Intermittent Preventive Treatment of Malaria in School-age Children to Decrease Community Transmission

NCT07246525 | Not Yet Recruiting Phase 4

• 2 other identifiers: CRITICalU01AI186861
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 1

Brief Summary

The CRITICal study aims to estimate the effectiveness of intermittent preventive treatment in school children (IPTsc) with dihydroartemisinin-piperaquine (DP) for reducing community level malaria burden. Given that school-aged children are the primary drivers of transmission, the study hypothesis is that IPTsc will reduce this infectious reservoir and thus the burden of malaria in persons of all ages in surrounding communities.

Conditions

Malaria

Keywords

intermittent preventive treatment; school children; dihydroartemisinin-piperaquine

Outcome Measures

Primary Outcomes (1)

• Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area during the period the intervention is implemented

  malaria incidence: the number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area, per unit time, divided by the total population of the target area in patients of all ages over the 24-month intervention period

  24 months after intervention implemented

Secondary Outcomes (13)

• Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area after the intervention is competed

  12 months after intervention is completed

• Parasite prevalence among community residents 12 months after the intervention is implemented

  12 months after the intervention is implemented

• Parasite prevalence among community residents 24 months after the intervention is implemented

  24 months after the intervention is implemented

• Parasite prevalence among community residents 12 months after the intervention is completed

  12 months after the intervention is completed

• Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is implemented

  12 months after the intervention is implemented

Study Arms (2)

IPTsc

EXPERIMENTAL

DP will be administered approximately every 2 months for two years to all eligible children enrolled in primary schools serving the target areas from clusters randomized to the interventional arm.

Drug: dihydroartemisinin-piperaquine

No IPTsc

NO INTERVENTION

No IPTsc (standard of care)

Interventions

dihydroartemisinin-piperaquine DRUG

D-Artepp, is manufactured by Guilin Pharmaceutical Co Ltd, and is prequalified by the WHO and approved for use in Uganda by the National Drug Authority. Standard treatment doses of DP (once a day x 3 days) will be administered using weight-based guidelines targeting a total dose of 6.4 mg/kg dihydroartemisinin and 51.2 mg/kg of piperaquine as per manufacturer's instructions.

Also known as: D-Artepp

IPTsc

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child currently attending the participating school.
• Agreement of parent/guardian to provide informed consent.
• Agreement of children aged 8-17 years to provide assent.

You may not qualify if:

• Missing school on three consecutive days of the school survey.

Sponsors & Collaborators

• Infectious Diseases Research Collaboration, Uganda: collaborator
• Ministry of Health, Uganda: collaborator
• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Uganda

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Grant Dorsey, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grant Dorsey, MD, PhD

CONTACT

415-310-0525; grant.dorsey@ucsf.edu

Tamara Clark, MHS

CONTACT

415-517-3444; tamara.clark@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be an open label, phase IV, cluster-randomized trial to evaluate the effectiveness of IPTsc with DP administered approximately every 2 months to children attending primary school. Clusters are geographically defined target areas surrounding government-run health facilities previously established and referred to as Malaria Reference Centers (MRCs). A total of 24 clusters (MRCs) will be included in the study. These clusters were selected based on participation in an on-going sentinel site malaria surveillance network in areas with moderate-high malaria transmission intensity. Clusters will be randomized in a 1:1 ratio such that all primary schools serving the populations of each target area will either receive IPTsc or not receive IPTsc.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)