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| Name | Class |
|---|---|
| Kamuzu University of Health Sciences | OTHER |
| Doris Duke Charitable Foundation | 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 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.
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).
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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 10 years old and all males) or chloroquine (females 10 years old or older). |
|
| Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ) | Experimental | 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). |
|
| 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 10 years old and all males) or chloroquine alone (females 10 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with anemia | World Health Organization age-sex definitions (binary) | 6-8 weeks after the last intervention |
| Mean hemoglobin concentration | g/dL (continuous) |
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Inclusion Criteria:
Students (enrolled in the primary intervention)
Exclusion Criteria:
Students (enrolled in the primary intervention)
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Cohee, MD MS | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kamuzu University of Health Sciences | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33767384 | Background | Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5. | |
| 33222799 | Background | Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22. |
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all individual participant data that underlie results in a publication
After results publication
Public access with registration to allow tracking
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D006886 | Hydroxychloroquine |
| C001205 | fanasil, pyrimethamine drug combination |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Students were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.
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Laboratory technicians processing samples will be blinded to participant's study arm.
|
| Chloroquine | Drug | Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2. |
|
|
| Sulfadoxine pyrimethamine | Drug | Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older). |
|
|
| 6-8 weeks after the last intervention |
| Total parasite density | log transformed (continuous) | 6-8 weeks after the last intervention |
| Rate of clinical malaria | cumulative incidence | through study completions, 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 |
| sustained attention | code transmission test score (continuous) | 6-8 weeks after the last intervention |
| selective attention | selective attention test score (continuous) | 6-8 weeks after the last intervention |
| Literacy skills | onetest reading test score (continuous) | 6-8 weeks after the last intervention |
| Math skills | onetest math score (continuous) | 6-8 weeks after the last intervention |
| D000079426 |
| Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |