UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011340 |
|---|---|
| Receipt number | R000013289 |
| Scientific Title | HIV/AIDS prevention research for MSM by development of a card tool |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2014/02/03 18:52:26 |
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Basic information
Public title
HIV/AIDS prevention research for MSM by development of a card tool
Acronym
HIV/AIDS prevention research for MSM by development of a card tool
Scientific Title
HIV/AIDS prevention research for MSM by development of a card tool
Scientific Title:Acronym
HIV/AIDS prevention research for MSM by development of a card tool
Region
| Japan |
Condition
Condition
AIDS
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Men who have sex with men (MSM) is delivered card tool, introduction card and condoms when HIV testing.
(1) More MSM can go to HIV testing according to schedule using card tool.
(2) More MSMs can go to HIV testing for the first time by introduction card.
(3) More MSMs can use condom by getting them as a privilege.
(4) More MSMs, who took HIV testing during the campaign period, can introduce their companies who have never take HIV testing to go to testing.
Epidemiological observation study (1)(2)(3) and intervention study (4) are undertaken for evaluation of card tool, introduction card and condom delivery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of card tool delivery and testing number who brought card tool are recorded. Questionnaire is conducted for evaluation.
(1) Days of difference between HIV testing date and scheduled date.
(2) The number of MSM who visited for the first time for a HIV test.
(3) A questionnaire: The number of MSM who became to use condom more often than ever.
(4) The number of MSM who brought introduction card to take HIV test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Delivery of introduction card and condoms
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
All of MSMs who visit for testing during the investigation period at the testing agencies.
Key exclusion criteria
MSM who refuse a co-operation for the investigation.
Target sample size
3600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo KATO |
Organization
School of Medicine, Keio University
Division name
Department of Microbiology and Immunology
Zip code
Address
35 Shinanomachi, Shinjuku-ku 160-8582, Japan
TEL
03-5843-7076
skato@a3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo KATO |
Organization
School of Medicine, Keio University
Division name
Department of Microbiology and Immunology
Zip code
Address
35 Shinanomachi, Shinjuku-ku 160-8582, Japan
TEL
03-5843-7076
Homepage URL
skato@a3.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京都南新宿検査相談室（東京都） Tokyo Metropolitan Minami-shinjuku Testing and Counseling Office
新宿区保健所（東京都） Shinjuku City, Public Health Center
豊島区池袋保健所（東京都） Toshima City, Ikebukuro Public Health Center
港区みなと保健所（東京都） Minato City, Minato Public Health Center
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 01 | 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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 01 | Day |
Last modified on
| 2014 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013289
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
