NCT06981442

Brief Summary

Arboviral diseases are viral diseases transmitted by mosquitoes of the Aedes genus and are constantly spreading throughout the world, constituting a significant threat to public health. In Africa, there is very little data on the epidemiological situation of Aedes-borne diseases and programs for monitoring these diseases are very limited. In the Democratic Republic of the Congo (DRC), several epidemics of yellow fever, dengue fever, chikungunya and Zika cases have been reported. In particular, in Kinshasa, the dengue and chikungunya viruses have previously been detected in patients with undifferentiated fevers and several studies have shown entomological transmission indices above the criteria and standards of the World Health Organization (WHO). The aim of our study is to implement and evaluate different strategies to control Aedes mosquitoes at different stages of their life cycle in the city of Kinshasa. In particular, a before-and-after interventional study will be piloted and tested in the health zone of Kinshasa, with the aim of providing preliminary evidence of the impact of vector control tools. Interventions will be implemented in 400 households for each arm for 12 months. Before, after and during the interventions, entomological surveys will be conducted in 160 households in each arm to define the density of the vectors. Mosquitoes will be tested for the possible presence of arbovirus RNA (dengue, chikungunya, Zika, yellow fever). During the pre-intervention period, a serological survey for the same diseases transmitted by the Aedes mosquito will be conducted on a sample of 450 people included in two health centers of reference for the health zone of Mont Ngafula 1. A questionnaire will also be administered before and after the intervention implementation to assess the community's knowledge, attitudes and practices towards Aedes mosquito vector control and Aedes-borne diseases. The integration of the data collected within the scope of this study will provide an assessment of the feasibility and impact of the tested methods on entomological indicators, as well as determining the exposure and knowledge of Aedes-borne diseases in the Mont Ngafula 1 area.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,050

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 26, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

April 8, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

Vector controlAedes mosquitoesDemocratic Republic of the Congo

Outcome Measures

Primary Outcomes (3)

  • Adult mosquito collection - Entomological Indicator

    Adult mosquitoes will be collected outdoor using Prokopack mosquito aspirator in 50 households at the center of each of the 4 study arms and using BG-Sentinel traps in 10 households at the center of each of the 4 study arms. Adult mosquitoes obtained through BG-GAT traps in Arm 3 will also be collected.

    Six collections in total: 1 at baseline, 4 during the intervention (one per trimester), 1 three months after completion of the intervention.

  • Mosquito larval survey - Entomological Indicator

    Larval surveys will be carried out in 100 households at the center of each of the 4 study arms. Immature mosquitoes obtained through the auto-dissemination stations in Arm 2 will also be collected.

    Six collections in total: 1 at baseline, 4 during the intervention (one per trimester), 1 three months after completion of the intervention.

  • Epidemiological indicator

    A sero-survey prospectively including 450 consenting subjects will be carried out in two hospitals in the health zone of Mont Ngafula 1, Kinshasa. The blood sample will be tested for antibodies against the main arboviruses (Yellow Fever, Dengue, Chikungunya, Zika). De-identified socio-demographic data will be collected.

    Once : before/at beginning of intervention

Secondary Outcomes (1)

  • Knowledge, attitudes, and practices.

    Twice in total: at the beginning of the study and three months after completion of the intervention.

Study Arms (4)

ARM 1_Community-based environmental management

EXPERIMENTAL

This intervention will be carried out by the community, who will have received training and information on the environmental management measures suitable for controlling the Aedes mosquito. It will involve a cluster of 400 households randomly assigned to this intervention.

Behavioral: Community-based environmental management

ARM 2_Community-based environmental management AND vector control against immature stages of Aedes

EXPERIMENTAL

This intervention combines community-based environmental management (specified in the first study arm) with vector control against immature stages of Aedes. It will involve a cluster of 400 households randomly assigned to this intervention.

Behavioral: Community-based environmental managementOther: Vector control against immature stages of Aedes

ARM 3_Community-based environmental management AND vector control against mature stages of Aedes

EXPERIMENTAL

This intervention combines community-based environmental management (specified in the first arm of the study) with vector control against the mature stages of Aedes. It will involve a cluster of 400 households randomly assigned to this intervention.

Behavioral: Community-based environmental managementOther: Vector control against the mature stages of Aedes

ARM 4_Control arm

NO INTERVENTION

No control interventions will be implemented. It will involve a cluster of 400 households randomly assigned to this arm.

Interventions

This intervention will be performed by the local community, who will have been previously informed and trained on the appropriate environmental management methods for the control of the Aedes mosquito. It will be based on the following elements: i) identification and removal of all artificial sources of reproduction of the Aedes mosquito inside and around the house (i.e. covering abandoned containers and/or storage containers to avoid water accumulation); ii) regular collection and disposal of household waste; iii) identification and resolution of all artificial sources of reproduction of the Aedes vector in or around the house (i.e. natural cavities such as tree holes will be filled to prevent water accumulation). This intervention will be carried out as a single intervention in Arm 1, in combination with a larvicidal intervention in Arm 2 and in combination with the intervention against the adult stage of the Aedes mosquito in Arm 3.

