Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

This is an individually randomized, controlled, single blind four 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 chloroquine (CQ) (IPT-SPCQ). Arm 3: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ).Arm 4: 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 two 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-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 13 years old and all males) or chloroquine alone (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.

Students will be randomized to four arms Arm 1: intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTsc-DP); Arm 2: intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine (IPTsc-SPCQ). Arm 3: intermittent preventive treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPTsc-SPAQ); Arm 4 the control arm. Females 13 years and older (likely post-menarche) in Arms 1, 2 and 3 will receive chloroquine alone.

All students are treated at each intervention. Treatment will be with DP (females less than 13 years old and all males) or chloroquine (females 13 years old or older).

All students are treated at each intervention. Treatment will be with SP and CQ (females less than 13 years old and all males) or chloroquine (females 13 years old or older).

All students are treated at each intervention. Treatment will be with SP and AQ (females less than 13 years old and all males) or chloroquine (females 13 years old or older).

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 all study arms. Treatment in combination with SP in Arm 2 (females less than 13 years old and all males).

Treatment in combination with CQ in Arm 2 (females less than 13 years old and all males). Treatment in combination with AQ in Arm 3 (females less than 13 years old and all males).

P. falciparum prevalence among children less than 5 years old living in households with study participants

Rate of clinical malaria among children less than 5 years old living in households with study participants

Student Inclusion Criteria: Currently enrolled in the study school Plan to attend the study school for the remainder of the school year Parent/guardian available to provide written informed consent Student Exclusion Criteria: Current evidence of severe malaria or danger signs Known adverse reaction to the study drugs History of cardiac problems or fainting Taking medications known to prolong QT Family history of prolonged QT History of epilepsy or psoriasis Taking cotrimoxazole for long-term prophylaxis Younger child Inclusion Criteria Slept in the household for most nights in the last month Age 6-59 months Parent/guardian available to provide written informed consent Younger child Exclusion Criteria - Current evidence of severe malaria or danger signs