UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044750
Receipt number R000051109
Scientific Title A Randomized Controlled Trial on Improving Health Literacy for Cervical Cancer Prevention Using Information and Communication Technology
Date of disclosure of the study information 2021/07/15
Last modified on 2024/01/10 14:08:18

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Basic information

Public title

Research on improving health literacy for cervical cancer prevention using information and communication technology

Acronym

HPV Vaccine Health Literacy Survey by using SNS

Scientific Title

A Randomized Controlled Trial on Improving Health Literacy for Cervical Cancer Prevention Using Information and Communication Technology

Scientific Title:Acronym

HPV Vaccine Health Literacy Research

Region

Japan


Condition

Condition

Cervical Cancer

Classification by specialty

Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Usefulness of SNS

Basic objectives2

Others

Basic objectives -Others

uptake improvement

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

health literacy and knowledge

Key secondary outcomes

Vaccine uptake


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

the intervention of communication opportunity by using a SNS(Line)

Interventions/Control_2

No intervention by post

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

18 years-old <=

Age-upper limit

35 years-old >

Gender

Male and Female

Key inclusion criteria

No HPV vaccine or less than 3 doses of HPV vaccine
Japanese male and female undergraduate and graduate students of Akita Prefectural University between the ages of 18-35

Key exclusion criteria

Those who received three doses of HPV vaccine.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name KYOKO
Middle name
Last name NOMURA

Organization

Akita University Graduate School of Medicine

Division name

Department of Environmental Health Science and Public Health,

Zip code

010-8543

Address

1-1-1 Hondo Akita

TEL

018-884-6087

Email

knomura@med.akita-u.ac.jp


Public contact

Name of contact person

1st name KYOKO
Middle name
Last name NOMURA

Organization

Akita University Graduate School of Medicine

Division name

Department of Environmental Health Science and Public Health,

Zip code

010-8543

Address

1-1-1 Hondo, Akita

TEL

018-884-6087

Homepage URL


Email

knomura@med.akita-u.ac.jp


Sponsor or person

Institute

Grants-in-Aid for Scientific Research

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

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

Akita University School of Medicine Research Cooperation Office, General Affairs Division

Address

1-1-1 Hondo, Akita

Tel

018-884-6210

Email

soken@hos.akita-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

2021 Year 07 Month 15 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

517

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

2020 Year 04 Month 01 Day

Date of IRB

2020 Year 06 Month 01 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2021 Year 12 Month 20 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 07 Month 03 Day

Last modified on

2024 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051109


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name