An observational study in Human Immunodeficiency Viruses, sponsored by Queen Mary University of London. Completed at 6 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Queen Mary University of London · Observational
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 114 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
108 stable, virally suppressed PWH.
To achieve representation of underrepresented groups in HIV studies, a cap will be set on recruitment of men at 50%, white participants at 50% and age under 50y at 70%.
Exclusion Criteria:
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.
Other: 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.
Other: The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)
The Feasibility and Acceptability of Intervention Measure (FIM and AIM) are used to evaluate the feasibilit and acceptability of our implementation strategies. The FIM and AIM is a validated implementation outcome measure where higher scores indicate greater feasibility and acceptability
Proportion of participants that agree or completely agree (average score of 4 or higher) on the Feasibility of Intervention Measure (FIM) (a validated method)
To evaluate feasibility of CAB and RPV LA administration at clinics in England and community based settings by patients
Time frame: 12 months
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
To evaluate feasibility of CAB and RPV LA administration at 6 English clinics and decentralised community settings by healthcare professionals (HCPs)
Time frame: At Day 0, 4 Months and 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)
To evaluate acceptability of CAB and RPV LA by participants and clinic staff
Time frame: At Day 0, 4 Months and 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
To evaluate feasibility and acceptability of CAB and RPV LA by community site representatives
Time frame: At 8 months and 12 months
Proportion of injections occurring within target window from target date (± 7 days of target date)
To describe adherence to dosing window by clinicians
Time frame: 12 months
Proportion of injections occurring after target window with/without use of oral ART
To describe adherence to dosing window by clinicians
Time frame: 12 months
Incidence and extent of oral bridging use
To describe adherence to dosing window by clinicians
Time frame: 12 months
Qualitative interviews with nurses to ascertain the utility of the Blueprints by Community Nurse or Clinic Nurse
To evaluate the utility of the Blueprints by Community Nurse or Clinic Nurse
Time frame: 12 months
Questionnaire checklist of Blueprint activities documentation to ascertain adaptations to Blueprints
To evaluate the fidelity to Blueprint by Community Nurse or Clinic Nurse
Time frame: 12 months
Qualitative interviews to ascertain the utility of Facilitation Calls to improve implementation from the HIV clinic staff, Community Nurses, Clinic Nurses
To evaluate the utility of Facilitation Calls to improve implementation from the HIV clinic staff, Community Nurses, Clinic Nurses
Time frame: 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
To describe the change in treatment satisfaction score over time and by setting
Time frame: 12 months
Validated questionnaires to describe tolerability and acceptance of injections
To describe tolerability and acceptance of injections
Time frame: 12 Months
Validated questionnaires and qualitative interviews to ascertain participants' overall treatment experience preference and medical need for long-acting therapy
To describe participants' overall treatment experience preference and medical need for long-acting therapy
Time frame: 12 Months
Qualitative interviews to ascertain patient preference for setting they receive injections and the reasons for their choice
To describe patient preference for setting they receive injections and the reasons for their choice
Time frame: 12 Months
Incidence of CAB and RPV LA related ADRs (adverse drug reactions) and all SAEs
To describe safety of CAB and RPV LA
Time frame: 12 months
Proportion of participants who do not progress to injections/discontinuation during oral lead in
To describe safety of CAB and RPV LA
Time frame: 12 months
Proportion of participants who discontinue CAB and RPV LA, for all cause, virological reasons or tolerability
To describe safety of CAB and RPV LA
Time frame: 12 months
Proportion of participants who are virologically suppressed (plasma HIV-1 RNA VL<50 c/mL) at month 4 and 12 (with +/- 6-week window)
To describe effectiveness of CAB and RPV LA
Time frame: 12 months
Proportion participants with VL ≥ 50 c/mL at M4 and M12 (with a +/- 6-week window
To describe effectiveness of CAB and RPV LA
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Queen Mary University of London