Comparing Chemoprevention Approaches for School-based Malaria Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

746 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-08-26

Brief Summary

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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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Detailed Description

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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).

Conditions

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Malaria,Falciparum Anemia in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Laboratory technicians processing samples will be blinded to participant's study arm.

Study Groups

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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).

Group Type EXPERIMENTAL

Dihydroartemisinin-Piperaquine

Intervention Type DRUG

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

Chloroquine

Intervention Type DRUG

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

Control

Students will not receive preventive treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Dihydroartemisinin-Piperaquine

Intervention Type DRUG

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

Chloroquine

Intervention Type DRUG

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

Interventions

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Dihydroartemisinin-Piperaquine

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

Chloroquine

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

Intervention Type DRUG

Other Intervention Names

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DP DuoCotecxin Artekin Eurartesim Ridmal Aralen

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes