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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018699
Receipt No. 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

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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
Email 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
Email mtakano@acc.ncgm.go.jp

Sponsor
Institute AIDS Clinical Center, National Center for Global Health and Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021642

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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