UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025369 |
|---|---|
| Receipt number | 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 | 2019/12/26 19:22:14 |
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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 | 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
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
dmizushi@acc.ncgm.go.jp
Sponsor or person
Institute
AIDS Clinical Center, National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029210
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
