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

January 28, 2026 updated by: MAINDO ALONGO, Gardiens de Vies

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive predictive value (PPV) and negative predictive value (NPV) of MagiA H3S device
Time Frame: Baseline
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.
Baseline
Sensitivity and specificity of MagiA H3S device to dignose HIV, HBV, HCV and syphilis.
Time Frame: Baseline
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.
Baseline
Stratum-specific sensitivity and specificity of the H3S test.
Time Frame: Baseline
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.
Baseline
SE and SP, PPV and NPV of the MagIA TREATB test among pregnants women.
Time Frame: Up to 4 weeks
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.
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
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.
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
Baseline
Cotation of usability of the MagiA device from the users' perspective.
Time Frame: From baseline
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.
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
Prevalence of HIV, HBV, HCV and Syphilis using laboratory tests results of pregnant women in DRC.
Up to 4 weeks from baseline
Proportion of pregnant women who accepted the antenatal screening of HIV, HBV, HCV and Syphilis
Time Frame: Baseline
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.
Baseline
Proportion of positive results returned to pregnant women attending prenatal clinics in selected sites in the DRC.
Time Frame: Baseline
Number of positive test results for HIV, HBV, HCV and Syphilis communicated to pregnant women who tested positive during antenatal consultations.
Baseline
Cotation of Treatment adherence among positive pregnant women recieving treatment
Time Frame: Through study completion, an average of 2 year
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.
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
Rate of newborns of pregnant women infected with HBV who received the hepatitis B vaccine
At delivery
Rate of mother-to-child transmission for HIV, syphilis, HCV, and HBV.
Time Frame: 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
For each of the four infections: ratio between number of newborns born to positive pregnant women and number of positive newborns is calculated
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
Time Frame: Perioperative/Periprocedural
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.
Perioperative/Periprocedural
Cost-effectiveness of the MAGIA TREAT B diagnostic test to identify pregnant women eligible for antiviral prophylaxis against hepatitis B
Time Frame: Perioperative/Periprocedural
  • 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.
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
Time Frame: through study completion, an average of 2 years.
  • 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.
through study completion, an average of 2 years.
Odds of pregnant women's preference regarding HBV diagnostic strategy for antenatal prophylaxis.
Time Frame: One month after inclusion
Preference estimated as odd ratio from a discrete choice experiment.
One month after inclusion
Cotation of the capacity of health facilities to provide essential hepatitis care services
Time Frame: 1 to 2 months before the begining of the study
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.
1 to 2 months before the begining of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gardiens de Vies

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut Pasteur
MagIA Diagnostics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: KANA LINGAMBU, MPH, Gardiens de Vies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 676/CNES/BN/PMMF/2025
  • 101159665 (Other Grant/Funding Number: Global Health EDCTP3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

From the end of the study up to 5 years later

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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