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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036636
Receipt No. R000041388
Scientific Title A cluster randomized study to assess the effects of social media networking (SNS) educational intervention designed to improve the knowledge of HPV vaccination and HPV vaccination uptake rates among young female adults
Date of disclosure of the study information 2019/05/01
Last modified on 2019/05/08

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Basic information
Public title Improving knowledge of susceptibility to cervical cancer, severity of cervical cancer, and benefit from HPV vaccination among young female adults
Acronym Teikyo Cervical Cancer Study (TCCS)
Scientific Title A cluster randomized study to assess the effects of social media networking (SNS) educational intervention designed to improve the knowledge of HPV vaccination and HPV vaccination uptake rates among young female adults
Scientific Title:Acronym Health literacy for cervical cancer and HPV vaccination
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The object of the proposed study is to develop a SNS-based innovative informatics platform against unvaccinated young female adults to facilitate delivery of accurate knowledges about HPV vaccination, and vaccination completion rates. To our knowledge, this is the first study to design and develop an intervention model to recruit young female adults into health survey for prevailing accurate information regarding HPV vaccination after vaccination crisis in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improving knowledge of susceptibility to cervical cancer, severity of cervical cancer, cervical screening test, and benefit from HPV vaccination measured by health belief model.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Arm 1) no intervention (control)
Interventions/Control_2 Arm 2) an educational brochure about adolescent vaccines mailed home (printed-based)
Interventions/Control_3 Arm 3) a curriculum implemented by SNS (SNS-based).
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
26 years-old >=
Gender Female
Key inclusion criteria 1st or 2nd year female students and their parents with written informed consent1) young female adults aged 18 years to 26 years, and (2) persons being available for SNS-based educational messages and follow-up questionnaire. Exclusion criteria are: (1) persons who faces mental and physical challenges that make it difficult to use the SNS-based program and person who had already received three doses vaccine completion.
Key exclusion criteria None
Target sample size 3500

Research contact person
Name of lead principal investigator
1st name Kazunori
Middle name
Last name Nagasaka
Organization Teikyo University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 173-8605
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Email nagasakak-tky@umin.ac.jp

Public contact
Name of contact person
1st name Kazunori
Middle name
Last name Nagasaka
Organization Teikyo University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 173-8605
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL +81-03-3964-1211
Homepage URL
Email teikyoHPV2019@gmail.com

Sponsor
Institute Department of Obstetrics and Gynecology, Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Supported in part by a research grant from Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. / MSD K.K.
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 Teikyo University Ethics Committee
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
Tel 03-3964-7256
Email turb-office@teikyo-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
2019 Year 05 Month 01 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
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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 28 Day
Date of IRB
2019 Year 03 Month 22 Day
Anticipated trial start date
2019 Year 04 Month 19 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 01 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041388

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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