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EDCTP portfolio: Clinical Research & Development Fellowships

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The SAVING project is helping to create an environment able to rapidly introduce new vaccines into Ghana.

Accelerating new vaccine use in Ghana

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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 challenge

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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

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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.

Impact

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

Bringing antiretroviral drugs to children

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

EDCTP portfolio: HIV & HIV-associated infections

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. 

watermark

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

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M