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Professor Vivi Maketa

Call Career Development Fellowship (CDF)
Programme EDCTP2
Start Date 2020-10-01
End Date 2023-09-30
Project Code TMA2019CDF-2699
Status Active

Title

Comparison of intermittent screening (using ultra sensitive malaria Rapid Diagnostic test) and treatment (using a newly registered antimalarial Pyronaridine-Artesunate – PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas (ULTRAPYRAPREG)

Objectives

Main objective The main objective is to assess that the proportion of maternal malaria, maternal anemia, spontaneous abortions or intrauterine death during pregnancy, fetal morbidity and neonatal mortality at childbirth is non inferior when using ISTp-US-Py compared to IPTp-SP. Secondary objective The secondary objectives are to assess that: During pregnancy: - The proportion of asymptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of parasitic densities is not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP - The incidence of spontaneous abortions or intrauterine deaths is not higher when using ISTp-US-Py compared to IPTp-SP After the birth: In women: - The proportion symptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP - The parasitic densities are not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP In the offspring: - Intrauterine death - The fetal morbidities (Preterm birth, Low-birth-weight) are not higher when using C compared to IPTp-SP During the 28 days period following the birth: - The neonatal and early neonatal mortality of the offspring are not higher when using ISTp-US-Py compared to IPTp-SP

Host Organisation

Institution Country
University of Kinshasa (UNIKIN) The Democratic Republic of The Congo

Study Design

This is a 2 arms 1.1 ratio randomized non-inferiority trial. An unique registration number will be associated with a randomization list number, generated before the start of the study and which will determine the assignment of the study participant to one of the study groups. - The ISTp-US-Py group will comprise pregnant women who will be screened monthly from the beginning of the 2nd trimester with us-RDT and who will be treated with Pyramax® if the test is positive. - The IPTp-SP group will be pregnant women who will receive the standard regimen recommended by the Malaria National Control Program (MNCP) at week 16, 28, 32 and 36 of their pregnancy.

Sites

Maternité Esengo, Kisenso. Kinshasa

Current Organisation

UNIKIN

Current Job Title

Lecturer

Areas Of Specialisation

Malaria Neglected Infectious Diseases (NID)

Publications

Use of Iris Scanning for Biometric Recognition of Healthy Adults Participating in an Ebola Vaccine Trial in the Democratic Republic of the Congo: Mixed Methods Study (Preprint)
Authors:
Trésor Zola Matuvanga , author
Ginger Johnson , author
Ynke Larivière , author
Emmanuel Esanga Longomo , author
Junior Matangila , author
Vivi Maketa , author
Bruno Lapika , author
Patrick Mitashi , author
Paula Mc Kenna , author
Jessie De Bie , author
Jean-Pierre Van Geertruyden , author
Pierre Van Damme , author
Hypolite Muhindo Mavoko , author
Date:
2021-03-06
Journal:
Content:
Identifiers:
DOI: 10.2196/preprints.28573
Algorithm for the support of non-related (serious) adverse events in an Ebola vaccine trial in the Democratic Republic of the Congo
Authors:
Gwen Lemey , author
Ynke Larivière , author
Trésor Matuvanga Zola , author
Vivi Maketa , author
Junior Matangila , author
Patrick Mitashi , author
Peter Vermeiren , author
Séverine Thys , author
Jessie De Bie , author
Hypolite Mavoko Muhindo , author
Raffaella Ravinetto , author
Pierre Van Damme , author
Jean-Pierre Van Geertruyden , author
Date:
2021-06-01
Journal:
BMJ Global Health
Content:
Identifiers:
DOI: 10.1136/bmjgh-2021-005726
Use of Iris Scanning for Biometric Recognition of Healthy Adults Participating in an Ebola Vaccine Trial in the Democratic Republic of the Congo: Mixed Methods Study
Authors:
Trésor Zola Matuvanga , author
Ginger Johnson , author
Ynke Larivière , author
Emmanuel Esanga Longomo , author
Junior Matangila , author
Vivi Maketa , author
Bruno Lapika , author
Patrick Mitashi , author
Paula Mc Kenna , author
Jessie De Bie , author
Jean-Pierre Van Geertruyden , author
Pierre Van Damme , author
Hypolite Muhindo Mavoko , author
Date:
2021-08-09
Journal:
Journal of Medical Internet Research
Content:
Identifiers:
DOI: 10.2196/28573

Projects

UltraPyrapreg
Fellow:
Vivi Maketa
Collaborators:
Name Country Institution
Vivi Maketa The Democratic Republic of The Congo University of Kinshasa
Objectives:
Main objective The main objective is to assess that the proportion of maternal malaria, maternal anemia, spontaneous abortions or intrauterine death during pregnancy, fetal morbidity and neonatal mortality at childbirth is non inferior when using ISTp-US-Py compared to IPTp-SP. Secondary objective The secondary objectives are to assess that: During pregnancy: - The proportion of asymptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of parasitic densities is not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP - The incidence of spontaneous abortions or intrauterine deaths is not higher when using ISTp-US-Py compared to IPTp-SP After the birth: In women: - The proportion symptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP - The parasitic densities are not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP In the offspring: - Intrauterine death - The fetal morbidities (Preterm birth, Low-birth-weight) are not higher when using C compared to IPTp-SP During the 28 days period following the birth: - The neonatal and early neonatal mortality of the offspring are not higher when using ISTp-US-Py compared to IPTp-SP
Sites:
Maternité Esengo, Kinshasa, DRC
Study Design:
s a 2 arms 1.1 ratio randomized non-inferiority trial. An unique registration number will be associated with a randomization list number, generated before the start of the study and which will determine the assignment of the study participant to one of the study groups. - The ISTp-US-Py group will comprise pregnant women who will be screened monthly from the beginning of the 2nd trimester with us-RDT and who will be treated with Pyramax® if the test is positive. - The IPTp-SP group will be pregnant women who will receive the standard regimen recommended by the Malaria National Control Program (MNCP) at week 16, 28, 32 and 36 of their pregnancy.
Subjects:
Pregant women
Outcomes:
Primary outcome The primary outcome will be the assessment of asymptomatic/symptomatic malaria during pregnancy and of the malaria related morbidities in the offspring Secondary outcomes During pregnancy, the following outcomes will be assessed in the study participants: - The asymptomatic/symptomatic malaria - The parasitic density of women who will have malaria - The presence of anemia - The incidence of spontaneous abortions or intrauterine deaths After the birth, the outcomes will be assessed as following: In the mother - The asymptomatic/symptomatic malaria - The PD - The presence of anemia In the offspring - Fetal morbidity - Intra uterine death Within the 28 days of post-partum, the following outcomes will be assessed in the infant - The early neonatal mortality (death within 7 days of life) - The neonatal mortality (death within 28 days of life)
Start Date:
2020-10-01
End Date:
2023-10-01

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