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

”

Bringing antiretroviral drugs to children

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

The challenge

Women are disproportionately affected by HIV. In sub-Saharan Africa four out of five new HIV infections in people aged 10–19 are among girls. Globally, of every five new infections among young people aged 15–24 years, three are in young women.

As a result, there is great interest in the development of interventions that prevent infection in young women, and also in combining interventions for HIV prevention and contraception. However, the success of these interventions will depend not only on the efficacy of their medical components but also on their acceptability to and use by target populations. 

The UPTAKE project aims to strengthen the connections between new product developers and vulnerable user communities, such as female sex workers and at-risk adolescents and young women. By ensuring that the preferences of such groups are factored into early product development, the project will make it more likely that new products are used and successfully reduce transmission of infection.

The project has a particular focus on pre-exposure prophylaxis, PrEP, use of antiretroviral drugs to prevent infection, particularly injectable and implantable long-acting PrEP. PrEP has been convincingly shown to significantly reduce the risk of HIV infection, but daily drug taking imposes a high treatment burden on young people, limiting its effectiveness in practice. The project will also explore the potential of combination interventions that combine long-acting PrEP with long-acting contraceptives.

Based on an innovative collaboration of academic, public health and product development organisations, the UPTAKE project is using behavioural research to explore the attitudes and preferences of key target groups, to understand the likely facilitators of and obstacles to the use of new devices. It will also develop and evaluate interventions to promote use of existing long-acting contraceptives, to inform approaches used when long-acting PrEP and combination devices are introduced. It will also carry out cost-effectiveness studies based on integration of long-acting PrEP into sexual and reproductive health services.

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 UPTAKE project will accelerate the introduction of novel products for HIV prevention in vulnerable groups by catalysing innovative collaborations between product developers, policymakers and user communities.

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