Malawi International Center of Excellence in Malaria Research School-based Cohort

Study Overview
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Brief Summary
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A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P. falciparum (Pf) infections in school-age children and determine the impact of the screen-and-treat approach on Pf infection and anemia prevalence among students in two different transmission settings. Investigators aimed to evaluate how frequently malaria rapid diagnostic tests (mRDTs) fail to detect low-parasite-density infections as well as whether low-density infections contribute to the burden and health consequences of Pf infection in school-age children and whether they contain gametocytes, the parasite stage required for transmission from humans to mosquitos.

Detailed Description
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Students were enrolled in four schools in southern Malawi in the rainy (March-May) and dry season (Sept-Nov) of 2015. 15 students per grade-level (grades 1-8), were invited to participate. Following enrollment, students were evaluated at baseline for screening-and-treatment, and followed-up 1, 2 and 6 weeks later. At each follow-up visit, a blood sample was obtained for microscopy and molecular detection of parasites and students were interviewed about bed net use the night prior, current or recent illness, and use of antimalarial treatment. At the final visit, a mRDT and hemoglobin test were repeated, and parents were interviewed and portable medical records (health passports) were reviewed to identify intercurrent fever or malaria treatment.

Official Title
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Epidemiology of Malaria in Malawi: Human Hosts and Parasites in Three Districts Part 2: Cross-sectional Surveillance (School-based Cohorts)

Conditions
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Malaria, Malaria,Falciparum, Anemia

Intervention / Treatment
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* Other: Screening and treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Randomly selected student at a participating school Exclusion Criteria: Parent or guardian not available for consent Age <5 or >= 16 years Known allergy or adverse reaction to lumefantrine-artemether Child will not attend this school during the time of the survey For the dry season survey (Sept-Oct 2015), participants in the rainy season survey (April-May 2015)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All students<br>All participating students were screened for Pf infection using malaria rapid diagnostic tests (mRDTs) and treated if positive. All were followed 1, 2, and 6 weeks after screening-and-treatment. | Other: Screening and treatment<br>* Students were screened by mRDTs and treated with artemether-lumefantrine if positive<br>* Other names: mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P. falciparum infection | Any stage Pf infection detected by quantitative polymerase chain reaction (PCR) | 6 weeks after screening | 
| P. falciparum gametocyte presence | Pfs25 quantitative reverse transcriptase PCR | 6 weeks after screening | 
| P. falciparum gametocyte density | Pfs25 quantitative reverse transcriptase PCR | 6 weeks after screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microscopic P. falciparum infection | Pf infection detected by microscopy | 6 weeks after screening | 
| Anemia | Hb measured by Hemocue and categorized using WHO age and gender specific values | 6 weeks after screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cohort, screen and treat, artemether-lumefantrine