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Recruiting NCT07389057

Assessing the Feasibility of Combining Dihydroartemisinin Piperaquine and Primaquine for Malaria Mass Drug Administration in High Endemic Communities in the Eastern Region of Ghana

Trial Parameters

Condition Malaria Asymptomatic Parasitaemia
Sponsor Noguchi Memorial Institute for Medical Research
Study Type INTERVENTIONAL
Phase N/A
Enrollment 9,000
Sex ALL
Min Age 3 Months
Max Age N/A
Start Date 2023-11-01
Completion 2026-11-30
Interventions
DHAPSingle low dose PQ

Brief Summary

Previous malaria control studies in Ghana have shown that community-wide approaches can substantially reduce malaria infections. In a mass testing, treatment and tracking (MTTT) study, more than 75% of people in target communities were reached, leading to a 24% reduction in asymptomatic malaria after one year. However, rapid diagnostic tests (RDTs) can miss very low-level infections, meaning some infected individuals are not treated and can continue to spread malaria. A pilot malaria mass drug administration (MDA) study using artemether-lumefantrine (AL) in the Eastern Region of Ghana showed a very large reduction (over 95%) in parasite carriage after repeated rounds of treatment. Despite this success, malaria infections later fluctuated, possibly because some parasites remained in mosquitoes and because mature gametocytes-the parasite stage responsible for transmission-are not fully eliminated by standard malaria medicines. To better interrupt malaria transmission, this study will use MDA with dihydroartemisinin-piperaquine (DHAP) combined with a single low dose of primaquine (PQ), which targets these transmission stages. The intervention will be given to the whole community every two months (six times per year) and compared with the current standard malaria control measures. The study will examine whether this approach reduces malaria parasite carriage, whether malaria returns after treatment stops, and whether repeated MDA affects malaria drug resistance markers in the population. This two-year implementation research will generate practical evidence to guide national malaria policy in Ghana and inform the potential use of MDA in other malaria-endemic African countries.

Eligibility Criteria

Inclusion Criteria: * must be aged 3 months and above and * be resident in the communities for the period of the study, * completed and signed a consent form from the parent or guardian of children below 18 years * Completed and signed assent for 12-17 years old children. * Completed and signed consent for those from age 18 years and above. Exclusion Criteria: * Pregnant women * individual with a life-threatening illness (excluding malaria) * less than 10Kg body weight (or less than 1 year old) * individuals who had experienced adverse effects related to primaquine or * known to be G6PD deficient .

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