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Clinical Trials/NCT07358767
NCT07358767CompletedNot Applicable

Determining the Impact of Malaria Mass Drug Administration on Malaria Prevalence in Under 15 Children and Pregnant Women

Noguchi Memorial Institute for Medical Research0 sites3,300 target enrollmentStarted: July 1, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,300

Study Overview

Brief Summary

This is a clinical trial being done to find better ways to reduce malaria in the community. Malaria is caused by a parasite that is spread by mosquitoes. Some people, especially adults, can carry the malaria parasite without feeling sick, but mosquitoes can still pick up the parasite from them and pass it to others. This makes it hard to stop malaria, particularly among children and pregnant women who are more likely to become ill.

The purpose of this study is to reduce malaria by removing the parasite from as many people in the community as possible, including those who do not have symptoms. By treating everyone, the study aims to reduce the spread of malaria and protect vulnerable groups such as children.

All members of households that agree to take part will be tested for malaria. After testing, everyone will be given malaria medicine, whether or not they feel sick. Participants will be followed up to check for any side effects, such as stomach upset, dizziness, or weakness.

By reducing the amount of malaria parasite in the community, mosquitoes will be less likely to spread malaria from one person to another. If many people participate, malaria illness in the community may decrease, children may stay healthier, and families may spend less money on malaria treatment. The results of this study will help inform future malaria control efforts in similar communities.

Detailed Description

Background Rapid scale-up of malaria control interventions in the past decade led to a reasonable decrease in the burden of malaria. The challenges involved with translating research scenarios into implementation are enormous and needs to be clearly understood. In an era with decreasing funding for the health system, it is important to understand not only the economic impact of MDA in the health of under 15 children but also its effect on the partial immunity of the population. Interventions focused on clearing the parasites in asymptomatic individuals in combination with intensive use of other control measures could pave the way for pre-elimination of malaria in endemic communities, especially in an era when the SAR-var-2 virus is ravaging countries across the world. It is important to generate data on the trends on the population acquired anti-malarial immunity over time following MDA. This information could be very important for national malaria control programmes for decision-making and planning scale-up of malaria MDA, either nationally or regionally.

Several studies in Ghana have demonstrated very high levels of asymptomatic malaria in both under five and school age children who have a higher risk of coming down with clinical malaria or continue to serve as a transmission reservoir. IPT of children in a community in the southern parts of the country reportedly reduced the parasite load by 90 % in two years. It has been demonstrated that IPT using SP impacted the production of protective antibodies against malaria. Immuno-suppression has also been reported from experimental studies of artemisinin-derivatives. In Ghana, malaria incidence during the post-intervention period with SP was increased by 62% in infants who received six monthly artesunate + amodiaquine, but this rebound was not seen in children aged one year or more at the time of drug administration. This rebound effect has been observed where the IPT intervention targeted only children leaving out the adults who could be asymptomatic but transmitting. Though this study targets the entire population, the effect of MDA on malaria prevalence will be evaluated in under 15 children. While there are concerns that eliminating the parasite in an endemic community could lead to a rebound or fatalities should the parasites be reintroduced, malaria passive case detection and management will therefore continue to be through the health facilities in the study areas. A recent study in Mali demonstrated that implementing SMC does not affect acquired immunity in children following four rounds.

In a pilot scale-up study of MTTT in the Pakro subdistrict of Ghana, a coverage of more than 79% and a reduction in asymptomatic malaria prevalence of 24% was achieved, and a reduction of 67% in severe anaemia following 3-rounds of MTTT interventions over 1-year only. These results could be further improved if the sub-microscopic parasitaemia is targeted through malaria MDA.

Aims or Objectives of study

Primary objective The main aim of this study is to determine the impact of implementing malaria MDA on malaria prevalence in under 15 children.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Months to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • participant must be aged 2 months and above
  • be resident in the communities for the period of the study.
  • willingness to participate will be proven by a completed and signed consent or assent form.
  • Administrative authorization is obtained from the Ghana Health Service and NMIMR IRB.

Exclusion Criteria

  • an individual intends to stay less than one year in the study site or
  • an individual who would be absent at some time due to schooling in a boarding school
  • has a life-threatening illness (excluding malaria).
  • Pregnant women will be tested and if positive referred to the Pokrom Health Centre for appropriate management.

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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