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Randomized Trial of Vaginal Self Sampling for Human Papillomavirus (HPV)

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ClinicalTrials.gov Identifier: NCT01095198
Recruitment Status : Unknown
Verified July 2011 by McMaster University.
Recruitment status was:  Enrolling by invitation
First Posted : March 30, 2010
Last Update Posted : July 21, 2011
Sponsor:
Collaborators:
Juravinski Cancer Centre Foundation
Merck Frosst Canada Ltd.
Public Health Agency of Canada (PHAC)
Information provided by:
McMaster University

Brief Summary:

Up to 30% of Canadian women do not participate in Pap smear screening for cervical cancer prevention despite many being members of family practices and having access to family physicians. One reason is reluctance to undergo pelvic examination.

The investigators purpose is to determine whether the offer of vaginal self sample collection for oncogenic human papillomavirus (HPV) testing increases participation in cervical cancer screening compared to repeat reminder for Pap smear testing among female family practice members who have not previously responded to invitations for Pap testing.


Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Cervical Intraepithelial Neoplasia Device: offer of vaginal self collection Other: 2nd reminder letter for Pap testing Phase 2 Phase 3

Detailed Description:

Pap smear screening for cervical cancer precursors has substantially reduced the incidence of invasive cervical cancer in Canada. While regular Pap screening can give up to 90% protection against cervical cancer, about 30% of Canadian women do not participate in regular screening.

Pap screening in Ontario is opportunistic. There are women who have family doctors and regularly present for other medical issues at their physician's office but forego Pap smear testing.

Numerous studies have shown that women are able to self collect vaginal samples, and that these samples can be tested for the presence of oncogenic human papillomavirus. A recent meta-analysis showed that HPV testing through physician collected samples had a sensitivity of 80%-90% for detection of cervical intraepithelial neoplasia (CIN) 2 or worse, and a specificity of 86%-95%. In comparison, a meta-analysis of self collected vaginal samples tested for HPV showed a sensitivity of 74% and a specificity of 88%.

Studies have reported that women find self collection acceptable. However, we have found that many women are more comfortable if a health care professional is available to help if needed, and so this option should be provided for self-testing.

We are proposing a randomized controlled trial to see whether (a) the offer of a vaginal self collection kit together with a second reminder for Pap testing will increase cervical screening participation amongst "never-screened" and "hard to reach" women, as compared to (b) a second reminder letter alone.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Vaginal Self Sampling for Human Papillomavirus to Increase Cervical Cancer Screening Participation
Study Start Date : April 2010
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2nd Reminder Letter
50% of study participants who are overdue for Pap testing and do not respond to initial reminder letter will be be mailed a standard second reminder letter
Other: 2nd reminder letter for Pap testing
Women in both groups will receive a letter informing them that they are due for cervical screening. This is a standard letter, and is signed by the patient's individual family physicians. It will advise the patient that this is the second reminder letter that she is due for cervical cancer screening, and will invite her to phone the physician's office to obtain an appointment for Pap testing.
Other Name: reminder letter

Experimental: Offer of Vaginal Self Collection
50% of study participants who are overdue for Pap testing and do not respond to initial reminder letter will be selected to be mailed a second reminder letter and offer of vaginal self collection
Device: offer of vaginal self collection
Women assigned to the intervention group will be offered the opportunity to self collect a vaginal specimen for HPV testing. They will be sent a letter explaining that a study of self testing is being performed, and will invite her to participate in this study. The letter will state that, if the patient prefers, she can perform a vaginal self-test in addition to, or instead of Pap smear testing. Patients are told that they have the option of completing the self-test on their own or in their physician's office with the help of their physician or practice staff. The letter will be accompanied by a self collection kit consisting of: a swab and test tube, pamphlet (with written instructions and diagram outlining procedure), instructional DVD and return envelope.
Other Name: flocked swab (Copan Diagnostics Inc.)

Other: 2nd reminder letter for Pap testing
Women in both groups will receive a letter informing them that they are due for cervical screening. This is a standard letter, and is signed by the patient's individual family physicians. It will advise the patient that this is the second reminder letter that she is due for cervical cancer screening, and will invite her to phone the physician's office to obtain an appointment for Pap testing.
Other Name: reminder letter




Primary Outcome Measures :
  1. uptake of screening invitation [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Cervical Intraepithelial Neoplasia (CIN) 3 identified [ Time Frame: 18 months ]


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Ages Eligible for Study:   35 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • members of consenting family physicians identified through OSCAR EMR
  • overdue for Pap smear testing
  • have not presented for Pap smear screening after 1 reminder letter

Exclusion Criteria:

  • currently attending colposcopy clinic
  • institutionalized
  • without a cervix

Information from the National Library of Medicine

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): NCT01095198


Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S4L8
Sponsors and Collaborators
McMaster University
Juravinski Cancer Centre Foundation
Merck Frosst Canada Ltd.
Public Health Agency of Canada (PHAC)
Investigators
Principal Investigator: Alice Lytwyn, MD, FRCPC McMaster University

Responsible Party: Alice Lytwyn, McMaster University
ClinicalTrials.gov Identifier: NCT01095198     History of Changes
Other Study ID Numbers: RCTself
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by McMaster University:
vaginal self collection
human papillomavirus (hpv)
cervical intraepithelial neoplasia

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Papillomavirus Infections
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Tumor Virus Infections