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

July 19, 2011 updated by: McMaster University

Randomized Controlled Trial of Vaginal Self Sampling for Human Papillomavirus to Increase Cervical Cancer Screening Participation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1440

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S4L8
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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
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 Names:
  • reminder letter
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 Names:
  • flocked swab (Copan Diagnostics Inc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
uptake of screening invitation
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cervical Intraepithelial Neoplasia (CIN) 3 identified
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Merck Frosst Canada Ltd.
Public Health Agency of Canada (PHAC)
Juravinski Cancer Centre Foundation

Investigators

  • Principal Investigator: Alice Lytwyn, MD, FRCPC, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

November 1, 2012

Study Completion (ANTICIPATED)

January 1, 2013

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (ESTIMATE)

March 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCTself

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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