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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

Malaria is the second biggest killer in Mozambique, with an estimated nine million cases every year and more than 14,000 deaths. 

In past decades, a range of elimination projects have been organised in the south of the country, where transmission is lowest. Although the number of cases has fallen, elimination has not been achieved. With elimination part of the Global Technical Strategy for Malaria up to 2030, elimination in this area could be a stepping stone to national elimination in Mozambique.

In 2015–2018, the Magude project evaluated a malaria elimination package comprising intensified vector control and six-monthly mass antimalarial drug administration for two consecutive years. This averted three-quarters of expected cases of malaria. Follow-up reactive targeted mass drug administration increased the number of cases averted still further, to 79.1%. The results suggest that time-limited mass drug administration reduced transmission sufficiently to enable initiation of more targeted (focal) mass drug administration, as recommended by WHO.

Based in part on these findings, the Mozambique National Malaria Control Programme has included the goal of elimination of malaria in areas of low transmission intensity in its national malaria strategic plan for 2017–2022.

The ADAM project is supporting the National Malaria Control Programme, one of the three project partners, in development of guidelines for use of the mass drug administration strategy. Through consultation with key stakeholders, it is developing a delivery strategy and monitoring plan for introduction of population-wide and follow-up targeted mass drug administration into routine programmes. It is also developing data collection and visualisation systems to facilitate monitoring of activities.

In addition, the project is piloting implementation of the new approaches in programmatic contexts to identify practical barriers and enablers. It is also supporting the development of policy and guidelines in consultation with Mozambique’s Malaria Elimination Technical Working Group.

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 ADAM project is supporting the introduction into routine programmatic use of a malaria elimination strategy that has proven highly effective in reducing the incidence of malaria. It will act as a demonstration project, generating learning that will facilitate the wider rollout of the strategy across Mozambique. In doing so, it will further lower the burden of one of the country’s leading causes of death.

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