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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

Molecular tests are the gold standard technology for identifying SARS-CoV-2 infections. However, polymerase chain reaction (PCR) testing relies on laboratory facilities that are not widespread in Africa, and transport of samples inevitably delays diagnosis.

This lack of capacity severely curtails the ability of many countries in sub-Saharan Africa to rapidly identify and isolate cases, undertake contact tracing, and provide care for people with SARS-CoV-2 infections.

The Suitcaselab project is evaluating an innovative solar-powered ‘laboratory in a suitcase’ that can provide rapid results on COVID-19 infections in the field with relatively easy-to-use equipment.

The mobile suitcase detects the genetic material of SARS-CoV-2 without the need for the repeated heating and cooling cycles required of PCR-based laboratory tests. It is easy to use, powered by solar panels, requires no cold chain storage of reagents, and gives results within 20 minutes. Molecular probes specific for SARS-CoV-2 have been developed, and initial results suggest that the mobile suitcase lab performs as well as conventional PCR-based methods.

A second key feature of the set up is a specially designed ‘glove box’, which can be used to inactivate clinical samples and prevent any risk of transmission of virus to testers. 

The project is being run as a multi-country trial, with seven sub-Saharan African countries with past experience of using the mobile suitcase lab evaluating the SARS-CoV-2 assays. In each location, samples will be analysed from confirmed cases and from controls (contacts who tested negative), providing data on 3,500 samples in total.

The project will play an important role in linking multiple countries in sub-Saharan Africa and in ensuring the adoption of common operating procedures. It is also engaging with key regional bodies such as the WHO Regional Office for Africa and the Africa Centre for Disease Control and Prevention, and project partners include several members of the EDCTP-funded ALERRT and PANDORA-ID-NET epidemic preparedness networks.

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 Suitcaselab project will generate rigorous data on the performance of a rapid molecular diagnostic test for SARS-CoV-2 that could potentially be used at drop-in centres, or at sites such as airports, and in remote locations.  Use of the equipment could help to rapidly identify people with COVID-19 infections so they can be isolated and treated, and so trace and isolate and other control measures can be rapidly 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