Improving Aedes control through community mobilization to reduce dengue incidence in Brazil: a cluster randomized controlled trial
Dengue infection
The present study will follow a pragmatic cluster RCT design with randomization at the census tract level with equal allocation to the two arms. There will be 34 clusters in each arm of 86 children aged between 2 to 12 years old for a total of 5,848 children enrolled in the study. Household visits will occur every six months for a total of six visits over a 3-year period to cover both dry and rainy seasons. At allocation, community mobilization activities will begin and locally customized activities will be implemented. Customized community activities will be developed during community meetings, lead by community members. There will be volunteers from the communities, who will serve as organizers and educators trained by facilitators from the research team. Inter-community visits will be organized to share experiences between communities and to strengthen the group dynamics and the collective preventive action. The control group will receive standard vector control in Fortaleza as determined by the Municipal Health Department of Fortaleza, which includes the application of temephos, an organophosphate larvicide, in all water storage containers during outbreaks as well as insecticide spraying inside households and of the surrounding environment. Baseline and follow-up findings will be presented individually during households visits and by cluster during community meetings to further engage households and community members. The duration of data collection is two years. Added 05/05/2026: Information for Site 2 The present study will follow a pragmatic cluster RCT design with randomization at the sub-ward (community) level. Following removal of 8 clusters from the allocation procedure due to risk of contamination, there will be 30 intervention clusters and 38 control clusters of 86 children aged between 2 to 12 years old, with for a total of 5,848 children enrolled in the study. Household visits will occur at baseline and endline, with both visits occuring at th
Current key inclusion criteria as of 05/05/2026: Site 1 (Fortaleza, Brazil): Eligibility will be evaluated on three levels: clusters, households, and individual. The inclusion criteria are: 1. Any of the 3,020 census tracts from the 2010 Census 2. Households permanently inhabited 3. Children aged 3 to 9 years Site 2 (Dhaka, Bangladesh): Eligibility will be evaluated on three levels: clusters, households, and individual. The cluster inclusion criteria are: areas of Dhaka city will be selected for inclusion in the study based on the research team’s assessment of research feasibility and an aim for balance in the number of clusters in slum and non-slum areas. Any households within the selected clusters will be eligible to participate in the study if they 1. Have at least one child between the ages of 2 and 12 years old, who has lived in the household for at least 6 months, and 2. There is a parent/guardian or other adult caregiver that can provide informed consent. _____ Previous key inclusion criteria: Site 1 (Fortaleza, Brazil): Eligibility will be evaluated on three levels: clusters, households, and individual. The inclusion criteria are: 1. Any of the 3,020 census tracts from the 2010 Census 2. Households permanently inhabited 3. Children aged 3 to 9 years Added 07/02/2025: Site 2 (Dhaka, Bangladesh): Eligibility will be evaluated on three levels: clusters, households, and individual. The cluster inclusion criteria are: for areas of Dhaka city will be selected for inclusion in the study based on recent data on dengue prevalence. Any households within the selected clusters will be eligible to participate in the study if they 1. Have at least one child between the ages of 2 and 12 years old, who has lived in the household for at least 6 months, and 2. There is a parent/guardian or other adult caregiver that can provide informed consent.
Current key exclusion criteria as of 05/05/2026: Site 1 (Fortaleza, Brazil): 1. Census tracts where interventions outside of vector control standard practices occurred within the last 5 years 2. Census tracts deemed to insecure for study personnel (determined based upon the opinion of the research team and stakeholders) 3. Clusters with less than 120 households 4. Abandoned or non-permanent households or households with the intention to move outside of the household during the study period 6. Children with chronic disease or other health condition that preclude participation in the study 7. Parents or guardians who are unable to give informed consent Site 2 (Dhaka, Bangladesh): Clusters will be excluded from the study if: 1. They contain fewer than 200 households as the research team's assessments suggested that 200 households are required to obtain the needed sample size. Households will be excluded from participating in the study if: 1. They intend to move outside of the cluster during the period of the study (2025-2027) 2. They do not have any children between the ages of 2 and 12 years old 3. The child has a chronic disease or other health condition that precludes participation in the study 4. There is not a parent/guardian or other adult caregiver that can provide informed consent. Additionally, households will be excluded from participating in the entomology assessment if there is no electricity in their home (electricity is required for the mosquito traps). There are no exclusion criteria for the qualitative components of the study. _____ Previous key exclusion criteria: Site 1 (Fortaleza, Brazil): 1. Census tracts where interventions outside of vector control standard practices occurred within the last 5 years 2. Census tracts deemed to insecure for study personnel (determined based upon the opinion of the research team and stakeholders) 3. Clusters with less than 120 households 4. Abandoned or non-permanent households or households with the intenti