UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the new HIV testing system and surveillance of HIV incidence in MSM
Title of the study (Brief title)	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	Shinichi Oka
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
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	Misao Takano
Organization	National Center for Global Health and Medicine
Division name	Department of Biobank
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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