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

NCT07358767 | Completed

• 1 other identifier: NoguchiMIMR 2
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The difference in the prevalence of malaria asymptomatic parasitaemia in children <15 years in the intervention arm compared to the control over time.

  The 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.

  From enrolment of participants to end of treatment every two months over 24 months

Secondary Outcomes (3)

• Changes prevalence of anaemia in children <15 years over time

  From the enrolment of participants to end of treatment every two months over 24 months

• 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 months

• 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 months

Study Arms (2)

Intervention arm: treated Artemeher Lumefantrine (AL) during MDA, Control arm no intervention

ACTIVE COMPARATOR

Trained community health workers (CHWs) will conduct door-to-door testing of all participants in intervention arm for malaria parasites using RDTs. This is to determine malaria prevalence. All participants are treated in the intervention arm irrespective of 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. Treatment using AL will be conducted following the Ghana National Malaria Treatment Guidelines and followed-up for 4 days (day 1, 2, 3 and 7). Those who receive the treatment will be observed for 30 minutes to ensure that they retain the drug. Those who vomit within this period will have the treatment repeated. Since it is required that patients eat before taking the drug, and household members may not have food when they are tested, some will have to take the medicine later after eating. The research team will pass round to verify that the participants adhering to treatment.

Drug: Artemether-lumefantrine (AL)

Control arm

NO INTERVENTION

There will be intervention in the control arm. CHWs will will conduct two rounds of screening with RDTs at baseline and at evaluation, and treating positive cases with AL. In both arms, if a participant become febrile at any time, they will be tested and treated if confirmed positive for malaria by CHWs or referred to the health facility for further investigation. All participants will be tested to determine the prevalence at baseline and endline. This is meant to allow for comparison across sites. Hospital data will also be assessed to determine the impact of the interventions on prevalence of symptomatic malaria parasitaemia in the communities.

Interventions

Artemether-lumefantrine (AL) DRUG

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.

Intervention arm: treated Artemeher Lumefantrine (AL) during MDA, Control arm no intervention

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noguchi Memorial Institute for Medical Research: lead

Study Sites (1)

Pokrom sub district

Koforidua, Eastern Region, 233, Ghana

Location

Related Publications (16)

• Ndong IC, Okyere D, Enos JY, Mensah BA, Nyarko A, Abuaku B, Amambua-Ngwa A, Merle CSC, Koram KA, Ahorlu CS. Prevalence of asymptomatic malaria parasitaemia following mass testing and treatment in Pakro sub-district of Ghana. BMC Public Health. 2019 Dec 3;19(1):1622. doi: 10.1186/s12889-019-7986-4.

  PMID: 31795981 BACKGROUND

• Mahamar A, Issiaka D, Youssouf A, Niambele SM, Soumare HM, Attaher O, Barry A, Narum DL, Duffy PE, Greenwood B, Fried M, Dicko A. Effect of 4 years of seasonal malaria chemoprevention on the acquisition of antibodies to Plasmodium falciparum antigens in Ouelessebougou, Mali. Malar J. 2021 Jan 7;20(1):23. doi: 10.1186/s12936-020-03542-9.

  PMID: 33413417 BACKGROUND

• Dicko A, Sagara I, Sissoko MS, Guindo O, Diallo AI, Kone M, Toure OB, Sacko M, Doumbo OK. Impact of intermittent preventive treatment with sulphadoxine-pyrimethamine targeting the transmission season on the incidence of clinical malaria in children in Mali. Malar J. 2008 Jul 8;7:123. doi: 10.1186/1475-2875-7-123.

  PMID: 18611271 BACKGROUND

• Sarpong N, Owusu-Dabo E, Kreuels B, Fobil JN, Segbaya S, Amoyaw F, Hahn A, Kruppa T, May J. Prevalence of malaria parasitaemia in school children from two districts of Ghana earmarked for indoor residual spraying: a cross-sectional study. Malar J. 2015 Jun 25;14:260. doi: 10.1186/s12936-015-0772-6.

