The ILANA study: a paradigm shift in ensuring equity of clinical implementation in HIV research

Introduction Cabotegravir and Rilpivirine (CAB+RPV-LA) is recommended as a treatment for HIV-1 allowing people living with HIV to receive two-monthly injectable treatment, rather than daily pills. Providing injectable therapy in a system designed to provide and manage patients on oral treatments poses logistical challenges namely how resources are used to accommodate patient preference within constrained health economies with capacity limitations. In this pragmatic multi-centre study, we aim to understand the implementation of CAB-RPV-LA administration in two settings via mixed methods to explore perspectives of participants and the clinical team delivering CAB+RPV-LA. Methods and Analysis Women, racially minoritised people and older people are chronically under-represented in HIV clinical trials so the ILANA trial has set recruitment caps to ensure recruitment of 50% women, 50% ethnically-diverse people and 30% over 50 years of age to include a more representative study population. Utilising a mixed-methods approach, the primary objective is to identify and evaluate the critical implementation strategies for CAB+RPV-LA in both hospital and community settings. Secondary objectives include evaluating feasibility and acceptability of CAB+RPV-LA administration at UK clinics and community settings from the perspective of HIV care providers, nurses, and representatives at community sites, evaluating barriers to implementation, the utility of implementation strategies, and adherence. Ethics and Dissemination Ethical approval has been obtained from the Health Research Authority Research Ethics Committee (REC reference: 22/PR/0318). The dissemination strategy has been formulated with the SHARE Collaborative Community Advisory Board in order to maximise the impact of this work on clinical care and policy. This strategy draws upon and leverages existing resources within the participating organisations, such as their academic infrastructure, professional relationships and community networks fully. The strategy will particularly harness the Public Engagement Team and press office to support dissemination of findings. Registration Number [ClinicalTrials.gov][1] Identifier: [NCT05294159][2] Strengths and Limitations of the Study 1. This trial employs an anti-racist, anti-sexist, anti-ageist approach to protocol design, building equitable recruitment into the fabric of the protocol. 2. This is the first implementation study to evaluate delivery of long-acting injectable HIV antiretrovirals (LAIs) in both community and clinic settings and the first UK-based trial of LAI to evaluate routine clinical practice within the National Health Service (NHS). 3. The trial also contains a mixed-methods sub-study exploring reasons for trial non-participation. 4. Trial sites are all large, urban centres. Further studies of implementation of LAIs in smaller and rural settings will be needed. 5. The small sample size and specific targets for women and racially-minoritised groups aims to be representative of people living with HIV in the UK, but may not be representative of all people choosing the option of injectable medication. ### Competing Interest Statement CO has received research grants and honoraria from: ViiV Healthcare Ltd, GSK, GILEAD, MSD, Janssen & Astrazeneca. SU has none to declare. HZF has received travel grants and honoraria from: Janssen-Cilag; travel grants from GILEAD, ViiV Healthcare Ltd, European Society of Clinical Virology, British HIV Association and the European AIDS Clinical Society None of the other authors have competing interests to declare in relation to this research. ### Clinical Protocols ### Funding Statement ViiV Healthcare Ltd, research grant to Queen Mary University of London ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Study was reviewed and approved by Research Ethics Committee and Health Research Authority. Reference: 22/PR/0318 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05294159&atom=%2Fmedrxiv%2Fearly%2F2022%2F11%2F30%2F2022.11.30.22282915.atom