PrEP-LANA (Pre-exposure Prophylaxis- Long-acting Novel Antiviral Agent)

Summary

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.

Conditions

• PrEP
• PrEP Adherence Experiences
• PrEP Adherence Perspectives
• PrEP Uptake
• Equity
• Community Setting

Sponsors & Collaborators

• Barts & The London NHS Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Chelsea and Westminster NHS Foundation Trust

  collaborator OTHER

• Liverpool University Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Homerton University Hospital NHS Foundation Trust

  collaborator OTHER

• University Hospital of Wales, Cardiff

  collaborator UNKNOWN

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• University Hospitals Sussex NHS Foundation Trust

  collaborator OTHER_GOV

• Barking, Havering and Redbridge University Hospitals NHS Trust

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Chloe Orkin · Queen Mary University of London

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2028-05-31

Completion

2028-06-30