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Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy: a Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Uganda
Bugoye Level III Health Center
RECRUITING
Kasese
Contact Information
Primary
Boyce
roboyce@med.unc.edu
(919) 932-0688
Time Frame
Start Date: 2026-09-27
Estimated Completion Date: 2028-09
Participants
Target number of participants: 300
Treatments
Experimental: A single dose of Dihydroartemisinin Piperaquine
A single administration of Dihydroartemisinin Piperaquine as a focal mass drug administration Focal Mass Drug Administration.
Experimental: Monthly dose of Dihydroartemisinin Piperaquine
Monthly doses of Dihydroartemisinin Piperaquine for household members
No_intervention: Control
Participants in this arm will receive current standard of care.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov