๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Primary residence (i.e., where a person lives for โฅ 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 โฅ8 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 โค22 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 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
๐
What it tests
- Dihydroartemisinin Piperaquine
Bugoye Level III Health Center
Kasese, Uganda
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.