NCT06648603

Brief Summary

This project focuses on addressing arboviral outbreaks in Ivory Coast by involving local communities in the sustainable control of Aedes mosquitoes, utilizing scientific advice and environmental interventions. It will evaluate the impact of a participatory strategy on decreasing mosquito populations and the risk of virus transmission, aiming to provide insights for policy development on disease prevention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 15, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
Last Updated

October 22, 2024

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

July 1, 2024

Last Update Submit

October 21, 2024

Conditions

Keywords

Aedes AegyptiVector controlCommunity based interventionParticipatory researchDengueAfricaIvory Coast

Outcome Measures

Primary Outcomes (1)

  • Aedes aegypti mean number per trap per day

    Biting rate is the mean number of Aedes females per trap and per day. The proportion of unfed, fed, half-gravid and gravid females will be estimated.

    Continuously during months 1-4 (baseline) and months 5-17 (trial)

Secondary Outcomes (7)

  • House index

    Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)

  • Pupal indices: pupae per person index, pupa index and pupae per hectare index

    Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)

  • Adults: parity rate

    Continuously during months 1-4 (baseline) and months 5-17 (trial)

  • Knowledge, attitudes, and practices on Dengue prevention among the population of Cocody-Bingerville

    Before (month 1) the start of the trial and at the end of the trial (month 12)

  • Mapping and describe Aedes aegypti breeding sites, focusing on their geographic and ecological characteristics. This mapping will be used to enhance targeted larval control efforts in these areas.

    Before (month 1) the start of the trial and at the end of the trial (month 12)

  • +2 more secondary outcomes

Study Arms (4)

Control

NO INTERVENTION

Non-intervened control arm: no community-based larval source management (LSM) or BG-GAT intervention

Community-based larval source management

EXPERIMENTAL

LSM intervention arm: Aedes larval source reduction carried out by trained and supervised local community members

Behavioral: Community-based larval source management

Enhanced Aedes adults trapping (BG-GAT)

EXPERIMENTAL

BG-GAT intervention arm: Aedes adult mass trapping by BG-GAT set up and maintained by trained and supervised local community members

Device: Enhanced Aedes adults trapping (BG-GAT)

Community-based larval source management + Enhanced Aedes adults trapping (BG-GAT)

EXPERIMENTAL

Combined LSM and BG-GAT intervention arm: simultaneous Aedes larval source reduction and Aedes adult mass trapping by BG-GAT carried out by trained and supervised local community members

Combination Product: Community-based larval source management with Enhanced Aedes adults trapping (BG-GAT)

Interventions

This project will foster active engagement with community stakeholders, including healthcare workers, community leaders, and other key informants, through participatory meetings aimed at co-creating and developing larval source reduction measures tailored to community's needs. This method emphasizes a participatory framework, ensuring that interventions are both community-informed and culturally relevant.

Community-based larval source management

Furthermore, the project intends to determine whether the addition of cost-effective, gravid female mosquito-targeting traps, specifically two Biogents Gravid Aedes Traps (BG-GAT) per household, can improve the overall success of these community-based intervention.

Enhanced Aedes adults trapping (BG-GAT)

The community-based interventions and the BG-GAT deployment will be evaluated in combination to assess their individual and synergistic effects on vector control. This dual strategy combines local participation and practical, evidence-based solutions to address mosquito-borne illness transmission.

Community-based larval source management + Enhanced Aedes adults trapping (BG-GAT)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Geographical location: households must be located within the designated clusters in the two districts involved in the trial.
  • Participation in cluster arms: households must belong to a cluster that is assigned to one of the four arms (1. Control, 2. Community-based larval source management, 3 Enhanced Aedes adults trapping (BG-GAT), 4. Enhanced Aedes adults trapping (BG-GAT) + Community-based larval source management).
  • Willingness to participate: households agreed to allow researchers to place mosquito traps and conduct larval and adult mosquito surveys.
  • Socio-Environmental Data: households must agree and provide consent to participate to the socio-environmental questionnaire.

You may not qualify if:

  • Outside of trial clusters: households located outside the designated clusters in the two districts were excluded.
  • Refusal to participate: households that do not consent to mosquito trap placement or surveys
  • Inaccessibility: households that are not accessible for regular visits or data collection (e.g., due to relocation or difficult terrain).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Suisse de Recherches Scientifiques en Côte d'Ivoire

Abidjan, Côte d’Ivoire

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Pie Müller, PD, PhD

    Swiss Tropical & Public Health Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statistician unaware of the arms allocation
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Cluster randomized trial with 2x2 factorial design - 40 clusters, 10 clusters per study arm (4 arms)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

October 18, 2024

Study Start

July 15, 2023

Primary Completion

July 31, 2024

Study Completion

September 30, 2024

Last Updated

October 22, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations