CORAL - CabOtegravir and Rilpivirine ReAL World Experience
Research type
Research Study
Full title
A non-interventional, multi-method, prospective cohort study to characterise the real-world implementation, roll out, safety and patient experience of the long-acting injectable HIV treatment regimen of 2-monthly cabotegravir and rilpivirine
IRAS ID
323249
Contact name
Fiona Cresswell
Contact email
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The long-acting injectable antiretroviral therapy (ART) regimen of cabotegravir and rilpivirine given 2-monthly is a widely welcomed paradigm shift in HIV treatment in the United Kingdom. It was approved by the NICE in 2022 and The British HIV Association (BHIVA) has released guidance on its use. Current trial data suggest it is a well-liked and efficacious regimen. There are numerous advantages to this regimen over traditional daily oral ART, such as less user-dependence and potential stigma reduction.
Outside of clinical trials and the very recent wider roll-out, this treatment regimen has only been used in select circumstances on compassionate grounds, in a small number of individuals. As such, there is a lack of data on feasibility, acceptability, and clinical outcomes in real-world clinical practice. It has been left up to individual clinics to determine the best ways in which to integrate injectable service delivery within their respective settings and there is a need to understand different implementation strategies planned/adopted and to share experiences.
It is not currently known what proportion of people living with HIV (PLWH) in the UK would be eligible for the regimen according to the BHIVA criteria, how many of those eligible will be approached about a treatment switch, and how many of these will opt to switch. Characterising this adoption cascade, as well as the individual and system-related factors at play is important as it will enable a better understanding of the ultimate uptake of the regimen.
CORAL is a non-interventional, multi-centre, prospective observational study with a nested qualitative component, set across 10 NHS HIV treatment centres who have planned/commenced the delivery of injectable ART. We will capture clinical and qualitative data from participants and healthcare workers, to help determine barriers and facilitators to the implementation and delivery of the regimen and describe different implementation approaches.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0534
Date of REC Opinion
27 Jul 2023
REC opinion
Further Information Favourable Opinion