UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043560
Receipt number R000049745
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
Date of disclosure of the study information 2021/03/09
Last modified on 2021/03/09 13:58:42

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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 or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049745


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name