CABFIDENCE CAB+RPV LA study
Research type
Research Study
Full title
CABFIDENCE: Global Real-World Evidence Cohort Study to evaluate Utilization, Clinical and Patient-Reported Outcomes among CAB+RPV LA users.
IRAS ID
365876
Contact name
Joseph Heskin
Contact email
Sponsor organisation
ViiV Healthcare
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 9 months, 31 days
Research summary
The study is a global non-interventional prospective observational cohort study among people living with HIV treated with cabotegravir+rilpivirine long acting (CAB+RPV LA). The study will assess the global utilization patterns, adherence, persistence, discontinuation, virologic effectiveness, and patient-reported outcomes of this regimen in a real-world clinical setting.
The study aims to enroll up to approximately 2,000 participants. Anticipated countries include United Kingdom, Italy, Portugal, France, Spain, Germany, Japan, South Korea, Taiwan, Australia, Canada, and the United States.
The study population will include treatment-experienced virologically suppressed (VL < 50 copies/mL) individuals who are 18 years or older and either received or are starting CAB+RPV LA with every 2-month dosing schedule.
Retrospective participants will include individuals who initiated CAB+RPV LA from January 2023 and will be followed for up to two years. Prospective participants will include individuals enrolled from November 2025 until study size is reached and will be followed for a minimum of two years, unless they withdraw from the study, are lost to follow-up, or pass away.
Participants who discontinue and switch to a subsequent regimen or who experience CVF will be followed-up for a minimum of 6 months and may be extended until viral load assessment is completed, with a maximum duration of 12 months.
Data for this study will be obtained via the following sources:
- Participant medical information via site-completed electronic case report form at enrollment and at minimum of two annual follow-ups (unless participant discontinued CAB+RPV LA).
- Participant surveys: Prospective participants will be asked to complete an online survey at enrollment, at month 12, and if they discontinue CAB+RPV LA. The baseline survey will be administered prior to the first CAB+RPV LA injection. Participants will be asked to complete the WHOQOL-HIV BREF, HIVTSQs, and the HIVTSQc and several bespoke questionnaires developed for this study.REC name
London - London Bridge Research Ethics Committee
REC reference
26/LO/0320
Date of REC Opinion
12 May 2026
REC opinion
Further Information Favourable Opinion