Comparing Chemoprevention Approaches for School-based Malaria Control
- Conditions
- Malaria,FalciparumAnemia in Children
- Interventions
- Registration Number
- NCT05244954
- Lead Sponsor
- University of Maryland, Baltimore
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 746
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent Screening and Treatment (IST) Chloroquine 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). Intermittent Preventive Treatment (IPT) Chloroquine 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). Intermittent Screening and Treatment (IST) Dihydroartemisinin-Piperaquine 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). Intermittent Preventive Treatment (IPT) Dihydroartemisinin-Piperaquine 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).
- Primary Outcome Measures
Name Time Method P. falciparum gametocyte carriage 6-8 weeks after the last intervention detected by q-rtPCR (binary)
P. falciparum infection 6-8 weeks after the last intervention detected by polymerase chain reaction (PCR, binary)
- Secondary Outcome Measures
Name Time Method Number of participant with anemia 6-8 weeks after the last intervention World Health Organization age-sex definitions (binary)
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
Mean hemoglobin concentration 6-8 weeks after the last intervention g/dL (continuous)
Trial Locations
- Locations (1)
Kamuzu University of Health Sciences
🇲🇼Blantyre, Malawi