Brief Title
Randomized Trial of Vaginal Self Sampling for Human Papillomavirus (HPV)
Official Title
Randomized Controlled Trial of Vaginal Self Sampling for Human Papillomavirus to Increase Cervical Cancer Screening Participation
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.
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 Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
uptake of screening invitation
Secondary Outcome
Cervical Intraepithelial Neoplasia (CIN) 3 identified
Condition
Human Papillomavirus Infection
Intervention
offer of vaginal self collection
Study Arms / Comparison Groups
2nd Reminder Letter
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
1440
Start Date
April 2010
Completion Date
January 2013
Primary Completion Date
November 2012
Eligibility 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
Gender
Female
Ages
35 Years - 69 Years
Accepts Healthy Volunteers
No
Contacts
Alice Lytwyn, MD, FRCPC, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01095198
Organization ID
RCTself
Study Sponsor
McMaster University
Collaborators
Juravinski Cancer Centre Foundation
Study Sponsor
Alice Lytwyn, MD, FRCPC, Principal Investigator, McMaster University
Verification Date
July 2011