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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab [Срок оценки: Baseline]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• Women in labor or who refuse to give their consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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