Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy

NCT07021430 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: 24-3166R21AI180728
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria Prevention

Keywords

Malaria; Focal mass drug administration; Dihydroartemisinin-piperaquine

Outcome Measures

Primary Outcomes (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)

  Day 1 to study completion, generally 5 months

Secondary Outcomes (11)

• Percent of household members enrolled

  At enrollment visit (Day 1)

• Refusal to receive fMDA

  Day 1 to study completion, generally 5 months

• fMDA Adherence

  Day 1 to study completion, generally 5 months

• P. falciparum parasitemia among household members

  Day 1 to study completion, generally 5 months

• P. falciparum parasitemia among pregnant women

  Day 1 to study completion, generally 5 months

Study Arms (3)

A single dose of Dihydroartemisinin Piperaquine

EXPERIMENTAL

A single administration of Dihydroartemisinin Piperaquine as a focal mass drug administration Focal Mass Drug Administration.

Drug: Dihydroartemisinin Piperaquine

Monthly dose of Dihydroartemisinin Piperaquine

EXPERIMENTAL

Monthly doses of Dihydroartemisinin Piperaquine for household members

Drug: Dihydroartemisinin Piperaquine

Control

NO INTERVENTION

Participants in this arm will receive current standard of care.

Interventions

Dihydroartemisinin Piperaquine DRUG

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

Also known as: Focal Mass Drug Administration

A single dose of Dihydroartemisinin Piperaquine; Monthly dose of Dihydroartemisinin Piperaquine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Bugoye Level III Health Center

Kasese, Uganda

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Ross Boyce, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 15, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

UG (1)