HIV - Human Immunodeficiency VirusMAGICS MAMNCT07388979
MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo
An observational study of HIV - Human Immunodeficiency Virus and HBV (Hepatitis B Virus), run by Gardiens de Vies.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV)
- What is being tested?
- MAGIA H3S
- How many people
- 7,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 21 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women attending antenatal care clinics among the 20 health facilities included for this study in DRCongo.
Who may be able to join
- 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
Who cannot join
- Women in labor or who refuse to give their consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV), Syphilis, Mother-to-Child Transmission, Performance
- Being tested
- MAGIA H3S
- Keywords
- Triple elimination, Mother-to-child transmission, Democratic republic of the Congo
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis B, Hepatitis C, Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGIA H3SDiagnostic test
MagiA H3S : Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (18)
Positive predictive value (PPV) and negative predictive value (NPV) of MagiA H3S device
NPV and PPV calculated for each of the four diseases, using the laboratory tests as the reference for the entire population and according to different geographical area and socio-demographic context.
Measured: Baseline
Sensitivity and specificity of MagiA H3S device to dignose HIV, HBV, HCV and syphilis.
For each of the four diagnoses, the Sensitivity and specificity of the MAGIA H3S will calculated and compared to the sensitivity and specificity of RDTs test, using fourth generation ELISA as the reference.
Measured: Baseline
Stratum-specific sensitivity and specificity of the H3S test.
For each of the four diagnoses, the sensitivity and specificity of the MagIA H3S device will be calculated by stratifying them according to known infection and/or treatment history.
Measured: Baseline
SE and SP, PPV and NPV of the MagIA TREATB test among pregnants women.
Performance evaluation of MagiA TREATB test in detection of HbeAg, ALT and HbsAg quantification among pregnant women. The MagiA TREAT-B test that detect the Hbe-Ag, the ALT level and quantifies HbsAg will be compared to the laboratory tests as the reference.
Measured: Up to 4 weeks
Se and Sp of the MagIA TREAT-B test in postpartum women, 6 months after delivery
Performance evaluation of MagiA TREATB test in detection of HbeAg, ALT and HbsAg quantification women who gave birth. The MagiA TREAT-B test that detect the Hbe-Ag, the ALT level and quantifies HbsAg will be compared to the laboratory tests as the reference.
Measured: 6 month post partum
Number and types of usage errors observed during the study as well as any malfunctions of the MagiA H3S device.
Measured: Baseline
Cotation of usability of the MagiA device from the users' perspective.
System usability scale will be used to assess the usability of use of the MagiA H3S test from healthcare personnel who have used the diagnostic tests. The score's scale ranges from 1 to 5. 1 means strongly disagree and 5 strongly agree.
Measured: From baseline
Prevalence of HIV, hepatitis B and C viruses, and syphilis among pregnant women in the DRC.
Prevalence of HIV, HBV, HCV and Syphilis using laboratory tests results of pregnant women in DRC.
Measured: Up to 4 weeks from baseline
Proportion of pregnant women who accepted the antenatal screening of HIV, HBV, HCV and Syphilis
The number of pregant women who accepted antenatal screening (rapid diagnostic tests and MagiA H3S) to detect HIV, HBV, HCV, and syphilis compared to total number of pregnant women attending antenatal services.
Measured: Baseline
Proportion of positive results returned to pregnant women attending prenatal clinics in selected sites in the DRC.
Number of positive test results for HIV, HBV, HCV and Syphilis communicated to pregnant women who tested positive during antenatal consultations.
Measured: Baseline
Cotation of Treatment adherence among positive pregnant women recieving treatment
Treatment adherence of study participants receiving treatment will be assessed at each follow-up visit using the 8-item Morisky Medication Adherence Scale. The Morisky adherence scale yields a score ranging from 0 to 8, with higher scores indicating better adherence to treatment.
Measured: Through study completion, an average of 2 year
Proportion of vaccinated newborn born from positive HBV positive pregnants women within the first 24 hours.
Rate of newborns of pregnant women infected with HBV who received the hepatitis B vaccine
Measured: At delivery
Rate of mother-to-child transmission for HIV, syphilis, HCV, and HBV.
For each of the four infections: ratio between number of newborns born to positive pregnant women and number of positive newborns is calculated
Measured: 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
Medical-economic evaluation of the MAGIA H3S diagnostic test by analyzing the costs associated with its implementation and its cost-effectiveness, compared to the absence of screening in routine antenatal care (status quo), and with the implementation of rapid HIV, HBV, HCV, and syphilis tests.
Measured: Perioperative/Periprocedural
Cost-effectiveness of the MAGIA TREAT B diagnostic test to identify pregnant women eligible for antiviral prophylaxis against hepatitis B
- Total economic cost of introducing the MAGIA TREAT B test to identify pregnant women eligible for antiviral prophylaxis against Hepatitis B.
- Cost-effectiveness assessment of the MAGIA TREAT B test, compared to the status quo and to viral load quantification or the HbeAg test.
Measured: 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
- Total economic cost of introducing the MAGIA TREATB test to identify women infected with hepatitis B virus who are eligible for long-term treatment for their own health
- Cost-effectiveness assessment of the MAGIA TREAT B test, compared to the status quo, as well as to the use of the APRI score, or the measurement of viral load and/or ALT levels.
Measured: through study completion, an average of 2 years.
Odds of pregnant women's preference regarding HBV diagnostic strategy for antenatal prophylaxis.
Preference estimated as odd ratio from a discrete choice experiment.
Measured: One month after inclusion
Cotation of the capacity of health facilities to provide essential hepatitis care services
Health facility service availability and readiness will be presented as percentage ranging from 0% to 100% for included indicators using the WHO's Service Availability and Readiness Assessment (SARA) tool. The study will describe the percentage of service availability and readiness for each health facility.
Measured: 1 to 2 months before the begining of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion21 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Gardiens de Vies
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, MagIA Diagnostics
- Responsible party
- Principal investigator, MAINDO ALONGO, Gardiens de Vies
- Investigators
- KANA LINGAMBU, MPH, Study chair, Gardiens de Vies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388979
- Sponsor's protocol ID
- 676/CNES/BN/PMMF/2025
- Other IDs
- 101159665
- Acronym
- MAGICS MAM
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD from this research will be shared upon written 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