Project overview
The long-acting injectable cabotegravir and rilpivirine (CAB+RPV) represents a promising and widely welcomed paradigm shift in HIV treatment.
This combination antiretroviral treatment (cART) for HIV is given by intramuscular injection once every 2-months. The regimen was approved by the National Institute of Clinical Excellence and British HIV Association in 2022 following clinical trials which showed it was equally effective as oral cART and well tolerated. These clinical trials, however, are in highly controlled environments and don’t always reflect what happens with in real world. Therefore, there is currently no real-world data on implementation strategies, feasibility, patient experiences or the clinical outcomes of injectable cabotegravir and rilpivirine in the UK.
To develop our knowledge of injectable cabotegravir and rilpivirine in real-world settings, this observational cohort study will capture routine clinical data from adults receiving injectable cabotegravir and rilpivirine, as well as a group receiving oral CART for comparison. In addition, all participants will be invited to complete questionnaires to track treatment satisfaction and quality of life across three timepoints in this year-long observational study. A subset of participants will further be invited to take part in in-depth interviews with a view to gaining a deeper understanding of participants’ experiences and perceptions of injectable cabotegravir and rilpivirine. We will also speak to the healthcare workers facilitating or delivering this new treatment to understand their views on factors that have enhanced or delayed its roll out in HIV services. This study is being conducted across 11 different NHS HIV centres in the UK with varying cohort sizes and geographical locations to ensure data will be representative of the UK.
The purpose of the CORAL study is to deepen our understanding of the rollout, uptake and effectiveness of injectable CAB+RPV in the real world. Capturing this data as the regimen is implemented across the country will form a basis for future work to optimise use of injectable CAB+RPV as a treatment option.