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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031460
Receipt No. R000035885
Scientific Title Research on provision of Effective HIV testing program for MSM and development of intervention for high risk group:Expansion of HIV testing opportunities by disseminating HIV self-testing kits and bio-behavior surveys
Date of disclosure of the study information 2018/02/26
Last modified on 2019/03/14

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Basic information
Public title Research on provision of Effective HIV testing program for MSM and development of intervention for high risk group:Expansion of HIV testing opportunities by disseminating HIV self-testing kits and bio-behavior surveys
Acronym Expansion of HIV testing opportunities by disseminating HIV self-testing kits and bio-behavior surveys
Scientific Title Research on provision of Effective HIV testing program for MSM and development of intervention for high risk group:Expansion of HIV testing opportunities by disseminating HIV self-testing kits and bio-behavior surveys
Scientific Title:Acronym Expansion of HIV testing opportunities by disseminating HIV self-testing kits and bio-behavior surveys
Region
Japan

Condition
Condition HIV infection
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To conduct HIV testing using a self-testing kit, and assess its effectiveness among MSM.
HIV prevalence will be assessed and the data generated will be used to clarify the current conditions of HIV spread among gay and bisexual men, in order to promote HIV prevention activities in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HIV prevalence among MSM who used the HIV testing kit
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Participants undergo HIV testing using the self-testing kit. Participant puncture own fingertip with the included small puncture instrument (lancet) and place a drop of your blood on the filter paper. Participant return the filter paper after it has dried in the envelope by mail.
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 Men who have/have had sex with men aged over 20 years
MSM who can speak and understand Japanese or English
Read all instruction and show willingness to participate in this trial
Key exclusion criteria None
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyo Kaneko
Organization School of Nursing, Nagoya City University
Division name Global and Community Health
Zip code
Address Kawasumi1, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi
TEL 052-853-8065
Email noriyok@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyo Kaneko
Organization School of Nursing, Nagoya City University
Division name Global and Community Health
Zip code
Address Kawasumi1, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi
TEL 052-853-8065
Homepage URL
Email noriyok@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University
Institute
Department

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

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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 26 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
2018 Year 02 Month 16 Day
Date of IRB
2018 Year 02 Month 16 Day
Anticipated trial start date
2018 Year 02 Month 26 Day
Last follow-up date
2020 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
2018 Year 02 Month 24 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035885

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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