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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 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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Screening and Treatment (IST) | Experimental | 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) | 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). |
|
| Control | No Intervention | Students will not receive preventive treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydroartemisinin-Piperaquine | Drug | Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| P. falciparum infection | detected by polymerase chain reaction (PCR, binary) | 6-8 weeks after the last intervention |
| P. falciparum gametocyte carriage | detected by q-rtPCR (binary) | 6-8 weeks after the last intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participant with anemia | World Health Organization age-sex definitions (binary) | 6-8 weeks after the last intervention |
| Mean hemoglobin concentration | g/dL (continuous) |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function test scores | standardized scores | 6-8 weeks after the last intervention |
| Reading test scores | standardized scores | 6-8 weeks after the last intervention |
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 |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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.
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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 2 and those who test positive in Arm 1. |
|
|
| 6-8 weeks after the last intervention |
| Total parasite density | log transformed (continuous) | 6-8 weeks after the last intervention |
| Gametocyte density | log transformed (continuous) | 6-8 weeks after the last intervention |
| Rate of clinical malaria | cumulative incidence | from the first intervention to 6-8 weeks after the last intervention |
| P. falciparum prevalence among household members | detected by PCR | 6-8 weeks after the last intervention |
| Math test scores | standardized scores | 6-8 weeks after the last intervention |
| School attendance | number of days missed based on registers and spot checks | from the first intervention to 6-8 weeks after the last intervention |
| Mean infectiousness | regression modeled infectiousness based on gametocyte density, gametocyte sex ratio, symptom status, and other predictors of infectiousness | from the first intervention to 6-8 weeks after the last intervention |
| Performance characteristics of conventional RDT | compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score | through study completion, on average 6 months |
| Performance characteristics of high-sensitivity RDT | compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score | through study completion, on average 6 months |
| 24492859 | Background | Halliday KE, Okello G, Turner EL, Njagi K, Mcharo C, Kengo J, Allen E, Dubeck MM, Jukes MC, Brooker SJ. Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial. PLoS Med. 2014 Jan 28;11(1):e1001594. doi: 10.1371/journal.pmed.1001594. eCollection 2014 Jan. |
| D000079426 |
| Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |