Dengue infection Infections and Infestations Dengue
Conditions
Interventions
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 ag
Sponsors
Université de Montréal
Universidade Estadual do Ceara
Institut de Recherche pour le Développement
Secretaria Municipal de Saúde de Fortaleza
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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 Added 07/02/2025: Site 2 (Dhaka, Bangladesh): Clusters will be excluded from the study if: 1. They experienced interventions outside of standard vector control practices within the last two years 2. They contain less than 62 households as our formative study suggested that 62-70 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 (2024-2027) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 07/02/2025: Measured twice over a 2-year period: 1. Rates of anti-dengue Immunoglobin G (IgG) seroconversion (from negative to positive at follow-up) to evaluate the incidence of primary infections, measured using enzyme-linked immunoabsorbent assays (ELISA) 2. Adult female mosquitoes per person (number found per 100 households examined) to evaluate the mosquitoes' density/presence, measured by visual inspection Previous primary outcome measures: Measured every 6 months over a 3-year period: 1. Rates of anti-dengue Immunoglobin G (IgG) seroconversion (from negative to positive at follow-up) to evaluate the incidence of primary infections, measured using enzyme-linked immunoabsorbent assays (ELISA) 2. Level of IgG to N-term-34kDa salivary peptide in blood (salivary biomarkers of Aedes exposure), measured using ELISA 3. Pupae per person (number of pupae found per 100 households examined) to evaluate the mosquitoes' density/presence, measured by visual inspection | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/02/2025: Measured twice over a 2-year period: 1. Anti-dengue IgG antibodies waning rates (from positive at baseline to negative at follow-up), measured using ELISA 2. Additional entomological indexes, based upon visual inspection 3. Self-reported health status and previous fever events, measured using a standardized questionnaire 4. Knowledge, attitudes and practices (KAP) changes, measured from questionnaires 5. Household social capital, measured from questionnaires 6. Social acceptability of activities, measured from focus groups and in-depth interviews 7. Implementation and adaptability processes, measured from focus groups and in-depth interviews 8. Potential for sustainability (intervention), measured from focus groups, in-depth interviews, and document analysis 9. Empowerment of individual and communities, measured from focus groups and in-depth interviews Sub study secondary outcome measures (added 05/05/2026): 1. The seroprevalence of Zika and chikungunya virus (IgG tested via ELISA) among a subsample (about 10%) of participating children at baseline. _____ Previous secondary outcome measures: Measured every 6 months over a 3-year period: 1. Anti-dengue IgG antibodies waning rates (from positive at baseline to negative at follow-up), measured using ELISA 2. Additional entomological indexes, based upon visual inspection 3. Self-reported health status and previous fever events, measured using a standardized questionnaire 4. Knowledge, attitudes and practices (KAP) changes, measured from focus groups and in-depth interviews 5. Household social capital, measured from focus groups and in-depth interviews 6. Social acceptability of activities, measured from focus groups and in-depth interviews 7. Implementation and adaptability processes, measured from focus groups and in-depth interviews 8. Potential for sustainability (intervention), measured from focus groups, in-depth interviews, and document analysis 9. Empower | — |
Countries
Bangladesh, Brazil
Outcome results
None listed