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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

HIV-positive individuals have to take lifelong treatment which is taxing. The challenge is to alleviate this burden and find ways to support adherence.

With this study we aim to introduce an innovative, accessible and affordable means of improving adherence to antiretroviral treatment, that exploits the large use of mobile phones in Tanzania and sub-Saharan Africa and involves patients in their own care.

The objective of the study is to investigate the effect of short message service (SMS) and real-time medication monitoring (RTMM), which both generate reminder cues and adherence performance reports for tailored feedback on adherence to treatment among HIV-positive individuals in the Kilimanjaro region, Tanzania.

We will conduct a randomised controlled three-armed clinical trial in which one arm will receive reminder SMS messages and another arm will use an RTMM device that generates SMS messages in case of no medication intake. Both systems will be used to generate reminder cues and adherence performance reports. These reports will be the basis for tailored feedback on adherence to treatment. The third arm is the control arm that will receive standard care only. We will compare adherence to treatment and virological outcome in all three arms to investigate the effect of SMS and RTMM messaging.

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 interventions may improve adherence to HIV therapy, thus contributing to a lower social and economic burden of HIV/AIDS in Tanzania. Secondly, the study will contribute to research capacity development at the Kilimanjaro Clinical Research Institute (KCRI), an institute with wide experience in the conduct of clinical trials. A mid-career postdoctoral researcher will acquire more experience in conducting and managing research while continuing her career in sub-Saharan Africa with greater seniority. In addition, a PhD student will be trained, which will lead to new opportunities for postdoc positions. The institutional capacity at KCRI will also be expanded (human resources and equipment).

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