BSMS > Research > Support and governance > JCRO > Current studies and feedback

Current studies and feedback

Find out about some of the studies currently supported by the JCRO.

BACKGROUND IMAGE FOR PANEL

Current studies

Title

CORAL: Open Cohort Study to Characterise Real World Experience of Long-acting Cabotegravir and Rilpivirine in United Kingdom

Chief Investigator

Dr. Fiona Cresswell

Grant Lead Institution and Sponsor

University of Sussex

Grant Funder

ViiV Healthcare UK Ltd

The purpose of this study is to characterise real world implementation, clinical outcomes and patient and clinician experience of 2-monthly long-acting injectable antiretroviral regimen of cabotegravir and rilpivirine in the UK. Injectable HIV treatment is a paradigm shift in HIV care which has only been possible through daily oral pill taking for the last 2 decades.

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. The project 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.

The CORAL study is in active phase and recruiting at the lead NHS site, University Hospitals Sussex NHS Trust. We are in the process of setting up further NHS sites, with a total recruitment target for the study of 200.

JCRO have provided support at all stages of the project to date:

Grant application – JCRO coordinated the budget, supported submission of the application form, SoECAT was also drafted and supported through to validation;
Study Setup – JCRO advised on the required documentation for HRA submission, coordinated the collaboration agreement, NHS site contracts, Local Information Packs
Active Stage – A JCRO Research Manager attends regular meetings with the CORAL team to provide advice and support around contracts, budgeting and the SoECAT. They work collaboratively with the Study Manager in responding to site queries to ensure sites are set up and opened on target.

Dr Fiona Cresswell quoted: “The JCRO have been incredibly helpful through every step of the research cycle from proposal development to project set up and delivery. They have shown real expertise and experience in budgeting and I would have been lost without their guidance"

Click here to CORAL webpage>

BACKGROUND IMAGE FOR PANEL

Title

Palliative Long-term Abdominal Drains Versus Repeated Drainage in Untreatable Ascites Due to Advanced Cirrhosis: A Randomised Controlled Trial (REDUCe 2 Study)

Chief Investigator

Sumita Verma (University of Sussex, BSMS)

Grant Lead Organisation

University Hospitals Sussex NHS Foundation Trust

Grant Sponsor

University of Sussex

Grant Funder

NIHR Health Technology Assessment (HTA)

Value of Grant

£1,936,183

The REDUCe 2 study is a 35-centre randomised controlled trial led by Professor Sumita Verma and awarded funding of £1,936,183 by NIHR Health Technology Assessment in February 2022. The study is hosted by University Hospitals Sussex NHS Foundation Trust and sponsored by the University of Sussex.

REDUCe 2 is recruiting 310 patients with end-stage liver disease and refractory ascites, randomised to either long-term abdominal drains (LTADs) or large volume paracentesis (LVP - standard of care requiring repeated hospitalisation for drainage). The trial runs for 57 months and aims to assess whether LTADs result in better health-related quality of life compared to standard of care in this group of patients. An embedded qualitative study also investigates perspectives on both LTADs and LVP by 30 patients, 20 caregivers and 30 health care professionals.

The study is now recruiting and the JCRO provided support at all stages of the project:

Grant stage: The JCRO supported an initial two-stage submission and the final two-stage funded resubmission. This involved bringing the PI, partner organisations, CTU, CRN and RDS together for regular meetings to discuss and review the project and agree costings. We managed the university, external and NHS costings, including finalising the research budget, coordination of various iterations of the SoECAT, completion of the budget pages of the application form and review of the justification of costs.

The JCRO led discussions with partners around Sponsorship in Principle, Lead Organisation and Research Capability Funding (RCF) for the grant.

Set up and active stages: The JCRO manages the contracting for REDUCe 2, including managing the site agreements for 35 NHS sites and drafting and coordinating the collaboration agreement with 12 parties.

A JCRO Research Manager attends regular meetings with the REDUCe 2 team to provide advice and support around contracts, budgeting and the SoECAT. They work collaboratively with the CTU Trial Manager in responding to site queries to ensure sites are set up and opened on target.

