AzTrials
AzTrials

Malaria PreventionEarly Phase 1NCT07021430

Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy

A Early Phase 1 study testing Dihydroartemisinin Piperaquine in people with Malaria Prevention, run by University of North Carolina, Chapel Hill at 1 site in Uganda.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Malaria Prevention
What is being tested?
Dihydroartemisinin Piperaquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUganda
Study dates
22 Apr 2026to Sep 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Boyce contact

(919) 932-0688

roboyce@med.unc.edu

Uganda1 site, 1 recruiting

  • Bugoye Level III Health Center

    Kasese

    Recruiting

Other trials in Uganda

About this study

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

Read the detailed description

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

Being tested
Dihydroartemisinin Piperaquine
Keywords
Malaria, Focal mass drug administration, Dihydroartemisinin-piperaquine
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dihydroartemisinin PiperaquineDrug

    Also called Focal Mass Drug Administration

    A single or monthly dose of Dihydroartemisinin Piperaquine based on weight will be taken orally.

Study groups in NCT07021430
Study groupRoleWhat they receive
A single dose of Dihydroartemisinin PiperaquineExperimentalA single administration of Dihydroartemisinin Piperaquine as a focal mass drug administration Focal Mass Drug Administration.
Receives: Drug: Dihydroartemisinin Piperaquine
Monthly dose of Dihydroartemisinin PiperaquineExperimentalMonthly doses of Dihydroartemisinin Piperaquine for household members
Receives: Drug: Dihydroartemisinin Piperaquine
ControlNo interventionParticipants in this arm will receive current standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 1 to study completion, generally 5 months

Secondary outcomes (11)

  1. Percent of household members enrolled

    Proportion of household members who consent to participate

    Measured: At enrollment visit (Day 1)

  2. Refusal to receive fMDA

    Proportion of eligible household members who decline any fMDA intervention

    Measured: Day 1 to study completion, generally 5 months

  3. fMDA Adherence

    Proportion of DP blister packs returned with all medication taken (i.e., pill counts)

    Measured: Day 1 to study completion, generally 5 months

  4. 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

    Measured: Day 1 to study completion, generally 5 months

  5. P. falciparum parasitemia among pregnant women

    Prevalence of P. falciparum parasitemia as measured by RDT or PCR among women during any point in pregnancy

    Measured: Day 1 to study completion, generally 5 months

  6. 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

    Measured: At time of birth/delivery

  7. 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)

    Measured: Day 1 to study completion, generally 5 months

  8. Maternal anemia

    Change in prevalence of maternal anemia, defined as Hemoglobin <11 g/dL among participants

    Measured: Day 1 to study completion, generally 5 months

  9. Adverse birth outcomes

    Composite of adverse events including spontaneous abortion, premature delivery (<37 weeks gestation), stillbirth, and low birthweight

    Measured: Day 1 to study completion, generally 5 months

  10. 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

    Measured: Day 1 to study completion, generally 5 months

  11. Number of adverse reactions to DP

    Number of dihydroartemisinin-piperaquine administrations that result in vomiting or other known side effects

    Measured: Day 1 to study completion, generally 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study start22 Apr 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021430
Sponsor's protocol ID
24-3166
Other IDs
R21AI180728
Status last verified
Oct 2026
First submitted
14 May 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dihydroartemisinin Piperaquine in people with Malaria Prevention, run by University of North Carolina, Chapel Hill at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Boyce ((919) 932-0688, roboyce@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of eligible household members receiving fMDA (time frame: Day 1 to study completion, generally 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07021430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in