Comparing Chemoprevention Approaches for School-based Malaria Control

• Status: Enrolling by invitation
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland, Baltimore
• Collaborators: Doris Duke Charitable Foundation; Kamuzu University of Health Sciences
• Treatments: Artenimol; Chloroquine; Piperaquine

Criteria

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