- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06648603
Citizen Action for Sustainable Dengue Control in Sub-Saharan Africa
October 21, 2024 updated by: Swiss Tropical & Public Health Institute
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This project targets the growing threat of Aedes mosquito-borne diseases such as dengue in Africa, focusing on the Anono and Gbagba communities in Abidjan, Ivory Coast, by transitioning from traditional control approaches to a community-driven strategy.
It focuses on educating and involving communities in the design of sustainable mosquito management measures, such as breeding site eradication and adult mosquito capturing, with scientific experts guiding the efforts.
The approach will entail conducting sociocultural surveys and interactive workshops while also encouraging local participation and multi-sectoral collaboration.
A randomized controlled trial (RCT) will test this effectiveness of this novel integrated community-based participatory intervention approach in reducing the transmission of Aedes mosquito and other arboviruses.
This effort seeks to develop a scalable model for arboviral disease control, promote community resilience, and inform policy recommendations for better public health outcomes in resource-constrained urban settings.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Abidjan, Côte D'Ivoire
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Non-intervened control arm: no community-based larval source management (LSM) or BG-GAT intervention
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Experimental: Community-based larval source management
LSM intervention arm: Aedes larval source reduction carried out by trained and supervised local community members
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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.
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Experimental: Enhanced Aedes adults trapping (BG-GAT)
BG-GAT intervention arm: Aedes adult mass trapping by BG-GAT set up and maintained by trained and supervised local community members
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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.
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Experimental: Community-based larval source management + Enhanced Aedes adults trapping (BG-GAT)
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
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aedes aegypti mean number per trap per day
Time Frame: Continuously during months 1-4 (baseline) and months 5-17 (trial)
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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.
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Continuously during months 1-4 (baseline) and months 5-17 (trial)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
House index
Time Frame: Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
|
House index: proportion of houses with at least one larva
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Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
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|
Pupal indices: pupae per person index, pupa index and pupae per hectare index
Time Frame: Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
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Pupae per person index: number of pupae per person Pupa index: number of pupae per house Pupae per hectare index: number of pupae per ha
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Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
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Adults: parity rate
Time Frame: Continuously during months 1-4 (baseline) and months 5-17 (trial)
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The parity rate (PR) (proposition of parous females) will be calculated to estimate vector longevity.
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Continuously during months 1-4 (baseline) and months 5-17 (trial)
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Knowledge, attitudes, and practices on Dengue prevention among the population of Cocody-Bingerville
Time Frame: Before (month 1) the start of the trial and at the end of the trial (month 12)
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A Knowledge, Attitudes, and Practices (KAP) study will be conducted to assess the communities' understanding, attitudes, practices, and beliefs related to dengue.
This will be done using a structured questionnaire developed specifically for this trial.
The questionnaire comprises both multiple-choice and open-ended questions, allowing for a comprehensive assessment of: 1) Knowledge: Understanding of dengue transmission, symptoms, and prevention, 2) Attitudes: Perceptions of dengue risk and confidence in prevention methods, 3) Practices: Reported behaviors to prevent dengue, such as mosquito control measures.
This structured tool will be used at both baseline and endline to measure changes and assess the effectiveness of the intervention."
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Before (month 1) the start of the trial and at the end of the trial (month 12)
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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.
Time Frame: Before (month 1) the start of the trial and at the end of the trial (month 12)
|
The geographic survey will collect household and environmental data, including demographic details, public space quality, water provision, sanitation access, and waste management practices.
It will map housing conditions, examining building types, construction materials, and key features like water storage and solid waste management.
The survey will also assess local built environments to inform interventions for improving living conditions and controlling mosquito breeding sites.
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Before (month 1) the start of the trial and at the end of the trial (month 12)
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Container index
Time Frame: before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
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Proportion of positive containers
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before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
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Breteau index
Time Frame: Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
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Number of positive containers per 100 houses
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Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pie Müller, PD, PhD, Swiss Tropical & Public Health Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2023
Primary Completion (Actual)
July 31, 2024
Study Completion (Actual)
September 30, 2024
Study Registration Dates
First Submitted
July 1, 2024
First Submitted That Met QC Criteria
October 16, 2024
First Posted (Actual)
October 18, 2024
Study Record Updates
Last Update Posted (Actual)
October 22, 2024
Last Update Submitted That Met QC Criteria
October 21, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C21047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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