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Clinical Trials/NCT07388979
NCT07388979
Not yet recruiting
Not Applicable

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

Gardiens de Vies0 sites7,500 target enrollmentStarted: March 1, 2026Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Gardiens de Vies
Enrollment
7,500
Primary Endpoint
Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts 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.

Outcomes

Primary Outcomes

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

Time Frame: Baseline

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.

Secondary Outcomes

  • 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)
  • Number and types of usage errors observed during the study as well as any malfunctions of the MagiA H3S device.(Baseline)
  • Cotation of usability of the MagiA device from the users' perspective.(From baseline)
  • Prevalence of HIV, hepatitis B and C viruses, and syphilis among pregnant women in the DRC.(Up to 4 weeks from baseline)
  • Proportion of pregnant women who accepted the antenatal screening of HIV, HBV, HCV and Syphilis(Baseline)
  • Proportion of positive results returned to pregnant women attending prenatal clinics in selected sites in the DRC.(Baseline)
  • Cotation of Treatment adherence among positive pregnant women recieving treatment(Through study completion, an average of 2 year)
  • Proportion of vaccinated newborn born from positive HBV positive pregnants women within the first 24 hours.(At delivery)
  • Rate of mother-to-child transmission for HIV, syphilis, HCV, and HBV.(Four to six weeks after birth for HIV, Six months after birth for HBV, at birth for syphilis and six weeks to tree months after birth for HCV post partum)
  • Cost-effectiveness of the MAGIA H3S diagnostic test(Perioperative/Periprocedural)
  • Cost-effectiveness of the MAGIA TREAT B diagnostic test to identify pregnant women eligible for antiviral prophylaxis against hepatitis B(Perioperative/Periprocedural)
  • Cost-effectiveness of the MAGIA TREAT B diagnostic test to identify women infected with hepatitis B virus who are eligible for long-term treatment for their own health(through study completion, an average of 2 years.)
  • Odds of pregnant women's preference regarding HBV diagnostic strategy for antenatal prophylaxis.(One month after inclusion)
  • Cotation of the capacity of health facilities to provide essential hepatitis care services(1 to 2 months before the begining of the study)

Investigators

Sponsor
Gardiens de Vies
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

MAINDO ALONGO

Principal Investigator

Gardiens de Vies

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