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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

With about 35,000 TB cases expected annually, Cameroon is a country with a relatively high incidence and prevalence of tuberculosis. The strategies adopted in Cameroon by the National Tuberculosis Control Program (NTCP) address all facets in the fight against tuberculosis as recommended by the WHO. The NTCP’s main objective of case finding is to identify patients with pulmonary tuberculosis (PTB) who are responsible for the transmission of the infection. However, based on a survey, the NTCP estimates that one of the main bottlenecks in finding TB cases is the fact that many people frequent informal health care providers, who give substandard care.

A survey conducted by the NTCP revealed that numerous informal healthcare providers (IHPs) were operating in major cities in Cameroon. The IHPs are not yet integrated into the NTCP network, but they are likely to provide health care to a significant number of TB suspects.

In 2015, Dr Kwedi, in collaboration with the NCTP, conducted a study to assess the feasibility of integrating IHPs into the NTCP in order to improve TB case detection in Yaoundé (intervention city) as compared to Douala (control city). This feasibility study showed that the IHPs were willing to collaborate with the NCTPs. They accepted to be trained, using NCTP tools and referring suspected TB cases to the NTCP for confirmation.

For this study, Dr Kwedi proposed to evaluate the effect of integrating the informal healthcare providers into the NTCP in order to improve TB case detection. The project takes place in three main cities in Cameroon: Douala, Buéa and Bafoussam. Informal healthcare providers receive proper training for handling TB suspects and their ability to refer TB suspects to the NCTP is intensively monitored. The project is a prospective quasi-experimental (pre/post) study to test an intervention that utilises a training tool intended to improve the IHPs ability to handle TB suspects and further refer them to the NCTP for case detection.

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 study is innovative in that it taps into a non-traditional TB case-finding strategy in the community. The results from this study will provide actionable evidence that may guide policy to transform the contribution of IHPs from a liability into an asset for TB control. Dr Kwesi expects that a formal path to integrate the IHPs into the official TB control services can be implemented.

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