UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058396 |
|---|---|
| Receipt number | R000066735 |
| Scientific Title | Japan Antiretroviral Decision and CAB+RPV Implementation Study |
| Date of disclosure of the study information | 2025/07/08 |
| Last modified on | 2025/07/08 08:16:42 |
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Basic information
Public title
Study on Decision-Making and Long-Acting Agents in HIV Treatment
Acronym
JADE Study
Scientific Title
Japan Antiretroviral Decision and CAB+RPV Implementation Study
Scientific Title:Acronym
JADE Study
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize the ART preferences of people living with HIV (PLWH) and the attitudes of both PLWH and healthcare professionals (HCPs) regarding oral versus long-acting injectable (LAI) therapies, to evaluate the implementation of shared Decision-Making (SDM) tools in guiding ART regimen changes and their impact on patient satisfaction, and to evaluate the implementation of cabotegravir (CAB) + rilpivirine (RPV) LA and its clinical outcomes.
Basic objectives2
Others
Basic objectives -Others
Implementation Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the utility of a Patient Screener and Shared Decision-Making Guide and the acceptability of CAB+RPV LA in PLWH and HCPs.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Patient Screener consists of five questions answered by PLWH. It is completed by the PLWH before the clinical consultation and is used by healthcare professionals to identify individuals who may be eligible candidates for CAB+RPV LA.Shared Decision-Making Guide is a leaflet that provides information on multiple ART options available in Japan, including oral ART regimens and a LAI, and is used to facilitate discussions between PLWH and healthcare professionals about potential switches to alternative ART regimens. At the time of enrollment, a baseline survey will be conducted. At the next visit within 4 month after the baseline survey, an interview regarding treatment options will be held between people living with HIV and healthcare providers using the Patient Screener and the Shared Decision-Making Guide. A post-intervention survey will be conducted following the interview.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Part I. Implementation of a Patient Screener and shared Decision-Making Guide
PLWH:
1.Over 18 years old
2.Agree to complete the Part I surveys
3.Virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months
4.Without present or past evidence of viral resistance to either CAB or RPV, and with no prior virological failure
5.Serologically negative for hepatitis B surface antigen
6.Not pregnant
7.Not breastfeeding
8.Must not use medicines contraindicated to CAB+RPV LA and oral CAB+RPV
HCPs:
1.Either a physician, nurse, or pharmacist working at the study sites
2.Agree to complete the Part I surveys
Part II. Implementation of CAB+RPV LA
PLWH:
1.Over 18 years old
2.Completed Part I of the study
3.Agree to complete the Part II survey and interview at M8
4.Will switch to CAB+RPV LA as part of their routine clinical care
5.Virologically suppressed (HIV- 1 RNA <50 copies/mL) for at least 6 months on ART
6.Without present or past evidence of viral resistance to either CAB or RPV, and with no prior virological failure
7.Serologically negative for HBs antigen
8.Not pregnant
9.Not breastfeeding
10.Must not use medicines contraindicated to CAB+RPV LA and oral CAB+RPV
HCPs:
1.Either a physician, nurse, or pharmacist working at the study sites
2.Have at least one patient that switched to CAB+RPV LA following use of the shared Decisions Making Tool and Patient Screener
3.Agree to complete the survey and interview
Key exclusion criteria
Individuals who meet any of the following criteria will be excluded from this study.
PLWH and HCPs:
1.Cognitively impaired
2.Unable to speak, read, and write in Japanese
3.Critically ill subjects
4.Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result or the participant's ability to participate in the trial.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Tanuma |
Organization
International University of Health and Welfare
Division name
Department of Infectious Diseases
Zip code
286-8686
Address
4-3 Kozunomori, Narita-City, Chiba, Japan
TEL
0476-20-7701
jadestudy2025@gmail.com
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Tanuma |
Organization
International University of Health and Welfare
Division name
Department of Infectious Diseases
Zip code
286-8686
Address
4-3 Kozunomori, Narita-City, Chiba, Japan
TEL
0476-20-7701
Homepage URL
jadestudy2025@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
ViiV Healthcare
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Area Institutional Review Board, International University of Health and Welfare
Address
4-3 Kozunomori, Narita-City, Chiba, Japan
Tel
0476-20-7708
rinri_md@ihwg.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
| 2025 | Year | 07 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066735
