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Study on Decision-Making and Long-Acting Agents in HIV Treatment

Japan Antiretroviral Decision and CAB+RPV Implementation Study - JADE Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058396
Enrollment
400
Registered
2025-07-08
Start date
2025-07-07
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection

Interventions

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 el

Sponsors

International University of Health and Welfare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
To evaluate the utility of a Patient Screener and Shared Decision-Making Guide and the acceptability of CAB+RPV LA in PLWH and HCPs.

Countries

Japan

Contacts

Public ContactJunko Tanuma

International University of Health and Welfare Department of Infectious Diseases

jadestudy2025@gmail.com0476-20-7701

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026