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

NOT_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

NCT07388979•Gardiens de Vies

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Yes

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.

Key Dates

Start Date

March 1, 2026

Primary Completion Date

December 31, 2026

Completion Date

December 21, 2027

Last Updated

February 5, 2026

Enrollment

7,500

ESTIMATED participants

Conditions

HIV - Human Immunodeficiency VirusHBV (Hepatitis B Virus)Hepatitis C Virus (HCV)SyphilisMother-to-Child TransmissionPerformancePoint of Care STI TestingTREAT B

Interventions

MAGIA H3S

DIAGNOSTIC_TEST

Contacts

MAINDO ALONGO, PhD

CONTACT

+243 815 188 470 mike.maindo@gardiensdevies.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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