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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000045691
Receipt No. 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 2021/10/06

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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
Email 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
Email mtakano@acc.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052148

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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