Comparing Chemoprevention Approaches for School-based Malaria Control

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 4

Conditions: Malaria,Falciparum; Anemia in Children

Treatments: Drug: Chloroquine; Drug: Dihydroartemisinin-Piperaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT05244954

HP-00098250

Details and patient eligibility

About

This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent screening and treatment (IST) - students will receive treatment if they have a positive high sensitivity rapid diagnostic test (RDT). Arm 2: Intermittent preventive treatment (IPT) - all students will receive treatment. Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, gametocyte carriage and gametocyte density, anemia, cognitive function and educational testing, as well as infection prevalence in student's households to assess the impact on transmission.

Full description

Students will be enrolled in a single primary school in Machinga District, Malawi. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT are and those that test positive in the IST arm will be treatment with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Enrollment: 746 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Students (enrolled in the primary intervention)

• 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 Household members (enrolled in the Household Prevalence survey)
• Slept in the household for most nights in the last month
• Age 6 months or older
• For minors, parent/guardian available to provide written informed consent

Exclusion criteria

Students (enrolled in the primary intervention)

• 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
• Girls 10 years old and older with epilepsy or psoriasis Household members (enrolled in the Household Prevalence survey)
• Household with more than one school-age child enrolled in the study
• Current evidence of severe malaria or danger signs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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746 participants in 3 patient groups

Intermittent Screening and Treatment (IST)

Experimental group

Description:

Students will be screened for infection using a higher sensitivity malaria rapid diagnostic test and treated if positive. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Treatment:

Drug: Dihydroartemisinin-Piperaquine

Drug: Chloroquine

Intermittent Preventive Treatment (IPT)

Experimental group

Description:

All students are treated at each intervention. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Treatment:

Drug: Dihydroartemisinin-Piperaquine

Drug: Chloroquine

Control

No Intervention group

Description:

Students will not receive preventive treatment.