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Completed

NCT Number: NCT05244954

Comparing Chemoprevention Approaches for School-based Malaria Control

This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent screening and treatment (IST) - students will receive treatment if they have a positive high sensitivity rapid diagnostic test (RDT). Arm 2: Intermittent preventive treatment (IPT) - all students will receive treatment. Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, gametocyte carriage and gametocyte density, anemia, cognitive function and educational testing, as well as infection prevalence in student's households to assess the impact on transmission.

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Key information

Conditions

Malaria,Falciparum Anemia in Children Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kamuzu University of Health Sciences

Blantyre, Malawi

About this study

Students will be enrolled in a single primary school in Machinga District, Malawi. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT are and those that test positive in the IST arm will be treatment with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Students (enrolled in the primary intervention)

  • Currently enrolled in the study school
  • Plan to attend the study school for the remainder of the school year
  • Parent/guardian available to provide written informed consent Household members (enrolled in the Household Prevalence survey)
  • Slept in the household for most nights in the last month
  • Age 6 months or older
  • For minors, parent/guardian available to provide written informed consent

Exclusion criteria

Students (enrolled in the primary intervention)

  • Current evidence of severe malaria or danger signs
  • Known adverse reaction to the study drugs
  • History of cardiac problems or fainting
  • Taking medications known to prolong QT
  • Family history of prolonged QT
  • Girls 10 years old and older with epilepsy or psoriasis Household members (enrolled in the Household Prevalence survey)
  • Household with more than one school-age child enrolled in the study
  • Current evidence of severe malaria or danger signs

Treatment and study plan

Dihydroartemisinin-Piperaquine

Drug

Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.

Other names: DP, DuoCotecxin, Artekin, Eurartesim, Ridmal

Chloroquine

Drug

Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.

Other names: Aralen

Primary outcomes

  1. P. falciparum infection

    Time frame: 6-8 weeks after the last intervention

    detected by polymerase chain reaction (PCR, binary)

  2. P. falciparum gametocyte carriage

    Time frame: 6-8 weeks after the last intervention

    detected by q-rtPCR (binary)

Secondary outcomes

  1. Number of participant with anemia

    Time frame: 6-8 weeks after the last intervention

    World Health Organization age-sex definitions (binary)

  2. Mean hemoglobin concentration

    Time frame: 6-8 weeks after the last intervention

    g/dL (continuous)

  3. Total parasite density

    Time frame: 6-8 weeks after the last intervention

    log transformed (continuous)

  4. Gametocyte density

    Time frame: 6-8 weeks after the last intervention

    log transformed (continuous)

  5. Rate of clinical malaria

    Time frame: from the first intervention to 6-8 weeks after the last intervention

    cumulative incidence

  6. P. falciparum prevalence among household members

    Time frame: 6-8 weeks after the last intervention

    detected by PCR

Other outcomes

  1. Cognitive function test scores

    Time frame: 6-8 weeks after the last intervention

    standardized scores

  2. Reading test scores

    Time frame: 6-8 weeks after the last intervention

    standardized scores

  3. Math test scores

    Time frame: 6-8 weeks after the last intervention

    standardized scores

  4. School attendance

    Time frame: from the first intervention to 6-8 weeks after the last intervention

    number of days missed based on registers and spot checks

  5. Mean infectiousness

    Time frame: from the first intervention to 6-8 weeks after the last intervention

    regression modeled infectiousness based on gametocyte density, gametocyte sex ratio, symptom status, and other predictors of infectiousness

  6. Performance characteristics of conventional RDT

    Time frame: through study completion, on average 6 months

    compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score

  7. Performance characteristics of high-sensitivity RDT

    Time frame: through study completion, on average 6 months

    compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Doris Duke Charitable Foundation
  • Kamuzu University of Health Sciences

Registry information

Official study title

Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Nov 15, 2022

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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