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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030146
Receipt No. R000034218
Scientific Title Decision Making and Adherence to Antiretroviral Therapy in Patients Infected with Human Immunodeficiency Virus in Japan: Observational Study
Date of disclosure of the study information 2017/12/01
Last modified on 2019/05/31

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Basic information
Public title Decision Making and Adherence to Antiretroviral Therapy in Patients Infected with Human Immunodeficiency Virus in Japan: Observational Study
Acronym DEARS - J
Scientific Title Decision Making and Adherence to Antiretroviral Therapy in Patients Infected with Human Immunodeficiency Virus in Japan: Observational Study
Scientific Title:Acronym DEARS - J
Region
Japan

Condition
Condition HIV infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the medication adherence at 48 weeks after initiation of treatment in ART-naive patients infected with Human Immunodeficiency Virus.
Basic objectives2 Others
Basic objectives -Others The aim of this study is to examine the relationship between medication adherence at 48 weeks and decisional conflict (scores), regret (scores) and virological outcomes at the initiation of ART therapy in ART-naive patients infected with Human Immunodeficiency Virus.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Medication adherence at 48 weeks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosed with HIV infection
ART-naive and newly starting ART
Key exclusion criteria Severe psychiatric disorder.
Cognitive impairment affecting answers to questionnaires
Mother tongue is not Japanese
Target sample size 225

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Sekine
Organization Tokyo Medical University
Division name Department of Pharmacy
Zip code
Address 160-0022, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Email y-sekine@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kawaguchi
Organization Tokyo University of Pharmacy and Life Sciences
Division name Department of Practical Pharmacy
Zip code
Address 192-0392, 1432-1 Horinouchi, Hachioji, Tokyo, Japan
TEL 042-676-1521
Homepage URL
Email tkawa@toyaku.ac.jp

Sponsor
Institute Tokyo Medical University
Department of Pharmacy
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京医科大学病院、国立病院機構大阪医療センター、国立病院機構九州医療センター、国立国際医療研究センター病院、国立病院機構名古屋医療センター、札幌医科大学附属病院
東北大学大学院、東京大学、東京薬科大学

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 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
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
2017 Year 10 Month 10 Day
Date of IRB
2017 Year 06 Month 27 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Before starting ART, decisional conflict, viral load, CD4 count, and QOL are assessed.
Medication adherence, viral load, CD4 count and QOL,were evaluated at week 4.
Medication adherence, decisional regret, QOL, viral load, and CD4 count were evaluated at week 24 and 48.

Management information
Registered date
2017 Year 11 Month 28 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034218

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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