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

Sponsor

Liverpool School of Tropical Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06083688

Collaborator

Kamuzu University of Health Sciences (Other)

1,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria,Falciparum Anemia in Children	Drug: Dihydroartemisinin-Piperaquine Drug: Chloroquine Drug: Sulfadoxine pyrimethamine Drug: Sulfadoxine-pyrimethamine-amodiaquine	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2024

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP) 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).	Drug: Dihydroartemisinin-Piperaquine Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Other Names: DP D-Artepp DuoCotecxin Artekin Eurartesim Ridmal Drug: Chloroquine 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). Other Names: Aralen Hydroxychloroquine Lariago
Experimental: Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ) 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).	Drug: Chloroquine 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). Other Names: Aralen Hydroxychloroquine Lariago Drug: Sulfadoxine pyrimethamine 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). Other Names: SP
Experimental: Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ) 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).	Drug: Chloroquine 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). Other Names: Aralen Hydroxychloroquine Lariago Drug: Sulfadoxine-pyrimethamine-amodiaquine Treatment in Arm 3 (females less than 13 years old and all males). Other Names: SPAQ SPAQ-Co
No Intervention: Control Students will not receive preventive treatment.

Outcome Measures

Primary Outcome Measures

Number of participants with P. falciparum infection [6-8 weeks after the last intervention]
detected by polymerase chain reaction (PCR, binary)

Secondary Outcome Measures

Number of participants with anemia [6-8 weeks after the last intervention]
World Health Organization age-sex definitions (binary)
Mean hemoglobin concentration [6-8 weeks after the last intervention]
g/dL (continuous)
Total parasite density [6-8 weeks after the last intervention]
log transformed (continuous)
Rate of clinical malaria [through study completion (approximately 6 months), and 6 months following the intervention]
cumulative incidence
sustained attention [6-8 weeks after the last intervention]
code transmission test score (continuous)
Literacy skills [6-8 weeks after the last intervention]
Early grade reading assessment
Math skills [6-8 weeks after the last intervention]
Early grade math assessment
P. falciparum prevalence among children less than 5 years old living in households with study participants [6-8 weeks after the last intervention]
detected by PCR
Rate of clinical malaria among children less than 5 years old living in households with study participants [through study completion (approximately 6 months)]
cumulative incidence