Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening

NCT ID: NCT00977392

Last Updated: 2013-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-03-31

Brief Summary

RATIONALE: Women who do not undergo routine cervical screening may be more likely to collect a self-sample for human papillomavirus testing.

PURPOSE: This randomized clinical trial is studying self-sampling in women who do not undergo routine cervical screening.

Detailed Description

OBJECTIVES:

• To ascertain whether women who do not attend for cervical screening are more likely to respond to the opportunity to collect a self-sample for human papillomavirus (HPV) testing, or to respond to a further invitation to undergo a cervical smear.
• To ascertain whether such women will attend for further investigation if they have a positive screening test (HPV test or cervical smear).

OUTLINE: Patients are randomized to 1 of 2 arms.

• Control: Patients receive an invitation for a routine cervical smear and a cervical screening survey. Information regarding attendance for smear or colposcopy is collected at the Primary Care Trust.
• Study (self-sampling kit): Patients receive an explanatory letter, an information sheet about the study, a consent form, information about human papillomavirus (HPV) and HPV testing, a self-sampling test kit, and an invitation to take their own HPV sample and return it to the research group for processing. Patients also receive a cervical screening survey. Patients who attend for further investigation following a positive HPV result go to St. Mary's Hospital Colposcopy Unit, Paddington. During this visit cervical smear tests are performed and women are offered immediate colposcopy so that they would not need to return for colposcopic examination if their smear test is abnormal.

This study is peer reviewed and funded or endorsed by cancer research UK.

Conditions

Health Status Unknown; Precancerous Condition

Keywords

human papilloma virus infection; health status unknown

Interventions

compliance monitoring

Intervention Type: BEHAVIORAL

cervical Papanicolaou test

Intervention Type: OTHER

educational intervention

Intervention Type: OTHER

screening questionnaire administration

Intervention Type: OTHER

survey administration

Intervention Type: OTHER

colposcopy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• No women who have written to the PCT to document their refusal to take part in the National Health Service Cervical Screening Program (NHSCSP)
• No women who are not due for routine screening as part of the NHSCSP

PATIENT CHARACTERISTICS:

• Not pregnant
• Have been sexually active

PRIOR CONCURRENT THERAPY:

• No prior total abdominal hysterectomy

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Barts and the London School of Medicine and Dentistry

OTHER

Sponsor Role: lead

Principal Investigators

Anne Szarewski, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

Barts and the London School of Medicine

London, England, United Kingdom

Countries

United Kingdom

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/21343937

HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial. Br J Cancer. 2011 Mar 15;104(6):915-20. doi: 10.1038/bjc.2011.48. Epub 2011 Feb 22.

Other Identifiers

CDR0000648274

Identifier Type: REGISTRY

Identifier Source: secondary_id

ISRCTN40182307

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20963

Identifier Type: -

Identifier Source: secondary_id

CRUK-Westminster-Self-Sampling

Identifier Type: -

Identifier Source: org_study_id