ILANA
Research type
Research Study
Full title
The ILANA Study: Implementing Long-Acting Novel Antiretrovirals
IRAS ID
313217
Contact name
Chloe Orkin
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Until now treatment for HIV infection has always been daily oral antivirals. Many people with HIV (PWH) find it challenging to take pills every day and this can be for many different reasons, such as the pressure to renew prescriptions in time, to have a supply of medication with them at all times, side effects, anxiety about taking pills, confidentiality concerns, and acting as a daily reminder of having HIV. Life circumstances such as unstable housing and personal commitments can add to these challenges. For some people, these challenges mean poor or no adherence to their treatment.
Long-acting (LA), intramuscular injectable HIV treatment with LA Cabotegravir and Rilpivirine (Vocabria and Rekambys) has been developed and shown to be effective and safe in three large phase III clinical trials. It is now recommended as a treatment option in both the British HIV Association, NICE and European guidelines and it is in use for NHS patients.
HIV clinic services have organised their systems around providing oral medications and there now needs to be a re-organisation of services to enable PWH to have the option of injectable therapy if they wish. The ILANA study is a study that is based at six HIV clinics in England. It will seek to gather information about implementing injectable therapy in a “real world” environment both in an HIV clinic and community-based settings such as third sector organisations, GP or pharmacy. The study will determine the factors which help increase the satisfaction and acceptability of injectable therapy by PWH, as well as factors which would help services and health care professionals (HCPs) deliver injectable therapy in the best way through questionnaires for both PWH and HCPs administered at three different times over a year of patient treatment with Vocabria and Rekambys.
Lay summary of study results: ILANA (Implementing Long-Acting Novel Antiretrovirals):A summary of ILANA, a study looking at whether giving CAB+RPV injections in HIV clinics and community settings is acceptable and practical for people living with HIV and healthcare staff
Background
Long-acting injectable cabotegravir and rilpivirine (CAB+RPV) is a new form of treatment for some people living with HIV. Instead of taking pills every day, an injection can be given every two months.
CAB+RPV injections have been found to be as effective as HIV pills in several clinical trials. It was approved for use on the NHS as HIV treatment for people with an undetectable viral load on 30 November 2021.
Providing CAB+RPV injections instead of pills means changing the way that HIV treatment is delivered in HIV clinics. It means that people with HIV need to come to the clinic more often (i.e., every two months for an injection rather than every six months to collect pills), and this puts pressure on staff time and use of rooms within the clinic.
Providing injections outside of the HIV clinic, within the community – such as in people’s homes, or at charities that support people with HIV – could help to relieve some of these pressures. It might also be appealing to people who find it challenging to attend the clinic, for example if the clinic is very far from their home or they feel worried about being seen entering an HIV clinic.
It is not known how people with HIV in England or their healthcare staff feel about receiving or providing CAB+RPV injections in the clinic and the community.
Who took part in the study and how was it carried out?
We designed the study with people living with HIV. Together, we set targets to ensure that that our participants were at least 50% women, 50% from racially minoritised backgrounds and 30% aged 50+ years. We did this because these groups have previously been underrepresented in HIV research.
114 people with HIV at six HIV clinics in England took part in the ILANA study for 12 months, beginning in summer 2022. 62 (54%) were women, 80 (70%) were from racially minoritised backgrounds, and 46 (40%) were aged 50+ years.
People with HIV taking part in ILANA received CAB+RPV injections for six months in the HIV clinic. After six months, they chose to either continue receiving their injections in the clinic or start receiving injections at the community setting offered by their clinic. Of the six HIV clinics that took part in ILANA, two offered CAB+RPV injections at a local HIV charity, three offered CAB+RPV injections at home, and one offered CAB+RPV injections at a community sexual health clinic.
27 (24%) chose to attend the community setting after six months, with 8 attending an HIV charity and 19 receiving their injections at home (nobody chose to receive their injections at the community sexual health clinic).
Everyone taking part in ILANA completed questionnaires throughout the study, and 14 people with HIV also took part in two interviews, at the beginning and end of the study. These helped us to understand:
• Whether and to what extent people with HIV liked CAB+RPV injections as a treatment, felt they were a good fit for their lives, and found them easy to use.
• Whether and to what extent people with HIV liked receiving treatment in a community setting, felt this was a good fit for their lives, and found it easy to do.What did people with HIV think of CAB+RPV injections as a treatment?
By the end of the study, we found that 85% of people with HIV taking part in ILANA said they liked CAB+RPV injections as a treatment, 87% felt they were a good fit for their lives, and 79% thought it was easy to use.
We found that more people who chose to receive injections in the community felt the injections were a good fit for their lives and felt they were easy to use, compared to people who stayed in the clinic. We also found that fewer Black people and fewer women felt CAB+RPV injections were a good fit for their lives and that they were easy to use, compared to non-Black people and men, respectively. But the proportion of people who liked the treatment was similar across all the groups.
From the interviews we learned that having previous challenges with taking pills – such as worrying about other people finding them – meant people really liked the CAB+RPV injections. People did have concerns about switching treatments in the beginning, including experiencing pain from the injections. By the end of the study, these concerns had mostly gone away. Pain varied with the individual, but nearly everyone said that the injections got less painful over time. Most found the CAB+RPV injections easy to use as a treatment and a good fit for their lives. For some, attending more frequent appointments was difficult, for example if their employer wasn’t very flexible with them taking time off to attend clinic. But the fact they really wanted the new treatment made them more willing to deal with these challenges.What did people with HIV think about receiving CAB+RPV injections in community settings?
We found that there were mixed views about receiving CAB+RPV injections in community settings. Among those who chose to have CAB+RPV injections in a community setting in the second half of the study, 73% liked receiving their injections in the community, 81% felt it was a good fit for their lives, and 81% thought it was easy to do.
But among those who chose to remain in the HIV clinic, only 33% liked the idea of receiving injections in the community, 35% felt it was a good fit for their lives, and 35% thought it would be easy to do.
The interviews highlighted that those who chose to remain in the clinic had concerns about receiving their injections in a community setting. For some, this was because they were worried about more people knowing their HIV status. Some were interested in receiving injections in a community setting that was not on offer at their clinic, such as at their GP. Many said they felt comfortable at the HIV clinic, so they didn’t need to go somewhere else. However, they did think other people might like to receive their injections in a community setting.
Those who received injections at home felt this was much easier than having to travel to the clinic, and one person said they preferred it as they did still worry occasionally about being seen entering the HIV clinic. One person who took part in the interviews attended a local HIV charity for their injections, which they found ok, but they preferred attending the clinic.Why is this important?
This study gives us insight into how best CAB+RPV injections can be delivered in the UK.
We have learned that it is an extremely popular treatment for people with HIV, although it won’t be for everyone. Some won’t meet the eligibility criteria, and some may dislike needles, find the injections too painful, or not want to attend the clinic every two months.
We have also learned that delivery of CAB+RPV injections in the community can work well for some people, but most people in our study felt community delivery wouldn’t be a good fit for them. This shows that it’s important to keep providing CAB+RPV injections in HIV clinics, while still looking for ways to reduce time and capacity pressures.Details of any further research planned
The clinic and community healthcare staff providing the injections as part of the ILANA study were also asked to complete questionnaires throughout the study. A smaller group volunteered to take part in interviews at the beginning and end of the study.
These results have not yet been analysed and will be shared once they have been written up.
We also plan to report on the findings from the No-LANA sub-study which evaluated the views of people who chose not to participate in ILANA. The analysis of this study is underway.Who funded and carried out this study?
ILANA was funded by ViiV Healthcare – the pharmaceutical company that markets CAB+RPV injections in the UK. The study was carried out by an independent research team based at Queen Mary University of London, called the SHARE Collaborative. All of SHARE’s research is focused on tackling the inequalities that lead to poor health outcomes for people with infectious diseases.
Where can I learn more about this study?We will be sharing all our outputs on the SHARE Collaborative website – https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.shareresearch.org.uk%2F&data=05%7C02%7CTracy.Hamrang%40hra.nhs.uk%7Cd6698af388dc4b0434d408dd405f12b4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638737499262582561%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1UiVGLBIz2wSs2SL5qXzOxVtYV%2F7YrmOUnmspioFaFQ%3D&reserved=0 – and our social media accounts: @shareeastlondon.bsky.social (BlueSky), @shareeastlondon (Instagram), Share-Research-Collaborative (LinkedIn)
REC name
London - City & East Research Ethics Committee
REC reference
22/PR/0318
Date of REC Opinion
19 Apr 2022
REC opinion
Favourable Opinion