Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dihydroartemisinin Piperaquine

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator