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

Not Applicable

Withdrawn

• Conditions: Cervix Diseases
• Interventions: Procedure: Self-collecting a vaginal sample with a swab for HPV testing; Procedure: Collection of cervical sample for routine cervical screening

• Registration Number: NCT02779621
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Primary Completion: 2017-01
• Study Completion: 2017-01-25
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-sampling	Self-collecting a vaginal sample with a swab for HPV testing	(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.
Self-sampling	Collection of cervical sample for routine cervical screening	(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.
Routine smear	Collection of cervical sample for routine cervical screening	(Collection of cervical sample for routine cervical screening) Women in the control arm will only receive the routine cervical screening invitation letter.

Primary Outcome Measures

Name	Time	Method
The total screening uptake rate in each arm	2 months since the recruitment	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.

Secondary Outcome Measures

Name	Time	Method
Assess the women's attitude towards self-sampling and its feasibility	2 months since the recruitment	Analysing data of user questionnaires
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 HPV positive women who have subsequently had a smear test	2 months since the HPV test result
Proportion of women attended colposcopy had a CIN2+	4 months since the smear result
Assess the women's attitude towards the feasibility of self-sampling	2 months since the recruitment	Analysing data of user questionnaires

Trial Locations

Locations (1)

University Hospital of Coventry & Warwickshire; 🇬🇧 Coventry, Warwickshire, United Kingdom