CRITICal Study

CRITICal Study

Project Title: Cluster randomised trial of intermittent preventive treatment of malaria in school-age children (IPTsc) to improve the health of students and decrease community transmission

Project period: 30 June 2025 to 30 June 2030

Project synopsis:

Principal investigators: Dr. Joaniter Nankabirwa and Prof Grant Dorsey

Co-investigators: Dr. Lauren Cohee, Prof Moses Kamya, Prof Philip Rosenthal, Prof Eve Worrall, Dr. Catherine Maiteki, Katherine Snyman

Project Partners: Infectious Diseases Research Collaboration, University of California, San Francisco, and Liverpool School of Tropical Medicine.

Project Funder: National Institute of Allergy and Infectious Diseases (NIAID)

Project Overview:

This is a cluster-randomised trial of malaria prevention using the antimalarial drug Dihydroartemisinin-Piperaquine (DP). The study is being implemented in 24 clusters, defined geographically as areas surrounding government-run health centres IIIs and IVs (Referred to as Malaria Reference Centres (MRCs) in this study). Study participants are primary school-going children whose schools are within or near the MRCs. School children act as reservoirs for malaria parasites, resulting in community malaria transmission. Following parental consent and assent for children 8 years and above, DP will be administered to primary school-going children every two months for 2 years in 12 intervention clusters, while 12 clusters will serve as control clusters. The study will assess how the intervention reduces malaria cases within communities surrounding MRCs (Measured at the MRCs) and among schoolchildren (measured during school surveys).

School surveys are conducted within the school with the highest enrolment in each MRC. Approximately 50 students will be selected to collect finger-prick blood samples for thick blood smears and storage on filter paper at baseline and in years 1, 2, and 3.

Other assessments, including school attendance, economic evaluation, adherence to study drugs, and resistance testing, will be done.

Project Summary:

The study is a phase IV, open-label, cluster-randomised trial to be conducted across 12 intervention and 12 control clusters over 5 years.

 Study Objectives:

1. To estimate the effectiveness of IPTsc with Dihydroartemisinin-Piperaquine (DP) in reducing community-level malaria burden.
2. To estimate the effectiveness of IPTsc with DP for reducing malaria burden in schoolchildren.
3. To estimate the cost-effectiveness of IPTsc with DP as a tool for reducing community-level malaria burden.
4. To test the impact of IPTsc with DP on markers of drug resistance.

Study Achievements:

1. Obtained administrative clearances within the 24 districts where the study is to be conducted.
2. Sensitisation of study stakeholders at district, subcounty, parish, local council, and school levels within study clusters, such as District Health officers, District Education Officers, and headteachers.
3. Mapped and ascertained total enrolments for participating schools.
4. Obtaining parental consent and assent from children 8 years and above.

Publications:

None