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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035304
Receipt No. R000040227
Scientific Title Establishment of MSM cohort in Tokyo toward the 2020 Tokyo Olympics in preparation for PrEP implementation and expansion.
Date of disclosure of the study information 2018/12/18
Last modified on 2019/06/18

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Basic information
Public title Establishment of MSM cohort in Tokyo toward the 2020 Tokyo Olympics in preparation for PrEP implementation and expansion.
Acronym Sexual health clinic MSM cohort study (SHC study)
Scientific Title Establishment of MSM cohort in Tokyo toward the 2020 Tokyo Olympics in preparation for PrEP implementation and expansion.
Scientific Title:Acronym Sexual health clinic MSM cohort study (SHC study)
Region
Japan

Condition
Condition HIV infection, Sexually transmitted infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to estimate incidence of HIV and STI among MSM in Japan and evaluate its risk factors. We establish MSM cohort where participants are examined HIV and other STIs tests every 3 months. Sample size is 500 MSM with at least 2 years follow up (1,000 person-years )
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of incidence of HIV among MSM cohort (/100 person-years)
Key secondary outcomes 1)Evaluation of incidence of STIs among MSM cohort (/100 person-years).
2)Evaluation of frequency of high risk sexual behaviors.
3)Evaluation of sample size and inclusion criteria for PrEP

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1)MSM who have anal sexual intercourse.
2)MSM who live in Japan and understand Japanese.
3)Those who give written informed consent.
Those who meet all criteria above are included.
Key exclusion criteria HIV-infected person
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Mizushima
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL 03-3202-7181
Email dmizushi@acc.ncgm.go.jp

Public contact
Name of contact person
1st name Misao
Middle name
Last name Takano
Organization National Center for Global Health and Medicine
Division name Sexual Health Clinic
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL http://shclinic.ncgm.go.jp/
Email info_shc@acc.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization ViiV Healthcare UK Ltd
Ministry of Health, Labor and Welfare
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 National Center for Global Health and Medicine
Address 1-21-1 Toyama,Shinjuku-ku,Tokyo, Japan
Tel 03-3202-7181
Email rinrijm@hosp.ncgm.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 国立研究開発法人 国立国際医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 18 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 27 Day
Date of IRB
2016 Year 09 Month 27 Day
Anticipated trial start date
2017 Year 01 Month 16 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We establish MSM cohort in Sexual Health clinic where participants are examined HIV and other STIs tests every 3 months. Sample size is 500 MSM with at least 2 years follow up (1,000 person-years )

Management information
Registered date
2018 Year 12 Month 18 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040227

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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