Clinical trial NCT01095198: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Human Papillomavirus Infection
Cervical Intraepithelial Neoplasia
Keywords: vaginal self collection
human papillomavirus (hpv)
cervical intraepithelial neoplasia
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Juravinski Cancer Centre Foundation
name: Merck Frosst Canada Ltd.
name: Public Health Agency of Canada (PHAC)
First posted: 2010-03-30
Enrollment: 1440
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: uptake of screening invitation
timeFrame: 18 months
Secondary outcomes:
measure: Cervical Intraepithelial Neoplasia (CIN) 3 identified
timeFrame: 18 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Alice Lytwyn, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: