Trial Information

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

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.