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.
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.
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
Parallel
DHAP
DrugA full 3-day course of oral DHAP will be based on weight and/or age taken once daily.
Single low dose PQ
DrugOne dose of PQ on day 3
Effect of DHAP and DHAP+PQ on the prevalence of malaria infection following MDA
Outcomes of primary objective: 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). Adjustments for potential confounders including participant'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.
Prevalence of symptomatic malaria among febrile participants attending health facilities in intervention arm compared to the control communities.
Data 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 prevalence of anaemia in children <15 years over time across arms
The 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.
Effect of MDA on the prevalence of resistance markers.
All samples from infected individuals will be analysed for markers of anti-malarial drug resistance to explore associations between treatment intakes and presence of mutations. DNA extracts from baseline and evaluation will be analysed to determine the frequency of mutations in the Multidrug resistant protein 1 (MDR1 - N86 allele\[56\]), Chloroquine resistance transporter (Pfcrt - T79 Allele) and the propeller domain of Pfkelch13 (PF3D7\_1343700 - C580, and C469F, K561H, R622I, A675V found in African isolates)\[33, 34\]. Amplicons will be sequenced, and DNA sequences will be analysed to identify specific single nucleotide polymorphisms (SNPs) related to anti-malarial resistance markers. Real time PCR analysis of the varATS gene will be used to determine the presence and quantity of P. falciparum parasites in each of the samples at the beginning and at evaluation.
Perception of the impact MDA implementation
Through qualitative research using questionnaires, focus group discussions and in-depth interviews, the population's perception of the impact MDA interventions as well as challenges affecting the process will be documented. The collected data will be transcribed and analysed thematically. A coding framework will be developed to identify key themes and patterns related to community perceptions of malaria, the effectiveness of the MDA and suggestions for improvement.
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Noguchi Memorial Institute for Medical Research
Lead sponsor
Medical Research Center Unit The Gambia (MRCG)
Collaborator