An Early Phase 1 interventional study of Dihydroartemisinin Piperaquine in Malaria Prevention, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in Uganda. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of North Carolina, Chapel Hill · Early Phase 1, Interventional, and Prevention
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.
The scientific objective of this pilot 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. The hypothesis is that eliminating the parasite reservoir within the household will provide a complementary layer of protection against Malaria in Pregnancy especially when access to care is limited and visits may be delayed or missed.
Aim 1: Determine the feasibility and acceptability of a Focal Mass Drug Administration program with dihydroartemisinin-piperaquine as a novel component of the Malaria in Pregnancy prevention package. The study team will conduct an open-label, randomized pilot study at a primary health center in rural western Uganda. The household members of women presenting to their first antenatal Clinic visit will be randomized 1:1:1: to (i) control (ii) one-time Focal Mass Drug Administration, or (iii) monthly Focal Mass Drug Administration. Using an established implementation framework, the study team will assess process measures such as the proportion of household members reached, willingness to take Dihydroartemisinin Piperaquine, adherence to the course of treatment, and frequency of adverse events.
Aim 2: Estimate the efficacy of Focal Mass Drug Administration to create a "safe zone" in the immediate home environment and ultimately prevent Malaria in Pregnancy. Using the study design outlined in Aim 1, The study team will follow participating pregnant women and associated households through delivery, including longitudinal assessments of P. falciparum infection. As a pilot study, the trial is deliberately not powered for statistical tests of significance, but The study team will measure the incidence of (i) clinical malaria, defined as the presence of typical symptoms (e.g., fever, lethargy) and a positive malaria rapid diagnostic test (Rapid Diagnostic Test), (ii) asymptomatic P. falciparum parasitemia and placental malaria by Polymerase Chain Reaction throughout pregnancy and (iii) the incidence of adverse birth outcomes (e.g., stillbirth, low birth weight). In addition, the study team will measure the prevalence of asymptomatic parasitemia in household members using Rapid Diagnostic Tests at three time points to estimate the effectiveness of Focal Mass Drug Administration at maintaining a parasite-free zone
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 300 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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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 negative
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single administration of Dihydroartemisinin Piperaquine as a focal mass drug administration Focal Mass Drug Administration.
Drug: Dihydroartemisinin Piperaquine
Monthly doses of Dihydroartemisinin Piperaquine for household members
Drug: Dihydroartemisinin Piperaquine
Participants in this arm will receive current standard of care.
Drug pages: Artenimol · Piperaquine
A single or monthly dose of Dihydroartemisinin Piperaquine based on weight will be taken orally.
Also known as: Focal Mass Drug Administration
Percent of eligible household members receiving fMDA
Proportion of eligible household members that receive fMDA intervention according to dosing schedule (i.e., one time or monthly)
Time frame: Day 1 to study completion, generally 5 months
Percent of household members enrolled
Proportion of household members who consent to participate
Time frame: At enrollment visit (Day 1)
Refusal to receive fMDA
Proportion of eligible household members who decline any fMDA intervention
Time frame: Day 1 to study completion, generally 5 months
fMDA Adherence
Proportion of DP blister packs returned with all medication taken (i.e., pill counts)
Time frame: Day 1 to study completion, generally 5 months
P. falciparum parasitemia among household members
Prevalence of P. falciparum parasitemia among household members at three time points (enrollment, mid-point, delivery) as measured by malaria rapid diagnostic test
Time frame: Day 1 to study completion, generally 5 months
P. falciparum parasitemia among pregnant women
Prevalence of P. falciparum parasitemia as measured by RDT or PCR among women during any point in pregnancy
Time frame: Day 1 to study completion, generally 5 months
P. falciparum parasitemia in peripheral and placental blood at delivery
Prevalence of P. falciparum parasitemia in peripheral and placental blood at delivery as measured by PCR
Time frame: At time of birth/delivery
Clinical malaria incidence among pregnant women
Incidence of clinical malaria among pregnant women, defined as the presence of acute febrile illness and a positive malaria rapid diagnostic test (RDT)
Time frame: Day 1 to study completion, generally 5 months
Maternal anemia
Change in prevalence of maternal anemia, defined as Hemoglobin \<11 g/dL among participants
Time frame: Day 1 to study completion, generally 5 months
Adverse birth outcomes
Composite of adverse events including spontaneous abortion, premature delivery (\<37 weeks gestation), stillbirth, and low birthweight
Time frame: Day 1 to study completion, generally 5 months
Co-occurrence of malaria parasitemia in mother and household members
Proportion of RDT+ individuals in each household stratified by parasitemia status of pregnant women at enrollment visit
Time frame: Day 1 to study completion, generally 5 months
Number of adverse reactions to DP
Number of dihydroartemisinin-piperaquine administrations that result in vomiting or other known side effects
Time frame: Day 1 to study completion, generally 5 months
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina at Chapel Hill.
Supporting information: Study protocol, Informed consent form
Time frame: beginning 9 and continuing for 36 months following publication
Access criteria: Requesting investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.
Data sharing details ↗ · unc.edu
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Artenimol · Piperaquine
University of North Carolina, Chapel Hill →