CHAPAS-5 is an innovative trial using a new approach to test different treatment combinations for children living with HIV in sub-Saharan Africa. It aims to find out which treatment are best for children. The trial will be testing several ART regimens simultaneously. It will also assess if two-drug ART is as good as three drug ART as first-line treatment in children. This hasn’t been tested in a clinical trial yet.

CHAPAS-5 includes a wide range of children under 30kg in weight, from 4 weeks old and up, who have confirmed HIV infection. The study involves both ART naïve children (those newly diagnosed and not yet on treatment) and ART experienced children (those already receiving ART who require a second line regimen). CHAPAS-5 will take place in Mozambique, Uganda and Zimbabwe.

More than 2.5 million children and adolescents are living with HIV worldwide. Compared with adults, they often have worse treatment outcomes and face more challenges in accessing and adhering to treatment. They need age-appropriate treatment options that are effective, easy to take, and widely accessible. To achieve this, we need more efficient studies to find the best treatment options for children and adolescents living with HIV.

CHAPAS-5 is the first HIV trial using a new design called PRACTical (Personalised Randomised Controlled Trial). This novel design allows the study to randomly assign participants between different sets of appropriate HIV treatments based on their clinical status, treatment history, drug resistance and drug availability by their age and weight.

CHAPAS-5 is also an adaptive clinical trial. This means that the study can adapt over time, for example by adding new treatment options.

At the end of the study, CHAPAS-5 will provide a ranking of treatments from best to worst in terms of how well they keep the HIV controlled.