Implementing Long-Acting Novel Antiretrovirals
- Conditions
- Human Immunodeficiency Viruses
- Interventions
- Other: The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)
- Registration Number
- NCT05294159
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
This is a 12-month, dual arm, phase 4, open-label, multi-centre study examining the implementation of LA intra-muscular (IM) drugs in clinics and decentralised community-based settings in the UK.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- ≥ 18 years of age
- Documented HIV-1 infection
- Virologically suppressed (HIV-1 RNA <50 copies/ml) on a stable antiretroviral regimen
- Able and willing to complete informed consent prior to inclusion
- No hepatitis B
- In accordance with EU license and NICE guidance
- Based on contraindication for CAB LA, RPV LA, in accordance with EU license and NICE guidance
- Prior virologic failure on substances of NNRTI or INI class
- Resistance mutations to any substance of the NNRTI or INI class
- Prior exposure to CAB + RPV LA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Clinic-based PLH on CAB+RPV LA The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM) All PWH participants will begin injections in the clinic setting in Phase 1. During Phase 1, PWH participants are screened and consented to participate in the study. During the screening phase, potential participants will be asked to identify their preferred location for phase 2 (decentralised site) and the reason for their preference. At the time of consent, patients will select their injection setting for Phase 2. Patients can select their preferred choice of setting until the 50 in-clinic numbers and 100 decentralised site places have been reached. After this, PWH participants will be allocated to the setting yet to reach its cap. In Phase 2, PWH participants will either continue to receive injection in clinic or receive injections from community nurses or clinic nurses at decentralised sites. Community-based PLH on CAB+RPV LA The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM) All PWH participants will begin injections in the clinic setting in Phase 1. During Phase 1, PWH participants are screened and consented to participate in the study. During the screening phase, potential participants will be asked to identify their preferred location for phase 2 (decentralised site) and the reason for their preference. At the time of consent, patients will select their injection setting for Phase 2. Patients can select their preferred choice of setting until the 50 in-clinic numbers and 100 decentralised site places have been reached. After this, PWH participants will be allocated to the setting yet to reach its cap. In Phase 2, PWH participants will either continue to receive injection in clinic or receive injections from community nurses or clinic nurses at decentralised sites.
- Primary Outcome Measures
Name Time Method Proportion of participants that agree or completely agree (average score of 4 or higher) on the Feasibility of Intervention Measure (FIM) (a validated method) 12 months To evaluate feasibility of CAB and RPV LA administration at clinics in England and community based settings by patients
- Secondary Outcome Measures
Name Time Method Incidence and extent of oral bridging use 12 months To describe adherence to dosing window by clinicians
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 To evaluate feasibility of CAB and RPV LA administration at 6 English clinics and decentralised community settings by healthcare professionals (HCPs)
Validated questionnaires and qualitative interviews to ascertain participants' overall treatment experience preference and medical need for long-acting therapy 12 Months To describe participants' overall treatment experience preference and medical need for long-acting therapy
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 To evaluate acceptability of CAB and RPV LA by participants and clinic staff
Proportion of injections occurring within target window from target date (± 7 days of target date) 12 months To describe adherence to dosing window by clinicians
Proportion of injections occurring after target window with/without use of oral ART 12 months To describe adherence to dosing window by clinicians
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 To describe the change in treatment satisfaction score over time and by setting
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 To evaluate feasibility and acceptability of CAB and RPV LA by community site representatives
Qualitative interviews with nurses to ascertain the utility of the Blueprints by Community Nurse or Clinic Nurse 12 months To evaluate the utility of the Blueprints by Community Nurse or Clinic Nurse
Questionnaire checklist of Blueprint activities documentation to ascertain adaptations to Blueprints 12 months To evaluate the fidelity to Blueprint by Community Nurse or Clinic Nurse
Qualitative interviews to ascertain patient preference for setting they receive injections and the reasons for their choice 12 Months To describe patient preference for setting they receive injections and the reasons for their choice
Qualitative interviews to ascertain the utility of Facilitation Calls to improve implementation from the HIV clinic staff, Community Nurses, Clinic Nurses 12 months To evaluate the utility of Facilitation Calls to improve implementation from the HIV clinic staff, Community Nurses, Clinic Nurses
Validated questionnaires to describe tolerability and acceptance of injections 12 Months To describe tolerability and acceptance of injections
Trial Locations
- Locations (6)
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, United Kingdom
Blizard Institute
🇬🇧London, United Kingdom
Royal Free Hospital NHS
🇬🇧London, United Kingdom
Chelsea & Westminster NHS Foundation Trust
🇬🇧London, United Kingdom
Guys' and St Thomas' NHS Trust
🇬🇧London, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom