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 AustraliaReportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Cancer

, 14:207

Epidemiology, prevention and public health

Abstract

BackgroundOrganized 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-DesignThe 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.

DiscussionThe 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 registrationANZCTR Identifier: ACTRN12613001104741; UTN: U1111-1148-3885

KeywordsHPV DNA testing Home-based Self-sample Cervical screening Participation Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-14-207 contains supplementary material, which is available to authorized users.

Download fulltext PDF



Autor: Farhana Sultana - Dallas R English - Julie A Simpson - Julia ML Brotherton - Kelly Drennan - Robyn Mullins - Stella Hele

Fuente: https://link.springer.com/







Documentos relacionados