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Open Access Study protocol

Rationale and design of the iPap trial: a randomized controlled trial of home-based HPV self-sampling for improving participation in cervical screening by never- and under-screened women in Australia

Farhana Sultana1, Dallas R English12, Julie A Simpson1, Julia ML Brotherton13, Kelly Drennan4, Robyn Mullins2, Stella Heley4, C David Wrede5, Marion Saville46 and Dorota M Gertig147*

Author Affiliations

1 Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia

2 Cancer Council Victoria, 615 St Kilda Road, Melbourne, Australia

3 National HPV Vaccination Program Register, Victorian Cytology Service, PO Box 310, East Melbourne, Vic, 3002, Australia

4 VCS Inc, 265 Faraday Street, Carlton, Vic, 3053, Australia

5 Royal Women’s Hospital, Locked Bag 300, Cnr Flemington Road and Grattan Street, Parkville, Victoria, 3052, Australia

6 VCS Pathology, 265 Faraday Street, Carlton, Vic, 3053, Australia

7 Victorian Cervical Cytology Registry, PO Box 161, Carlton South, Vic, 3053, Australia

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BMC Cancer 2014, 14:207  doi:10.1186/1471-2407-14-207

Published: 19 March 2014

Abstract

Background

Organized screening based on Pap tests has substantially reduced deaths from cervical cancer in many countries, including Australia. However, the impact of the program depends upon the degree to which women participate. A new method of screening, testing for human papillomavirus (HPV) DNA to detect the virus that causes cervical cancer, has recently become available. Because women can collect their own samples for this test at home, it has the potential to overcome some of the barriers to Pap tests. The iPap trial will evaluate whether mailing an HPV self-sampling kit increases participation by never- and under-screened women within a cervical screening program.

Methods/Design

The iPap trial is a parallel randomized controlled, open label, trial. Participants will be Victorian women age 30–69 years, for whom there is either no record on the Victorian Cervical Cytology Registry (VCCR) of a Pap test (never-screened) or the last recorded Pap test was between five to fifteen years ago (under-screened). Enrolment information from the Victorian Electoral Commission will be linked to the VCCR to determine the never-screened women. Variables that will be used for record linkage include full name, address and date of birth. Never- and under-screened women will be randomly allocated to either receive an invitation letter with an HPV self-sampling kit or a reminder letter to attend for a Pap test, which is standard practice for women overdue for a test in Victoria. All resources have been focus group tested. The primary outcome will be the proportion of women who participate, by returning an HPV self-sampling kit for women in the self-sampling arm, and notification of a Pap test result to the Registry for women in the Pap test arm at 3 and 6 months after mailout. The most important secondary outcome is the proportion of test-positive women who undergo further investigations at 6 and 12 months after mailout of results.

Discussion

The iPap trial will provide strong evidence about whether HPV self-sampling could be used in Australia to improve participation in cervical screening for never-and under-screened women.

Trial registration

ANZCTR Identifier: ACTRN12613001104741; UTN: U1111-1148-3885

Keywords:
HPV DNA testing; Home-based; Self-sample; Cervical screening; Participation