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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011340
Receipt No. 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

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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
Email 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
Email skato@a3.keio.jp

Sponsor
Institute School of Medicine, Keio University
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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