Comparing Chemoprevention Approaches for School-based Malaria Control
NCT05244954 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 746
Last updated 2022-11-15
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.
Conditions
- Malaria,Falciparum
- Anemia in Children
Interventions
- 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.
Sponsors & Collaborators
-
Kamuzu University of Health Sciences
collaborator OTHER -
Doris Duke Charitable Foundation
collaborator OTHER -
University of Maryland, Baltimore
lead OTHER
Principal Investigators
-
Lauren Cohee, MD MS · University of Maryland, Baltimore
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2022-08-26
- Completion
- 2022-08-26
Countries
- Malawi
Study Locations
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