UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052148