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Trial registered on ANZCTR


Registration number
ACTRN12613001104741
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
2/10/2013
Date last updated
6/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Home-based human papillomavirus (HPV) self-sampling for improving participation in cervical screening
Scientific title
Randomized controlled trial of home-based HPV self-sampling for improving participation in cervical screening by never and under screened women, when compared to reminder letters to attend for a Pap test
Secondary ID [1] 283300 0
Nil
Universal Trial Number (UTN)
U1111-1148-3885
Trial acronym
iPAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer 290185 0
Condition category
Condition code
Cancer 290569 290569 0 0
Cervical (cervix)
Public Health 290626 290626 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288019 0
Early detection / Screening
Comparator / control treatment
Reminder letter to attend for a Pap test (standard practice in Victoria)
Control group
Active

Outcomes
Primary outcome [1] 290588 0
Proportion of women who participate, by returning the self-sampling kit to the Victorian Cytology Services Laboratory for women in the intervention arm, and notification of a Pap test result to the Victorian Pap test Registry for women allocated to the reminder letter arm
Timepoint [1] 290588 0
3 months after mailout of the last batch of self-sampling kits. We will also be looking at participations at 6 months of mailout of the last batch of self-sampling kits given that these are never and underscreened women
Secondary outcome [1] 304854 0
To determine proportion of women who have a positive screening test who undergo appropriate further investigation using the Victorian Pap test Registry
Timepoint [1] 304854 0
6 months and 12 months after the mailout of the test positive letter
Secondary outcome [2] 304855 0
To determine women’s experience with self-sampling including reasons for not returning a complete kit using the survey questionnaire
Timepoint [2] 304855 0
3 months after the mailout of the survey questionnaire

Eligibility
Key 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)
Minimum age
30 Years
Maximum age
69 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Pregnant women
-Women with a history of hysterectomy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Two different data sources will be used to identify women for the study: The Victorian Cervical Cytology Registry (VCCR) and the Victorian Electoral Roll (VER). We will link the VCCR dataset to the VER dataset to identify women with no history of a previous Pap smear. Variable that will be used in the linkage includes full name, address, and date of birth. After linkage between the VER and VCCR datasets have occurred, two dataset will be generated. These are neverscreened women, appearing on the electoral roll only, and underscreened women, who are lapsed screeners based on the information from the Registry alone. Within each screening groups women will be allocated a study ID number. Randomization will be performed using this study ID number (but no other information). An external statistician will oversee the complete process of randomization to comply with ethics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be randomly allocated to the intervention and the current practice arm in a 7:1 randomization ratio, stratified by their screening history (i.e never and underscreened). Underscreened women will be further stratified by year of last Pap test (5 years, 6 years, 7 years, 8 years, 9 years and 10-14 years).

Within strata, simple randomization will be performed in the presence of an external staistician and will be computer generated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We plan to contact 16,000 women, including 8,000 who have never attended a Pap smear (i.e. never screened group) and 8,000 who had their last Pap smear 5 or more years ago (i.e. under-screened group). Within each of these groups, 7000 women will be randomly allocated to the HPV self-sampling kit group and 1000 to receive a reminder letter to attend a health practitioner for a Pap test. With 7000 women receiving the HPV self-sampling kit within each screening group and based on the conservative estimate of 20% participation (the literature suggest this estimate could be somewhere between 20-30% participation) and prevalence of positive result for HPV test of 10%, we will have at least 140 women invited for a follow-up Pap smear. With 140 women we will obtain a 95% confidence interval of +/- 5 % points around an estimated follow-up proportion of 90%. For the primary aim, with 7000 women in the HPV arm and 1000 women in the standard practice arm, we have 95% confidence and 87% power to detect an absolute difference of 4 % points assuming that 15% of those receiving standard screening practice attend a Pap smear.

