Effectiveness and Cost-effectiveness of Integrated Model for Malaria and Helminth Control
NCT06182176 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2024-03-20
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.
Conditions
- Malaria
- Soil Transmitted Helminths
- Schistosomiasis
- Seasonal Malaria Chemoprevention
- Mass Drug Administration With Anthelminthic Drugs
Interventions
- DRUG
-
Sulphadoxine-pyrimethamine and Amodiaquine
The intervention drugs are standard drugs approved by the World Health Organisation for the preventive treatment of malaria (sulphadoxine-pyrimethamine and amodiaquine), schistosomiasis (praziquantel) and soil-transmitted helminths (albendazole).
Sponsors & Collaborators
-
Kintampo Health Research Centre, Ghana
collaborator OTHER -
London School of Hygiene and Tropical Medicine
lead OTHER
Principal Investigators
-
Kwaku Poku Asante, MD, MPH, PhD · Kintampo Health Research Centre, Ghana
-
Muhammed O AFOLABI, MD, MPH, PhD · London School of Hygiene and Tropical Medicine
-
Dennis Adu-Gyasi, PhD · Kintampo Health Research Centre, Ghana
-
Brian O Greenwood, MD · London School of Hygiene and Tropical Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-27
- Primary Completion
- 2024-11-29
- Completion
- 2026-01-12
More Related Trials
-
Intermittent Preventive Treatment (IPTp) Versus Rapid Diagnostic Testing (RDT) and Treatment of Malaria in Pregnancy
NCT00432367 ·Status: COMPLETED ·Phase: PHASE3
-
Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali
NCT00623155 ·Status: COMPLETED ·Phase: NA
-
Malaria Prevalence in Children
NCT00322816 ·Status: COMPLETED
-
Effectiveness of Intermittent Preventive Treatment for Malaria in Children
NCT00119132 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Intermittent Preventive Treatment of Malaria in Schoolchildren
NCT00852371 ·Status: COMPLETED ·Phase: PHASE3
-
Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali
NCT03035305 ·Status: COMPLETED ·Phase: NA
-
MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention
NCT05085340 ·Status: COMPLETED
-
Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana
NCT00857077 ·Status: COMPLETED ·Phase: NA
-
Control of Pregnancy Associated Malaria With Intermittent Preventive Treatment
NCT00258024 ·Status: COMPLETED ·Phase: NA
-
Host Immune Dynamics Following Seasonal Malaria Chemoprevention in African Children
NCT06524336 ·Status: ACTIVE_NOT_RECRUITING
-
Relationship Between HIV and Malaria in Ugandan Children
NCT00356824 ·Status: COMPLETED
-
Impact of Seasonal Malaria Chemoprevention on Immunity Against Malaria Among Children in Northern Benin
NCT05650502 ·Status: COMPLETED
-
A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
NCT00738946 ·Status: COMPLETED ·Phase: NA
-
Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children
NCT00561899 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Prevention of Severe Anaemia in Gambian Children
NCT00131716 ·Status: COMPLETED ·Phase: PHASE3
-
Perennial Malaria Chemoprevention in the Malaria Vaccine Era
NCT07322068 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy
NCT01084213 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
NCT00261222 ·Status: COMPLETED ·Phase: PHASE2
-
Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity
NCT02769013 ·Status: COMPLETED
-
Intermittent Preventive Treatment With Antimalarials in Kenyan Infants
NCT00111163 ·Status: COMPLETED ·Phase: NA
-
Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants
NCT00206739 ·Status: COMPLETED ·Phase: PHASE4
-
Parasite Clearance and Protection from Infection (PCPI) in Cameroon
NCT06173206 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial of Intermittent Treatment in the Prevention of Malaria in Senegalese Children
NCT00132561 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Gut and Azithromycin Mechanisms in Infants and Children II
NCT04315272 ·Status: COMPLETED ·Phase: PHASE4
-
A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda
NCT00118027 ·Status: COMPLETED ·Phase: NA