IGHID 12334 - After the Flood: Optimal Strategies to Prevent Malaria Epidemics Caused by Severe Flooding

NCT06870344 | Active Not Recruiting DMC

• 2 other identifiers: 24-02331R01AI173558-01A1
• Study Type: interventional
• Target: 36,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test different ways to prevent malaria infections after flooding. To accomplish this, the investigators will assign villages to different control strategies and measure the number of malaria infections in each of the villages. Residents of all villages will receive new bed nets, but in some villages, residents will be provided with a monthly medication Dihydroartemisinin-piperaquine (DP) (a drug that is approved by the World Health Organization (WHO) and regulatory authorities and widely used in Africa for Malaria treatment. This drug is not approved by Food and Drug Administration (FDA) because it is not used in the US,) to prevent malaria, while others will also receive a treatment that can be placed into pools of water around the home to prevent mosquitoes from breeding there. The investigators will monitor the participant and their household members for mosquitoes and malaria over a period of 12 months after the flooding This study is important because, similar approaches could be used to prevent malaria after floods, which is occurring more frequently.

Conditions

Malaria Infection; Malaria Falciparum

Keywords

Flooding, malaria incidence; malaria; plasmodium

Outcome Measures

Primary Outcomes (1)

• A. Cluster-level Incidence of malaria in children ≤ 12 years of age

  The cluster-level incidence of confirmed, symptomatic malaria in children ≤ 12 years of age, defined as fever (Temp ≥38 degrees Celsius (°C)) or a subjective history or fever in the prior 24 hours as the cause of care seeking and a positive malaria diagnostic test (i.e., Rapid Diagnostic Test (RDT) or microscopy), per 1,000 residents over the twelve-month period of observation. Incident cases will be captured at neighboring health facilities. In addition, the investigators will conduct a series of household surveys at baseline and 1-, 3-, 6-, and 12-months post-flooding in order to monitor temporal changes in the spatial distribution of malaria parasitemia, vector populations, and resulting social/economic impacts.

  up to 12 months after the flooding

Secondary Outcomes (11)

• A. Cluster-level Incidence of malaria among all residents

  1-, 3-, 6-, and 12-months post flooding.

• Change in prevalence of anemia in children <5 years of age

  baseline, 6-, and 12 months after the flooding

• Change in WHO Indicators of Acute Malnutrition in children <5 years of age

  baseline, 6, and 12-months post flooding.

• Change in WHO Indicators of Chronic Malnutrition in children <5 years of age

  baseline, 6, and 12-months post flooding.

• Prevalence of parasitemia in children

  1-, 3-, 6-, and 12-months post flooding.

Study Arms (3)

Control Arm: Provision of new Long-lasting Insecticidal Net (LLIN(s) the participant household

OTHER

Control Arm: Provision of new LLIN(s) to bring the household up to WHO "universal coverage" targets defined as one LLIN per every two household residents.

Other: Long-lasting Insecticidal Net

Dihydroartemisinin Piperaquine (DP)

ACTIVE COMPARATOR

LLIN + monthly DP for children ≤12 years of age In addition to receipt of LLIN(s) as described above, children ≥2 to ≤12 years of age will be screened for DP administration. If no contraindications are noted, weight-based DP will be administered by the parent/caregiver under the supervision of the study team. Participants will be observed for \~ 30 minutes. Any adverse events will be documented. Tablets for administration on Days 2 and 3 will be provided. Administration will be repeated at months 2 and 3 post-flooding.

Drug: Dihydroartemisinin piperaquine

Dihydroartemisinin Piperaquine(DP)+Bacillus thuringiensis israelensis(Bti)

ACTIVE COMPARATOR

LLIN + DP + Bti In addition to receipt of LLIN(s) and DP, study staff will provide the adult participant with an 8-oz packet of Bti, a pair of latex gloves, a teaspoon, and a tracking form. A staff member will then survey an area (50 m radius) around the house and demonstrate appropriate application in up to 5 potential breeding sites. Household members will be instructed to repeat application every 2 weeks for the 3 months post-flooding.

Combination Product: Dihydroartemisinin piperaquine + Bacillus thuringiensis israelensis

Interventions

Dihydroartemisinin piperaquine DRUG

Taken orally. 11 kg to less than 17 kg 1 tablet per day for 3 days 40 mg 320 mg 17 kg to less than 25 kg 1½ tablets per day for 3 days 60 mg 480 mg 25 kg to less than 36 kg 2 tablets per day for 3 days 80 mg 640 mg 36 kg to less than 60 kg 3 tablets per day for 3 days 120 mg 960 mg 60 kg to less than 80 kg 4 tablets per day for 3 days 160 mg 1280 mg 80 kg or more 5 tablets per day for 3 days 200 mg 1600 mg For patients weighing less than 11 kg, alternative formulations supplying lower amounts of active substance should be preferred

Also known as: Eurartesim

Dihydroartemisinin Piperaquine (DP)

Dihydroartemisinin piperaquine + Bacillus thuringiensis israelensis COMBINATION_PRODUCT

Study staff will provide adult participant with LLIN(s), DP and with an 8-oz packet of Bti, a pair of latex gloves, a teaspoon, and a tracking form. A staff member will then survey an area (50 m radius) around the house and demonstrate appropriate application in up to 5 potential breeding sites.

Dihydroartemisinin Piperaquine(DP)+Bacillus thuringiensis israelensis(Bti)

Long-lasting Insecticidal Net OTHER

Distribution of Long-lasting Insecticidal Net to all households on the study.

Also known as: bed nets

Control Arm: Provision of new Long-lasting Insecticidal Net (LLIN(s) the participant household

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent resident of flood-prone village in Kasese District with no plans to change residency in subsequent 12 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 (ICF). 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.

You may not qualify if:

• Temporary or part-time residence in study village
• Plans to move in the next 12 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.

Sponsors & Collaborators

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

Study Sites (1)

Mbarara University of Science and Technology (MUST)

Mbarara, PO Box 1410, Uganda

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Ross Boyce, MD, M.Sc.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is an open-label, cluster randomized controlled trial. randomized 1:1:1 within each stratum to either control (i.e., LLIN only) or one of the two intervention groups (DP or DP+Bti). Control - LLIN distribution Arm 1 - LLIN + monthly DP for children ≤12 years of age Arm 2 - LLIN + DP + Bti

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 11, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing through 36 months following publication
• Access Criteria: Requesting investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

UG (1)