Evaluating the Effectiveness and Cost-Effectiveness of Integrating Mass Drug Administration for Helminth Control with Seasonal Malaria Chemoprevention in Ghanaian Children (MALHELMIN)

November 14, 2024| Ongoing Project | Reading time: 5 min

Investigators
Dr. Muhammed O. Afolabi (London School of Hygiene & Tropical Medicine, London, UK), Prof. Kwaku Poku Asante (KHRC, Research and Development Division, Ghana Health Service, Kintampo North Municipality, Bono East Region, Ghana), Dr. Dennis Adu-Gyasi (KHRC, Research and Development Division, Ghana Health Service, Centre for Research in Applied Biology, School of Sciences, University of Energy and Natural Resources, Sunyani, Bono Region, Ghana, West Africa), Lucy Paintain (London School of Hygiene & Tropical Medicine, London, UK), Dr. Theresa Tawiah (KHRC, Research and Development Division, Ghana Health Service, Kintampo North Municipality, Bono East Region, Ghana), Dr. Sanni Ali (London School of Hygiene & Tropical Medicine, London, UK), Prof. Brian Greenwood (London School of Hygiene & Tropical Medicine, London, UK),

Introduction/Background

The Kintampo Health Research Centre (KHRC), with funding from the London School of Hygiene & Tropical Medicine and UK Research and Innovation (UKRI), is implementing the SMC/MDA (MALHELMIN) drug trial, a transformative study aimed at advancing malaria and helminth treatment and control options, in Bono East Region. This study aims to evaluate how effective and cost-efficient it is to combine mass treatment for helminth infections with seasonal malaria prevention for Ghanaian school aged children.

Background

Malaria remains a major health challenge in Sub-Saharan Africa (SSA), excessively affecting children under five, with over 90% of malaria cases and related fatalities occurring in this region. The situation is intensified by the prevalence of helminth infections, which affects over 1 billion individuals globally, including more than 800 million children in SSA. Among these, worms that infect us from the contact with the soil (such as hookworm, pinworm, roundworm, and whipworm) and parasites that cause bloody urination (Schistosoma species) are prevalent, contributing to severe health consequences. These co-infections can worsen malaria outcomes, such as anaemia, which leads to higher mortality and impacts growth, cognitive development, and educational attainment among children.

Despite efforts like the 2012 London Declaration on Neglected Tropical Diseases, aimed for 75% treatment coverage for parasitic worms by 2020, current programs have not met these goals. However, the Seasonal Malaria Chemoprevention (SMC) initiative has exceeded 75% coverage and effectively reduced uncomplicated and severe malaria cases in children. This success prompted the World Health Organization (WHO) to recommend expanding SMC programs to include other high-risk age groups and areas with high seasonal malaria infections.

Objectives
The main objective of this study is to evaluate the effectiveness of combining SMC and deworming drugs on anaemia prevalence and intensity of malaria-helminth co-infection in school-aged children. This study also seeks to determine the costs and cost-effectiveness of delivering an integrated malaria-deworming approach to the children.

Study Methodology and Rationale
This is a cluster randomised controlled, pragmatic programme-led study to evaluate the effectiveness of co-administration of SMC and Mass Drug Administration (MDA) for schistosomiasis and STH in reducing anaemia being implemented in Pru East in the Bono East region of Ghana. Malaria and helminth infections are common at this site. The study uses medications approved by the World Health Organization (WHO), such as sulphadoxine-pyrimethamine and amodiaquine for malaria, and albendazole and praziquantel for helminths.

The trial involves over 1,200 children, aged 5 to 10 years, who are split evenly between two communities: one group receives a combined treatment of SMC and deworming drugs, while the other receives SMC with Vitamin A and Zinc. Researchers will then analyse anaemia prevalence and compare the effectiveness and cost-effectiveness of the integrated approach. Health assessments are done before and after the treatments to check their haemoglobin levels, clinical malaria cases, and any side effects.

Doses were based on the children’s ages, and what the control programmes (National Malaria Elimination Programme and National Neglected Tropical Diseases Programme) recommend for the two diseases under supervision. Before starting, samples were collected, and this will be repeated at the post-treatment evaluation visit.

Informed consent was sought from parents or guardians before all study activities begun. After consultations and health evaluations, qualified children were enrolled in the trial and closely monitored by study staff from KHRC during treatment.

Safety and Monitoring
Trained staffs monitored children for adverse reactions, particularly during the initial SMC and MDA cycles, while caregivers were instructed to report any issues. Serious adverse events were reported within 24 hours to Ghana's regulatory authority. Local health centres were also prepared to manage severe cases.

Expected Outcomes
The integration of malaria and helminth treatments could lead to improved health outcomes in children through reduced anaemia and malaria severity. By combining drug administration, the intervention is expected to lower costs and increase coverage effectiveness, maximizing the health impact among malaria endemic populations.

Conclusion
This study seeks to enhance child health in Sub-Saharan Africa by combining SMC with helminth control, potentially establishing a model for integrated disease management in regions with high co-infection rates. The structured monitoring and cost-analysis approach will offer data on both health impacts and financial sustainability. Through the MALHELMIN drug trial, KHRC is not only working to expand the range of effective malaria treatments but is also exploring innovative trial designs that can adapt to evolving challenges in malaria care, especially in children.