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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045620
Receipt No. R000052084
Scientific Title Surveillance of HIV-infected pregnancy and establish of Awareness-raising method for prevention of HIV mother-to child transmission in Japan
Date of disclosure of the study information 2021/10/01
Last modified on 2021/10/01

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Basic information
Public title Surveillance of HIV-infected pregnancy and establish of Awareness-raising method for prevention of HIV mother-to child transmission in Japan
Acronym HIV-MTCT prevention project in japan
Scientific Title Surveillance of HIV-infected pregnancy and establish of Awareness-raising method for prevention of HIV mother-to child transmission in Japan
Scientific Title:Acronym HIV-MTCT prevention project in japan
Region
Japan

Condition
Condition HIV
Classification by specialty
Medicine in general Hematology and clinical oncology Infectious disease
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Surveillance of HIV-infected pregnancy and establish of Awareness-raising method for prevention of HIV mother-to child transmission in Japan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Rate of HIV mother-to-child transmission
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria HIV-infected pregnancy
Key exclusion criteria none
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Tsunekazu
Middle name
Last name Kita
Organization Nara prefecture general medical center
Division name obstetrics&gynecology
Zip code 630-8581
Address 2-897-5,shichijyonishimachi,Nara city, Nara prefecture
TEL 0742-46-6001
Email obgy@nara-hp.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Sugiura
Organization Nara prefecture general medical center
Division name obstetrics&gynecology
Zip code 630-8581
Address 2-897-5,shichijyonishimachi,Nara city, Nara prefecture
TEL 0742-46-6001
Homepage URL http://hivboshi.org
Email atsushi7707@yahoo.co.jp

Sponsor
Institute Research on HIV/AIDS
Institute
Department

Funding Source
Organization Research on HIV/AIDS
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 Nara prefecture general medical center
Address 2-897-5,shichijyonishimachi,Nara city, Nara prefecture
Tel 0742-46-6001
Email obgy@nara-hp.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
2021 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2021 Year 04 Month 01 Day
Date of IRB
2021 Year 05 Month 14 Day
Anticipated trial start date
2021 Year 05 Month 14 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Surveillance of HIV-infected pregnancy and establish of Awareness-raising method for prevention of HIV mother-to child transmission in Japan

Management information
Registered date
2021 Year 09 Month 30 Day
Last modified on
2021 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052084

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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