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A Randomized control trial to evaluate Human papillomavirus (HPV) DNA self-sampling as a primary cervical screening test in women

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001003763
Enrollment
390
Registered
2013-09-10
Start date
2011-11-21
Completion date
2012-09-14
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 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.

Interventions

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 d

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.

Sponsors

Professor Eliza LY Wong, Associate Professor
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Female aged 35 to 65 who have ever had sexual experience and are able to give a written informed consent.

Exclusion criteria

Women who have never had sex, had total hysterectomy, or currently pregnant were excluded from the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026