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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07358767
Enrollment
3300
Registered
2026-01-22
Start date
2021-07-01
Completion date
2023-03-31
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Impact,, malaria, mass drug administration, under 15 children, pregnant women

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. Secondary objectives 1. To determine the prevalence of malaria asymptomatic parasitaemia in populations within the Pakro sub district. 2. To assess the effect of malaria MDA on anaemia in under 15 children. 3. To determine the effect of malaria MDA on febrile patients attending health facilities in intervention arm compared to the control arm. 4. To assess the effect of scaling up malaria MDA on malaria antibodies over time in asymptomatic participants. Study participants: Community entry activities to sensitise the chiefs and the general population will be conducted at the beginning of the study through meetings and durbars. Once the community leaders and the population have accepted the project, the households will be numbered and participants in each household will be registered during a household census. All households will be given a unique identification code. Everyone within the household will be assigned a code that links them to a particular household and community. After obtaining consent from the household heads, the children will be enrolled but individual assent and consent will be obtained from the other adolescents and adults in the household. The intervention study will target all the household members. The primary outcome will be based on data from all enrolled participants. The effect of the interventions on secondary outcome 1 will be observed in all children aged 2 months to 14 years randomly. In addition, selected under 15 children will have in addition to the other data, their Hb readings taken to assess the level of anaemia. The effect of the interventions on secondary outcome 2 will be observed in all under 15 children. Furthermore, the effect of the intervention on secondary outcomes 3 and 4 will be observed in all participants. The investigators hypothesize that within the study population, the prevalence of asymptomatic parasitaemia should drop by 90% by the end of the first year and by 95% by the end of the second year. This is estimated based on the findings of Ahorlu and colleagues, 2011. In the same light the investigators expect that anaemia should drop by the same proportion.

Interventions

All participants will be treated in the intervention arm irrespective of RDT test results while only the positive cases will be treated in the control arm. For molecular studies, 200ul (two drops) of blood will be collected on filter paper during screening. We will use the Ghana Malaria Treatment Guidelines and followed-up for four days (day 1, 2, 3 and 7). Treated participants will be observed for 30 minutes to ensure that they retain the drug. Those who vomit within this period will repeated treatment. It is required that patients eat before taking the drug, and participants may not have food when they are tested, and would have to take the medicine later after eating. This means that some of the treatment will be unobserved. However, the research team will pass round to vrify participants adherence to treatment. They will ask to see the drug package to ensure that the participants are taking the treatment correctly. This also assures the population that the research team cares.

Sponsors

Noguchi Memorial Institute for Medical Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a clinical study to be undertaken within a 24-month framework in 8 communities in the Eastern Region of Ghana. The study is designed to compare the baseline to evaluation findings following the interventions. Interventions will be implemented at the community level. An intervention entails testing with RDTs and treatment of all participants with ACTs. 7 interventions and surveys will be undertaken. RDTs are used during interventions to determine the prevalence over time. The study will be conducted in two arms - arm 1 will constitute the MDA intervention arm, while arm 2 will constitute the control arm. there are 4 communities in each arm. Arm 1: All participants in the intervention arm are treated with ACTS by CHWs who go from door-to-door during each MDA round. Arm 2: in the control arm (no intervention). One rounds of mass screening with RDTs, and treatment of confirmed positive cases with ACTS will be done. (one at baseline and one at evaluation).

Eligibility

Sex/Gender
ALL
Age
2 Months to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
The difference in the prevalence of malaria asymptomatic parasitaemia in children <15 years in the intervention arm compared to the control over time.From enrolment of participants to end of treatment every two months over 24 monthsThe asymptomatic parasitaemia will be compared over time and between intervention arms using chi-square tests (or fisher exact tests) and logistic regression (or conditional logistic regression). Baseline Comparison of Patients: Summary statistics (proportions for categorical variables and means or medians with variances or IQRs for continuous variables) and graphs will be used to detect presence of outliers or unusual observations, and to assess validity of assumptions for statistical tests. Participants will be compared between the two study arms (Intervention communities and control communities) with respect to baseline demographic, clinical and parasitological characteristics. Statistical analysis of the above comparisons for continuous variables will be based on graphs, t-test (or Wilcoxon test), and ANOVA (or Kruskal-Wallis test). Categorical variables will be compared using chi-square tests. All analyses will be performed for the whole population in each arm.

Secondary

MeasureTime frameDescription
Changes prevalence of anaemia in children <15 years over timeFrom the enrolment of participants to end of treatment every two months over 24 monthsThe difference in prevalence of anaemia in children \<15 years in the control arm compared to the control. To test for anaemia in children under 15, a portable automated Hemocue photometer will be used to determine the concentration of Haemoglobin. Anaemia in this study is defined as Hb levels less than 10g/dl. Particiapnts with severe anaemia (Hb less than 7g/dl) will be referred to the Health Centre for follow up. Comparisons of anaemia in children \<15 years across time and study arms will be assessed through Cochrane Armitage test of trends and using chi-square tests (or fisher exact tests) respectively. A binomial logistic regression will be used to test impact of intervention on febrile illnesses.
The difference in symptomatic malaria cases attending health facilities in intervention arm compared to the control arm.From enrolment of participants to end of treatment every two months over 24 monthsData for symptomatic parasitaemia at the hospitals and those collected at the community will be compared over time and between intervention arms using chi-square tests (or fisher exact tests) and logistic regression (or conditional logistic regression). Adjustments for potential confounders including patient's age and use of ITN and baseline temperature will be considered. In addition, these outcomes will also be compared over time using Cochrane Armitage test of trends.
Changes in prevalence of anti-plasmodium antibodies between baseline and evaluation in the intervention and control arm.From enrolment of participants to end of treatment every two months over 24 monthsAnti PfEMP1 response Total plasma IgG levels were will be measured as to a recently described panel of microsphere bead coupled proteins consisting of 39 P. falciparum derived antigens and tetanus toxoid using the Luminex platform. The panel included VAR2CSA and 35 HIS-tagged CIDR proteins representing all three main groups of PfEMP1. Specifically, 19 different sequence variants of CIDRα1, 12 different variants of CIDRα2-6 and 4 different CIDRδ/γ domain proteins produced in Drosophila Sf9 cells will be included. In addition, the protein array included circumsporozoite protein 1 (CSP1), merozoite surface protein 1 (MSP1) and apical membrane antigen 1 (AMA1). The Luminex-based assays will be performed at NMIMR.

Countries

Ghana

Contacts

PRINCIPAL_INVESTIGATORNdong Ignatius Cheng, PhD

NMIMR

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026