NCT03074435

Brief Summary

This study evaluates the benefit to use 1) insecticide residual sprayings, 2) larvicides, 3) Ivermectin for domestic animals and 4) behaviour change communication strategy to complement the universal coverage with LLINs through a cluster randomized trial.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,776

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2016

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

November 4, 2016

Last Update Submit

September 30, 2024

Conditions

Malaria

Keywords

Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

  • Malaria incidence density

    Malaria cases (whole population, every ages) registered in the local health system.

    continuous monitoring during 2 years

Secondary Outcomes (2)

  • Entomological Inoculation Rate

    Every 8 weeks during 2 years

  • Malaria prevalence

    Every 4 months during 2 years

Study Arms (5)

Control arm (LLIN-alone)

NO INTERVENTION

The baseline and control intervention (LLIN-alone) correspond to what is implemented in each country by their respective National Malaria Control Programs (NMCP). This include universal coverage with Long-Lasting insecticidal Nets (LLIN). This arm is common to both countries (Burkina Faso and Côte d'Ivoire)

LLIN + indoor residual sprayings

EXPERIMENTAL

LLIN+IRS arm consisted in applying, in addition to LLINs, IRS with Actellic® 300CS (Syngenta AG, Basel, Switzerland) at a target dosage of 1 g. of active ingredient (pirimiphos-methyl) per m² in every houses of the selected villages. This arm is common to both countries (Burkina Faso and Côte d'Ivoire)

Device: Indoor residual sprayings

LLIN + Larvicide

EXPERIMENTAL

The intervention consists in treating Anopheles breeding sites with BTI biological larvicide, in addition to LLINs. This arm was implemented in Côte d'Ivoire only.

Device: Larvicide

LLIN+ One-health Ivermectin

EXPERIMENTAL

This arm consists in monthly injections of ivermectin to peri-domestic farm animals (mammals) during 4 consecutive months, oin addition to LLINs. This arm was implemented in Burkina Faso only.

Biological: Ivermectin

LLIN + Behaviour Change Communication

EXPERIMENTAL

BCC complementary intervention (LLIN+BCC arm) was designed to target the following behaviors in the human population: (i) everyone sleep under an LLIN every night, (ii) every household and community member cleans up its environment to limits mosquito proliferation, (iii) every pregnant woman asks for, and takes the intermittent preventive treatment of malaria during pregnancy (ITP) and, (iv) people in charge of \<5 y/o children come to see an health worker within 24h in case of fever. The intervention involve one health worker from the community per 35 households. Every health worker has the objective to perform 15 home visits (15-20 min), 20 interpersonal talks (15-20 min) and 4 group talks (15-30 min) per months.

Behavioral: BCC

Interventions

Indoor residual sprayingsDEVICE

Houses will be spayed with this formulation containing Pyrimiphos methyl.

Also known as: Actellic
LLIN + indoor residual sprayings
LarvicideDEVICE

Larval breeding sites will be treated with larvicide

LLIN + Larvicide
BCCBEHAVIORAL
LLIN + Behaviour Change Communication
IvermectinBIOLOGICAL
LLIN+ One-health Ivermectin

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
For Cross-sectional surveys only, maximum age for participating in the study was 21 y/o in Côte d Ivoire and 18 y/o in Burkina Faso.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Institut de Recherche en Sciences de la Santé

Bobo-Dioulasso, Burkina Faso

Location

Institut Pierre Richet

Bouaké, Côte d’Ivoire

Location

Related Publications (9)

  • Bationo CS, Gaudart J, Dieng S, Cissoko M, Taconet P, Ouedraogo B, Some A, Zongo I, Soma DD, Tougri G, Dabire RK, Koffi A, Pennetier C, Moiroux N. Spatio-temporal analysis and prediction of malaria cases using remote sensing meteorological data in Diebougou health district, Burkina Faso, 2016-2017. Sci Rep. 2021 Oct 8;11(1):20027. doi: 10.1038/s41598-021-99457-9.

    PMID: 34625589BACKGROUND

  • Taconet P, Porciani A, Soma DD, Mouline K, Simard F, Koffi AA, Pennetier C, Dabire RK, Mangeas M, Moiroux N. Data-driven and interpretable machine-learning modeling to explore the fine-scale environmental determinants of malaria vectors biting rates in rural Burkina Faso. Parasit Vectors. 2021 Jun 29;14(1):345. doi: 10.1186/s13071-021-04851-x.

