NCT00977392

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

The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Barts and the London School of Medicine and Dentistry · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	compliance monitoring
OTHER	cervical Papanicolaou test
OTHER	educational intervention
OTHER	screening questionnaire administration
OTHER	survey administration
PROCEDURE	colposcopy

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-02-01
• Completion: 2011-03-01
• First posted: 2009-09-15
• Last updated: 2013-08-07

Locations

1 site across 1 country: United Kingdom