UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence of rectal gonorrhea and chlamydia infection among HIV-infected men who have sex with men in Japan
Acronym	Rectal gonorrhea and chlamydia infection study in HIV-infected MSM
Scientific Title	Prevalence of rectal gonorrhea and chlamydia infection among HIV-infected men who have sex with men in Japan
Scientific Title:Acronym	Rectal gonorrhea and chlamydia infection study in HIV-infected MSM
Region	Japan

Condition
Condition	Rectal gonorrhea and chlamydia infection
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of prevalence of rectal gonorrhea and chlamydia infection among HIV-infected men who have sex with men
Basic objectives2	Others
Basic objectives -Others	Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of prevalence of rectal gonorrhea and chlamydia infection among HIV-infected MSM in Japan in cross-sectional study
Key secondary outcomes	Evaluation of factors associated with rectal gonorrhea and chlamydia infection in cross-sectional study

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	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	1,000 HIV-infected MSM in National center for Global Health and Medicine receive test for rectal gonorrhea and chlamydia infection.
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	HIV-infected MSM in National center for Global Health and Medicine
Key exclusion criteria	Person younger than 20 years old
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 (ACC)
Zip code	162-8655
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Email	dmizushi@acc.ncgm.go.jp

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

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

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Medical Research Management, Management and Planning Bureau, 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	国立国際医療研究センター（東京）/National Center for Global Health and Medicine(Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 22 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	Main results already published
Date of protocol fixation	2016 Year 11 Month 21 Day
Date of IRB	2016 Year 11 Month 21 Day
Anticipated trial start date	2016 Year 12 Month 22 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 22 Day
Last modified on	2019 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029210