title: Home-based HPV self-sampling improves participation by never-screened and under-screened women: Results from a large randomized trial (iPap) in Australia.
abstract: We conducted a randomized controlled trial to determine whether HPV self-sampling increases participation in cervical screening by never- and under-screened (not screened in past 5 years) women when compared with a reminder letter for a Pap test. Never- or under-screened Victorian women aged 30-69 years, not pregnant and with no prior hysterectomy were eligible. Within each stratum (never-screened and under-screened), we randomly allocated 7,140 women to self-sampling and 1,020 to Pap test reminders. The self-sampling kit comprised a nylon tipped flocked swab enclosed in a dry plastic tube. The primary outcome was participation, as indicated by returning a swab or undergoing a Pap test; the secondary outcome, for women in the self-sampling arm with a positive HPV test, was undergoing appropriate clinical investigation. The Roche Cobas® 4800 test was used to measure presence of HPV DNA. Participation was higher for the self-sampling arm: 20.3 versus 6.0% for never-screened women (absolute difference 14.4%, 95% CI: 12.6-16.1%, p < 0.001) and 11.5 versus 6.4% for under-screened women (difference 5.1%, 95% CI: 3.4-6.8%, p < 0.001). Of the 1,649 women who returned a swab, 45 (2.7%) were positive for HPV16/18 and 95 (5.8%) were positive for other high-risk HPV types. Within 6 months, 28 (62.2%) women positive for HPV16/18 had colposcopy as recommended and nine (20%) had cytology only. Of women positive for other high-risk HPV types, 78 (82.1%) had a Pap test as recommended. HPV self-sampling improves participation in cervical screening for never- and under-screened women and most women with HPV detected have appropriate clinical investigation.
authors: Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
authors: Farhana
authors: F
authors: Sultana
authors: Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.|Cancer Council Victoria, Melbourne, Victoria, Australia.
authors: Dallas R
authors: DR
authors: English
authors: Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
authors: Julie A
authors: JA
authors: Simpson
authors: Victorian Cervical Cytology Registry, Victorian Cytology Service, East Melbourne, Victoria, Australia.
authors: Kelly T
authors: KT
authors: Drennan
authors: Cancer Council Victoria, Melbourne, Victoria, Australia.
authors: Robyn
authors: R
authors: Mullins
authors: Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.|National HPV Vaccination Program Register, Victorian Cytology Service, East Melbourne, Victoria, Australia.
authors: Julia M L
authors: JM
authors: Brotherton
authors: Department of Oncology and Dysplasia, The Royal Women's Hospital, Parkville, Victoria, Australia.|Department of Obstetrics and Gynaecology, The University of Melbourne, Carlton, Victoria, Australia.
authors: C David
authors: CD
authors: Wrede
authors: Victorian Cytology Service, Carlton, Victoria, Australia.
authors: Stella
authors: S
authors: Heley
authors: Department of Obstetrics and Gynaecology, The University of Melbourne, Carlton, Victoria, Australia.|Victorian Cytology Service, Carlton, Victoria, Australia.
authors: Marion
authors: M
authors: Saville
authors: Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.|Victorian Cervical Cytology Registry, Victorian Cytology Service, East Melbourne, Victoria, Australia.
authors: Dorota M
authors: DM
authors: Gertig
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia / Q000453:epidemiology; D005260:Female; D006801:Humans; D008403:Mass Screening; D008875:Middle Aged; D065006:Papanicolaou Test / Q000379:methods*; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis / Q000453:epidemiology* / Q000821:virology*; D010349:Patient Compliance; D015995:Prevalence; D012648:Self Care / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology
keywords: HPV; RCT; never-screened; self-sampling; under-screened