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| Name | Class |
|---|---|
| Kamuzu University of Health Sciences | OTHER |
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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 amodiaquine (AQ) (IPT-SPAQ). 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 and disease incidence in young children sleeping student's households to assess the impact on transmission.
Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the 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 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP) | Experimental | All students are treated at each intervention. Treatment will be with DP (females less than 13 years old and all males) or chloroquine (females 13 years old or older). |
|
| Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ) | Experimental | All students are treated at each intervention. Treatment will be with SP and AQ (females less than 13 years old and all males) or chloroquine (females 13 years old or older). |
|
| Control | No Intervention | Students will not receive preventive treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydroartemisinin-Piperaquine | Drug | Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with P. falciparum infection | detected by polymerase chain reaction (PCR, binary) | 6-8 weeks after the last intervention |
| Number of participants with anemia | World Health Organization age-sex definitions (binary) | 6-8 weeks after the last intervention |
| Rate of clinical malaria | cumulative incidence | through study completion (approximately 6 months), and 6 months following the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mean hemoglobin concentration | g/dL (continuous) | 6-8 weeks after the last intervention |
| Literacy skills | Early grade reading assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Total parasite density | log transformed (continuous) | 6-8 weeks after the last intervention |
Student Inclusion Criteria:
Student Exclusion Criteria:
Younger child Inclusion Criteria
Younger child Exclusion Criteria
- Current evidence of severe malaria or danger signs
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malaria Alert Centre | Blantyre | Malawi |
All individual participant data that underlie results in a publication
After publication
Public access with registration to allow tracking
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Students will be randomized to three arms Arm 1: intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTsc-DP); Arm 2: intermittent preventive treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPTsc-SPAQ); Arm 3 the control arm. Females 13 years and older (likely post-menarche) in Arms 1 and 2 will receive chloroquine alone.
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| Chloroquine | Drug | Treatment will be with CQ alone if female and 13 years old or older in both intervention arms. |
|
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| Sulfadoxine-pyrimethamine-amodiaquine | Drug | Treatment in Arm 2 (females less than 13 years old and all males). |
|
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| 6-8 weeks after the last intervention |
| Math skills | Early grade math assessment | 6-8 weeks after the last intervention |
| Rate of school absenteeism among participants | Proportion of days absent among days where attendance is assessed | through study completion (approximately 6 months) |
| P. falciparum prevalence among children less than 5 years old living in households with study participants | detected by PCR | 6-8 weeks after the last intervention |
| Rate of clinical malaria among children less than 5 years old living in households with study participants | cumulative incidence | through study completion (approximately 6 months) |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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