SHINE-NWL
Research type
Research Study
Full title
An Implementation Study of HPV Self-Sampling Using Diagnostic Tampons in North West London Primary Care Settings
IRAS ID
355725
Contact name
Ishani Patel
Contact email
Sponsor organisation
NHS North West London Integrated Care Board
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
The SHINE-NWL study is a pragmatic mixed-methods implementation study evaluating HPV Diagnostic Tampon (DT) self-sampling in North West London (NWL) across two phases of activity.
The project is being coordinated with the NHS Cervical Screening Programme (CSP) to ensure it complements the national self-swab pilot currently being implemented.
CSP-approved laboratories such as TDL are not currently set up to analyse tampon samples. As such, a two-phase approach has been designed, with initial evidence gathered through an existing workflow, and a later phase conducted once a CSP-approved workflow has been established.
Phase 1
● A real-world evaluation to assess the effectiveness of this self-sampling pathway as an alternative screening method, while examining its potential to increase overall screening rates and reduce screening inequalities in NWL.
● Participants: 1,000 cervical screening non-attenders in 8 GP Practices/PCNs across the 8 boroughs in NWL
● Practice-led: Women will collect the tampon from their GP practice and will be asked to return their sample to the practice.
● It will use an existing UKAS accredited laboratory and assay workflow employed in private practice (Alderley Lighthouse Labs, Viasure).Phase 2
● The purpose of this phase is to generate evidence for the DT to be subsequently accepted onto the CSP and its results included in the Cervical Screening Management System (CSMS) and to understand the impact of offering a self-service model.
● Participants: 5,000 cervical screening non-attenders in the same GP Practices/PCNs in NWL
● Choice of self-served or practice led: Women will have the choice of (1) collecting from and dropping off at the GP practice or (2) ordering the tampon online and returning by post.
● It will use an NHS CSP-approved laboratory and assay (TDL, Hologic) - this workflow is in development, hence not ready for Phase 1.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
25/LO/0558
Date of REC Opinion
26 Aug 2025
REC opinion
Further Information Favourable Opinion