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test the safety and efficacy of this new formulation in young children

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Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

The challenge

National malaria control strategies in pregnant women rely primarily on effective case management along with the use of long-lasting insecticide-treated nets (LLINs) throughout pregnancy. This includes intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters in malaria-endemic regions in sub-Saharan Africa.

For IMPTp, three 3 or more doses are recommended by the national malaria control programme of Burkina Faso but available data suggests that only 19% of eligible women received this in 2016 despite observed high attendance to the antenatal clinic. Therefore, adherence to IPTp may be affected by perceptions, acceptability and contextual factors which need to be understood better to improve the effectiveness of these health interventions.

In addition, all malaria cases should be confirmed either by microscopy or using a rapid diagnostic test (RDTs) before any treatment. Despite the crucial role of RDTs in improving malaria case management, many malaria cases are missed in pregnant women due to the recommended RDTs which are unable to detect very low parasitaemia. Identifying lower density infections in pregnant women using highly-sensitive RDTs (HS-RTDs) and clearing them with an effective ACT could improve the outcome of the pregnancy.

Dr Tahita aims to determine operational feasibility and impact of additional screening with HS-RDTs and treatment with dihydroartemisinin-piperaquine (DP) on placental malaria (PM) and low birth weight (LBW) in a context of IPTp-SP, in rural central Burkina Faso. Dr Tahita devised a 2-arm randomised controlled trial with a nested qualitative behavioural study to address three specific questions.

First, the study will determine the benefit of additional screening with HS-RDTs and treatment with DP relative to PM, LBW and peripheral malaria infection at delivery. Secondly, the study will assess the determinants of poor coverage and improve the number of IPTp doses received using reminders (phone call or text message). Finally, Dr Tahita aims to assess the performance of the new HS-RDTs in comparison to the RDTs currently deployed by the National Malaria Control Program in Burkina Faso.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

In addition to its capacity development impact on the fellow and his team, the study results once disseminated properly may contribute to improving outcomes of malaria in pregnancy in sub-Saharan Africa.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact