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

No results posted yet for this study

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06182176 on ClinicalTrials.gov