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

Barts and the London School of Medicine and Dentistry

Status: Completed

Conditions: Precancerous Condition; Health Status Unknown

Treatments: Other: survey administration; Procedure: colposcopy; Other: cervical Papanicolaou test; Other: screening questionnaire administration; Behavioral: compliance monitoring; Other: educational intervention

Study type: Observational

Funder types: Other

Identifiers

NCT00977392

ISRCTN40182307 (Registry Identifier)

CRUK-Westminster-Self-Sampling

CDR0000648274 (Registry Identifier)

EU-20963

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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