Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058396) titled 'Study on Decision-Making and Long-Acting Agents in HIV Treatment' on July 8.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - HIV infection Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 400

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066735

Disclaimer: Curated by HT Syndication.