Clinical trial NCT04858087: Malawi International Center of Excellence in Malaria Research School-based Cohort
Official title: Epidemiology of Malaria in Malawi: Human Hosts and Parasites in Three Districts Part 2: Cross-sectional Surveillance (School-based Cohorts)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Malaria,Falciparum
Anemia
Keywords: cohort
screen and treat
artemether-lumefantrine
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: Michigan State University
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-04-26
Enrollment: 786
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 students per grade (1 through 8) were randomly sampled in four primary schools

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.

Eligibility criteria: 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)

Primary outcomes:
measure: P. falciparum infection
timeFrame: 6 weeks after screening
measure: P. falciparum gametocyte presence
timeFrame: 6 weeks after screening
measure: P. falciparum gametocyte density
timeFrame: 6 weeks after screening
Secondary outcomes:
measure: Microscopic P. falciparum infection
timeFrame: 6 weeks after screening
measure: Anemia
timeFrame: 6 weeks after screening
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland, Baltimore
name: Miriam Laufer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cohee LM, Peterson I, Buchwald AG, Coalson JE, Valim C, Chilombe M, Ngwira A, Bauleni A, Schaffer-DeRoo S, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-Based Malaria Screening and Treatment Reduces Plasmodium falciparum Infection and Anemia Prevalence in Two Transmission Settings in Malawi. J Infect Dis. 2022 Aug 12;226(1):138-146. doi: 10.1093/infdis/jiac097.