The goal of this 12-month implementation science study is to generate the evidence required to ensure long-acting cabotegravir (LA CAB) as pre-exposure prophylaxis (PrEP) can be delivered in an equitable manner within the NHS. This study will recruit both PrEP users and healthcare professionals (HCPs).
The main questions it aims to answer are:
* What do healthcare providers think about the feasibility of delivering LA CAB PrEP within sexual health services in the NHS? * How many participants stay on/remain consistent with LA CAB PrEP injections at Month 12 (PrEP persistence)?
Participants (200 PrEP users) will be followed for 12-months and asked to complete surveys at 3 study visits. A subset of 20 participants will also be asked to complete interviews about their experiences. We will also ask 20 HCPs at participating locations to complete surveys and interviews at both baseline and month 12.
A core principle of equity (understanding any difference in impact on underserved populations) will be applied throughout the study. To ensure representation of a diverse group of participants that reflects the demographic groups most affected by incident HIV and most underserved by PrEP in the UK, enrolment targets will be applied and meticulously managed by the central study team, as follows:
* A cap of 30% (n=60) will be applied to recruitment of White cisgender men who have sex with men who are not otherwise part of other under-represented groups (as defined below), * At least 70%% (n=140) of participants will represent groups currently underserved by PrEP and fall into one (or more) of the following socio-demographic categories: women (defined cisgender or transgender) OR as transgender men OR non-binary individuals OR age\<25 yrs, OR sex workers OR people who inject drugs OR racially minoritised heterosexual men.
Adults who are aged > 18 years at time of consent (including people of child-bearing capacity and age, non-pregnant or pregnant adults)
Attending a participating NHS sexual healthcare service
Prescribed LA CAB for PrEP according to NICE and NHS eligibility criteria (including those newly prescribed and those already using LA CAB)
Non-reactive / negative HIV Antigen/Antibody test and HIV RNA test at time of LA CAB for PrEP initiation (performed under routine care)
One or more reactive or positive HIV test results at enrolment visit, even if HIV infection is not confirmed.
Currently enrolled in interventional trial of PrEP agents, HIV vaccine trial or experimental medication.
Plan to relocate out of the area during the study period. Note: "Plan to relocate out of the area" is defined as a stated intention at enrolment to move residence outside the catchment area of a participating study site during the study period, such that ongoing clinical management would likely transfer to a non-participating team.
The participants in this study are 1) PrEP users and 2) NHS healthcare providers (HCPs) recruited from 12 study sites (sexual health clinics and associated non-specialist service delivery sites) that currently deliver PrEP. HCP participants will include doctors, nurses and pharmacists who currently provide injectable PrEP. Note: PrEP user participants are those who are both naive (new to ) to any PrEP modality, and PrEP experienced (former or current oral and/ or injectable PrEP users), on PrEP in accordance with NHS and NICE guidelines (28).
Other
Prospective
Not listed
Feasibility of LA CAB delivery (HCP perspective): Mean Feasibility of Intervention Measure (FIM) score among healthcare professionals
Mean score on the validated Feasibility of Intervention Measure (5-point Likert scale; higher scores indicate greater perceived feasibility) assessing delivery of long-acting cabotegravir PrEP in NHS sexual health services, supplemented by qualitative thematic analysis of semi-structured interviews with HCPs.
PrEP persistence on long-acting cabotegravir: Proportion of participants remaining on long-acting cabotegravir PrEP at Month 12 without interruption
Persistence defined as the proportion of participants who remain on long-acting cabotegravir injections at Month 12 with no documented interruption; interruption defined as two missed consecutive injections without oral bridging per Summary of Product Characteristics (SmPC).
Acceptability of LA CAB (HCPs and PrEP users): Mean Acceptability of Intervention Measure (AIM) score
Mean score on the AIM (5-point Likert scale; higher scores indicate greater acceptability) among healthcare professionals and PrEP users.
Appropriateness of LA CAB (HCPs and PrEP users): Mean Intervention Appropriateness Measure (IAM) score
Mean score on the IAM (5-point Likert scale; higher scores indicate greater appropriateness of LA CAB delivery).
Feasibility of LA CAB (PrEP user perspective): Mean Feasibility of Intervention Measure (FIM) score among PrEP users
Mean FIM score assessing perceived feasibility of LA CAB delivery among PrEP users, supplemented by qualitative interview data.
Implementation fidelity and adaptation: Proportion of sites adhering to implementation blueprints and description of adaptations
Assessment of fidelity to site-specific delivery blueprints, including HIV and STI testing strategies, monitoring frequency, and management algorithms; includes documentation and categorisation of adaptations and reasons for change.
HIV incidence and status: HIV incidence rate and proportion remaining HIV-negative
Incidence of HIV infection per 100 person-years and proportion of participants HIV-negative at Month 12, in relation to HIV testing algorithm.
Sexually transmitted infection (STI) incidence: Incidence of STIs
Incidence rate of laboratory-confirmed sexually transmitted infections, stratified by PrEP persistence status and testing strategy of those on LA CAB, over study period in relation to the STI testing algorithm described in the blueprints
Injection site reactions: Incidence and severity of injection site reactions
Frequency and severity grading of injection site reactions associated with LA CAB administration.
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Queen Mary University of London
Lead sponsor
Barts Helth NHS Trust
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Chelsea and Westminster NHS Foundation Trust
Collaborator
Liverpool University Hospitals NHS Foundation Trust
Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborator
University Hospital Birmingham NHS Foundation Trust
Collaborator
Homerton University Hospital NHS Foundation Trust
Collaborator
University Hospital of Wales, Cardiff
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
University Hospitals Sussex NHS Foundation Trust
Collaborator
Barking, Havering and Redbridge University Hospitals NHS Trust
Collaborator
King's College Hospital NHS Trust
Collaborator
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