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

Completed

• Conditions: Malaria,Falciparum; Anemia; Malaria
• Interventions: Other: Screening and treatment

• Registration Number: NCT04858087
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-03-24
• Primary Completion: 2015-11-13
• Study Completion: 2015-11-13
• Status Verified: 2021-04
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 786

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All students	Screening and treatment	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.

Primary Outcome Measures

Name	Time	Method
P. falciparum gametocyte density	6 weeks after screening	Pfs25 quantitative reverse transcriptase PCR
P. falciparum infection	6 weeks after screening	Any stage Pf infection detected by quantitative polymerase chain reaction (PCR)
P. falciparum gametocyte presence	6 weeks after screening	Pfs25 quantitative reverse transcriptase PCR

Secondary Outcome Measures

Name	Time	Method
Anemia	6 weeks after screening	Hb measured by Hemocue and categorized using WHO age and gender specific values
Microscopic P. falciparum infection	6 weeks after screening	Pf infection detected by microscopy