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 Type
OBSERVATIONAL
Enrollment
7,500
MagiA H3S : Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis
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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 to 2 months before the begining of the study
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