Effectiveness and Cost-effectiveness of Integrated Model for Malaria and Helminth Control

• Status: Not yet recruiting
• Trial end date: 2026-01-12
• Target enrollment: 0
• Participant gender: All

Summary

Malaria remains a major health problem, especially among children living in sub-Saharan Africa where more than 90% of the disease and deaths occur. Adding to this high burden among the children is the co-existence of parasitic worms in their intestines and urinary tract. The combined infection of malaria and parasitic worms in these children has additive adverse effects of anaemia, poor physical and cognitive development, and death. Existing control programmes for the parasitic worms are operating sub-optimally despite the 2012 London Declaration on Neglected Tropical Diseases (NTDs) of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year as the London Declaration on NTDs has achieved more than 75% treatment coverage and prevented 75-85% of cases of uncomplicated and severe malaria in children. The remarkable success of SMC has led to the recent WHO recommendation for its extension to other at-risk age groups and in highly seasonal malaria transmission settings outside the Sahel region. This encouraging development supports the need to explore the possibility of integrating helminth control programmes with other successful delivery platforms such as SMC. However, limited empirical evidence exists on an integrated approach that integrated the control of malaria and parasitic worms in a safe, acceptable, easy-to-deliver and effective manner.

To address this knowledge gap, the investigators conducted a randomised controlled trial in the first stage of this project to establish the feasibility and safety of integrating helminth control with SMC among Senegalese children. This second stage will assess the effectiveness and cost-effectiveness of using SMC platform to deliver deworming drugs to preschool and school-aged children living in communities where the burden of malaria and parasitic worms is high in central Ghana. One thousand, two hundred children aged 1-14 years will be randomly assigned equally to two study communities where antimalarial (SMC) drugs and deworming drugs will be administered in combination to the children living in one study community, and antimalarial (SMC) drugs alone will be delivered to the children living in the second study community. The effectiveness of the combined delivery will be determined by checking whether the combined antimalarial and deworming drugs prevent anaemia in the children who receive the combined drugs compared to the children who receive antimalarial drugs only. We will also determine the cost and cost-effectiveness of this approach by estimating the incremental cost savings due to cases of moderate and severe anaemia averted by giving antimalarial and deworming drugs together to the children. The findings of this study would provide evidence to boost public health recommendations for an integrated control of malaria and parasitic worms among children living in the poorest countries of the world. The findings may also reinforce the empirical evidence that the future direction of healthcare systems in developing countries should be comprehensive health management rather than vertical management of a single disease.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: Kintampo Health Research Centre, Ghana
• Treatments: Amodiaquine; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Male and female children aged 1-14 years;

• Provision of written informed consent by the parent/caregiver and a positive assent by children aged ≥ 7 years (in line with legal regulations in Ghana);

• Willingness to provide finger prick blood samples, urine, and stool samples;

• Residence in the study area for at least the past six months and willingness to be available in the study area for follow-up about 6 months after enrolment

Exclusion Criteria:

• Acutely ill child at the time of the drug administration;

• A child whose parents/caregivers decline to provide consent;

• A known HIV-positive child receiving co-trimoxazole prophylaxis;

• A child who has received a dose of either Sulphadoxine-pyrimethamine (SP), amodiaquine (AQ), albendazole (ALB) or praziquantel (PZQ) during the previous six months.

• A child with a known allergy to any of SP, AQ, ALB or PZQ.