Project Title: IDEAS Study
Project Description: Integrated surveillance of neglected tropical disease (NTD) and malaria in antenatal populations in Tanzania, is a Cross-sectional and maternal cohort study and secondary analysis of the-identified cohort data from children aged 6 months to 10 years. The study will be conducted at Kiwangwa and Fukayosi wards, Bagamoyo district, Tanzania. The sample size will be 1170 pregnant women and 10 healthcare providers. Secondary analysis of the-identified cohort data will be from 700 children. Objectives of the... Integrated surveillance of neglected tropical disease (NTD) and malaria in antenatal populations in Tanzania, is a Cross-sectional and maternal cohort study and secondary analysis of the-identified cohort data from children aged 6 months to 10 years. The study will be conducted at Kiwangwa and Fukayosi wards, Bagamoyo district, Tanzania. The sample size will be 1170 pregnant women and 10 healthcare providers. Secondary analysis of the-identified cohort data will be from 700 children. Objectives of the project are: The overall objective of the study is to evaluate the use of antenatal surveillance as an efficient cross-disease platform for monitoring trends in parasitological and coverage outcomes for malaria, schistosomiasis and STH. Specifically: 1) To compare the prevalence of infection and intervention coverage for schistosomiasis, soil-transmitted helminths and malaria in antenatal populations to that in children aged 6m-10yrs, at two time points 2) To quantify prevalence of female genital schistosomiasis (FGS) in pregnant women and relationships between FGS and parasitological co-infections with maternal and birth outcomes. 3) To compare prevalence of molecular markers of malaria drug resistance and metrics of transmission intensity in pregnant women to that in children aged 6m-10yrs, at two time points. 4) To assess the feasibility and acceptability of integrated screening for malaria and NTDs in pregnant women The PIs will be responsible for delegating the receiving, entering, cleaning, querying, analyzing and storing all data that accrues from the study. Trained study staff will enter the data into the participants' clinical record form, which will be in an electronic format using tablet. The Investigators will maintain appropriate medical and research records for this study in compliance with ICH E6 GCP and regulatory and institutional requirements for the protection of confidentiality of participants. Data and samples collected will be provided to the Sponsor to allow study related documentation and laboratory analyses where these analyses cannot be done in Tanzania. Study documents will be retained for a minimum of 20 years after the end of the clinical trial. Any publication or presentation, abstracts and press releases related to the trial must be approved by all parties' representatives before submission of the manuscript. Either partner must have the opportunity to review the proposed abstract, manuscript or presentation before submission for publication/presentation. Data from the study may also be used as part of a thesis for a PhD, MD or Masters. Publications arising from this study will be made open access.
Principal Investigator : Ally Olotu
Department Name :
Time frame: (2023-05-01) - (2024-12-31)
The Regents of The University of California (UCSF) (Normal)
External Collaborating Partners
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