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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025369
Receipt No. R000029210
Scientific Title Prevalence of rectal gonorrhea and chlamydia infection among HIV-infected men who have sex with men in Japan
Date of disclosure of the study information 2016/12/22
Last modified on 2017/06/23

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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
Middle name
Last name Daisuke Mizushima
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center (ACC)
Zip code
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
Middle name
Last name Daisuke Mizushima
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center (ACC)
Zip code
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
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)/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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 22 Day
Last follow-up date
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
2017 Year 06 Month 23 Day


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

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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