Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening
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.
Health Status Unknown
Behavioral: compliance monitoring
Other: cervical Papanicolaou test
Other: educational intervention
Other: screening questionnaire administration
Other: survey administration
|Official Title:||The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial|
- Comparison of the percentages of women responding to the invitation to return a self-sampling kit vs responding to an invitation for a cervical smear [ Designated as safety issue: No ]
- Response to the invitation for further investigation following a positive test result (colposcopy for women with a smear showing mild dyskaryosis or above, smear +/- colposcopy for those with a positive HPV test) [ Designated as safety issue: No ]
- Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977392
|Barts and the London School of Medicine|
|London, England, United Kingdom, SW15 5PN|
|Principal Investigator:||Anne Szarewski, MD||Queen Mary University of London|