- Planned participants: 7500
- From Mar 2026 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Women in labor or who refuse to give their consent.
Who the study is looking for
- 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
Sex: Female · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.