UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045691 |
|---|---|
| Receipt number | R000052148 |
| Scientific Title | Online survey for MSM on sexual behavior, drug use, access to PrEP drug and HIV testing service during the COVID-19 pandemic. |
| Date of disclosure of the study information | 2021/10/06 |
| Last modified on | 2022/01/04 11:27:31 |
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Basic information
Public title
Online survey for MSM on sexual behavior during the COVID-19 pandemic in Japan
Acronym
Online survey for MSM on sexual behavior during the COVID-19 pandemic in Japan
Scientific Title
Online survey for MSM on sexual behavior, drug use, access to PrEP drug and HIV testing service during the COVID-19 pandemic.
Scientific Title:Acronym
Online survey for MSM on sexual behavior, drug use, access to PrEP drug and HIV testing service during the COVID-19 pandemic.
Region
| Japan |
Condition
Condition
Sexually transmitted infection
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this survey is to investigate how COVID-19 pandemic affected on the sexual behaviors, drug use, access to PrEP drugs and HIV testing services for MSM in Tokyo.
Basic objectives2
Others
Basic objectives -Others
epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the number of sexual partners, frequency of sexual activity and sexual desire during the COVID-19 pandemic.
Key secondary outcomes
1)Percentage of people who had difficulty obtaining PrEP drugs.
2)Percentage of people who could receive sexually transmitted infection, including HIV tests.
3)Changes in recreational drug use and alcohol intake during the COVID-19 pandemic.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1)Man who have sex with men.
2)Person who live in Japan and can understand Japanese.
3)Person who indicated his intention to participate in this reserch.
Those who meet all criteria above are included
Key exclusion criteria
HIV infected person
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Misao |
| Middle name | |
| Last name | Takano |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
mtakano@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Misao |
| Middle name | |
| Last name | Takano |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
mtakano@acc.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Medical Research Management, Management and Planning Bureau National Center for Global Health and Medicine
Address
1-21-1, Toyama, Shinjuku, Tokyo, Japan
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 06 | 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
645
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
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this survey is to investigate how COVID-19 pandemic affected on the sexual behaviors, drug use, access to PrEP drug and HIV testing service for MSM in Tokyo.
Management information
Registered date
| 2021 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052148
