UMIN-CTR Clinical Trial

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
Email	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
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	Tokyo Medical University Institutional Review Board
Address	6-1-1, Sinjuku, Shinjuku-ku,Tokyo
Tel	03-3351-6141
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034218