This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.
Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,000
Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older).
Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.
Treatment in Arm 2 (females less than 13 years old and all males).
Malaria Alert Centre
Blantyre, Malawi
Number of participants with P. falciparum infection
detected by polymerase chain reaction (PCR, binary)
Time frame: 6-8 weeks after the last intervention
Number of participants with anemia
World Health Organization age-sex definitions (binary)
Time frame: 6-8 weeks after the last intervention
Rate of clinical malaria
cumulative incidence
Time frame: through study completion (approximately 6 months), and 6 months following the intervention
Mean hemoglobin concentration
g/dL (continuous)
Time frame: 6-8 weeks after the last intervention
Literacy skills
Early grade reading assessment
Time frame: 6-8 weeks after the last intervention
Math skills
Early grade math assessment
Time frame: 6-8 weeks after the last intervention
Rate of school absenteeism among participants
Proportion of days absent among days where attendance is assessed
Time frame: through study completion (approximately 6 months)
P. falciparum prevalence among children less than 5 years old living in households with study participants
detected by PCR
Time frame: 6-8 weeks after the last intervention
Rate of clinical malaria among children less than 5 years old living in households with study participants
cumulative incidence
Time frame: through study completion (approximately 6 months)
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