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

NCT06182176 | Unknown DMC

• 1 other identifier: 29839
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Haemoglobin (Hb) concentration measured by HemoCue®

  Comparison of the pre- and post-intervention values of Hb concentration of study children

  On the day of inclusion, and post-intervention at the end of malaria transmission season i.e. one month after the last SMC cycle.

Secondary Outcomes (5)

• Incidence of clinical malaria, defined as fever of >37.5C

  Detected by passive case detection during the surveillance period, an average of 5 months after co-administration of the study medications

• Change in prevalence of anaemia on the day of inclusion, and post-intervention at the end of malaria transmission season; anaemia will be defined as Hb less than 11 g/dL

  On the day of inclusion, and post-intervention at the end of malaria transmission season i.e. one month after the last SMC cycle.

• Incidence of solicited adverse events and adverse drug reactions

  During a period of six consecutive days after co-administration of study medications

• Prevalence of P.falciparum and helminth co-infection

  On the day of inclusion, and post-intervention at the end of malaria transmission season i.e. one month after the last SMC cycle.

• Density of P.falciparum and helminth co-infection

  On the day of inclusion, and post-intervention at the end of malaria transmission season i.e. one month after the last SMC cycle.

Other Outcomes (2)

• The cost per child treated per year and the cost per anaemia case averted

  At post-intervention at the end of malaria transmission season i.e. one month after the last SMC cycle.

• Estimates of incremental cost-effectiveness

  At post-intervention at the end of malaria transmission season i.e. one month after the last SMC cycle.

Study Arms (2)

SMC plus anthelminthics group

EXPERIMENTAL

Anthelminthic drugs (albendazole and praziquantel) will be administered 24 hours (on Day 0) before administration of the following SMC drugs: Sulphadoxine-pyrimethamine (SP) on Day 1 and Amodiaquine (AQ) daily on Days 1, 2 and 3.

Drug: Sulphadoxine-pyrimethamine and Amodiaquine

SMC group

ACTIVE COMPARATOR

Participants randomized into the control communities will receive Vitamin A and Zinc supplements as control drugs on Day 0. On Day 1, these participants will receive the SMC drug (Sulphadoxine-pyrimethamine) (SP) and Amodiaquine (AQ) daily on Days 1,2 and 3.

Drug: Sulphadoxine-pyrimethamine and Amodiaquine

Interventions

Sulphadoxine-pyrimethamine and Amodiaquine DRUG

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).

Also known as: SPAQ

SMC group; SMC plus anthelminthics group

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Kintampo Health Research Centre, Ghana: collaborator

MeSH Terms

Conditions

Malaria; Schistosomiasis

Interventions

fanasil, pyrimethamine drug combination; Amodiaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Trematode Infections; Helminthiasis

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kwaku Poku Asante, MD, MPH, PhD

  Kintampo Health Research Centre, Ghana

  STUDY CHAIR

• Muhammed O AFOLABI, MD, MPH, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Dennis Adu-Gyasi, PhD

  Kintampo Health Research Centre, Ghana

  STUDY DIRECTOR

• Brian O Greenwood, MD

  London School of Hygiene and Tropical Medicine

  STUDY DIRECTOR

Central Study Contacts

Muhammed O AFOLABI, MD, MPH, PhD

CONTACT

+447535954947; Muhammed.Afolabi@lshtm.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 26, 2023
• Study Start: May 27, 2024
• Primary Completion: November 29, 2024
• Study Completion: January 12, 2026
• Last Updated: March 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Within 12 months of the study completion date
• Access Criteria: Open access requests will be entertained, the decision will be made by the Principal Investigator, quality of the request will be reviewed before granting it