UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018699 |
|---|---|
| Receipt number | R000021642 |
| Scientific Title | Development of the new HIV testing system and surveillance of HIV incidence in MSM |
| Date of disclosure of the study information | 2015/08/20 |
| Last modified on | 2017/08/17 19:15:34 |
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Basic information
Public title
Development of the new HIV testing system and surveillance of HIV incidence in MSM
Acronym
New HIV testing system and incidence survey in MSM
Scientific Title
Development of the new HIV testing system and surveillance of HIV incidence in MSM
Scientific Title:Acronym
New HIV testing system and incidence survey in MSM
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the HIV incidence in MSM using commercial facilities of Shinjuku 2 chome
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Annual HIV incidence in MSM
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Promote HIV testing and distribute HIV testing kits to MSM using commercial facilities in Shinjuku 2 chome.
Intervention period : From August 20, 2015 to March 31, 2017
Intervention : Banner advertisements about HIV testing promotion are posted on dating SNS site for MSM and lead to study website.
Banner advertisement will be changed every 3 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Man who have sex with men
Key exclusion criteria
Not applicable
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Oka |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
oka@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misao Takano |
Organization
National Center for Global Health and Medicine
Division name
Department of Biobank
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
http://hivcheck.jp
mtakano@acc.ncgm.go.jp
Sponsor or person
Institute
AIDS Clinical Center, National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 17 | Day |
Last modified on
| 2017 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021642
