UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036636 |
|---|---|
| Receipt number | 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 | 2025/01/08 19:49:36 |
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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
| Obstetrics 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
Female students 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
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
teikyoHPV2019@gmail.com
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Teikyo University School of Medicine
Institute
Department
Personal name
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
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
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0311588
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0311588
Number of participants that the trial has enrolled
267
Results
The Communicative and Critical Health Literacy scales were used as health literacy scales. Participants knowledge and health literacy improved regardless of the method of education. Medical professionals in Japan must provide accurate scientific knowledge regarding routine HPV vaccination and the risk of cervical cancer in young women to improve their health literacy and subsequently increase HPV vaccination rates in Japan, which may lead to cervical cancer elimination.
Results date posted
| 2025 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 267 participants, 188 completed all questionnaires 3 times. The mean age was 21 (standard deviation 1.67) years. Participant affiliations included Nursing (27.1%), Medicine (23.9%), Pharmaceutical (20.7%), Medical technology (14.9%), Literature (8.0%), Economics (2.7%), Law (1.6%), Foreign Language (0.5%), and Science and Technology (0.5%). Those who had any medical professionals in their family accounted for 38.3%. Non-smokers accounted for 98.8%, and 67.6% were aware of the importance of a balanced diet. Regarding exercise frequency, 60.6% did not exercise, and 15.4%, 19.7%, and 2.66% exercised once a week, two or three times a week, and daily, respectively. A total of 80.3% had not consulted an obstetrician or gynecologist before; 81.9% had routine vaccinations conducted in accordance with Japanese law; 56.9% had not been vaccinated for HPV; and 9.6%, 7.4%, and 25.5% had received an HPV vaccination once, twice, and thrice, respectively.
Participant flow
Students were assured that study participation was voluntary and would not interfere with their academic activities. We included female students aged 18-26 years who could access and use print-based or SNS-based educational programs and complete the follow-up questionnaire comprising 20 questions and the Communicative and Critical Health Literacy CCHL scale. We excluded students who experienced mental and physical challenges during the study. According to the research protocol, students with mental or physical challenges were to be excluded. However, in practice, the study only included students who volunteered to participate, and no students with psychological or physical difficulties were actually enrolled. This exclusion criterion did not affect the study outcome, as no participants in the study were found to meet this criterion. The universities were selected based on logistical considerations and feasibility. While the focus on private universities facilitated recruitment and ensured voluntary participation, this choice may limit the generalizability of the findings. Due to funding constraints and logistical challenges, the recruitment pool was not expanded beyond these institutions.
Adverse events
None
Outcome measures
Participants responded to five questions on the CCHL scale, with scores ranging from 1 very easy to 5 very difficult, focusing on HPV vaccination and cervical cancer screening. The within-individual health literacy score was calculated as the mean of the scores for these five questions. A score of 3 was considered highly health literate because it represented participants who had significant knowledge within both groups. The number of participants classified as high and low will be approximately half at the time of the first survey. As the total number of participants was smaller than expected, we considered it would be difficult to find significant between-group differences if the participant number was skewed toward one group or the other. On the CCHL scale, the average of the 1-5 rating scale was used as another objective rating figure.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
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
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041388
