Dr Paul Sondo

Burkina Faso

EDCTP portfolio: Career Development Fellowships

Dr Paul Sondo aims to establish whether a combined strategy of seasonal malaria chemoprevention (SMC) with nutrients and vitamin A-Zinc supplementation will improve SMC outcomes and reduce malnutrition.

Combining seasonal malaria chemoprevention with nutrients and vitamin supplementation

Malaria and malnutrition represent major public health concerns worldwide and especially in sub-Saharan Africa. In Burkina Faso, the burden of malaria and associated mortality among children under 5 years old remains high, despite the implementation of Seasonal Malaria Chemoprophylaxis (SMC), an intervention aimed at reducing malaria prevalence among children aged 6-59 months.

This raises the question which hidden factors possibly affect the responsiveness of SMC intervention negatively. Malnutrition, and in particular micronutrient deficiency, is one of the factors that may negatively affect the effectiveness of SMC, while treating micronutrient deficiencies is known to reduce malaria mortality prevalence in highly prevalent malaria zones such as rural settings.

The challenge

Dr Sondo hypothesises that a combined strategy of SMC with a daily oral nutrients supplement, either Vitamin A-Zinc or Plumpy’Nut®, a fortified peanut butter-like paste, will enhance the immune response. This would decrease the incidence of malaria in this population and also reduce the burden of malnutrition among children under SMC coverage.

Prior to the SMC implementation by the National Malaria Control Program, children under SMC coverage will be identified through the Health and Demographic Surveillance System (HDSS). Children will be randomly assigned to one of three groups: a) SMC alone, b) SMC + Vitamin A-Zinc, or c) SMC+Plumpy’Nut®.

After each SMC monthly distribution, children will be visited at home to confirm drug administration and followed up for six months. Anthropometric indicators will be recorded at each visit. Blood samples will be collected for thick and thin film and haemoglobin measurement and spotted onto filter paper for further PCR analyses.

The primary outcome will be measured by the incidence of malaria in each group. Secondary outcome measures include mid-upper arm circumference gain and weight gain from baseline measurements, coverage and compliance to SMC, and prevalence of molecular markers of antimalarial resistance Pfcrt, Pfmdr1, Pfdhfr and Pfdhps.

The project

If successful, this project may serve as a pilot demonstrating the value of an integrated strategy. While relying on existing strategies, implementation of a joint intervention will be scalable to country and regional levels.

Impact


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.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Malaria and malnutrition represent major public health concerns worldwide and especially in sub-Saharan Africa. In Burkina Faso, the burden of malaria and associated mortality among children under 5 years old remains high, despite the implementation of Seasonal Malaria Chemoprophylaxis (SMC), an intervention aimed at reducing malaria prevalence among children aged 6-59 months.

This raises the question which hidden factors possibly affect the responsiveness of SMC intervention negatively. Malnutrition, and in particular micronutrient deficiency, is one of the factors that may negatively affect the effectiveness of SMC, while treating micronutrient deficiencies is known to reduce malaria mortality prevalence in highly prevalent malaria zones such as rural settings.

Dr Sondo hypothesises that a combined strategy of SMC with a daily oral nutrients supplement, either Vitamin A-Zinc or Plumpy’Nut®, a fortified peanut butter-like paste, will enhance the immune response. This would decrease the incidence of malaria in this population and also reduce the burden of malnutrition among children under SMC coverage.

Prior to the SMC implementation by the National Malaria Control Program, children under SMC coverage will be identified through the Health and Demographic Surveillance System (HDSS). Children will be randomly assigned to one of three groups: a) SMC alone, b) SMC + Vitamin A-Zinc, or c) SMC+Plumpy’Nut®.

After each SMC monthly distribution, children will be visited at home to confirm drug administration and followed up for six months. Anthropometric indicators will be recorded at each visit. Blood samples will be collected for thick and thin film and haemoglobin measurement and spotted onto filter paper for further PCR analyses.

The primary outcome will be measured by the incidence of malaria in each group. Secondary outcome measures include mid-upper arm circumference gain and weight gain from baseline measurements, coverage and compliance to SMC, and prevalence of molecular markers of antimalarial resistance Pfcrt, Pfmdr1, Pfdhfr and Pfdhps.

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.

If successful, this project may serve as a pilot demonstrating the value of an integrated strategy. While relying on existing strategies, implementation of a joint intervention will be scalable to country and regional levels.

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

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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