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Study protocol
COESA - Sustainable, healthy cities: Protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach
Kate Zinszer
Universite de Montreal
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1388-1145
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Dengue is increasing in its global presence with an estimated 4 billion people at-risk of infection in at least 128 countries. Despite the promising results of EcoHealth and community mobilization approaches to Aedes reduction, more evidence of their efficacy on reducing dengue risk is needed. The principal research question is to determine if interventions based upon community mobilization reduce the risk of dengue virus infection among children 3 to 9 years old compared to usual dengue control practice in Fortaleza, Brazil. Methods: The present study will follow a pragmatic cluster randomized controlled trial (cRCT) design with randomization at the census tract level with equal allocation to the two arms. In each arm, there will be 34 clusters of 86 children between 3 to 9 years old for an expected total of 5,848 children enrolled in the study, assuming a risk reduction of 29.5% based upon findings from a previous multi-site cRCT. The primary outcomes are rates of anti-dengue Immunoglobulin G (IgG) seroconversion and adult female Aedes density. The intervention is based upon a participatory health research approach, Socializing Evidence for Participatory Action (SEPA), where the research evidence is used to foster community engagement and ownership of the health issue and solution. Following allocation, intervention communities will develop and implement their own solutions that will likely include a wide variety of collective events and media approaches. Data collection activities over a period of three years include household visits for blood collection, household surveys, and entomological surveys; and qualitative activities including focus groups, indepth interviews, and document analysis to evaluate the process, acceptability, fidelity, and sustainability of the intervention. Study participants will be aware of their assignment and all research staff will be blinded although the intervention assignment will likely be revealed to field staff through interaction with participants. Discussion: The results of our study will provide evidence on community mobilization as an intervention for dengue control. We anticipate that if community mobilization is effective in Fortaleza, the results of this study will help develop evidence-based vector control programs in Brazil, and also in other countries struggling with Aedes-transmitted diseases.
Keywords
cluster randomized controlled trial, dengue, community-based intervention, mixed methods, community empowerment, vector control, Brazil, Aedes mosquitos
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CURRENT STATUS: Published
Published
On 14 Feb, 2020
No community comments so far
Editorial decision: Accept
On 09 Sep, 2019
Editor assigned
On 07 Sep, 2019
Submission checks complete
On 06 Sep, 2019
Version 2
Posted 02 Oct, 2019
No comments provided
Editorial decision: Minor revision
On 10 Aug, 2019
No comments provided
Editorial decision: Minor revision
On 25 Jun, 2019
Review #3 received
Received 24 Jun, 2019
Review #2 received
Received 24 Jun, 2019
Review #1 received
Received 20 Jun, 2019
Review #4 received
Received 18 Jun, 2019
Reviewer #4 agreed
On 14 Jun, 2019
Reviewer #2 agreed
On 11 Jun, 2019
Reviewer #3 agreed
On 11 Jun, 2019
Reviewer #1 agreed
On 10 Jun, 2019
Reviewers invited
Invitations sent on 08 Jun, 2019
Editor assigned
On 04 Jun, 2019
Submission checks complete
On 24 May, 2019
First submitted
On 17 Apr, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
COESA - Sustainable, healthy cities: Protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach
Kate Zinszer
Universite de Montreal
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1388-1145
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Published
On 14 Feb, 2020
No community comments so far
Editorial decision: Accept
On 09 Sep, 2019
Editor assigned
On 07 Sep, 2019
Submission checks complete
On 06 Sep, 2019
Version 2
Posted 02 Oct, 2019
No comments provided
Editorial decision: Minor revision
On 10 Aug, 2019
No comments provided
Editorial decision: Minor revision
On 25 Jun, 2019
Review #3 received
Received 24 Jun, 2019
Review #2 received
Received 24 Jun, 2019
Review #1 received
Received 20 Jun, 2019
Review #4 received
Received 18 Jun, 2019
Reviewer #4 agreed
On 14 Jun, 2019
Reviewer #2 agreed
On 11 Jun, 2019
Reviewer #3 agreed
On 11 Jun, 2019
Reviewer #1 agreed
On 10 Jun, 2019
Reviewers invited
Invitations sent on 08 Jun, 2019
Editor assigned
On 04 Jun, 2019
Submission checks complete
On 24 May, 2019
First submitted
On 17 Apr, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Dengue is increasing in its global presence with an estimated 4 billion people at-risk of infection in at least 128 countries. Despite the promising results of EcoHealth and community mobilization approaches to Aedes reduction, more evidence of their efficacy on reducing dengue risk is needed. The principal research question is to determine if interventions based upon community mobilization reduce the risk of dengue virus infection among children 3 to 9 years old compared to usual dengue control practice in Fortaleza, Brazil. Methods: The present study will follow a pragmatic cluster randomized controlled trial (cRCT) design with randomization at the census tract level with equal allocation to the two arms. In each arm, there will be 34 clusters of 86 children between 3 to 9 years old for an expected total of 5,848 children enrolled in the study, assuming a risk reduction of 29.5% based upon findings from a previous multi-site cRCT. The primary outcomes are rates of anti-dengue Immunoglobulin G (IgG) seroconversion and adult female Aedes density. The intervention is based upon a participatory health research approach, Socializing Evidence for Participatory Action (SEPA), where the research evidence is used to foster community engagement and ownership of the health issue and solution. Following allocation, intervention communities will develop and implement their own solutions that will likely include a wide variety of collective events and media approaches. Data collection activities over a period of three years include household visits for blood collection, household surveys, and entomological surveys; and qualitative activities including focus groups, indepth interviews, and document analysis to evaluate the process, acceptability, fidelity, and sustainability of the intervention. Study participants will be aware of their assignment and all research staff will be blinded although the intervention assignment will likely be revealed to field staff through interaction with participants. Discussion: The results of our study will provide evidence on community mobilization as an intervention for dengue control. We anticipate that if community mobilization is effective in Fortaleza, the results of this study will help develop evidence-based vector control programs in Brazil, and also in other countries struggling with Aedes-transmitted diseases.
Figure 1
Figure 2
Figure 3