Implementing Long-Acting Novel Antiretrovirals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-18

Study Completion Date

2023-12-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Human Immunodeficiency Viruses

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinic-based PLH on CAB+RPV LA

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.

The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)

Intervention Type OTHER

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

Community-based PLH on CAB+RPV LA

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.

The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥ 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No