UMIN-CTR Clinical Trial

Basic information
Public title	Randomized comparison of several messages for increasing the rate of hepatitis virus testing
Acronym	RCT for increasing rate of Hepatitis virus testing
Scientific Title	Randomized comparison of several messages for increasing the rate of hepatitis virus testing
Scientific Title:Acronym	RCT for increasing rate of Hepatitis virus testing
Region	Japan

Condition
Condition	Viral Hepatitis
Classification by specialty	Hepato-biliary-pancreatic medicine Infectious disease Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of leaflets developed for increasing the rate of hepatitis virus testing
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Hepatitis virus testing rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	"Fear appeal-Reassuring" type leaflet
Interventions/Control_2	"Barrier removing" type leaflet
Interventions/Control_3	Standard leaflet
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Employees of study partner companies
Key exclusion criteria	Those who have experience of hepatitis virus testing
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Seiichiro Middle name Last name Yamamoto
Organization	National Cancer Center
Division name	Center for Cancer Control and Information Services
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo, Tokyo, Japan 104-0045
TEL	03-3542-2511
Email	siyamamo@ncc.go.jp

Public contact
Name of contact person	1st name Seiichiro Middle name Last name Yamamoto
Organization	National Cancer Center
Division name	Center for Cancer Control and Information Services
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo, Tokyo, Japan 104-0045
TEL	03-3542-2511
Homepage URL
Email	siyamamo@ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	National Cancer Center
Address	5-1-1, Tsukiji, Chuo, Tokyo, Japan 104-0045
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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	医療法人社団如水会今村病院（佐賀県）

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 15 Day

Related information
URL releasing protocol	Not available
Publication of results	Unpublished

Result
URL related to results and publications	Study on going
Number of participants that the trial has enrolled	872
Results	On going
Results date posted	2020 Year 03 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 12 Month 31 Day
Baseline Characteristics	On going
Participant flow	On going
Adverse events	Not applicable
Outcome measures	On going
Plan to share IPD	Shareble
IPD sharing Plan description	Will be planned after study finished

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2019 Year 01 Month 21 Day
Date of IRB	2019 Year 01 Month 24 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 05 Month 31 Day
Date trial data considered complete	2020 Year 08 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 03 Month 13 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045379