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Not yet recruiting NCT07388979

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

— Observational HIV - Human Immunodeficiency Virus HBV (Hepatitis B Virus) Hepatitis C Virus (HCV) Syphilis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MAGIA H3S.
Who it may be relevant to
Registry conditions: HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV), Syphilis. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab [Time frame: Baseline]
Secondary outcome measures (12)
  • Positive predictive value (PPV) and negative predictive value (NPV) of MagiA H3S device [Time frame: Baseline]
  • Sensitivity and specificity of MagiA H3S device to dignose HIV, HBV, HCV and syphilis. [Time frame: Baseline]
  • Stratum-specific sensitivity and specificity of the H3S test. [Time frame: Baseline]
  • SE and SP, PPV and NPV of the MagIA TREATB test among pregnants women. [Time frame: Up to 4 weeks]
  • Se and Sp of the MagIA TREAT-B test in postpartum women, 6 months after delivery [Time frame: 6 month post partum]
  • Number and types of usage errors observed during the study as well as any malfunctions of the MagiA H3S device. [Time frame: Baseline]
  • Cotation of usability of the MagiA device from the users' perspective. [Time frame: From baseline]
  • Prevalence of HIV, hepatitis B and C viruses, and syphilis among pregnant women in the DRC. [Time frame: Up to 4 weeks from baseline]
  • Proportion of pregnant women who accepted the antenatal screening of HIV, HBV, HCV and Syphilis [Time frame: Baseline]
  • Proportion of positive results returned to pregnant women attending prenatal clinics in selected sites in the DRC. [Time frame: Baseline]
  • Cotation of Treatment adherence among positive pregnant women recieving treatment [Time frame: Through study completion, an average of 2 year]
  • Proportion of vaccinated newborn born from positive HBV positive pregnants women within the first 24 hours. [Time frame: At delivery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07388979 · 676/CNES/BN/PMMF/2025 · 101159665

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