Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening
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|ClinicalTrials.gov Identifier: NCT00977392|
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment|
|Health Status Unknown Precancerous Condition||Behavioral: compliance monitoring Other: cervical Papanicolaou test Other: educational intervention Other: screening questionnaire administration Other: survey administration Procedure: colposcopy|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial|
|Study Start Date :||June 2009|
|Primary Completion Date :||February 2010|
|Study Completion Date :||March 2011|
- 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
- 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)
- Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977392
|Barts and the London School of Medicine|
|London, England, United Kingdom, SW15 5PN|
|Principal Investigator:||Anne Szarewski, MD||Queen Mary University of London|