UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031460 |
|---|---|
| Receipt number | 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 | 2020/10/19 10:18:07 |
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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 | 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
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
noriyok@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035885
