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

Phase 2/Phase 3
35 Years
69 Years
Open (Enrolling by invite only)
Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia

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Trial Information

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

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

uptake of screening invitation

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Alice Lytwyn, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster University


Canada: Ethics Review Committee

Study ID:




Start Date:

April 2010

Completion Date:

January 2013

Related Keywords:

  • Human Papillomavirus Infection
  • Cervical Intraepithelial Neoplasia
  • vaginal self collection
  • human papillomavirus (hpv)
  • cervical intraepithelial neoplasia
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Warts
  • Carcinoma in Situ
  • Papillomavirus Infections