IPT with sulfadoxine-pyrimethamine versus intermittent screening and treatment of malaria in pregnancy

Project Coordinator:                 Prof Brian Greenwood (LSHTM, UK)

Co-Principal investigator:       Prof Daniel Chandramohan (LSHTM, UK)

Trial Coordinator:                      Dr Harry Tagbor (KNUST, Ghana)

Site PIs:

Dr Sheick Coulibaly (Université de Ouagadougou, Burkina Faso), Dr. Kalifa Bojang (MRC Gambia), Dr Abraham Hodgson, Dr John Williams (Navrongo Health Research Centre, Ghana), Dr Kassoum Kayentao (Malaria Research and Training Centre (MRTC), Mali)

Objective

The goal of this project was to determine whether scheduled intermittent screening with malaria rapid diagnostic tests and treatment of RDT positive women (ISTp) with an ACT (artemether-lumefantrine) is an effective alternative to intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP).

Study design

This was a Phase IV, two-arm, multi-centre, open, randomised control trial looking at the efficacy of intermittent screening and treatment with artemether-lumefantrine compared to IPTp-SP in pregnancy, carried out across five sites in West Africa with low levels of SP resistance: Burkina Faso (Ziniare), Ghana (Navrongo), Mali (San and Kita) and The Gambia (Basse). A total of 5,354 primi- or secundigravidae women were enrolled.

Results and Conclusion

In areas of low SP resistance intermittent screening and treatment (ISTp) is not inferior to IPTp with SP in preventing low birth weight and maternal anaemia and was tolerated better, but more women experienced clinical malaria in the ISTp that in the IPTp group. ISTp was also less cost effective than IPTp-SP.

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)

Publications

Tagbor, H., et al. (2015). "A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy." PLoS One 10(8): e0132247.

Awine, T., et al. (2016). "The risk of malaria in Ghanaian infants born to women managed in pregnancy with intermittent screening and treatment for malaria or intermittent preventive treatment with sulfadoxine/pyrimethamine." Malar J 15: 46.

Williams, J. E., et al. (2016). "The Performance of a Rapid Diagnostic Test in Detecting Malaria Infection in Pregnant Women and the Impact of Missed Infections." Clin Infect Dis 62(7): 837-844.

Williams, J., et al. (2016). "Non-falciparum malaria infections in pregnant women in West Africa." Malar J 15: 53.

Fernandes, S., et al. (2016). "Cost effectiveness of intermittent screening followed by treatment versus intermittent preventive treatment during pregnancy in West Africa: analysis and modelling of results from a non-inferiority trial." Malar J 15(1): 493.

Pell, C., et al. (2014). "The acceptability of intermittent screening and treatment versus intermittent preventive treatment during pregnancy: results from a qualitative study in Northern Ghana." Malar J 13: 432.