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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Health Status Unknown, Precancerous Condition

Intervention / Treatment
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* Behavioral: compliance monitoring
* Other: cervical Papanicolaou test
* Other: educational intervention
* Other: screening questionnaire administration
* Other: survey administration
* Procedure: colposcopy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Women in Westminster Primary Care Trust (PCT) area eligible for routine cervical screening who have not responded to two invitations to attend for smears 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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: compliance monitoring|nan|
|Other: cervical Papanicolaou test|nan|
|Other: educational intervention|nan|
|Other: screening questionnaire administration|nan|
|Other: survey administration|nan|
|Procedure: colposcopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human papilloma virus infection, health status unknown