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

NCT01095198 | Unknown Phase 2

• 1 other identifier: RCTself
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus Infection; Cervical Intraepithelial Neoplasia

Keywords

vaginal self collection; human papillomavirus (hpv); cervical intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

• uptake of screening invitation

  18 months

Secondary Outcomes (1)

• Cervical Intraepithelial Neoplasia (CIN) 3 identified

  18 months

Study Arms (2)

2nd Reminder Letter

ACTIVE COMPARATOR

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

Offer of Vaginal Self Collection

EXPERIMENTAL

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; Other: 2nd reminder letter for Pap testing

Interventions

offer of vaginal self collection DEVICE

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.

Also known as: flocked swab (Copan Diagnostics Inc.)

Offer of Vaginal Self Collection

2nd reminder letter for Pap testing OTHER

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.

Also known as: reminder letter

2nd Reminder Letter; Offer of Vaginal Self Collection

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• currently attending colposcopy clinic
• institutionalized
• without a cervix

Sponsors & Collaborators

• McMaster University: lead
• Juravinski Cancer Centre Foundation: collaborator
• Merck Frosst Canada Ltd.: collaborator
• Public Health Agency of Canada (PHAC): collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Dysplasia

Interventions

Vaginal Smears

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Obstetrical and Gynecological; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alice Lytwyn, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

CA (1)