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

McMaster University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Human Papillomavirus Infection; Cervical Intraepithelial Neoplasia

Treatments: Other: 2nd reminder letter for Pap testing; Device: offer of vaginal self collection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01095198

RCTself

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,440 estimated patients

Sex: Female

Ages: 35 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,440 participants in 2 patient groups

2nd Reminder Letter

Active Comparator group

Description:

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

Treatment:

Other: 2nd reminder letter for Pap testing

Offer of Vaginal Self Collection

Experimental group

Description:

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

Treatment:

Device: offer of vaginal self collection

Other: 2nd reminder letter for Pap testing