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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

220 Participants
are grouped into 3 trial groups

Locations

This trial has no locations

Sponsors and collaborators

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