    PMID: 34187546BACKGROUND

  • Soma DD, Zogo B, Taconet P, Some A, Coulibaly S, Baba-Moussa L, Ouedraogo GA, Koffi A, Pennetier C, Dabire KR, Moiroux N. Quantifying and characterizing hourly human exposure to malaria vectors bites to address residual malaria transmission during dry and rainy seasons in rural Southwest Burkina Faso. BMC Public Health. 2021 Jan 30;21(1):251. doi: 10.1186/s12889-021-10304-y.

    PMID: 33516197BACKGROUND

  • Soma DD, Zogo B, Hien DFS, Hien AS, Kabore DA, Kientega M, Ouedraogo AG, Pennetier C, Koffi AA, Moiroux N, Dabire RK. Insecticide resistance status of malaria vectors Anopheles gambiae (s.l.) of southwest Burkina Faso and residual efficacy of indoor residual spraying with microencapsulated pirimiphos-methyl insecticide. Parasit Vectors. 2021 Jan 18;14(1):58. doi: 10.1186/s13071-020-04563-8.

    PMID: 33461621BACKGROUND

  • Soma DD, Zogo BM, Some A, Tchiekoi BN, Hien DFS, Pooda HS, Coulibaly S, Gnambani JE, Ouari A, Mouline K, Dahounto A, Ouedraogo GA, Fournet F, Koffi AA, Pennetier C, Moiroux N, Dabire RK. Anopheles bionomics, insecticide resistance and malaria transmission in southwest Burkina Faso: A pre-intervention study. PLoS One. 2020 Aug 3;15(8):e0236920. doi: 10.1371/journal.pone.0236920. eCollection 2020.

    PMID: 32745085BACKGROUND

  • Zogo B, Soma DD, Tchiekoi BN, Some A, Ahoua Alou LP, Koffi AA, Fournet F, Dahounto A, Coulibaly B, Kande S, Dabire RK, Baba-Moussa L, Moiroux N, Pennetier C. Anopheles bionomics, insecticide resistance mechanisms, and malaria transmission in the Korhogo area, northern Cote d'Ivoire: a pre-intervention study. Parasite. 2019;26:40. doi: 10.1051/parasite/2019040. Epub 2019 Jul 12.

    PMID: 31298995BACKGROUND

  • Zogo B, Koffi AA, Alou LPA, Fournet F, Dahounto A, Dabire RK, Baba-Moussa L, Moiroux N, Pennetier C. Identification and characterization of Anopheles spp. breeding habitats in the Korhogo area in northern Cote d'Ivoire: a study prior to a Bti-based larviciding intervention. Parasit Vectors. 2019 Mar 27;12(1):146. doi: 10.1186/s13071-019-3404-0.

    PMID: 30917867BACKGROUND

  • Zogo B, Tchiekoi BN, Koffi AA, Dahounto A, Ahoua Alou LP, Dabire RK, Baba-Moussa L, Moiroux N, Pennetier C. Impact of sunlight exposure on the residual efficacy of biolarvicides Bacillus thuringiensis israelensis and Bacillus sphaericus against the main malaria vector, Anopheles gambiae. Malar J. 2019 Feb 26;18(1):55. doi: 10.1186/s12936-019-2687-0.

    PMID: 30808348BACKGROUND

  • Moiroux N, Zongo I, Assi SB, Some A, Tchiekoi NB, Zogo B, Soma DD, Hien DFDS, Taconet P, Ahoua Alou LP, Lefevre T, Cohuet A, Fournet F, Mouline K, Koffi AA, Dabire RK, Pennetier C. Efficacy of non-pyrethroid indoor residual spraying or intensive behaviour change communication in combination with long-lasting insecticidal nets for malaria control in west Africa: a pragmatic, cluster-randomised, controlled trial. Lancet Glob Health. 2025 Sep;13(9):e1605-e1616. doi: 10.1016/S2214-109X(25)00216-5.

    PMID: 40845886DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Cédric Pennetier, PhD

    Institut de Rehcerche pour le Développement

    PRINCIPAL INVESTIGATOR

  • Nicolas Moiroux, PhD

    Institut de Recherche pour le Developpement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a cluster-randomized, parallel with baseline, trial. The study is bi-centric for the evaluation of two arms (LLIN+IRS and LLIN+BCC)
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2016

First Posted

March 8, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 1, 2024

Record last verified: 2024-09

Locations

BU(1)CÔ(1)