Trials / Not Yet Recruiting
Not Yet RecruitingNCT07388979
MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo
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
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 7,500 (estimated)
- Sponsor
- Gardiens de Vies · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
- HIV - Human Immunodeficiency Virus
- HBV (Hepatitis B Virus)
- Hepatitis C Virus (HCV)
- Syphilis
- Mother-to-Child Transmission
- Performance
- Point of Care STI Testing
- TREAT B
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-12-31
- Completion
- 2027-12-21
- First posted
- 2026-02-05
- Last updated
- 2026-02-05
Source: ClinicalTrials.gov record NCT07388979. Inclusion in this directory is not an endorsement.