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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

Pregnant women are particularly vulnerable to the effects of malaria. Infections can lead to anaemia, and are a common cause of spontaneous abortion, stillbirth, pre-term delivery, and low birth weight, with long-term implications for infant health and development. 

To reduce the risk of malaria infections during pregnancy, WHO recommends preventive use of antimalarial drugs, an approach known as intermittent preventive treatment of malaria in pregnancy (IPTp). WHO recommends that antimalarial drugs are provided during antenatal visits. However, in Kenya, although use of antenatal care is very high, only 25% of pregnant women receive three or more doses of IPTp.

The IPTp project aims to use a policy implementation framework to achieve increased use of IPTp in Kenya, in line with national health policy, by engaging with a range of national stakeholders. It is increasing the understanding of IPTp among programme implementers and service providers, as well as their capacity to promote IPTp use among service users. It is also undertaking community engagement to raise awareness of IPTp and promote self-care more generally in pregnant women. Finally, it is strengthening the capacity of county authorities to deliver and monitor IPTp use.

The project brings together a range of stakeholders with a common interest in prevention of malaria in pregnancy. These include the Population Council Kenya, Kisumu Medical and Education Trust, the Midwives Association of Kenya, county health management teams, the National Malaria Control Programme, and the Reproductive Maternal Health Services Unit.

The recent decentralisation of Kenya’s health system provides an opportunity to achieve sustainable change at the county level. The project is initially focusing on the two high-prevalence malaria-endemic counties in Kenya with the lowest uptake of IPTp.

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.

The Revive IPTp project will reinvigorate efforts to deliver a proven intervention to a vulnerable group experiencing some of the worst impacts from malaria. Lessons learned from the project will support the introduction of similar approaches in other counties and potentially in other malaria-endemic countries where use of IPTp is suboptimal.

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