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Comparing Chemoprevention Approaches for School-based Malaria Control

Primary Purpose

Malaria,Falciparum, Anemia in Children

Status
Completed
Phase
Phase 4
Locations
Malawi
Study Type
Interventional
Intervention
Dihydroartemisinin-Piperaquine
Chloroquine
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria,Falciparum focused on measuring malaria, school, chemoprevention, preventive treatment, screening and treatment, education, cognitive function, adolescent, hemoglobin

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kamuzu University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intermittent Screening and Treatment (IST)

Intermittent Preventive Treatment (IPT)

Control

Arm Description

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).

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).

Students will not receive preventive treatment.

Outcomes

Primary Outcome Measures

P. falciparum infection
detected by polymerase chain reaction (PCR, binary)
P. falciparum gametocyte carriage
detected by q-rtPCR (binary)

Secondary Outcome Measures

Number of participant with anemia
World Health Organization age-sex definitions (binary)
Mean hemoglobin concentration
g/dL (continuous)
Total parasite density
log transformed (continuous)
Gametocyte density
log transformed (continuous)
Rate of clinical malaria
cumulative incidence
P. falciparum prevalence among household members
detected by PCR

Full Information

First Posted
January 11, 2022
Last Updated
November 14, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
Kamuzu University of Health Sciences, Doris Duke Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05244954
Brief Title
Comparing Chemoprevention Approaches for School-based Malaria Control
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 26, 2022 (Actual)
Study Completion Date
August 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Kamuzu University of Health Sciences, Doris Duke Charitable Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria,Falciparum, Anemia in Children
Keywords
malaria, school, chemoprevention, preventive treatment, screening and treatment, education, cognitive function, adolescent, hemoglobin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Laboratory technicians processing samples will be blinded to participant's study arm.
Allocation
Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent Screening and Treatment (IST)
Arm Type
Experimental
Arm Description
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).
Arm Title
Intermittent Preventive Treatment (IPT)
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Students will not receive preventive treatment.
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinin-Piperaquine
Other Intervention Name(s)
DP, DuoCotecxin, Artekin, Eurartesim, Ridmal
Intervention Description
Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
Aralen
Intervention Description
Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.
Primary Outcome Measure Information:
Title
P. falciparum infection
Description
detected by polymerase chain reaction (PCR, binary)
Time Frame
6-8 weeks after the last intervention
Title
P. falciparum gametocyte carriage
Description
detected by q-rtPCR (binary)
Time Frame
6-8 weeks after the last intervention
Secondary Outcome Measure Information:
Title
Number of participant with anemia
Description
World Health Organization age-sex definitions (binary)
Time Frame
6-8 weeks after the last intervention
Title
Mean hemoglobin concentration
Description
g/dL (continuous)
Time Frame
6-8 weeks after the last intervention
Title
Total parasite density
Description
log transformed (continuous)
Time Frame
6-8 weeks after the last intervention
Title
Gametocyte density
Description
log transformed (continuous)
Time Frame
6-8 weeks after the last intervention
Title
Rate of clinical malaria
Description
cumulative incidence
Time Frame
from the first intervention to 6-8 weeks after the last intervention
Title
P. falciparum prevalence among household members
Description
detected by PCR
Time Frame
6-8 weeks after the last intervention
Other Pre-specified Outcome Measures:
Title
Cognitive function test scores
Description
standardized scores
Time Frame
6-8 weeks after the last intervention
Title
Reading test scores
Description
standardized scores
Time Frame
6-8 weeks after the last intervention
Title
Math test scores
Description
standardized scores
Time Frame
6-8 weeks after the last intervention
Title
School attendance
Description
number of days missed based on registers and spot checks
Time Frame
from the first intervention to 6-8 weeks after the last intervention
Title
Mean infectiousness
Description
regression modeled infectiousness based on gametocyte density, gametocyte sex ratio, symptom status, and other predictors of infectiousness
Time Frame
from the first intervention to 6-8 weeks after the last intervention
Title
Performance characteristics of conventional RDT
Description
compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score
Time Frame
through study completion, on average 6 months
Title
Performance characteristics of high-sensitivity RDT
Description
compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score
Time Frame
through study completion, on average 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Cohee, MD MS
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamuzu University of Health Sciences
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all individual participant data that underlie results in a publication
IPD Sharing Time Frame
After results publication
IPD Sharing Access Criteria
Public access with registration to allow tracking
Citations:
PubMed Identifier
33767384
Citation
Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.
Results Reference
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PubMed Identifier
33222799
Citation
Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22.
Results Reference
background
PubMed Identifier
24492859
Citation
Halliday KE, Okello G, Turner EL, Njagi K, Mcharo C, Kengo J, Allen E, Dubeck MM, Jukes MC, Brooker SJ. Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial. PLoS Med. 2014 Jan 28;11(1):e1001594. doi: 10.1371/journal.pmed.1001594. eCollection 2014 Jan.
Results Reference
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Comparing Chemoprevention Approaches for School-based Malaria Control

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