Implementing Long-Acting Novel Antiretrovirals - the ILANA Study

Brief Summary

Detailed Description

Cabotegravir and Rilpivirine (CAB+RPV) LA, is recommended in European US and British guidelines as a treatment for HIV-1 that allows PWH to receive a 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 a constrained health economy with capacity limitations. Exploring the use of alternative settings for injection, including community-based settings to deliver CAB+RPV LA, has the potential to expand options and potentially improve clinic capacity. Many PWH report high levels of stigma when attending the HIV clinic which can affect engagement with care, so receiving care in a community setting may provide additional choices and the possibility of receiving treatment in a less medicalized setting. Implementation studies in Europe are also assessing this in their countries. The National Health Service (NHS) in the UK is a very specific health environment where people are entitled to treatment and care which is free at the point of delivery. Unlike other medical specialties where primary care physicians are responsible for prescribing treatment for chronic conditions, PWH are managed and receive their HIV treatment in HIV and sexual health clinics. For the circa 105K people with HIV in the UK, outcomes are excellent. More than 95% of those on treatment have undetectable viral loads. However, around 8100 people in the UK are not able to take oral ART successfully. US guidelines have specified that LA CAB+ RPV is particularly important for those who experience pill fatigue, stigma and have fears of inadvertent disclosure. This is highly relevant to the ethnically diverse population of people in the UK living with HIV, many of whom come from marginalized and minoritized communities in which stigma is rife and in whom the treatment outcomes are the poorest. Women, racially minoritized people and older people are chronically under-represented in HIV clinical trials which is why we have set recruitment caps to ensure we recruit 50% women, 50% ethnically diverse people and 30% over 50 years of age. This is to ensure that we go beyond lip-service and hold ourselves to account in designing our trials with peer researcher involvement from the outset and committing to include a more representative study population. We will achieve this by engaging actively with community organisations to ensure awareness of this implementation trials. The study will be conducted at six large clinic sites both in London and outside of London. In this pragmatic real-world trial, each site will identify the most workable option to deliver of CAB+RPV LA according to SmPC license in the community setting within their region or borough.

Primary Outcomes

Secondary Outcomes

• Proportion of care provider and nurse participants that agree or completely agree (average score of 4 or higher) on the FIM and via qualitative interviews(At Day 0, 4 Months and 12 Months)
• Validated questionnaires and qualitative interviews to ascertain participants' overall treatment experience preference and medical need for long-acting therapy(12 Months)
• Proportion of care provider and nurse participants that agree or completely agree (average score of 4 or higher) Acceptability of Intervention Measure (AIM) (a validated method)(At Day 0, 4 Months and 12 Months)
• Proportion of injections occurring within target window from target date (± 7 days of target date)(12 months)
• Proportion of injections occurring after target window with/without use of oral ART(12 months)
• HIV Treatment Satisfaction Questionnaire (HIVTSQs-12) (a validated questionnaire) to assess and ascertain the change in treatment satisfaction score over time and by setting(12 months)
• Incidence and extent of oral bridging use(12 months)
• Proportion of community site representatives that agree or completely agree (average score of 4 or higher) score of on the FIM and AIM with in-depth qualitative interviews with community site representative(At 8 months and 12 months)
• Qualitative interviews with nurses to ascertain the utility of the Blueprints by Community Nurse or Clinic Nurse(12 months)
• Questionnaire checklist of Blueprint activities documentation to ascertain adaptations to Blueprints(12 months)
• Qualitative interviews to ascertain patient preference for setting they receive injections and the reasons for their choice(12 Months)
• Qualitative interviews to ascertain the utility of Facilitation Calls to improve implementation from the HIV clinic staff, Community Nurses, Clinic Nurses(12 months)
• Validated questionnaires to describe tolerability and acceptance of injections(12 Months)