“This project is part of the EDCTP2 programme supported by the European Union”

Impact and operational feasibility of adding malaria infection screening using an ultrasensitive RDT for placental and fetal outcomes in an area of high IPTP-SP coverage in Burkina Faso

Acronym: ASSER Malaria

Identity of the Site Study Coordinator

Dr Marc C. Tahita

Background:

Malaria infection during pregnancy is not only deleterious to the woman but it also puts her fetus at increased risk of adverse outcomes, such as preterm delivery, low birth weight, and intrauterine growth restriction. Additionally, all-cause mortality during the first year of life in babies born of women with malaria during pregnancy is also increased. Many interventions such as IPTp-SP, LLINs have proven to be efficient at reducing malaria in pregnancy burden but adherence to recommended policies remain poor. In sub-Saharan Africa, malaria in pregnancy is often asymptomatic and many malaria infections may be missed due the inadequate performance of the current rapid diagnostic test to detect low-level parasitemias. Therefore, additional strategies such us intermittent screening with highly-sensitive rapid diagnostic tests (HS-RDTs) and treatment with an effective ACT in addition to IPTp-SP could reduce placental malaria (PM), peripheral malaria infection at delivery and low birth weight (LBW).

Methods:

This study is a phase IV, 2-arms randomized open trial with a nested study (qualitative social behavioral study) to be conducted in Nanoro district, Burkina Faso. Pregnant women will be recruited during weekly antenatal care visits randomized into two arms and followed on a monthly basis until delivery. In the intervention arm, monthly screening using HS-RDTs and treatment of those found to be infected (irrespective of parasite density) with dihydroartemisinin-piperaquine will be performed. In addition, a reminder (phone call or home visit) will be sent in order to increase the uptake of IPTp-SP doses taken per women. During scheduled and unscheduled visits blood samples will be taken for malaria diagnosis (RDTs blood slides), heamoglobin measurement and filter paper for subsequent genotyping.  

Discussion:

Current routine diagnostic methods used for malaria (microscopy and RDTs) present important limitations for the detection of low-density infections. HS-RDTs could contribute to unveil the real burden of malaria infection during pregnancy, but data on their performance in the screening of malaria infection in pregnancy remain scarce. The present protocol aims to determine the operational feasibility and the impact of additional screening with HS-RDTs and treatment with DP on PM, LBW and peripheral malaria infection at delivery in a high burden setting in Burkina Faso. We will also assess the determinants of the poor coverage and improve the number of IPTp doses received using phone call or SMS as a reminder.

Trial registration: ClinicalTrials.gov, ID: NCT04147546 (14 October 2019).

General objective

To determine the operational feasibility and the impact of additional screening with HS-RDTs and treatment with DP on PM, LBW and peripheral malaria infection at delivery in in Burkina Faso

Specific objectives are the following:

To determine the additional benefits of proactively screening with HS-RDTs and treatment of confirmed infected women with DHA-PQ on preventing placental P. falciparum malaria, LBW and peripheral malaria infection at delivery

To assess the determinants of the poor coverage and improve the number of IPTp doses received using phone call or SMS as a reminder