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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039468
Receipt No. R000044823
Scientific Title Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease: cluster randomized study
Date of disclosure of the study information 2020/02/12
Last modified on 2020/02/12

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Basic information
Public title Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease
Acronym Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease
Scientific Title Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease: cluster randomized study
Scientific Title:Acronym Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease: cluster randomized study
Region
Japan Africa

Condition
Condition Domestic dog bite injury and/or domestic dog mediated human rabies
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Canine rabies is enzootic and, routine control measures, supplies of biologics, relevant recommendations and educational programs are either nonexistent, inoperative or patchy leading to rabies being endemic, wide spread and a neglected disease in Zambia and most other developing countries. There is usually lack of effective educational outreach activities at the community level which has led to gaps in knowledge on best ways to avoid animal bites and administer first aid following animal bites or other forms of exposure. The engagement of community leaders and their communities through the provision of culturally appropriate rabies information, training, and promotion of skill-building activities could improve knowledge of rabies and its prevention. Based on this, an integrated community led-dog management approach will be conducted as a means to increase knowledge and awareness of responsible dog ownership and rabies disease so as to enhance uptake of rabies disease control and prevention activities through dog bite prevention and increased dog vaccination coverage respectively.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Dog vaccination coverage rate
Key secondary outcomes Knowledge, attitude and practice (KAP) levels of domestic dog-mediated human rabies, its prevention and control.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 3 days Village based participatory knowledge exchange/discussion and training meetings on dog bites and rabies disease and their prevention. This is for the intervention arm
Interventions/Control_2 No intervention activities for the control arm
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The study participants target are all permanent residents households heads, adults aged 16 years and above who will agree to join the study.
Key exclusion criteria Household heads and/or representatives who decline to participate in the study and those who may be visitors in the study area/period and are not permanent residents will be excluded.
Target sample size 360

Research contact person
Name of lead principal investigator
1st name Gelly
Middle name Simakechula
Last name Chikuni
Organization Nagasaki University
Division name School of tropical Medicine and Global Health
Zip code 852-8523
Address 1-12-4 Sakamoto, Nagasaki
TEL 080-9801-4159
Email gsimakechula@gmail.com

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Kaneko
Organization Nagasaki University
Division name Institute of Tropical Medicine, Nagasaki University
Zip code 852-8523
Address 1-12-4 Sakamoto, Nagasaki
TEL +81-95-819-7866
Homepage URL http://www.tm.nagasaki-u.ac.jp/nekken/english/research/eco-epidemiology.html
Email skaneko@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University, School of Tropical Medicine and Global Health
Institute
Department

Funding Source
Organization Nagasaki University,
School of Tropical Medicine and Global Health
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University, School of Tropical Medicine and Global Health Ethical Committee
Address 852-8523, 1-12-4 Sakamoto, Nagasaki, Japan
Tel 095-819-7583
Email tmgh_jimu@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 09 Month 30 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 04 Month 30 Day
Date of IRB
2020 Year 02 Month 28 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 02 Month 12 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044823

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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