NCT05244954

Comparing Chemoprevention Approaches for School-based Malaria Control

Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• Malaria,Falciparum
• Anemia in Children

Interventions

Type	Name	Description
DRUG	Dihydroartemisinin-Piperaquine	Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.
DRUG	Chloroquine	Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-08-26
• Completion: 2022-08-26
• First posted: 2022-02-17
• Last updated: 2022-11-15

Locations

1 site across 1 country: Malawi