Comparing Chemoprevention Approaches for School-based Malaria Control

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05244954
Collaborator
Kamuzu University of Health Sciences (Other), Doris Duke Charitable Foundation (Other)
750
1
3
7
107.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Students will be randomized to intermittent screening-and-treatment (IST - Arm 1), intermittent preventive treatment (IPT - Arm 2), or control with no preventive treatment (Arm 3). Females less that 10 years of age (pre-menarche) and all males will be treated with DP if they are in Arm 2 or test positive in Arm 1. Females 10 years and older will be treated with chloroquine if they are in Arm 2 or test positive in Arm 1.Students will be randomized to intermittent screening-and-treatment (IST - Arm 1), intermittent preventive treatment (IPT - Arm 2), or control with no preventive treatment (Arm 3). Females less that 10 years of age (pre-menarche) and all males will be treated with DP if they are in Arm 2 or test positive in Arm 1. Females 10 years and older will be treated with chloroquine if they are in Arm 2 or test positive in Arm 1.
Masking:
Single (Outcomes Assessor)
Masking Description:
Laboratory technicians processing samples will be blinded to participant's study arm.
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intermittent Screening and Treatment (IST)

Students will be screened for infection using a higher sensitivity malaria rapid diagnostic test and treated if positive. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Drug: Dihydroartemisinin-Piperaquine
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
  • Drug: Chloroquine
    Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.
    Other Names:
  • Aralen
  • Experimental: Intermittent Preventive Treatment (IPT)

    All students are treated at each intervention. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

    Drug: Dihydroartemisinin-Piperaquine
    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
  • Drug: Chloroquine
    Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.
    Other Names:
  • Aralen
  • No Intervention: Control

    Students will not receive preventive treatment.

    Outcome Measures

    Primary Outcome Measures

    1. P. falciparum infection [6-8 weeks after the last intervention]

      detected by polymerase chain reaction (PCR, binary)

    2. P. falciparum gametocyte carriage [6-8 weeks after the last intervention]

      detected by q-rtPCR (binary)

    Secondary Outcome Measures

    1. Number of participant with anemia [6-8 weeks after the last intervention]

      World Health Organization age-sex definitions (binary)

    2. Mean hemoglobin concentration [6-8 weeks after the last intervention]

      g/dL (continuous)

    3. Total parasite density [6-8 weeks after the last intervention]

      log transformed (continuous)

    4. Gametocyte density [6-8 weeks after the last intervention]

      log transformed (continuous)

    5. Rate of clinical malaria [from the first intervention to 6-8 weeks after the last intervention]

      cumulative incidence

    6. P. falciparum prevalence among household members [6-8 weeks after the last intervention]

      detected by PCR

    Other Outcome Measures

    1. Cognitive function test scores [6-8 weeks after the last intervention]

      standardized scores

    2. Reading test scores [6-8 weeks after the last intervention]

      standardized scores

    3. Math test scores [6-8 weeks after the last intervention]

      standardized scores

    4. School attendance [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kamuzu University of Health Sciences Blantyre Malawi

    Sponsors and Collaborators

    • University of Maryland, Baltimore
    • Kamuzu University of Health Sciences
    • Doris Duke Charitable Foundation

    Investigators

    • Principal Investigator: Lauren Cohee, MD MS, University of Maryland School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lauren Cohee, Visiting Assistant Professor, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT05244954
    Other Study ID Numbers:
    • HP-00098250
    First Posted:
    Feb 17, 2022
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Lauren Cohee, Visiting Assistant Professor, University of Maryland, Baltimore
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2022