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

NCT ID: NCT02779621

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-01-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-collecting a vaginal sample with a swab for HPV testing

Intervention Type: PROCEDURE

The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay.

Collection of cervical sample for routine cervical screening

Intervention Type: PROCEDURE

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)

Routine smear

(Collection of cervical sample for routine cervical screening) Women in the control arm will only receive the routine cervical screening invitation letter.

Group Type: ACTIVE_COMPARATOR

Collection of cervical sample for routine cervical screening

Intervention Type: PROCEDURE

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)

Interventions

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.

Intervention Type: 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)

Intervention Type: PROCEDURE

Other Intervention Names

Copan Floq is used for self-sampling; Routine cervical smear test

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Copan Italia SPA , Via F. Perotti, 10, 25125 Brescia, Italy

UNKNOWN

Sponsor Role: collaborator

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ceri Jones

Role: STUDY_DIRECTOR

Head of Research, Development & Innovation, UHCW, Coventry

Locations

University Hospital of Coventry & Warwickshire

Coventry, Warwickshire, United Kingdom

Countries

United Kingdom

Other Identifiers

203560

Identifier Type: -

Identifier Source: org_study_id