UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061925 |
|---|---|
| Receipt number | R000070858 |
| Scientific Title | Effects of Interactive Information Provision by Community Pharmacists to Pharmacy Visitors on HPV Vaccination Uptake and Intention to Recommend HPV Vaccination: A Cluster Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/16 11:29:38 |
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Basic information
Public title
An Ongoing Questionnaire Survey on Vaccination Among Patients Visiting Pharmacies
Acronym
An Ongoing Questionnaire Survey on Vaccination Among Patients Visiting Pharmacies
Scientific Title
Effects of Interactive Information Provision by Community Pharmacists to Pharmacy Visitors on HPV Vaccination Uptake and Intention to Recommend HPV Vaccination: A Cluster Randomized Controlled Trial
Scientific Title:Acronym
Effects of Interactive Information Provision by Community Pharmacists to Pharmacy Visitors on HPV Vaccination Uptake and Intention to Recommend HPV Vaccination: A Cluster Randomized Controlled Trial
Region
| Japan |
Condition
Condition
For healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of HPV-related information provision to pharmacy visitors through poster and leaflet displays in addition to interactive counseling by community pharmacists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Increase in the score of the Attitude to be Vaccinated against HPV (aHPV) subscale of the Vaccination & HPV Knowledge (THinK) questionnaire at 3 months after the intervention
Key secondary outcomes
(1) Scores of the kHPV (knowledge about HPV) and kV (knowledge about vaccination) subscales of the THinK questionnaire
(2) Comparison of aHPV (Attitude to be Vaccinated against HPV) subscale scores of the THinK questionnaire between the interactive information provision group and the passive information provision group at 1 and 2 months after the intervention
(3) Vaccination Readiness (7C) total score and individual factor scores
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Pharmacy visitors receive information on HPV and HPV vaccination through poster displays and leaflet distribution, plus interactive face-to-face communication by community pharmacists
Interventions/Control_2
Control group: Pharmacy visitors receive information on HPV and HPV vaccination through poster displays and leaflet distribution
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patients aged 18-75 years visiting participating community pharmacies.
2 Individuals who understand the study procedures and provide written informed consent.
3 Individuals who are able to complete the questionnaires using the specified method during the study period.
Key exclusion criteria
1 Individuals who decline to participate in the study.
2 Individuals deemed ineligible by the principal investigator based on medical or ethical considerations.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Practical Education and Research Division
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi University
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
Research Ethics Committee of Hoshi University
Address
142-8501, 2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
y-hashiguchi@hoshi.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
| 2026 | Year | 07 | 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
| 2026 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 06 | Month | 16 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070858
