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Accuracy and acceptability towards cervical screening by self-collected vs clinician-collected sampling for Human papillomavirus (HPV) DNA testing in female sex workers.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000906752
Enrollment
100
Registered
2013-08-14
Start date
2009-11-03
Completion date
2010-05-04
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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-s

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.

Sponsors

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
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Eligible participants must be a female sex worker, were aged 18 years or over

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026