Within each stratum (never screened and under screened) the proportion of women in each arm participating (i.e. primary outcome) will be calculated as will the absolute difference in the proportion of participation between HPV self sampling and current policy arms and the corresponding 95% confidence interval and two-sided p-value. An intention to treat approach will be used for the analysis, with women who subsequently report they are adequately screened, are pregnant, or have had a hysterectomy, analysed within the arm to which they were randomised. We will also calculate adjusted participation rates, in which women who report that they are pregnant, have had a hysterectomy, or that they are adequately screened are removed from the denominators. Additionally, the distribution of age and SES will be compared between the women who participate and not participate within each screening group and trial arm stratum.
Estimates and 95% confidence intervals of the proportion of women having appropriate further investigation (i.e. secondary outcome) in the sub-groups of positive HPV test and positive Pap test for each stratum will also be calculated.
The responses to the different items (i.e. items within the themes: psycho-social, feasibility and practical issues) of the questionnaire survey completed by the women randomised to the home-based self-sampling will be summarised and reported as the total number and proportion within each category of the items. We will also report the reasons for not returning a self-sampling kit.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/02/2014
Actual
24/03/2014
Date of last participant enrolment
Anticipated
26/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288033 0
Government body
Name [1] 288033 0
National Health and Medical Research Council
Country [1] 288033 0
Australia
Primary sponsor type
Individual
Name
Associate Prof Dorota Gertig
Address
Medical Director,
Victorian Cervical Cytology Registry
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 286750 0
Individual
Name [1] 286750 0
Professor Dallas English
Address [1] 286750 0
Director of the Centre for MEGA Epidemiology,
Level3, 207 Bouverie Street
Melbourne School of Population and Global Health
The University of Melbourne
VIC 3010
Country [1] 286750 0
Australia
Secondary sponsor category [2] 286751 0
Individual
Name [2] 286751 0
Associate Professor Julie Simpson
Address [2] 286751 0
Centre for MEGA Epidemiology
Level3, 207 Bouverie Street
Melbourne School of Population and Global Health
The University of Melbourne
VIC 3010
Country [2] 286751 0
Australia
Secondary sponsor category [3] 286752 0
Individual
Name [3] 286752 0
Associate Professor Marion Saville
Address [3] 286752 0
Executive Director,
Victorian Cytology Service Inc
PO BOX 178
Carlton South VIC 3053
Country [3] 286752 0
Australia
Secondary sponsor category [4] 286753 0
Individual
Name [4] 286753 0
Dr. Julia Brotherton
Address [4] 286753 0
Epidemiologist,
National HPV Vaccination Program Register
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002
Country [4] 286753 0
Australia
Secondary sponsor category [5] 286754 0
Individual
Name [5] 286754 0
Dr. Farhana Sultana
Address [5] 286754 0
PhD Student
Centre for MEGA Epidemiology
Level3, 207 Bouverie Street
Melbourne School of Population and Global Health
The University of Melbourne
VIC 3010
Country [5] 286754 0
Bangladesh
Secondary sponsor category [6] 286755 0
Individual
Name [6] 286755 0
Kelly Drennan
Address [6] 286755 0
Victorian Cervical Cytology Registry
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002
Country [6] 286755 0
Australia
Other collaborator category [1] 277636 0
Individual
Name [1] 277636 0
Ms Robyn Mullins
Address [1] 277636 0
Senior Research Fellow,
Centre for Behavioural Research in Cancer
Cancer Council Victoria
100 Drummond Street,
Carlton VIC 3053
Country [1] 277636 0
Australia
Other collaborator category [2] 277637 0
Individual
Name [2] 277637 0
Dr. Stella Heley
Address [2] 277637 0
Liaison Physician,
Victorian Cytology Service Inc
PO BOX 178
Carlton South VIC 3053
Country [2] 277637 0
Australia
Other collaborator category [3] 277638 0
Individual
Name [3] 277638 0
Dr. David Wrede
Address [3] 277638 0
Consultant Gynaecologist/Lead for Dysplasia
Royal Women's Hospital
Locked Bag 300
Cnr Flemington Road and Grattan Street
Parkville Victoria 3052
Country [3] 277638 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289955 0
Department of Health Human Research Ethics Committee
Ethics committee address [1] 289955 0
50 Lonsdale Street
Melbourne VIC 3000
Ethics committee country [1] 289955 0
Australia
Date submitted for ethics approval [1] 289955 0
Approval date [1] 289955 0
08/08/2013
Ethics approval number [1] 289955 0
05/13

Summary
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.
Trial website
http://www.vccr.org/HPVselfsample/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43270 0
A/Prof Dorota Gertig
Address 43270 0
Medical Director,
Victorian Cervical Cytology Registry
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002
Country 43270 0
Australia
Phone 43270 0
+613 92500370
Fax 43270 0
+613 84176835
Email 43270 0
[email protected]
Contact person for public queries
Name 43271 0
Kelly Drennan
Address 43271 0
Victorian Cervical Cytology Registry
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002
Country 43271 0
Australia
Phone 43271 0
+613 84176817
Fax 43271 0
+613 84176836
Email 43271 0
[email protected]
Contact person for scientific queries
Name 43272 0
Dorota Gertig
Address 43272 0
Medical Director,
Victorian Cervical Cytology Registry
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002
Country 43272 0
Australia
Phone 43272 0
+613 92500370
Fax 43272 0
+613 84176835
Email 43272 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHome-based HPV self-sampling improves participation by never-screened and under-screened women: Results from a large randomized trial (iPap) in Australia.2016https://dx.doi.org/10.1002/ijc.30031
N.B. These documents automatically identified may not have been verified by the study sponsor.