Focal Mass Drug Administration to Help Protect Pregnant Women from Malaria
Official title: Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy: a Pilot Randomized Controlled Trial
Run by University of North Carolina, Chapel Hill · NCT07021430 · Data updated 2026-11-12
This pilot tests whether giving a single or ongoing dose of dihydroartemisinin-piperaquine to household members of pregnant women can reduce malaria in pregnancy, especially when care access is limited.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Kasese) |
| Status | Recruiting |
| Started | April 22, 2026 |
| Main results expected | September 2028 |
| Study ends | September 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07021430 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Households in Kasese District with a pregnant woman presenting for antenatal care at Bugoye Level III Health Center, where participants are willing to consent and comply with study procedures.
✕Probably not a fit
Pregnant women or household members who do not participate or who do not respond to the intervention may not experience protection.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase pilot study will be conducted at a rural Ugandan health center to see if a focal mass drug administration approach is feasible and acceptable. Household members of pregnant women will be randomized to no intervention, a one-time focal mass drug administration, or monthly focal dosing. The study will measure how many people are reached, willingness to take the medication, adherence, and adverse events, while also estimating the potential to create a malaria-free zone around the home to protect against malaria in pregnancy. Dihydroartemisinin-piperaquine is the drug used in this program, aiming to complement existing prevention strategies and improve outcomes when access to care is limited.
Why it matters
Potential benefit: If successful, the approach could add a new layer of protection against malaria in pregnancy by reducing household parasite reservoirs.
How similar studies have gone: Prior studies in malaria prevention support mass drug administration approaches; however, this household-focused, focal strategy/testing in pregnancy is innovative and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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's running
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Bugoye Level III Health Center
Kasese, Uganda Recruiting
Study contacts
- Principal investigator: Ross Boyce, MD — University of North Carolina, Chapel Hill
- Study coordinator: Boyce
- Email: roboyce@med.unc.edu
- Phone: (919) 932-0688
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.