Anemia in Children, Malaria,Falciparum
Conditions
Keywords
malaria, school, chemoprevention, preventive treatment, screening and treatment, education, cognitive function, adolescent, hemoglobin
Brief 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).
Interventions
DRUGDihydroartemisinin-Piperaquine
Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.
DRUGChloroquine
Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.
Sponsors
Kamuzu University of Health Sciences
Doris Duke Charitable Foundation
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Laboratory technicians processing samples will be blinded to participant's study arm.
Intervention model description
Students will be randomized to intermittent screening-and-treatment (IST - Arm 1), intermittent preventive treatment (IPT - Arm 2), or control with no preventive treatment (Arm 3). Females less that 10 years of age (pre-menarche) and all males will be treated with DP if they are in Arm 2 or test positive in Arm 1. Females 10 years and older will be treated with chloroquine if they are in Arm 2 or test positive in Arm 1.
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P. falciparum infection | 6-8 weeks after the last intervention | detected by polymerase chain reaction (PCR, binary) |
| P. falciparum gametocyte carriage | 6-8 weeks after the last intervention | detected by q-rtPCR (binary) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participant 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) |
| Gametocyte density | 6-8 weeks after the last intervention | log transformed (continuous) |
| Rate of clinical malaria | from the first intervention to 6-8 weeks after the last intervention | cumulative incidence |
| P. falciparum prevalence among household members | 6-8 weeks after the last intervention | detected by PCR |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reading test scores | 6-8 weeks after the last intervention | standardized scores |
| Math test scores | 6-8 weeks after the last intervention | standardized scores |
| School attendance | from the first intervention to 6-8 weeks after the last intervention | number of days missed based on registers and spot checks |
| Mean infectiousness | from the first intervention to 6-8 weeks after the last intervention | regression modeled infectiousness based on gametocyte density, gametocyte sex ratio, symptom status, and other predictors of infectiousness |
| Performance characteristics of conventional RDT | through study completion, on average 6 months | compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score |
| Performance characteristics of high-sensitivity RDT | through study completion, on average 6 months | compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score |
| Cognitive function test scores | 6-8 weeks after the last intervention | standardized scores |
Countries
Malawi
Outcome results
None listed