UMIN-CTR Clinical Trial

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 Noriyo Middle name Last name Kaneko
Organization	School of Nursing, Nagoya City University
Division name	Global and Community Health
Zip code	4678601
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 Noriyo Middle name Last name Kaneko
Organization	School of Nursing, Nagoya City University
Division name	Global and Community Health
Zip code	4678601
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	Institutional Review Board, Graduate School of Nursing
Address	Kawasumi1, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi
Tel	052-853-8065
Email	noriyok@med.nagoya-cu.ac.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

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	Completed
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	2020 Year 04 Month 30 Day
Date trial data considered complete	2020 Year 04 Month 30 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 02 Month 24 Day
Last modified on	2020 Year 10 Month 19 Day

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