ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

Cervical (cervix)

Public Health

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]

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]

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]

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]

To determine proportion of women who have a positive screening test who undergo appropriate further investigation using the Victorian Pap test Registry

Timepoint [1]

6 months and 12 months after the mailout of the test positive letter

Secondary outcome [2]

To determine women’s experience with self-sampling including reasons for not returning a complete kit using the survey questionnaire

Timepoint [2]

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Professor Dallas English

Address [1]

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]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Associate Professor Julie Simpson

Address [2]

Centre for MEGA Epidemiology
Level3, 207 Bouverie Street
Melbourne School of Population and Global Health
The University of Melbourne
VIC 3010

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Associate Professor Marion Saville

Address [3]

Executive Director,
Victorian Cytology Service Inc
PO BOX 178
Carlton South VIC 3053

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Dr. Julia Brotherton

Address [4]

Epidemiologist,
National HPV Vaccination Program Register
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Dr. Farhana Sultana

Address [5]

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]

Bangladesh

Secondary sponsor category [6]

Individual

Name [6]

Kelly Drennan

Address [6]

Victorian Cervical Cytology Registry
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002

Country [6]

Australia

Other collaborator category [1]

Individual

Name [1]

Ms Robyn Mullins

Address [1]

Senior Research Fellow,
Centre for Behavioural Research in Cancer
Cancer Council Victoria
100 Drummond Street,
Carlton VIC 3053

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr. Stella Heley

Address [2]

Liaison Physician,
Victorian Cytology Service Inc
PO BOX 178
Carlton South VIC 3053

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr. David Wrede

Address [3]

Consultant Gynaecologist/Lead for Dysplasia
Royal Women's Hospital
Locked Bag 300
Cnr Flemington Road and Grattan Street
Parkville Victoria 3052

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Department of Health Human Research Ethics Committee

Ethics committee address [1]

50 Lonsdale Street
Melbourne VIC 3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/08/2013

Ethics approval number [1]

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

A/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

Phone

+613 92500370

Fax

+613 84176835

dgertig@vcs.org.au

Contact person for public queries

Name

Kelly Drennan

Address

Victorian Cervical Cytology Registry
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002

Country

Australia

Phone

+613 84176817

Fax

+613 84176836

kdrennan@vcs.org.au

Contact person for scientific queries

Name

Dorota Gertig

Address

Medical Director,
Victorian Cervical Cytology Registry
Victorian Cytology Service Inc
Level 1, 250 Victoria Parade
East Melbourne VIC 3002

Country

Australia

Phone

+613 92500370

Fax

+613 84176835

dgertig@vcs.org.au

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

Source	Title	Year of Publication	DOI
Embase	Home-based HPV self-sampling improves participation by never-screened and under-screened women: Results from a large randomized trial (iPap) in Australia.	2016	https://dx.doi.org/10.1002/ijc.30031

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically