NCT02779621

The Potential for HPV Self-testing to Promote Participation in Cervical Screening

A Pragmatic Randomized Control Trial Which Evaluates the Potential for HPV Self-testing to Promote Participation in Cervical Screening (PROMOTER) Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust · Academic / Other
• Sex: Female
• Age: 30 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To explore the potential for vaginal self-sampling to increase participation in cervical screening, we offer the option of self-sampling to a group of non-participants in cervical screening (intervention), in addition to the routine screening (smear) test. Women in the control group will only receive the routine screening invitation letter. The total screening uptake rate, 2 months since the recruitment in each group will be compared.

Detailed description

The aim of this research is to assess the feasibility of making vaginal self sampling available to women who have declined smear testing (defaulters), through the NHS to prevent cervical cancer. We plan to identify all defaulters living in Coventry between 30 and 40 years (n≈6000) from the cervical screening call-recall system. They will be randomized 1:1 to intervention and control arms. Women in the control arm will be sent a routine screening letter reminding them to have a smear test. Women in the intervention arm will be given the option of self-sampling for HPV testing, if they do not wish to have a smear test. They could order a self-HPV test by returning a slip in the pre-paid envelope. We then send the woman a vaginal self-collection kit. Self-collected sample will be returned to the laboratory for HPV testing. Whilst HPV positives (10-15%) will be advised to have a smear test, HPV negatives will be advised to accept their next smear test invitation.

Conditions

• Cervix Diseases

Interventions

Type	Name	Description
PROCEDURE	Self-collecting a vaginal sample with a swab for HPV testing	The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay.
PROCEDURE	Collection of cervical sample for routine cervical screening	This is the routine cervical screening test available to the public through the NHS. This sample is collected by a clinician (usually a Practice Nurse)

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-25
• First posted: 2016-05-20
• Last updated: 2017-02-24

Locations

1 site across 1 country: United Kingdom