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Trial registered on ANZCTR


Registration number
ACTRN12613001003763
Ethics application status
Approved
Date submitted
26/08/2013
Date registered
10/09/2013
Date last updated
10/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized control trial to evaluate Human papillomavirus (HPV) DNA self-sampling as a primary cervical screening test in women
Scientific title
A randomized control trial to evaluate the acceptability and accuracy of human papillomavirus (HPV) DNA self-sampling as a primary cervical screening test in women, compared with clinician-sampling.
Secondary ID [1] 283085 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 289921 0
Human papillomavirus (HPV) 289922 0
Condition category
Condition code
Cancer 290295 290295 0 0
Cervical (cervix)
Public Health 290296 290296 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants were randomized into two arm:
Arm 1: HPV DNA self-sampling before Pap smear
Arm 2: Pap smear before HPV DNA self-sampling

Participants were explained the study detail before agreeing to participate, they performed both HPV DNA self-sampling and Pap smear.

Each woman was given a long-handled, sterile Dacron swab in a wrapper, a plastic vial and a specimen bag. The participant was directed to a private, well-lit room. Verbal and written instructions for cell collection and diagram of the female genital anatomy were provided. The participant inserted the swab into her vagina at least 2 inches deep following with five full rotations of the swab. The participant then pulled out the swab, placed it in the plastic vial and be sealed in a specimen bag.

Each woman was examined by clinicians. The clinician collected a Pap smear sample from the ectocervix using a cytobrush. The cytobrush was placed into a 20 ml vial containing phosphate-buffered saline. Research staff pipetted 1 ml of this solution to a vial for the purpose of HPV DNA test.

Both self-sampling and Pap smear were conducted on the same day one immediately after the other.
Intervention code [1] 287802 0
Early detection / Screening
Comparator / control treatment
Cervical screening of Pap smear (HPV DNA testing)
Control group
Active

Outcomes
Primary outcome [1] 290323 0
Participants' acceptability towards HPV DNA self-sampling vs clinician sampling. Each participant was asked the acceptability towards both sampling methods, by means of face-to-face interview using a structured questionnaire. After having both screening tests performed, they were again asked the acceptability and preferences toward both methods.
Timepoint [1] 290323 0
same day as the screening was done, after obtaining all samples
Secondary outcome [1] 304306 0
Evaluation of the accuracy of self-collected vaginal samples for HPV DNA testing in comparison to clinician-obtained cervical samples
Timepoint [1] 304306 0
After obtaining all samples

Eligibility
Key inclusion criteria
Female aged 35 to 65 who have ever had sexual experience and are able to give a written informed consent.
Minimum age
35 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who have never had sex, had total hysterectomy, or currently pregnant were excluded from the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on 50% of acceptance of HPV sampling from our previous pilot study, the minimum sample size was estimated at 390 participants with 95% power at 5% level of statistical level.

Acceptability of self-sampling method and Pap smear was compared using McNemar test. The agreement between HPV detection by two methods was determined by kappa statistic. Statistical significance was considered when p-vales were < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5340 0
Hong Kong
State/province [1] 5340 0

Funding & Sponsors
Funding source category [1] 287842 0
Government body
Name [1] 287842 0
Research Office
Food and Health Bureau
The Government of the Hong Kong Special Administrative Region
Address [1] 287842 0
Research Office
Food and Health Bureau
9/F, Rumsey Street Multi-storey Carpark Building
2 Rumsey Street, Sheung Wan
Country [1] 287842 0
Hong Kong
Primary sponsor type
Individual
Name
Professor Eliza LY Wong, Associate Professor
Address
Rm 503, School of Public Health Building, Prince of Wales Hospital, 30-32
Ngan Shing Street, Shatin, New Territories
Country
Hong Kong
Secondary sponsor category [1] 286570 0
None
Name [1] 286570 0
Address [1] 286570 0
Country [1] 286570 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289783 0
Joint The Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [1] 289783 0
Flat 3C, Block B, Staff Quarters, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories
Ethics committee country [1] 289783 0
Hong Kong
Date submitted for ethics approval [1] 289783 0
Approval date [1] 289783 0
02/03/2011
Ethics approval number [1] 289783 0
CRE-2011.111-T

Summary
Brief summary
The study measures the acceptability of HPV DNA self sampling in the general population of women in Hong Kong, and accuracy of self- and clinician-collected samples for HPV DNA testing. Participants were randomized into 2 arms, to have either self-sampling or clinician-sampling first. The results of this study would facilitate guidelines implementation for new cervical screening programme.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42402 0
Prof Eliza LY Wong
Address 42402 0
Rm 503, School of Public Health Building, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories
Country 42402 0
Hong Kong
Phone 42402 0
+ 852 2252 8772
Fax 42402 0
Email 42402 0
lywong@cuhk.edu.hk
Contact person for public queries
Name 42403 0
Prof Eliza LY Wong
Address 42403 0
Rm 503, School of Public Health Building, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories
Country 42403 0
Hong Kong
Phone 42403 0
+ 852 2252 8772
Fax 42403 0
Email 42403 0
lywong@cuhk.edu.hk
Contact person for scientific queries
Name 42404 0
Prof Eliza LY Wong
Address 42404 0
Rm 503, School of Public Health Building, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories.
Country 42404 0
Hong Kong
Phone 42404 0
+ 852 2252 8772
Fax 42404 0
Email 42404 0
lywong@cuhk.edu.hk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary