Comparing Chemoprevention Drugs for School-based Malaria Control
- Conditions
- Anemia in ChildrenMalaria,Falciparum
- Interventions
- Registration Number
- NCT05980156
- 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 preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence in young children sleeping student's households to assess the impact on transmission.
- Detailed Description
Students attending a single primary school in Machinga District, Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 646
Students (enrolled in the primary intervention)
- Previously enrolled in NCT05244954
- 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 Younger children in participant households (enrolled in the Household Prevalence survey)
- Slept in the household for most nights in the last month
- Age 6-59 months
- 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
- Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole
- Epilepsy
- 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 Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP) 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). Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ) Sulfadoxine pyrimethamine All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older). Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP) 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 Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ) Chloroquine All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).
- Primary Outcome Measures
Name Time Method Number of participants with P. falciparum infection 6-8 weeks after the last intervention detected by polymerase chain reaction (PCR, binary)
- Secondary Outcome Measures
Name Time Method Total parasite density 6-8 weeks after the last intervention log transformed (continuous)
Rate of clinical malaria through study completions, approximately 6 months cumulative incidence
P. falciparum prevalence among children less than 5 years old living in households with study participants 6-8 weeks after the last intervention detected by PCR
sustained attention 6-8 weeks after the last intervention code transmission test score (continuous)
Number of participants 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)
selective attention 6-8 weeks after the last intervention selective attention test score (continuous)
Literacy skills 6-8 weeks after the last intervention onetest reading test score (continuous)
Math skills 6-8 weeks after the last intervention onetest math score (continuous)
Trial Locations
- Locations (1)
Kamuzu University of Health Sciences
🇲🇼Blantyre, Malawi