UMIN-CTR Clinical Trial

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	Delay expected
Results Delay Reason	Delayed to start the research due to COVID-19 limitations in travel to the research site and eventual change of research site.
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	Enrolling by invitation
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 08 Month 07 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 08 Month 27 Day

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