Condition category
Infections and Infestations
Date applied
21/11/2013
Date assigned
21/11/2013
Last edited
14/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Anita Lim

ORCID ID

Contact details

Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
a.lim@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15712

Study information

Scientific title

Human Papillomavirus (HPV) testing on self-collected samples to increase uptake of cervical screening in non-attenders: a pilot study

Acronym

Study hypothesis

Objectives
To assess the feasibility and acceptability of offering vaginal self-sampling for HPV testing in general practice to cervical screening non-attenders to increase coverage.

Methodology
Women aged 28-64 who are at least 6 months overdue their smear will be flagged in the EMIS electronic patient record system at GP surgeries. GPs, nurses and healthcare practitioners will be asked to offer flagged women a self-sampling study kit for HPV testing, when they consult for any reason. Women will take their sample in the GP surgery bathrooms or at home. Samples will be analysed by Barts Health NHS Trust pathology lab.

Results will be sent to the women via post. Women who test HPV negative will be exited from the study. Women who test HPV positive will be asked to attend their GP surgery for a smear. Women who attend for a smear will be managed according to their cytology (as usual) on the NHS Cervical Screening Programme. Women who test HPV positive and have not attended for a smear by the end of the study will be invited for a study colposcopy at Whipp's Cross Hospital.

Ethics approval

13/LO/1441; First MREC approval date 24/10/2013

Study design

Non-randomised; Interventional; Design type: Screening

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

Colposcopy: Colposcopy is a medical diagnostic procedure to examine an illuminated, magnified view of the cervix to check for cervical abnormalities.
HPV testing: Self-collected vaginal sample for HPV testing
Follow Up Length: 6 month(s); Study Entry : Other; Details: Women will be invited to take part when they attend their GP surgery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proportion of women who return a self-collected sample for HPV testing measured at the end of the study

Secondary outcome measures

1. Proportion of women who are found to have cervical intraepithelial neoplasia; Timepoint(s): End of study
2. Proportion of women who are found to test HPV positive; Timepoint(s): End of study

Overall trial start date

06/01/2014

Overall trial end date

06/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 28-64 years who are eligible for cervical screening and are at least 6 months overdue (i.e. no cervical cytology recorded in the GP records in the past 3.5 years if aged 28-49 or 5.5 years if aged women 50-64)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200; We have estimated that with 5 GP surgeries, the sample size will be anywhere between 45 and 337. 200 women is our rough estimate.

Participant exclusion criteria

1. Women unable to provide informed consent (e.g. because of learning difficulties)
2. Women whose command of English is not sufficient to obtain informed consent
3. Women in whom cervical screening is inappropriate, for example because they are pregnant or terminally ill

Recruitment start date

06/01/2014

Recruitment end date

06/06/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

R&D Office
Queen Mary University of London
Barts & London School of Medicine The QMI building
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK; Grant Codes: C8162/A10406

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes