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NCT Number: NCT07246525

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

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.

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Key information

Conditions

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

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Infectious Diseases Research Collaboration

Kampala, Uganda

Location contact

Joaniter Nankabirwa, MBChB, MSc, PhD

CONTACT

[email protected]

About this study

The CRITICal study is 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. The intervention will be delivered for 2 years and evaluations will continue for 1 additional year after the intervention is stopped. The primary outcome of the study will be malaria incidence within the population of the target areas. Secondary outcomes will include the the prevalence of parasitemia and molecular markers of DP resistance at the community level; the prevalence of parasitemia, anemia, and school attendance among children attending primary school; and estimates of the cost-effectiveness of IPTsc.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: D-Artepp

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

    Time frame: 24 months after intervention 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

Secondary outcomes

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

    Time frame: 12 months after intervention is completed

    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 12 months after intervention is completed

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

    Time frame: 12 months after the intervention is implemented

    Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys

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

    Time frame: 24 months after the intervention is implemented

    Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys

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

    Time frame: 12 months after the intervention is completed

    Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys

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

    Time frame: 12 months after the intervention is implemented

    Proportion of parasite positive samples with molecular markers of DP resistance detected

  6. Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 24 months after the intervention is implemented

    Time frame: 24 months after the intervention is implemented

    Proportion of parasite positive samples with molecular markers of DP resistance detected

  7. Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is completed

    Time frame: 12 months after the intervention is completed

    Proportion of parasite positive samples with molecular markers of DP resistance detected

  8. Parasite prevalence among schoolchildren 12 months after the intervention is implemented

    Time frame: 12 months after the intervention is implemented

    Proportion of blood smears positive for parasites by microscopy at the time of school surveys

  9. Parasite prevalence among schoolchildren 24 months after the intervention is implemented

    Time frame: 24 months after the intervention is implemented

    Proportion of blood smears positive for parasites by microscopy at the time of school surveys

  10. Parasite prevalence among schoolchildren 12 months after the intervention is completed

    Time frame: 12 months after the intervention is completed

    Proportion of blood smears positive for parasites by microscopy at the time of school surveys

  11. Anemia prevalence among schoolchildren 12 months after the intervention is implemented

    Time frame: 12 months after the intervention is implemented

    Proportion of children with anemia at the time of school surveys

    Anemia defined based on WHO criteria as:

    • hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
    • hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
    • hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period

  12. Anemia prevalence among schoolchildren 24 months after the intervention is implemented

    Time frame: 24 months after the intervention is implemented

    Proportion of children with anemia at the time of school surveys

    Anemia defined based on WHO criteria as:

    • hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
    • hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
    • hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period

  13. Anemia prevalence among schoolchildren 12 months after the intervention is completed

    Time frame: 12 months after the intervention is completed

    Proportion of children with anemia at the time of school surveys

    Anemia defined based on WHO criteria as:

    • hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
    • hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
    • hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period

Study contacts

Contact information is provided by the study sponsor or research team.

Grant Dorsey, MD, PhD

CONTACT

[email protected]

415-310-0525

Tamara Clark, MHS

CONTACT

[email protected]

415-517-3444

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Infectious Diseases Research Collaboration, Uganda
  • Ministry of Health, Uganda
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Cluster Randomized Trial of Intermittent Preventive Treatment of Malaria in School-age Children to Improve the Health of Students and Decrease Community Transmission

Acronym: CRITICal

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 24, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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