UMIN-CTR Clinical Trial

Public title

Clinical Study on Co-Infection of Multiple HBV Genotypes in Men Who Have Sex with Men in Mongolia

Acronym

MSM cohort in Mongolia

Scientific Title

Clinical Study on Co-Infection of Multiple HBV Genotypes in Men Who Have Sex with Men in Mongolia

Scientific Title:Acronym

MSM cohort in Mongolia

Region

Asia(except Japan)

Condition

HIV infection, Hepatitis B, Hepatitis C, Syphilis

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

For HBV, it is not known whether multiple genotypes can co-infect the same host individual, or not. In order to aid the future HBV vaccine policies, this study aims to investigate if HBV genotype A would infect MSM with high incident rate of HBV genotype D in Mongolia. In addition to HBV infection, other STIs such as HIV, HCV, and syphilis are also examined with rapid diagnostic kits. To explore efficacy of NGOs' activities for prevention of STIs including early HIV treatment as prevention, incidence of these STIs is also studied.

Basic objectives2

Others

Basic objectives -Others

Epidemiological observation

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Whether HBV genotype A would co-infect carriers of HBV genotype D, or not.

Key secondary outcomes

1. If HBV genotype A is spread in MSM in Mongolia
2. If HBV would produce recombinant strains
3. If HIV infection would affect co-infection of HBV genotypes
4. Incidence of HIV, HCV and syphilis in Mongolian MSM
5. HIV subtype spread in MSM in Mongolia
6. HCV genotype spread in MSM in Mongolia

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

1. Age 20yrs old and above
2. Man who have sex with men
3. Able to agree to written informed consent and willing to participate

Key exclusion criteria

None

Target sample size

1500

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Oka

Organization

National Center for Global Health and Medicine

Division name

AIDS Clinical Center

Zip code

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655 Japan

TEL

03-5273-5193

Email

oka@acc.ncgm.go.jp

Name of contact person

1st name
Middle name
Last name	Misao Takano

Organization

National Center for Global Health and Medicine

Division name

Biobank

Zip code

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655 Japan

TEL

03-3202-7181

Homepage URL

Email

mtakano@acc.ncgm.go.jp

Institute

AIDS Clinical Center, National Center for Global Health and Medicine

Institute

Department

Personal name

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

1. The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Japan
2. AIDS/STI Surveillance and Research Department, National Center for Communicable Diseases, Mongolia
3. Together Center, Mongolia
4. Rainbow Clinic, Mongolia

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Together Center, Ulaanbaatar, Mongolia
Rainbow Clinic, Ulaanbaatar, Mongolia

Date of disclosure of the study information

2016

Year

09

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

20

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Together Center and Rainbow Clinic in Ulaanbaatar support MSM. Daily activities of Together Center and Rainbow Clinic include HIV/HBV/HCV/Syphilis testing. Clients who visited Together Center and Rainbow Clinic receive explanation on this study and provide written consent are enrolled as participants of this study.MSM who provide written consent will go through enrollment procedure with deep vein authentication system and receive a unique Study ID anonymously before blood collection. Sample collection, storage and data collection are handled anonymously. Consented MSM will provide background data such as age and sexual history on same-sex experiences, answering to written questionnaire sheets by themselves. 10ml of blood sample will be collected from participants and tested for HV/HBV/HCV/Syphilis infections with rapid testing kits respectively. The leftover of the serum samples after these tests will be frozen and stored at NCCD in Ulaanbaatar for shipment to Japan for further analysis.
After the enrollment, when the participant visits Together Center or Rainbow Clinic, repeat blood sample collection to screen for HIV/HBV/HCV/Syphilis infection and store blood samples until the end of the study duration.

Registered date

2016

Year

09

Month

16

Day

Last modified on

2019

Year

02

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027731