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

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Anemia; Malaria,Falciparum; Malaria

Treatments: Other: Screening and treatment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04858087

U19AI089683 (U.S. NIH Grant/Contract)

HP-00052129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 786 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

786 participants in 1 patient group

All students

Description:

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.

Treatment:

Other: Screening and treatment