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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Juravinski Cancer Centre Foundation
Merck Frosst Canada Ltd.
Public Health Agency of Canada (PHAC)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01095198
First received: March 29, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Vaginal Self Sampling for Human Papillomavirus to Increase Cervical Cancer Screening Participation

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • uptake of screening invitation [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cervical Intraepithelial Neoplasia (CIN) 3 identified [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1440
Study Start Date: April 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 69 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Alice Lytwyn, McMaster University
ClinicalTrials.gov Identifier: NCT01095198     History of Changes
Other Study ID Numbers: RCTself
Study First Received: March 29, 2010
Last Updated: July 19, 2011
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014