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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

An effective response to emergency infectious disease outbreaks requires strong health systems, including the capacity to carry out high-quality clinical research. The 2014–16 West Africa outbreak highlighted significant deficiencies in both these areas in the countries affected.

During the Ebola outbreak, the clinical response in Sierra Leone was strengthened through a long-standing partnership between King’s Health Partners in London, UK, and partner institutions in Sierra Leone; 14% of all Ebola cases in the country were treated in units supported by the partnership.

The ID-CLINICAL-CAPACITY project built on this existing Europe–Africa partnership to enhance the capacity for clinical research on Ebola and other regionally important infectious diseases in Sierra Leone. Working with key local academic and clinical partners, the project focused on developing individual research skills, the development of infrastructure to support research, and creation of an enabling environment for clinical research.

Additional material on research was introduced into undergraduate teaching at the College of Medicine and Allied Health Sciences (COMAHS), the only medical and pharmacy school in Sierra Leone. Extracurricular research training was also organised and several students were mentored through research projects.

Building on a widespread desire to play a more significant role in research, workshops, seminars and training were organised for clinicians at key clinical centres, the 34 Military and Connaught Hospitals. Six clinicians received one-to-one mentorship and were supported through successful research projects leading to published outputs.

The project also enabled Connaught Hospital to upgrade its status, so that it was able to isolate and treat patients with a wide range of infections. An electronic data management and records system has been introduced, as well as structured assessments and data capture. These systems will facilitate both clinical management and research.

To facilitate drafting of research proposals, the project supported the development of guidelines and templates for clinical research. Members of the partnership have also contributed to technical working groups set up by Sierra Leone’s Ministry of Health and Sanitation to integrate research priorities into strategic plans.

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 ID-CLINICAL-CAPACITY project has built on a strong existing partnership between institutions in Sierra Leone and Europe to enhance both clinical and research capacity in facilities central to the responses to outbreaks of Ebola and other infectious disease. It has increased the preparedness of the country to address future outbreaks and to play a more significant role in research undertaken during emergencies.

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