Prevention Malawi – ISTp versus IPTp-SP

Principal Investigator: Prof Feiko Ter Kuile (LSTM, UK)

Project Collaborators:

Dr Linda Kalilani (College of Medicine, Malawi), Dr Mwayiwawo Madanitsa (College of Medicine, Malawi), Doreen Ali (National Malaria Control Programme, Malawi), Dr Brian Faragher (LSTM, UK), Prof Kara Hanson (LSHTM, UK), Silke Lutzelschwab (LSHTM, UK), Prof Stephen Rogerson (University of Melbourne, Australia)


The objective was to determine whether scheduled intermittent screening with malaria rapid diagnostic tests (RDTs) and treatment of RDT-positive women with dihydroartemisinin-piperaquine (ISTp-DP) was more efficacious than intermittent preventative treatment with sulfadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters of pregnancy in an area with decreasing malaria transmission and high levels of SP resistance in southern Malawi.

Study design

This was an open-label, two-arm individually randomized superiority trial among 1,873 pregnant women at three sites with high SP resistance in Southern Malawi. Additional sub-studies include a cost-effectiveness and acceptability, and an immunological study.

Results and Conclusion

The prevalence of adverse live birth outcome was similar in the ISTp-DP and IPTp-SP arms however the prevalence of malaria at delivery was higher in the ISTp-DP arm. The results demonstrated that scheduled screening for malaria parasites with the current generation of RDTs three to four times during pregnancy as part of focused antenatal care was not superior to IPTp-SP in this area with high malaria transmission and high SP resistance and was associated with higher fetal loss and more malaria at delivery.

Impact of the research

The results formed an important part of the evidence reviewed by WHO’s Evidence Review Group meeting in July 2015 which considered the potential role of ISTp as an alternative to IPTp-SP to control malaria in pregnancy. The group concluded there is no clearly defined role for ISTp at present, even in areas of SP resistance (World Health Organization WHO/HTM/GMP/2015.9). This view was accepted by WHO’s MPAC (WHO Malaria Policy Advisory Committee (2016). Malar J 15(1): 117).