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Can monthly malaria pills sharpen Children's minds?

NCT ID NCT07798583

Prevention Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether giving schoolchildren in Kenya an antimalarial drug every month, instead of every three months, better protects their brain function and school performance. Researchers will enroll 1,500 children aged 6 to 10 from six primary schools. Half will receive monthly doses of dihydroartemisinin-piperaquine, and half will get quarterly doses, for 24 months. The study measures changes in executive function, literacy, numeracy, and school attendance to see if more frequent prevention helps children learn and thrive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dihydroartemisinin-piperaquine (DP), an antimalarial drug given as intermittent preventive treatment
What this could lead to
If monthly dosing works better, it could improve brain function and school outcomes for millions of children in malaria-prone areas.
What could go wrong
The trial is large but still one study; results may not apply to other regions, and monthly dosing may raise costs or side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2028

An estimate. Start dates often move.

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 10 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 6 to 10 years at enrollment * Enrollment in a participating primary school in Siaya County, Kenya * Residence within the participating school's catchment area with no plans to relocate during the study period * Parent or legal guardian able and willing to provide informed consent * Child able and willing to provide assent, as applicable according to local regulations and age requirements * Willingness to comply with study procedures and follow-up visits Exclusion Criteria: * Known hypersensitivity or contraindication to dihydroartemisinin-piperaquine (DP) * Severe acute illness requiring urgent medical evaluation or hospitalization at enrollment * Known cardiac disease or history of conditions associated with increased risk of QT prolongation * Severe malnutrition requiring urgent referral or treatment * Recent antimalarial treatment within the protocol-defined washout period * Severe anemia (hemoglobin \<7 g/dL) at screening * Measured fever (≥38.0°C) or acute febrile illness requiring evaluation at screening * Any medical, social, or behavioral condition that, in the opinion of the investigators, would make participation unsafe or interfere with study participation or interpretation of study results

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Conditions

The condition(s) this trial relates to.

anemia Inflammation Literacy Plasmodium falciparum malaria malaria prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asymptomatic malaria Intermittent preventive treatment Malaria

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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