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

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT04858087

Collaborator

University of Malawi College of Medicine (Other), Michigan State University (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

786

Enrollment

7.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria Malaria,Falciparum Anemia	Other: Screening and treatment

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 Design

Study Type:

Observational

Actual Enrollment :

786 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 24, 2015

Actual Primary Completion Date :

Nov 13, 2015

Actual Study Completion Date :

Nov 13, 2015

Arms and Interventions

Arm	Intervention/Treatment
All students 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 Students were screened by mRDTs and treated with artemether-lumefantrine if positive Other Names: mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrine

Arm

Intervention/Treatment

All students

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

Students were screened by mRDTs and treated with artemether-lumefantrine if positive

Other Names:

mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrine

Outcome Measures

Primary Outcome Measures

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
P. falciparum gametocyte density [6 weeks after screening]
Pfs25 quantitative reverse transcriptase PCR

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)