UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058929 |
|---|---|
| Receipt number | R000067389 |
| Scientific Title | The prospective and cross-sectional study to detect undiagnosed blood borne viruses (BBV) infections at HIV and STI clinics in Japan |
| Date of disclosure of the study information | 2025/08/30 |
| Last modified on | 2025/08/29 14:35:35 |
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Basic information
Public title
The prospective and cross-sectional study to detect undiagnosed blood borne viruses (BBV) infections at HIV and STI clinics in Japan
Acronym
The study to detect undiagnosed BBV infections
Scientific Title
The prospective and cross-sectional study to detect undiagnosed blood borne viruses (BBV) infections at HIV and STI clinics in Japan
Scientific Title:Acronym
The study to detect undiagnosed BBV infections
Region
| Japan |
Condition
Condition
HIV, hepatitis B, hepatitis C, hepatatis D
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the prevalence and incidence of BBV (HIV, HBV, HCV, and HDV) in Japan at high risk of STI infection (HIV-positive MSM, HIV-negative MSM, and female commercial sex workers (CSW) and transgender persons at high risk of STIs).
Basic objectives2
Others
Basic objectives -Others
To compare the prevalence of BBV cases diagnosed in routine practice with BBV cases diagnosed by opt-out-like methods and to evaluate the usefulness of opt-out-like methods.
To assess risk factors for BBV infection in Japan.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the prevalence and incidence of BBV in each group, data of phase 1, phase 2, and phase 3 will be collected.
Key secondary outcomes
To evaluate the usefulness of the optout method, data of phase 1 and phase 2 will be compared.
Evaluate how risk factors and behaviors such as genders, anal intercourse, PrEP use, intravenous drug use, and CSW affect BBV infection in each population.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
blood draw
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. ACC or SHC patients those who had their first visit at NCGM in 2017 or later (most of them are MSM).
2. Women and trans gender who see PHC or IDC.
Key exclusion criteria
Persons under 18 years of age. Those who cannot read and write Japanese.
Target sample size
4600
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | UEMURA |
Organization
National Center for Global Health and Medicine, Japan Institute for Health Security
Division name
AIDS Clinical Ceneter
Zip code
1628655
Address
Toyama 1-21-1, Shinjuku, Tokyo, Japan
TEL
033202
uemura.h@jihs.go.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | UEMURA |
Organization
National Center for Global Health and Medicine, Japan Institute for Health Security
Division name
AIDS Clinical Ceneter
Zip code
1628655
Address
Toyama 1-21-1, Shinjuku, Tokyo, Japan
TEL
0332027181
Homepage URL
uemura.h@jihs.go.jp
Sponsor or person
Institute
Haruka Uemura, AIDS Clinical Center, National Center for Global Health and Meidicine, Japan institute for Health Security.
Institute
Department
Personal name
Funding Source
Organization
Gilead Sciences, Inc
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research of Japan Institute for Health Security
Address
Toyama 1-21-1, Shinjuku, Tokyo, Japan
Tel
0332027181
rinrijm@jihs.go.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
| 2025 | Year | 08 | Month | 30 | 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
| 2024 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067389
