UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035304
Receipt number 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 2023/07/11 16:36:41

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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 1000 MSM with at least 5 years follow up (5,000 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

1000


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 or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

ViiV Healthcare UK Ltd
Ministry of Health, Labor and Welfare
National Center for Global Health and Medicine

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

Suspended

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

2026 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 1000 MSM with at least 5 years follow up (5,000 person-years )


Management information

Registered date

2018 Year 12 Month 18 Day

Last modified on

2023 Year 07 Month 11 Day



Link to view the page

Value
https://center6.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