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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03074435




Registration number
NCT03074435
Ethics application status
Date submitted
4/11/2016
Date registered
8/03/2017

Titles & IDs
Public title
Insecticide Resistance Management in Burkina Faso and Côte D'Ivoire
Scientific title
Insecticide Resistance Management in Burkina Faso and Côte D'Ivoire: Research on Vector Control Strategies
Secondary ID [1] 0 0
15SANIN213
Secondary ID [2] 0 0
InstitutRD
Universal Trial Number (UTN)
Trial acronym
REACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Indoor residual sprayings
Treatment: Devices - Larvicide

No intervention: Control arm (LLIN-alone) - 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)

Experimental: LLIN + indoor residual sprayings - 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)

Experimental: LLIN + Larvicide - 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.

Experimental: LLIN+ One-health Ivermectin - 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.

Experimental: LLIN + Behaviour Change Communication - 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.


Treatment: Devices: Indoor residual sprayings
Houses will be spayed with this formulation containing Pyrimiphos methyl.

Treatment: Devices: Larvicide
Larval breeding sites will be treated with larvicide
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Malaria incidence density
Timepoint [1] 0 0
continuous monitoring during 2 years
Secondary outcome [1] 0 0
Entomological Inoculation Rate
Timepoint [1] 0 0
Every 8 weeks during 2 years
Secondary outcome [2] 0 0
Malaria prevalence
Timepoint [2] 0 0
Every 4 months during 2 years

Eligibility
Key inclusion criteria
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.
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
Accrual to date
Final
15776
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Burkina Faso
State/province [1] 0 0
Bobo-Dioulasso
Country [2] 0 0
Côte D'Ivoire
State/province [2] 0 0
Bouaké

Funding & Sponsors
Primary sponsor type
Government body
Name
Institut de Recherche pour le Developpement
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Institut de Recherche en Sciences de la Sante, Burkina Faso
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Institut Pierre Richet
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cédric Pennetier, PhD
Address 0 0
Institut de Rehcerche pour le Développement
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03074435