Randomized Trial of Vaginal Self Sampling for Human Papillomavirus (HPV) - Full Text View

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:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

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

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

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:

Neoplasms
Cervical Intraepithelial Neoplasia
Warts
Carcinoma in Situ
Papillomavirus Infections
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013