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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
        • Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. Geographical location: households must be located within the designated clusters in the two districts involved in the trial.
  2. 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).
  3. Willingness to participate: households agreed to allow researchers to place mosquito traps and conduct larval and adult mosquito surveys.
  4. Socio-Environmental Data: households must agree and provide consent to participate to the socio-environmental questionnaire.

Exclusion Criteria:

  1. Outside of trial clusters: households located outside the designated clusters in the two districts were excluded.
  2. Refusal to participate: households that do not consent to mosquito trap placement or surveys
  3. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Non-intervened control arm: no community-based larval source management (LSM) or BG-GAT intervention
Experimental: Community-based larval source management
LSM intervention arm: Aedes larval source reduction carried out by trained and supervised local community members
Behavioral: Community-based larval source management
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.
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
Device: Enhanced Aedes adults trapping (BG-GAT)
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.
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
Combination product: Community-based larval source management with 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Time Frame: Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
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
Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
Adults: parity rate
Time Frame: Continuously during months 1-4 (baseline) and months 5-17 (trial)
The parity rate (PR) (proposition of parous females) will be calculated to estimate vector longevity.
Continuously during months 1-4 (baseline) and months 5-17 (trial)
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)
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."
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.
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.
Before (month 1) the start of the trial and at the end of the trial (month 12)
Container index
Time Frame: before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
Proportion of positive containers
before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
Breteau index
Time Frame: Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)
Number of positive containers per 100 houses
Before (month 1), twice during (month 4, 8) and once at the end of the trial (month 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Tropical & Public Health Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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