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

NCT07388979 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 7500

Last updated 2026-02-05

No results posted yet for this study

Summary

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.

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

Interventions

DIAGNOSTIC_TEST

MAGIA H3S

MagiA H3S : Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis

Sponsors & Collaborators

  • Institut Pasteur

    collaborator INDUSTRY

  • MagIA Diagnostics

    collaborator INDUSTRY

  • Gardiens de Vies

    lead OTHER

Principal Investigators

  • KANA LINGAMBU, MPH · Gardiens de Vies

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2027-12-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07388979 on ClinicalTrials.gov