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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

Adolescent HIV patients face enormous challenges in accessing HIV care services. Given their risk-taking behaviour, this group also has worse treatment outcomes compared to other age groups. Poor treatment outcomes will impact negatively on HIV/AIDS management and control. The challenge is to get better evidence on the effectiveness of service delivery interventions to support adolescents’ linkage from HIV diagnosis to antiretroviral therapy (ART) initiation, retention on ART and adherence to ART.

Dr Ekwunife’s Adolescent Retention and Adherence Trial (ARA Trial) aims to improve the retention in care and adherence to antiretroviral therapy of adolescents living with HIV. The trial evaluates an incentive scheme to improve their retention in care and adherence to antiretroviral therapy. The scheme comprises a cash incentive conditioned on meeting the viral load target in combination with motivational interviewing. Motivational interviewing will help to sustain the demand for care and adherence to therapy aiming for attitude change.

The study is a cluster-randomised, controlled trial conducted in selected HIV treatment hospitals in Anambra State, Nigeria. Based on sample size calculation, twelve HIV treatment hospitals from Anambra have been selected, which were randomised to either intervention (six) or control arm (six). The control clinics provide routine HIV care without the intervention. The trial successfully recruited 251 HIV adolescents (126 in the intervention and 125 in the control arm). The trial was in its seventh month as at June 2019. We published the research protocol in Trials and presented two abstracts. Preliminary work was presented at the 13^th INTEREST conference in Accra, Ghana; the trial protocol was presented at the 9th EDCTP Forum in Lisbon, Portugal.

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.

As more than 80% of HIV–infected adolescents live in sub–Saharan Africa, improve retention in care and adherence to antiretroviral therapy of HIV-positive adolescents will have a huge potential impact.

Regarding the capacity development impact, Dr Ekwunife as the principal investigator already improved his qualifications substantially by successfully taking nine clinical trial short courses offered by The Global Health Network. He also has a mentor. Moreover, he also guides and trains 36 health personnel involved in the trial (3 per HIV treatment hospital). Additionally, he trains two collaborators, i.e. a research assistant (PhD candidate), a laboratory technologist (in charge of the central virological laboratory).

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