Click here to REDUCe 2 study webpage >

Title
Testing the feasibility and acceptability of case-finding and subsequentcomprehensive geriatric assessment intervention for older people with HIVwith frailty

Chief Investigator
Jaime Vera

Grant Lead Institution and Sponsor
University Hospitals Sussex NHS Foundation Trust (UHSx)

Grant Funder
NIHR, Research for Patient Benefit (RfPB).

Value of Grant
£249,990

This two centre feasibility study (UHSx and Kings College London), had confirmation by the NIHR in April 2020 to be funded.

84 older people with HIV and frailty will be recruited, and after being screened for frailty they will be randomised during their routine HIV annual health check to either receive standard care (from HIV experts and GPs), or they will have a comprehensive geriatric assessment (from HIV and elderly care experts). Questionnaires and interviews will ask about if older people with HIV happy to be tested for frailty?, How they feel about having a Comprehensive Geriatric Assessment?, Does a Comprehensive Geriatric Assessment help older people with HIV?.

It will be assessed if the team was able to recruit enough people into the study?, and if the study was acceptable to older people with HIV? The results are intended to help design a larger trial. They will also be fed back to people with HIV and health professionals.

The study is now active, with the study team commencing work on Work Package 1. The Clinical component of the research is due to start within the next couple of months. The JCRO have provided support, at all stages of the project to date:

Sponsorship in Principle: We led discussions with the lead Trust, BSUH and the University to decide which institution is most appropriate to Sponsor the Research.

Grant Support: We brought the different individual organisations together to cost the study liaising with the other HEI and the NHS Trust to compile the budget. Support was given to the CI in filling out the Budget pages of the Application form. The SoECAT (Schedule of Events Cost Attribution Template) was also drafted, and supported through the validation process.

Study Setup: The JCRO advised UHSx of the required documents needed for HRA submission, as well as Supported UHSx identify the nature of contracts needed. Guidance was given drafting the Tripartite Collaboration Agreement, and the sub-contractor template. The JCRO provided the review on behalf of the University of the Collaboration Agreement.

We also Liaised with the University Research Finance team around the advertisement and approval of the Research Assistant Post at the University, and provided support to UHSx on required NIHR Grant reporting processes.

BACKGROUND IMAGE FOR PANEL

Past studies

Title

PIBIK - A Phase IV Randomised, Open-Label Pilot Study to Evaluate Switching from Protease-Inhibitor based regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in virologically suppressed HIV-1 infected adults harbouring drug resistance mutations.

Chief Investigator
Collins Iwuji

Grant Lead Institution and Sponsor
University of Sussex (UoS)

Grant Funder
Gilead Sciences, Inc.

The PIBIK study is an active phase IV, open-label pilot study being supported by the Brighton and Sussex Clinical Trials Unit (BSCTU). The study is currently active and recruiting across 7 NHS sites, with a recruitment target of 100 patients. The JCRO have provided support in the following areas:

Contracts
We provided support for site agreements between UoS and NHS sites, Service Level and Technical Agreements with suppliers, as well as amendments to the funder contract. This has involved drafting agreements and liaising with sites for signature. JCRO support has helped speed up the process of contract signature, enabling sites to start recruiting as early as possible.
Finance
We have worked alongside the research finance team at UoS and BSCTU to ensure budgets are correctly set up on a per site basis, and that site budgets are accurately recorded in the NHS site agreements. The JCRO has developed a tracker to monitor site budgets against recruitment rates - this has required detailed tracking on a per patient visit and travel basis.

Researcher feedback

What researchers say:

“I really wondered what the JCRO would offer as there are so many different processes, but they added essential skills and different components to the grant application process”
“The professional and responsive JCRO support has my research activities enjoyable and very productive. I felt supported 100% by their excellent team”
“I have found them really helpful in sorting out contracts with collaborators”
“The JCRO were on hand to deal with liaising between ourselves and our funders and provided a lot of assistance with the service level agreement”
“I applied for 2 major grants during covid. Each stage was clarified for me and the processes streamlined and guidance was excellent. I am now planning my next venture with much more confidence.”