None listed
Conditions
Brief summary
This study is evaluating whether mailing a human papillomavirus (HPV) self-sampling kit will increase participation in cervical screening. Who is it for? You may be eligible to join this study if you are a Victorian woman aged between 30-69 years with no record of a Pap test in the Victorian Pap Test Registry (never screened) or the last recorded Pap test was at least 5 years ago (underscreened). Study details: The National Cervical Screening Program based on conventional Pap test has substantially reduced deaths from cervical cancer; however, some women are missing out on the benefit because they do not have regular Pap tests. A new method of screening has recently become available. This is based on testing for human papillomavirus (HPV), which is the virus that causes cervical cancer. Because women can obtain their own HPV sample at home, this test has the potential to overcome some of the reasons why women don’t have Pap tests. Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will be mailed an invitation letter and a testing kit, which includes an information brochure, HPV self-sampling kit, instruction sheet, pathology information form and a reply paid envelope. Participants in the other group will receive a reminder letter to attend for a Pap test, which is standard practice in Victoria. We will evaluate the proportion of women in each group who participate in screening, the proportion of women with a positive screening test who undergo appropriate further investigation, and women’s experiences with self-sampling over a period of 12 months.
Interventions
a)A pre-invitation letter will be sent out first. This letter will inform women that a kit will be sent and explaining the purpose of the kit.
b)Women will receive the kit within three weeks of mailout of the pre-invitation letter. The kit includes:
a.Invitation letter
b.Information brochure on HPV and cervical cancer
c.HPV self-sampling kit: includes a cotton tipped swab enclosed in a plastic tube within a ziplock bag
d.Instruction sheet (written and pictorial) for collection and mailing of the
a)A pre-invitation letter will be sent out first. This letter will inform women that a kit will be sent and explaining the purpose of the kit. b)Women will receive the kit within three weeks of mailout of the pre-invitation letter. The kit includes: a.Invitation letter b.Information brochure on HPV and cervical cancer c.HPV self-sampling kit: includes a cotton tipped swab enclosed in a plastic tube within a ziplock bag d.Instruction sheet (written and pictorial) for collection and mailing of the sample e.Pathology information form: asks for minimal information relevant to screening history, routinely collection information by the Registry, including women’s country of birth, information on indigenous status and hysterectomy status. We are also collecting specifically for the purposes of this study pregnancy status and her GP’s contact details if she wishes to provide them f.Reply paid envelope for return of the swab with the pathology information form The participants will be instructed (instruction sheet) to post their samples with the completed information form as soon as possible, preferably within 24 hours of collection.
Sponsors
Associate Prof Dorota Gertig
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
Victorian women with no record of a Pap test in the Victorian Pap test Registry (never screened) or the last recorded Pap test was at least 5 years ago (underscreened)
Exclusion criteria
-Pregnant women -Women with a history of hysterectomy
Outcome results
None listed