UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039273 |
|---|---|
| Receipt number | R000043714 |
| Scientific Title | A blinded RCT to verify the effect of changing the awareness and behavior of HPV vaccination by video viewing intervention for parents who have daughters of targeted generation |
| Date of disclosure of the study information | 2020/01/28 |
| Last modified on | 2022/01/29 09:41:54 |
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Basic information
Public title
A blinded RCT to verify the effect of changing the awareness and behavior of HPV vaccination by video viewing intervention for parents who have daughters of targeted generation
Acronym
RCT to verify changes in HPV vaccination behavior by video intervention
Scientific Title
A blinded RCT to verify the effect of changing the awareness and behavior of HPV vaccination by video viewing intervention for parents who have daughters of targeted generation
Scientific Title:Acronym
RCT to verify changes in HPV vaccination behavior by video intervention
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Measuring the effect of changing vaccination behavior by video viewing intervention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the rate of parent's who agree to vaccinate HPV vaccine for their daughter.
Key secondary outcomes
Consciousness and behavior change rate for HPV vaccination
Consultation email reply rate
HPV vaccination rate
HP access count
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Video including a message from a cervical cancer survivor
Interventions/Control_2
Not applicable
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Registered on the monitor of NTT Data Management Laboratories
Parents with daughters from 6th grade elementary school to 3rd grade junior high school student at the time of 2019 study participation
Key exclusion criteria
Not applicable
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | YUKIO |
| Middle name | |
| Last name | SUZUKI |
Organization
Yokohama City University graduate school of medicine
Division name
the department of Obstetrics and Gynecology
Zip code
236-0004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL
045-787-2800
yetii18@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Sukegawa |
Organization
Yokohama City University graduate school of medicine
Division name
the department of Obstetrics and Gynecology
Zip code
236-0004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL
045-787-2800
Homepage URL
aki69kin@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Yokohama City University graduate school of medicine
Address
Fukuura 3-9, Kanazawa-ku, Yokohama 236-0004, Japan.
Tel
0457872800
nextjim1@yokohama-cu.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
| 2020 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
2194
Results
The primary endpoint, "desired vaccination rate for daughters' HPV vaccination," was 25.6% in the intervention group and 18.1% in the control group (p <0.001).
Results date posted
| 2021 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the questionnaire monitors owned by NTT DATA, parents (fathers, mothers) who have daughter of the generation which was indicated HPV vaccination (6th grade to 3rd grade of high school) are targeted. Of the 2175 participants, 58.2% were men and 41.8% were women. The age group was 6.3% in their 30s, 60.0% in their 40s, and 33.6% in their 50s. There was 8.8% of HPV vaccination intentions before allocation, and 91.2% did not.
Participant flow
We solicited participation by e-mail from the questionnaire monitor owned by NTT DATA, and explained the purpose of this research to those who wished to join. Randomization was performed for those who confirmed their consent on the website.
Adverse events
This is a questionnaire survey, and there were no specific adverse events during the research.
Outcome measures
Desired rate of daughter's HPV vaccination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 29 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 28 | Day |
Last modified on
| 2022 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043714
