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Trial registered on ANZCTR


Registration number
ACTRN12613000906752
Ethics application status
Approved
Date submitted
6/08/2013
Date registered
14/08/2013
Date last updated
14/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Accuracy and acceptability towards cervical screening by self-collected vs clinician-collected sampling for Human papillomavirus (HPV) DNA testing in female sex workers.
Scientific title
A pilot study to evaluate accuracy and acceptability towards cervical screening by self-collected vs clinician-collected sampling for HPV DNA testing in female sex workers.
Secondary ID [1] 282980 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer 289805 0
Condition category
Condition code
Cancer 290155 290155 0 0
Cervical (cervix)
Public Health 290201 290201 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study participants were randomized into two groups:
Arm 1: HPV DNA self-collected sampling followed by HPV DNA clinician-collected sampling with Pap smear

Arm 2: HPV DNA clinician-collected sampling with Pap smear followed by HPV DNA self-collected sampling

1. The women preformed both HPV DNA self-collected sampling and HPV DNA clinician-collected sampling with Pap smear on the same day when they presented for women’s health checking.

2. Explanation and instruction of the HPV DNA self-sampling was given by a trained nurse to each participating women. Each women will be given a long-handled, sterile Dacron swab in a wrapper which is the same type used by the clinician, a plastic vial and a specimen bag. The subject 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 subject inserted the swab into her vagina at least 2 inches deep and then turn the swab two full rotations. Then the subject pulled out the swab and place it in the plastic vial which to be placed in the specimen bag. The subject then passed the specimen bag containing the vial to the nurse who would transfer the swab to the 20ml vial containing 5 ml of phosphate-buffered saline.

3. Each participant was examined by clinician who will first collect a Pap smear sample from the ectocervix using a cytobrush and then collect an clinician-ectocervical sample using a Dacron swab for HPV DNA sampling. The clinician directed the swab at the cervix and turn the swab two full rotations to maximize cell collection. The swab was placed into a 20 ml vial containing 5 ml of phosphate-buffered saline.
Intervention code [1] 287694 0
Early detection / Screening
Comparator / control treatment
Standard cervical screening of Pap smear, HPV DNA clinician-sampling before having HPV DNA self-sampling
Control group
Active

Outcomes
Primary outcome [1] 290186 0
Participants’ attitudes and acceptability towards self-collected HPV DNA testing.

The subject was asked her attitudes toward self-sampling including the confidence of skill, preference in the future and acceptability by means of face-to-face interview using a structured questionnaire. Therefore, the participants had an individual face to face interview conducted by the research nurse in the clinic. The questions were mainly divided into two sections. The first section covers socio-demographic measure, health status and lifestyle and behavioral variables of the participants and then the second section covered the attitudes and the acceptability to the self-collected sampling for HPV DNA testing.
Timepoint [1] 290186 0
same day as the screening was done, after obtaining all samples
Secondary outcome [1] 304072 0
Evaluation of the accuracy of self-collected vaginal samples for HPV DNA testing in comparison to clinician-obtained cervical samples and Pap smear finding.
Timepoint [1] 304072 0
After obtaining all samples

Eligibility
Key inclusion criteria
Eligible participants must be a female sex worker, were aged 18 years or over
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants were excluded from the study if they were currently pregnant, had presenting symptoms of cervical caner, and known abnormal Pap test results, genital cancer, cervical surgery, or immune treatment of the cervix within a half year.

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
A reasonable and acceptable sample size of 100 with 5% margin of error at 90% power would be targeted for the study. However, the final sample size was reduced to around 70 samples for this pilot trial because of reduction of granted budget.

Chi-square/Fisher's exact test and t-test were used to examine the differences of participants' attitudes towards two sampling methods. The agreement between HPV detection by two methods was determined by kappa statistic. McNemar's test was used to test the significance of unequal distribution of discordance results in detection of HPV DNA between 2 tests. 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] 5282 0
Hong Kong
State/province [1] 5282 0

Funding & Sponsors
Funding source category [1] 287752 0
University
Name [1] 287752 0
Direct Grant of Research, The Chinese University of Hong Kong.
Address [1] 287752 0
The Chinese University of Hong Kong, Shatin, N.T.
Country [1] 287752 0
Hong Kong
Primary sponsor type
Individual
Name
Professor Eliza LY Wong, Associate Professor, The Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong
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] 286473 0
None
Name [1] 286473 0
Address [1] 286473 0
Country [1] 286473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289698 0
Joint The Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [1] 289698 0
Flat 3C, Block B, Staff Quarters, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories
Ethics committee country [1] 289698 0
Hong Kong
Date submitted for ethics approval [1] 289698 0
Approval date [1] 289698 0
11/08/2009
Ethics approval number [1] 289698 0
CRE-2009.373-T

Summary
Brief summary
The study aimed to provide information of acceptability of HPV DNA self-sampling in female sex workers, and comparing the self-collected vaginal samples with clinician-collected cervical samples and Pap smear in Hong Kong. Participants were randomized into 2 groups, have either self-sampling or clinician sampling first. The results of this study will assist guidelines implementation for future cervical screening, and increase cervical screening uptake rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42030 0
Prof Eliza LY Wong
Address 42030 0
Rm 503, School of Public Health Building, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories
Country 42030 0
Hong Kong
Phone 42030 0
+ 852 2252 8772
Fax 42030 0
Email 42030 0
lywong@cuhk.edu.hk
Contact person for public queries
Name 42031 0
Prof Eliza LY Wong
Address 42031 0
Rm 503, School of Public Health Building, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories
Country 42031 0
Hong Kong
Phone 42031 0
+ 852 2252 8772
Fax 42031 0
Email 42031 0
lywong@cuhk.edu.hk
Contact person for scientific queries
Name 42032 0
Prof Eliza LY Wong
Address 42032 0
Rm 503, School of Public Health Building, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories.
Country 42032 0
Hong Kong
Phone 42032 0
+ 852 2252 8772
Fax 42032 0
Email 42032 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