Compass Trial: A Randomised Controlled Trial of Primary Human Papillomavirus (HPV) Testing for Cervical Cancer Screening in Australia: Pilot Study

Pilot Study for a trial in Human Papillomavirus (HPV) vaccinated and unvaccinated women presenting for cervical screening of 6 yearly HPV screening versus 3-yearly cytology screening to assess the feasibility via recruitment rates, cross sectional positivity rate and laboratory implementation.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001207707

Acronym

Compass

Enrollment

5001

Registered

2013-11-04

Start date

2013-10-31

Completion date

2014-12-01

Last updated

2026-06-29

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 is evaluating whether testing for certain types of Human Papillomavirus (HPV) is a more effective cervical cancer screening test than the Pap Smear test. Who is it for? You may be eligible to join this study if you are female, aged between 25 years and 64 years, an Australian resident in Victoria, and attends routine cervical screenings at one of the study’s participating health care practice. Trial details Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group will undergo three-yearly image read cytology screening with reflex HPV triage testing for low grade Possible/Definite Low-Grade Squamous Intraepithelial Lesion (p/d LSIL) smears. Participants in the second group will undergo six-yearly HPV screening with types 16/18 (+/- 45 in pilot study) genotyping and cytology triage of intermediate risk women with other oncogenic HPV infection. Participants in the third group will undergo a six-yearly HPV screening with types 16/18 (+/- 45 in pilot study) genotyping and dual-stained (DS) cytology (with p16/Ki67) triage of intermediate risk women with other oncogenic HPV infection.

Interventions

Intervention Arm 2: Five -yearly HPV screening with types 16/18 (+/-45 in pilot study) genotyping and cytology triage of intermediate risk women with other oncogenic HPV infection; The sample collected from participants in intervention arm 2 will be a Liquid Based Cytology (LBC) Pap test and collection should take 15 minutes and Intervention Arm 3: Five -yearly HPV screening with types 16/18 (+/-45 in pilot study) genotyping and dual-stained (DS) cytology (with p16/Ki67) triage of intermediate

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

25 Years to 64 Years

Healthy volunteers

Inclusion criteria

Australian female resident of Victoria Aged 25-64 Attending for routine cervical screening at a participating health care practice

Exclusion criteria

Total hysterectomy (uterus and cervix) Presence of symptoms for which cervical cancer must be excluded Currently undergoing treatment for cervical pre-cancer, or cancer Attending for follow-up of a prior cervical abnormality, including repeated "test of cure" procedures in which the woman has not yet been discharged back to routine screening Known pregnancy

Outcome results