  PMID: 26109461 BACKGROUND

• Ndong IC, Okyere D, Enos JY, Amambua-Ngwa A, Merle CSC, Nyarko A, Koram KA, Ahorlu CS. Challenges and perceptions of implementing mass testing, treatment and tracking in malaria control: a qualitative study in Pakro sub-district of Ghana. BMC Public Health. 2019 Jun 6;19(1):695. doi: 10.1186/s12889-019-7037-1.

  PMID: 31170964 BACKGROUND

• Boulanger D, Sarr JB, Fillol F, Sokhna C, Cisse B, Schacht AM, Trape JF, Riveau G, Simondon F, Greenwood B, Remoue F. Immunological consequences of intermittent preventive treatment against malaria in Senegalese preschool children. Malar J. 2010 Dec 17;9:363. doi: 10.1186/1475-2875-9-363.

  PMID: 21167018 BACKGROUND

• Diawara F, Steinhardt LC, Mahamar A, Traore T, Kone DT, Diawara H, Kamate B, Kone D, Diallo M, Sadou A, Mihigo J, Sagara I, Djimde AA, Eckert E, Dicko A. Measuring the impact of seasonal malaria chemoprevention as part of routine malaria control in Kita, Mali. Malar J. 2017 Aug 10;16(1):325. doi: 10.1186/s12936-017-1974-x.

  PMID: 28797263 BACKGROUND

• Organization, W.H., World malaria report 2018. 2018. World Health Organization: Geneva.

  BACKGROUND

• Organization, W.H., World malaria report 2019

  BACKGROUND

• Newell K, Kiggundu V, Ouma J, Baghendage E, Kiwanuka N, Gray R, Serwadda D, Hobbs CV, Healy SA, Quinn TC, Reynolds SJ. Longitudinal household surveillance for malaria in Rakai, Uganda. Malar J. 2016 Feb 9;15:77. doi: 10.1186/s12936-016-1128-6.

  PMID: 26861943 BACKGROUND

• Bousema T, Okell L, Felger I, Drakeley C. Asymptomatic malaria infections: detectability, transmissibility and public health relevance. Nat Rev Microbiol. 2014 Dec;12(12):833-40. doi: 10.1038/nrmicro3364. Epub 2014 Oct 20.

  PMID: 25329408 BACKGROUND

• Lindblade KA, Steinhardt L, Samuels A, Kachur SP, Slutsker L. The silent threat: asymptomatic parasitemia and malaria transmission. Expert Rev Anti Infect Ther. 2013 Jun;11(6):623-39. doi: 10.1586/eri.13.45.

  PMID: 23750733 BACKGROUND

• Samuels AM, Awino N, Odongo W, Abong'o B, Gimnig J, Otieno K, Shi YP, Were V, Allen DR, Were F, Sang T, Obor D, Williamson J, Hamel MJ, Patrick Kachur S, Slutsker L, Lindblade KA, Kariuki S, Desai M. Community-based intermittent mass testing and treatment for malaria in an area of high transmission intensity, western Kenya: study design and methodology for a cluster randomized controlled trial. Malar J. 2017 Jun 7;16(1):240. doi: 10.1186/s12936-017-1883-z.

  PMID: 28592250 BACKGROUND

• Ahorlu CK, Koram KA, Seakey AK, Weiss MG. Effectiveness of combined intermittent preventive treatment for children and timely home treatment for malaria control. Malar J. 2009 Dec 11;8:292. doi: 10.1186/1475-2875-8-292.

  PMID: 20003357 BACKGROUND

• Rao VB, Schellenberg D, Ghani AC. Overcoming health systems barriers to successful malaria treatment. Trends Parasitol. 2013 Apr;29(4):164-80. doi: 10.1016/j.pt.2013.01.005. Epub 2013 Feb 14.

  PMID: 23415933 BACKGROUND

• Otupiri, E., D. Yar, and J. Hindin, Prevalence of Parasitaemia, Anaemia and treatment outcomes of Malaria among School Children in a Rural Community in Ghana. Journal of Science and Technology (Ghana), 2012. 32(1): p. 1-10.

  BACKGROUND

MeSH Terms

Conditions

Malaria; Tooth, Impacted

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ndong Ignatius Cheng, PhD

  NMIMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 22, 2026
• Study Start: July 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 22, 2026

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)