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

NCT07388979 | Not Yet Recruiting DMC

• 2 other identifiers: 676/CNES/BN/PMMF/2025101159665
• Study Type: observational
• Target: 7,500
• Locations: 0 countries
• Sites: N/A

Brief 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

HBV (Hepatitis B Virus); Hepatitis C Virus (HCV); Syphilis; Mother-to-Child Transmission; Performance; Point of Care STI Testing; TREAT B; HIV - Human Immunodeficiency Virus

Keywords

Triple elimination; Mother-to-child transmission; Democratic republic of the Congo

Outcome Measures

Primary Outcomes (1)

• Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab

  Compare the sensitivity and specificity of the MAGIA H3S test with laboratory reference tests (ELISA/EIA for HIV, HBV and HCV, and syphilis) for detecting the following four markers in Congolese pregnant women: anti-HIV antibodies, anti-HCV antibodies, HBsAg and treponemal antibodies for syphilis.

  Baseline

Secondary Outcomes (18)

• Positive predictive value (PPV) and negative predictive value (NPV) of MagiA H3S device

  Baseline

• Sensitivity and specificity of MagiA H3S device to dignose HIV, HBV, HCV and syphilis.

  Baseline

• Stratum-specific sensitivity and specificity of the H3S test.

  Baseline

• SE and SP, PPV and NPV of the MagIA TREATB test among pregnants women.

  Up to 4 weeks

• Se and Sp of the MagIA TREAT-B test in postpartum women, 6 months after delivery

  6 month post partum

Interventions

MAGIA H3S DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending antenatal care clinics among the 20 health facilities included for this study in DRCongo.

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.

Sponsors & Collaborators

• Gardiens de Vies: lead
• Institut Pasteur: collaborator
• MagIA Diagnostics: collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis B; Hepatitis C; Syphilis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial

Study Officials

• KANA LINGAMBU, MPH

  Gardiens de Vies

  STUDY CHAIR

Central Study Contacts

MAINDO ALONGO, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 21, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From the end of the study up to 5 years later
• Access Criteria: Researcher must write a request by contacting the project coordinator, the president of MAGIA Diagnostics, and the study sponsor, the coordinator of GArdiens de Vies, at the following email addresses: paul.kauffmann@magia-diagnostics.com and olivier.kana@gardiensdevies.org