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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cervix Diseases
• Intervention / Treatment: Procedure: Self-collecting a vaginal sample with a swab for HPV testing; Procedure: Collection of cervical sample for routine cervical screening

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
      • University Hospital of Coventry & Warwickshire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All cervical screening programme defaulters living in Coventry

Exclusion Criteria:

1. Pregnancy
2. Total hysterectomy (abdominal/laparoscopic/vaginal)
3. Never been sexually active/ intimate
4. Women who cannot give valid, informed, written consent
5. HPV self-sample returned without a signed consent form
6. Women who request the research team to be excluded from the trial
7. Women who have written to the Screening Services to record their refusal to take part in the NHSCSP
8. Women who are identified as becoming pregnant or undergoing hysterectomy following the initial test will be excluded from the analysis of data for secondary outcomes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-sampling; (Self-collecting a vaginal sample with a swab for HPV testing) Women in the experimental arm will have the option of vaginal self-sampling for HPV testing, in addition to the routine screening test. They can choose one of them.	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.; Other Names: Copan Floq is used for self-sampling; 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); Other Names: Routine cervical smear test
Active Comparator: Routine smear; (Collection of cervical sample for routine cervical screening) Women in the control arm will only receive the routine cervical screening invitation letter.	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); Other Names: Routine cervical smear test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total screening uptake rate in each arm	In the experimental arm, the numerator will be the total number of smear tests + HPV self-tests. In the active control arm, it will be total number of smear tests.	2 months since the recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of HPV positive women who have subsequently had a smear test		2 months since the HPV test result
Proportion of smear positive women referred to colposcopy		1 month since the smear result
Proportion of women referred to colposcopy had attended colposcopy		3 months since the smear result
Proportion of women attended colposcopy had a CIN2+		4 months since the smear result
Assess the women's attitude towards self-sampling and its feasibility	Analysing data of user questionnaires	2 months since the recruitment
Assess the women's attitude towards the feasibility of self-sampling	Analysing data of user questionnaires	2 months since the recruitment

Collaborators and Investigators

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
• Collaborators: Abbott; Copan Italia SPA , Via F. Perotti, 10, 25125 Brescia, Italy
• Investigators: Study Director: Ceri Jones, Head of Research, Development & Innovation, UHCW, Coventry

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Actual): January 25, 2017

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases
• Other Study ID Numbers: 203560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No