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

Cervix Diseases Clinical Trial

— PROMOTER  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02779621
• Other study ID #: 203560
• Status: Withdrawn
• Phase: N/A
• First received: May 18, 2016
• Last updated: February 22, 2017
• Start date: January 2016
• Est. completion date: January 25, 2017

Study information

• Verified date: February 2017
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 25, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervix Diseases
• Uterine Cervical Diseases

Intervention

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.
• 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)

Locations

Country	Name	City	State
United Kingdom	University Hospital of Coventry & Warwickshire	Coventry	Warwickshire

Sponsors (3)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust	Abbott House, Vanwall Business Park, Maidenhead, Berkshire, SL6 4XF, UK, Copan Italia SPA , Via F. Perotti, 10, 25125 Brescia, Italy

Country where clinical trial is conducted

United Kingdom, 

Outcome

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