UMIN-CTR Clinical Trial

Basic information
Public title	A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan
Acronym	A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan
Scientific Title	A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan
Scientific Title:Acronym	A Web-based Randomized Controlled Trial Investigating Efficacy of Behavioral Insights with Simple Scientific Information For Recovering Low-HPV Vaccination Rate in Japan
Region	Japan

Condition
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of these behavioral insights utilizing fundamental scientific information on vaccine benefits, along with statistics on cervical cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of the willingness on the daughter's vaccination
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	provided the BI-material prior to answering questions related to preventive awareness, following consent for the online study
Interventions/Control_2	provided with the same material as that provided to the intervention group after all responses were completed
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	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants who are registered members of the research panel owned by Macromill, Inc. (Tokyo, Japan).
Key exclusion criteria	None
Target sample size	1660

Research contact person
Name of lead principal investigator	1st name YUKIO Middle name Last name SUZUKI
Organization	Yokohama City University Hospital
Division name	Department of Obstetrics and Gynecology
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	0457872800
Email	yetii18@yahoo.co.jp

Public contact
Name of contact person	1st name YUKIO Middle name Last name SUZUKI
Organization	Yokohama City University Hospital
Division name	Department of Obstetrics and Gynecology
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	0457872800
Homepage URL
Email	yetii18@yahoo.co.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	the Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Research Ethics Committee of Yokohama City University School of Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
Tel	0457872800
Email	yetii18@yahoo.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	A180200004
Org. issuing International ID_1	Yokohama City University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 09 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	1660
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 07 Day
Date of IRB	2018 Year 02 Month 27 Day
Anticipated trial start date	2018 Year 03 Month 12 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 03 Month 09 Day
Last modified on	2021 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049745