ARM 1_Community-based environmental managementARM 2_Community-based environmental management AND vector control against immature stages of AedesARM 3_Community-based environmental management AND vector control against mature stages of Aedes

Larvicidal control will be carried out through pyriproxifen-based autodissemination stations combined with Beauveria bassiana, implemented according to the manufacturer's recommended procedures.

ARM 2_Community-based environmental management AND vector control against immature stages of Aedes

The control of the adult Aedes mosquitoes will be carried out through mass trapping using BG-GAT traps implemented according to the manufacturer's recommended procedures. In each household, three traps will be deployed.

ARM 3_Community-based environmental management AND vector control against mature stages of Aedes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Belong to a household in one of the 4 health areas selected as study arms
  • From 18 years of age to consent for household enrollment and participation in the serosurvey
  • Consenting

You may not qualify if:

  • Not belong to a household in one of the 4 health areas selected as study arms
  • Under 18 years of age
  • Non-consenting
  • At health facility level:
  • From 18 years of age
  • Resident of the health zone of Mont Ngafula 1
  • Consenting
  • Under 18 years of age
  • Not resident in the health zone of Mont Ngafula 1
  • Seriously ill and hospitalized, requiring transfusion, presence of blood clotting disorders, allergies resulting from injections, adverse events associated with previous blood sampling, pregnancy
  • Non-consenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut National de Recherche Biomédicale, INRB

Kinshasa, République Démocratique Du Congo, Democratic Republic of the Congo

RECRUITING

Related Publications (5)

  • Mbanzulu KM, Wumba R, Mukendi JK, Zanga JK, Shija F, Bobanga TL, Aloni MN, Misinzo G. Mosquito-borne viruses circulating in Kinshasa, Democratic Republic of the Congo. Int J Infect Dis. 2017 Apr;57:32-37. doi: 10.1016/j.ijid.2017.01.016. Epub 2017 Jan 30.

    PMID: 28153792BACKGROUND
  • Proesmans S, Katshongo F, Milambu J, Fungula B, Muhindo Mavoko H, Ahuka-Mundeke S, Inocencio da Luz R, Van Esbroeck M, Arien KK, Cnops L, De Smet B, Lutumba P, Van Geertruyden JP, Vanlerberghe V. Dengue and chikungunya among outpatients with acute undifferentiated fever in Kinshasa, Democratic Republic of Congo: A cross-sectional study. PLoS Negl Trop Dis. 2019 Sep 5;13(9):e0007047. doi: 10.1371/journal.pntd.0007047. eCollection 2019 Sep.

    PMID: 31487279BACKGROUND
  • Selhorst P, Makiala-Mandanda S, De Smet B, Marien J, Anthony C, Binene-Mbuka G, De Weggheleire A, Ilombe G, Kinganda-Lusamaki E, Pukuta-Simbu E, Lubula L, Mbala-Kingebeni P, Nkuba-Ndaye A, Vogt F, Watsenga F, Van Bortel W, Vanlerberghe V, Arien KK, Ahuka-Mundeke S. Molecular characterization of chikungunya virus during the 2019 outbreak in the Democratic Republic of the Congo. Emerg Microbes Infect. 2020 Dec;9(1):1912-1918. doi: 10.1080/22221751.2020.1810135.

    PMID: 32787529BACKGROUND
  • Willcox AC, Collins MH, Jadi R, Keeler C, Parr JB, Mumba D, Kashamuka M, Tshefu A, de Silva AM, Meshnick SR. Seroepidemiology of Dengue, Zika, and Yellow Fever Viruses among Children in the Democratic Republic of the Congo. Am J Trop Med Hyg. 2018 Sep;99(3):756-763. doi: 10.4269/ajtmh.18-0156. Epub 2018 Jul 5.

    PMID: 29988000BACKGROUND
  • Weetman D, Kamgang B, Badolo A, Moyes CL, Shearer FM, Coulibaly M, Pinto J, Lambrechts L, McCall PJ. Aedes Mosquitoes and Aedes-Borne Arboviruses in Africa: Current and Future Threats. Int J Environ Res Public Health. 2018 Jan 28;15(2):220. doi: 10.3390/ijerph15020220.

    PMID: 29382107BACKGROUND

MeSH Terms

Conditions

Mosquito-Borne Diseases

Condition Hierarchy (Ancestors)

Vector Borne DiseasesInfections

Study Officials

  • Veerle Vanlerberghe

    Institute of Tropical Medicine Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Lepore

CONTACT

Wim Van Bortel

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

May 20, 2025

Study Start

March 26, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations