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

April 22, 2021 updated by: Miriam Laufer, University of Maryland, Baltimore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

15 students per grade (1 through 8) were randomly sampled in four primary schools

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Michigan State University
Kamuzu University of Health Sciences

Investigators

  • Principal Investigator: Miriam Laufer, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2015

Primary Completion (Actual)

November 13, 2015

Study Completion (Actual)

November 13, 2015

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00052129
  • U19AI089683 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data will be available via a publicly available database, such as ClinEpiDB

IPD Sharing Time Frame

After results publication

IPD Sharing Access Criteria

Public access with registration to allow tracking

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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