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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

The 2014–16 West African Ebola epidemic revealed that the countries affected – Guinea, Liberia and Sierra Leone – were poorly prepared to undertake clinical infectious disease research. As a result, this made it difficult to conduct clinical trials during the outbreak.

In addition, community mistrust and a lack of understanding of clinical research is a significant obstacle to research in such settings.

The SELeCT project had the highly specific aim of developing institutional capacity to conduct biomedical research and undertake clinical trials at St Joseph’s Catholic Hospital in Monrovia, home to 30% of the population of Liberia. The Hospital is an NGO providing primary healthcare services to the people of Monrovia, with a particular focus on the care of women and children. The project was led by the Barcelona Institute of Global Health (ISGlobal) and also included the Fundación Juan Ciudad NGO.

Through the project, 14 staff undertook six-month training on Good Laboratory Practice and Good Clinical Practice, through hands-on workshops and an e-learning programme. As part of their training, nine course participants successfully undertook a practical research exercise, to explore the burden of malaria among women attending antenatal care, which generated several research papers. This work found that 12% of mothers had malaria infections, including drug-resistant infections.

In addition, equipment was upgraded in hospital laboratories, and laboratory managers received training in Good Laboratory Practice and development of standard operating procedures.

The project also aimed to strengthen community engagement. Key community stakeholders – ten traditional leaders – were invited to a participatory workshop and provided guidance on Good Clinical Practice and Communication. They were also invited to join a community advisory board, established to provide community and stakeholder input into the design of research projects and to build trust with the local community.

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 SELeCT project has enhanced the capacity of St Joseph’s Catholic Hospital to take part in clinical research during infectious disease outbreaks. It has also stimulated interest in clinical research at the hospital, leading to further grant applications. The project has also helped to build stronger relationships with local communities, which will facilitate future research and inspire community confidence in research.

ISGlobal and the Hospital are also collaborating on the EDCTP-funded IGORCADIA project, a collaboration also involving the Liberian Medicines and Health Products Regulatory Agency, which is building capacity in regulation of diagnostics.

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