UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030146 |
|---|---|
| Receipt number | 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 | 2021/03/26 15:02:46 |
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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 | Yusuke |
| Middle name | |
| Last name | Sekine |
Organization
Tokyo Medical University
Division name
Department of Pharmacy
Zip code
160-0023
Address
160-0022, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
y-sekine@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kawaguchi |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Practical Pharmacy
Zip code
192-0392
Address
192-0392, 1432-1 Horinouchi, Hachioji, Tokyo, Japan
TEL
042-676-1521
Homepage URL
tkawa@toyaku.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Department of Pharmacy
Institute
Department
Personal name
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
Tokyo Medical University Institutional Review Board
Address
6-1-1, Sinjuku, Shinjuku-ku,Tokyo
Tel
03-3351-6141
d-irinri@tokyo-med.ac.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
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
Main results already published
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
| 2021 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034218
