Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy

Starting soon · Early Phase 1

Conditions studied: Malaria Prevention

In brief

The purpose of this study is to demonstrate the feasibility, acceptability, and preliminary effectiveness of a focal mass drug administration program for household members of pregnant women to protect against malaria in pregnancy.

Key facts

Study ID

NCT07021430

Run by

University of North Carolina, Chapel Hill

People needed

300

Starts

2026-07-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-20

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Primary residence (i.e., where a person lives for ≥ 6 months per year) in Kasese District with no plans to change residency in subsequent 6 months
• Able and willing to comply with all study procedures and be available for the duration of the study
• Able and willing to consent to study procedures as documented on informed consent form. For children (age <18 years), parent or guardian must provide consent. Children age ≥8 to 17 years will also be asked to provide written assent.
• Each pregnant women will also need to meet additional eligibility criteria:
• 18 years old or older Presenting to Bugoye Level III Health Center for antenatal care and plan to deliver at Bugoye Level III Health Center (i.e., not planned cesarean section) Gestational age ≤22 weeks Human Immunodeficiency Virus negative

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation:
• Temporary or part-time residence in Kasese District (i.e., where a person lives for < 6 months per year)
• Known plans to move within the next 6 months
• Unable or unwilling to provide consent
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
• In addition, individuals with any of the following will still be eligible to participate (e.g,, complete surveys, provide blood samples) but will not be eligible to receive Dihydroartemisinin Piperaquine if randomized to one of the intervention arms:
• Known arrythmia, QT prolongation, or seizure disorder will not be eligible to receive Dihydroartemisinin Piperaquine
• Use of potentially contraindicated medications outlined in Section 5.6
• Weight <5 kg
• Known allergic reaction to Dihydroartemisinin Piperaquine or other Artemisinin Combination Therapies

Where it is running

• Bugoye Level III Health Center — Kasese, Uganda, Uganda

Full record on ClinicalTrials.gov

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