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

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.

Conditions

• Human Papillomavirus Infection
• Cervical Intraepithelial Neoplasia

Interventions

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

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.

Sponsors & Collaborators

• Juravinski Cancer Centre Foundation

  collaborator OTHER

• Merck Frosst Canada Ltd.

  collaborator INDUSTRY

• Public Health Agency of Canada (PHAC)

  collaborator OTHER_GOV

• McMaster University

  lead OTHER

Principal Investigators

• Alice Lytwyn, MD, FRCPC · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

69 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2012-11-30

Completion

2013-01-31

Countries

• Canada

Study Locations