Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy (NCT07021430) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy
Uganda300 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 on…
What they're measuring
1
Percent of eligible household members receiving fMDA
Timeframe: Day 1 to study completion, generally 5 months