Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote d'Ivoire
1 other identifier
interventional
1,650
1 country
1
Brief Summary
The investigator plan to conduct a three-arm cluster-randomized control trial which compares two next generation of long-lasting Insecticidal Nets (LLINs); Veeralin®LLIN (PBO-py LLIN), Interceptor G2 (chlorfenapyr-py LLIN) to a standard py-LLIN in the department of Tiebissou Southern Bouake city, central Côte d'Ivoire. The primary objective of the project is to evaluate the efficacy of chlorfenapyr-pyrethroid and piperonyl-butoxide (PBO) synergist-pyrethroid LLINs on malaria case incidence in children aged 6 months to 10 years compared to standard pyrethroid-only LLINs. The secondary objectives are to evaluate the efficacy of the two intervention LLINs compared to the standard LLIN on a) malaria infection prevalence in the general population (both children and adults), b) vector density and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, changes in phenotypic resistance intensity and selection for molecular resistance mechanisms at baseline and 12 months post-LLIN distribution, in sentinel villages in each treatment arm will be investigate. It is vital to demonstrate that these next generation LLINs which are becoming the standard of care in Sub Saharan AFRICA, are superior to standard py-LLIN in the most extreme resistance areas as this is likely where alternative interventions will be most needed to keep malaria control on track. The trial will generate the first epidemiological evidence on the efficacy of PBO nets compared to py-LLIN in West Africa. UPDATE: Following 1 year of follow-up, the trial was extended to assess the impact of the nets over a 3 year follow-up. In addition, we introduced school-based net top ups in half of the clusters- to evaluate the impact of top-up strategies on net ownership, access and usage and malaria outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
March 19, 2026
March 1, 2026
3.4 years
February 27, 2023
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
malaria case incidence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Incidence of malaria cases (fever above 37.5C or history of a fever in the last 48 hours and a positive RDT) in children aged 6 months to 10 years.
Over one year follow up (UPDATE: over 3 years)
Secondary Outcomes (10)
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
Baseline
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
6 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
12 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
18 months post intervention
Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]
24 months post intervention
- +5 more secondary outcomes
Other Outcomes (13)
gSG6-P1 IgG seroprevalence using ELISA technique
baseline
gSG6-P1 IgG seroprevalence using ELISA technique
12 months post intervention
30 minutes mortality in wild Anopheles post exposure to various concentration insecticide in CDC bottle assay
Baseline
- +10 more other outcomes
Study Arms (6)
Py-PBO LLIN
EXPERIMENTALVeeralin is a long-lasting net of 130 deniers containing the pyrethroid insecticide alpha-cypermethrin 6.0 g/kg (216 mg/m2) and the synergist piperonyl butoxide (PBO) 2.2 g/kg (79.2 mg/m2) and manufactured by VKA polymers.
Py-CFP LLIN
EXPERIMENTALInterceptor® G2 is a long-lasting dual insecticide treated nets of 100 deniers combining Alpha-cypermethrin 2.4 g/kg (100 mg/m2) and Chlorfenapyr 4.8 g/kg (200 mg/m2) manufactured by BASF
Py LLIN
ACTIVE COMPARATORMAGNet® is a long-lasting net of 150 deniers containing the pyrethroid insecticide alpha-cypermethrin 5.8 g/kg (261 mg/m2) only and manufactured by VKA polymers.
Py-PBO LLIN with school-based top ups in years 2 and 3
EXPERIMENTALOur original arms from year 1 were split to either receive top ups or not
Py-CFP LLIN with school-based top ups in years 2 and 3
EXPERIMENTALOur original arms from year 1 were split to either receive top ups or not
Py LLIN with school-based top ups in years 2 and 3
EXPERIMENTALOur original arms from year 1 were split to either receive top ups or not
Interventions
Veeralin Long lasting insecticidal net with Alpha-cypermethrin Pyrethroid insecticide and PBO
Interceptor G2 dual active ingredient LLIN with with Alpha-cypermethrin Pyrethroid insecticide and Clorfenapyr
reference: standard pyrethroid LLIN
Nets (of the same type in the original arms) will be distributed via schools in years 2 and 3
Eligibility Criteria
You may qualify if:
- For adults: willing to participate and provide consent
- For children: Having a parents/adult caregiver willing to provide written consent for the household and clinical survey and assent for children over 10
- Residing in the village over the last 3 months
- Be aged 6 months to 9 years old at time of recruitment (for the cohort)
You may not qualify if:
- Children who are expected to be non-resident over the period of study will be excluded (for the cohort)
- Dwelling not found or vacant during the survey (for prevalence and entomological surveys)
- No adult caregiver capable to give informed consent (All activities)
- Habitants/selected participants severely ill
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Institut Pierre Richetcollaborator
- University of Ottawacollaborator
- University of Nevada, Las Vegascollaborator
- Swiss Tropical & Public Health Institutecollaborator
Study Sites (1)
Institut Pierre Richet
Bouaké, Côte d’Ivoire
Related Publications (1)
Sih C, Protopopoff N, Koffi AA, Ahoua Alou LP, Dangbenon E, Messenger LA, Kulkarni MA, Zoh MG, Camara S, Assi SB, N'Guessan R, Cook J. Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in Cote d'Ivoire: a three group, cluster randomised trial. Trials. 2024 Feb 28;25(1):151. doi: 10.1186/s13063-024-07969-2.
PMID: 38419075DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2023
First Posted
April 3, 2023
Study Start
October 2, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP