Cabotegravir and rilpivirine real-world experience
| ISRCTN | ISRCTN11668233 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11668233 |
| IRAS number | 323249 |
| Secondary identifying numbers | PF15151, IRAS 323249, CPMS 56893 |
- Submission date
- 05/02/2024
- Registration date
- 07/02/2024
- Last edited
- 08/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The purpose of the CORAL study is to obtain real-world data on the uptake, acceptability, and effectiveness of injectable 2-monthly long-acting cabotegravir and rilpivirine delivered in NHS clinics. Recent clinical trials have shown that the injectable long-acting cabotegravir and rilpivirine is safe, well tolerated and effective in controlling HIV. However, clinical trials are highly controlled environments and don’t always reflect what happens in the real world. Real-world data from NHS HIV clinics is needed to better understand the uptake of injectable HIV treatment, the effectiveness of the injectable treatment and whether injections will be received on time.
Who can participate?
Individuals aged 16 years old and over who are receiving treatment with long-acting cabotegravir and rilpivirine; and individuals receiving oral HIV treatment can be part of the comparator group.
What does the study involve?
If individuals provide their consent to participate, the staff members at their HIV clinic will complete a questionnaire with data on their gender, age, date of HIV diagnosis, routine blood results, medical treatment, and illnesses for up to the next 5 years. The data will be extracted from their medical records. Following this, every 6 months, data from their routine visits to the clinic, information on medical history, blood test results, treatment, and possible symptoms and illnesses relating to HIV or its treatment will be collected from their patient records.
The study will not test any drugs and will not interfere with any treatment the participants may receive at the clinic. Participants are consenting to allow the researchers to gather routinely collected information about them and their care.
Participants will be required to complete a questionnaire at the time of enrollment, and then after 6 and 12 months. The questionnaire will take a maximum of 30 minutes to complete. It can be completed online in the comfort of their own home or at the clinic. After the completion of each questionnaire, participants will be given a £20 shopping voucher as a thank you for their time and effort.
An additional sub-cohort of people with HIV who are either new to the CORAL study or exiting the CORAL main study, who have ever received a dose of long-acting cabotegravir and rilpivirine will be asked to provide consent for the collection of their routine clinical data.
What are the possible benefits and risks of taking part?
The study seeks to improve knowledge about long-acting antiretroviral treatment delivered through the NHS. Therefore, participation in the CORAL study does not include any additional risks.
Where is the study run from?
The study is being run by the University of Sussex and taking place in different UK HIV clinics.
When is the study starting and how long is it expected to run for?
January 2023 to December 2026. The first HIV clinic will start running the study in February 2024. Each HIV clinic will run the study for 2 years.
Who is funding the study?
The CORAL study has received funding from ViiV Healthcare LLC.
Who is the main contact for the study?
Please contact the study manager Dr Kate Alford - K.Alford@bsms.ac.uk or the chief investigator Dr Fiona Cresswell - F.Cresswell@bsms.ac.uk
Contact information
Public, Scientific
94 N-S road, University of Sussex, Falmer
Brighton
BN19PQ
United Kingdom
 ORCID ID |
0000-0001-5356-5644 |
|---|---|
| Phone | +44 (0)1273 877889 |
| K.Alford3@bsms.ac.uk |
Principal Investigator
Medical School Teaching building, University of Sussex , Falmer
Brighton
BN1 9XP
United Kingdom
| ORCID ID |
0000-0002-5070-532X |
|---|---|
| Phone | +44 (0)1273 877899 |
| f.cresswell@bsms.ac.uk |
Study information
| Study design | Non-interventional prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home, Hospital, Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A non-interventional, mixed-methods, 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 |
| Study acronym | CORAL (Cabotegravir and Rilpivirine Real wOrLd experience) |
| Study hypothesis | There are likely to be challenges in the implementation of long-acting (LA) cabotegravir+ rilpivirine (CAB+RPV) as part of routine clinical care in real-world settings; characterising these barriers will aid the development of strategies to overcome them. However, high levels of effectiveness and acceptability will be demonstrated in those who do switch to LA CAB+RPV in a real-world setting. |
| Ethics approval(s) |
Approved 27/07/2023, Seasonal REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048129; seasonal.rec@hra.nhs.uk), ref: 23/LO/0534 |
| Condition | People living with HIV on injectable antiretroviral treatment (CAB+RPV) |
| Intervention | Current interventions: This is a 2-year study (with a 12-month recruitment and a 12-month follow-up period for each participant), two-arm, multi-centre, mixed methods study examining the real-world experiences of people living with HIV and receiving long-acting (LA) injectable cabotegravir and rilpivirine (CAB+RPV). This is an observational study which includes completing some questionnaires. This study examines the adoption of LA CAB+RPV in different HIV services across the UK. Additionally, it will examine the acceptability, feasibility, fidelity and effectiveness of LA CAB+RPV. Participants are required to complete a health-related quality of life questionnaire (the HIVPROM) and a treatment experience and satisfaction questionnaire at three time points over the 1-year follow-up period (i.e., baseline, 6 months and 12 months (study end)). A sub-sample of participants, purposively selected to represent the population, will also be invited to share their experiences in an in-depth interview with a researcher, from 6 months onwards. Additionally, HIV clinical variables will be recorded from routine blood samples taken at each LA injectable appointment and information on injection schedule completion and reasons for any discontinuations will be captured from patients’ medical records. All study activities will take place at the patient's HIV service with the support of a research nurse, however, participant questionnaires will be available to complete online and at home. An additional sub-cohort called the CORAL-Light cohort will be recruited from those new to the CORAL study or exiting the main CORAL study. For these participants only routinely collected clinical data is collated, there are no procedures after provision of informed consent _____ Previous interventions as of 08/04/2025: This is a 2-year study (with a 12-month recruitment and a 12-month follow-up period for each participant), two-arm, multi-centre, mixed methods study examining the real-world experiences of people living with HIV and receiving long-acting (LA) injectable cabotegravir and rilpivirine (CAB+RPV). This is an observational study which includes completing some questionnaires. This study examines the adoption of LA CAB+RPV in different HIV services across the UK. Additionally, it will examine the acceptability, feasibility, fidelity and effectiveness of LA CAB+RPV. Participants are required to complete a health-related quality of life questionnaire (the HIVPROM) and a treatment experience and satisfaction questionnaire at three time points over the 1-year follow-up period (i.e., baseline, 6 months and 12 months (study end)). A sub-sample of participants, purposively selected to represent the population, will also be invited to share their experiences in an in-depth interview with a researcher, from 6 months onwards. Additionally, HIV clinical variables will be recorded from routine blood samples taken at each LA injectable appointment and information on injection schedule completion and reasons for any discontinuations will be captured from patients’ medical records. All study activities will take place at the patient's HIV service with the support of a research nurse, however, participant questionnaires will be available to complete online and at home. |
| Intervention type | Other |
| Primary outcome measure | Adoption of LA CAB+RPV measured using data collected from patient medical records at the end of the study (2 years from site opening) |
| Secondary outcome measures | 1. Acceptability of LA CAB+RPV will be assessed based on: 1.1. Findings from in-depth qualitative interviews and focus groups with patient participants and healthcare workers (HCWs) 1.2. Comparison of patient-reported outcomes, measured using the patient-reported outcome measure for adults living with HIV (HIV PROM) and the treatment satisfaction and treatment preference questionnaire, at months 0, 6 and 12 post-switch to LA CAB+RPV 2. The feasibility of LA CAB+RPV will be assessed based on: 2.1. Findings from in-depth qualitative interviews and focus groups with patient participants and HCWs 2.2. Patient and HCW questionnaires, measured using the treatment satisfaction and treatment preference questionnaire at months 0, 6 and 12 post-switch to LA CAB+RPV (patient) and the HCW survey collected during the participant recruitment period (HCWs) 3. Fidelity will be assessed based on the below and measured using data collected from participant medical records: 3.1. The proportion of injections delivered within the visit window 3.2. Number of oral bridging courses per patient per year 3.3. Fidelity to 2-monthly HIV viral load monitoring (+/- 2 weeks of target date) 4. Effectiveness assessed based on: 4.1. The proportion of those who begin LA CAB+RPV who remain virologically suppressed at 12 months (by FDA snapshot algorithm and intention to treat approach), and the proportion of those on oral ART who remain virologically suppressed at 12 months after the baseline date measured using data collected from participant medical records 4.2. The proportion of each group who have experienced virological failure at 12 months measured using data collected from participant medical records 4.3 The number of HIV-related medical events at 12 months measured using data collected from participant medical records |
| Overall study start date | 01/01/2023 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 200 plus 350 participants recruited into the CORAL-Light sub-cohort |
| Participant inclusion criteria | 1. Understand the participant information and the study requirements and has the capacity to consent 2. Willing to comply with study procedures 3. Age 16 years or above 4. Is a member of one of the following groups: 4.1. LA group - PLWH who have been recently switched (within the prior 6 months) or are prospectively switched to LA CAB+RPV during the enrolment period. This includes those who have received LA CAB+RPV outside of BHIVA criteria or on compassionate grounds. 4.2. Oral ART group - PLWH who are demographically similar but not eligible for LA CAB+RPV according to BHIVA eligibility criteria and who continue oral ART within the study period (e.g. those who are HBVcoreAb+ or who have an underlying drug resistance mutation that precludes use of LA CAB+RPV). The intervention group to the oral group will be matched 3:1 by calendar period and other key variables where possible. (added 08/04/2025) CORAL-Light sub-cohort: Anyone >16 years old who has received one or more doses of LA CAB+RPV who is not in the main CORAL study cohort or exiting the main CORAL cohort |
| Participant exclusion criteria | 1. In the opinion of the investigator is unable or unwilling to comply with the study requirements 2. Aged < 16 years old |
| Recruitment start date | 12/02/2024 |
| Recruitment end date | 30/06/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Cardiff
CF14 4HH
United Kingdom
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
London
SE1 7EH
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
University/education
University of Sussex, Falmer
Brighton
BN19XP
England
United Kingdom
| Phone | +44 (0)1273 877773 |
|---|---|
| researchsponsorship@sussex.ac.uk | |
| Website | https://www.sussex.ac.uk/ |
"ROR" |
https://ror.org/00ayhx656 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- ViiV Healthcare Limited
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Study results will be published in high-impact peer-reviewed journals and will be presented at national and international meetings. Publication will be following internationally recognized scientific and ethical standards concerning publications and authorships. We will ensure that all relevant stakeholders receive information on study outcomes. Full anonymity of participants’’ details will be maintained throughout, and no individual patient data will be presented |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later data |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 28/06/2023 | 07/02/2024 | No | No |
Additional files
Editorial Notes
08/04/2025: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2026 to 31/12/2026.
2. The interventions were changed.
3. The study website was added.
4. The inclusion criteria were updated.
5. The target number of participants was changed from 200 to 200 plus 350 participants recruited into the CORAL-Light sub-cohort
6. The recruitment end date was changed from 30/04/2025 to 30/06/2026.
7. The study participating centres Belfast Health and Social Care Trust, The Royal Wolverhampton NHS Trust were removed and The Newcastle upon Tyne Hospitals NHS Foundation Trust was added.
8. The plain English summary was updated to reflect these changes.
04/03/2024: Internal review.
05/01/2024: Study's existence confirmed by the Health Research Authority.
