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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

Recent WHO guidelines recommend antiretroviral therapy (ART) initiation for everyone diagnosed with HIV regardless of CD4+ cell count and pre-exposure prophylaxis for those at substantial risk of HIV infection. However, there are fears that initiating healthy people on treatment may instead result in poor treatment outcomes due to non-adherence. The challenge is to understand what may contribute to or diminish their adherence.

Dr Wanyama seeks to assess treatment outcomes, barriers and facilitators of adherence and linkage to care among individuals initiating ART under test-and-start guidelines in an urban HIV clinic in Uganda. She and her team will conduct a mixed-methods study. Key informant interviews and sessions will be conducted among healthcare providers to assess their experiences with patients initiating ART under test-and-start guidelines. In order to assess barriers and facilitators for adherence to ART, a purposively selected sample of 24 individuals will participate in-depth interviews. Participants will be classified as adherers if they reported adherence =95% with corresponding viral suppression. Non-adherers will be categorised as irregular (inconsistent or reporting adherence < 95%) or as lost to follow-up.

The quantitative study will involve a retrospective analysis of medical records of all HIV-positive individuals (>18 years) initiated on ART under a test-and-start approach at the Kawaala Health Centre III between January 2017 and January 2018 who were followed up for two years. Participants’ longitudinal data on socio-demographic characteristics, adherence, CD4 counts, viral loads (VLs), opportunistic infections and patient retention at 6, 12 and 24 months on ART will be abstracted. The study will determine the proportion of participants with viral suppression (VL =1000 copies/mL), the mean adherence using self-reports, the incidence of opportunistic infections, mortality rates, and retention in care rates at 6, 12 and 24

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.

Uganda has had three policy changes in HIV treatment guidelines. The test-and-start policy guidelines require ART initiation for everyone testing HIV-positive or at higher risk of HIV acquisition. This appears to be too ambitious. In Uganda, the majority of the population does not know their HIV status, while resources to meet the ART demand are insufficient. Findings from this study may therefore directly inform the policy debate on the pace of the fight against HIV/AIDS in Uganda. Additionally, findings from this study will inform interventions to address challenges in treatment adherence and linkage to care, especially among healthy individuals living with HIV.

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