Alternative prevention strategies, Kenya

Project Coordinators:

Dr Meghna Desai (CDC, USA), Clara Menendez (IS Global, Spain)

Co-investigators:            

Dr Simon Kariuki (KEMRI, Kenya), Prof Feiko ter Kuile (LSTM, UK), Julie Gutman (CDC, USA)

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Objective

The project aims were to compare intermittent screening and treatment (ISTp) or intermittent preventative treatment (IPTp) with Dihydroartemisinin-piperaquine (DP), versus IPTp with sulfadoxine-pyrimethamine (SP) in non-HIV positive pregnant women across four sites with high malaria transmission and SP resistance in Kenya.

Study design

An open-label three-arm, randomised, superiority trial it was conducted in four sites with high malaria transmission and sulfadoxine-pyrimethamine resistance in Nyanza Province, western Kenya. The primary outcome was malaria infection at delivery, defined as a composite of peripheral or placental parasitaemia detected by placental histology, microscopy, or rapid diagnostic test. At total of 1546 women were recruited into the trial.

Results and Conclusion

Compared with IPTp-SP, ISTp-DP was associated with a lower incidence of malaria infection during pregnancy and clinical malaria during pregnancy, whereas ISTp-DP was associated with a higher incidence of malaria infection and clinical malaria. Maternal and infant serious adverse events were least frequent in the ISTp-DP group

At the current levels of rapid diagnostic test (RDT) sensitivity, ISTp is not a suitable alternative to IPTp-SP, however DP is a promising alternative drug to replace SP for IPTp in areas of high SP resistance.

Impact of the research

The World Health Organisation’s Malaria Policy Advisory Committee considered the evidence from the trial and acceptability studies of IPTp with DP in 2015 and recommended a larger, definitive trial to evaluate the impact of DP for IPTp in preventing low birth weight, safety of repeated dosed and adherence to the requires three-day regimen (WHO Malaria Policy Advisory Committee (2016). Malar J 15(1): 117).

LSTM together with the IMPROVE partners is leading two new clinical trials of intermittent preventive therapy with dihydroartemisin-piperaquine as an alternative to the currently recommended drug, sulphadoxine-pyrimethamine, for the prevention of malaria in pregnancy in HIV-infected and uninfected pregnant women are currently underway in Kenya, Tanzania and Malawi.