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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

Ghana was one of three countries in sub-Saharan Africa selected to host a pilot implementation project for the RTS,S/AS01 malaria vaccine. The pilot project is anticipated to be a stepping stone towards a wider national rollout, which is likely to present significant practical challenges. 

More generally, with increasing numbers of vaccine products and associated technologies likely to become available over the next decade, there is a need to strengthen the capacity of key health systems bodies – such as the Ghana Foods and Drug Authority, Ghana’s Ministry of Health, and the Ghana Health Service – to identify and address implementation challenges. 

The SAVING project is making use of a framework (value chain) provided by the Access and Delivery Partnership. This recognises the importance of multiple aspects of health system function that must be systematically addressed if populations are to gain timely access to new medical interventions, such as regulatory processes, the national policy and regulatory environment, health technology assessment, procurement and supply chain management, delivery and implementation research, and monitoring for adverse events.

The project has adopted an approach based on implementation research to address these critical areas. It is therefore building implementation research capacity in partner institutions in Ghana, as well as capacity to apply evidence-based decision-making. At least two implementation research projects will be undertaken, on deployment of a mobile application and a patient information system, to gather evidence on implementation challenges and to learn lessons for future introductions.

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 SAVING project will strengthen the capacity of the health system in Ghana to evaluate and implement new health interventions in a timely fashion, accelerating the introduction not just of the new malaria vaccine but also of other health interventions.

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