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Swabs in Screening for HPV (SWISH)
Sponsor: Kirby Institute
Summary
This trial aims to evaluate if self-collected anal swabs (SCS) can be used for anal cancer screening. Currently, only clinician-collected anal swabs (CSC) are recommended for anal cancer screening, and this may be a barrier for people to access screening. About 700 people living with HIV (PLHIV) in Australia will randomly undergo a SCS followed by a CSC, or the other way around. Swabs will be tested for high-risk human Papillomavirus (HRHPV, which causes most anal cancer) and if the swab is positive for HRHPV, it will also be tested for pre-cancerous cells. The anal swabs will be tested for new biomarkers, "methylation", which might help us predict if precancerous lesions will develop into anal cancer. Everyone will be asked about their preferences for swab collection. If someone tests positive for HRHPV, they will receive further care. We expect that more screening options will result in more people being screened.
Official title: Randomised Controlled Trial of Self-collected vs Clinician-collected Anal Swabs for Anal Cancer Screening in People Living With HIV (PLHIV) in Australia
Key Details
Gender
All
Age Range
35 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2026-11-01
Completion Date
2030-12-31
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Self-collected anal swab
Each participant will be order-randomised to undergo a self-collected or clinician-collected anal swab first, with the alternate swab collected immediately afterwards. Both swab will be collected on the same day at the Baseline Visit.
Locations (10)
North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic
Cudgen, New South Wales, Australia
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia
Sydney Sexual Health Centre
Sydney, New South Wales, Australia
Easy Sydney Doctors
Sydney, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
St Vincent's Hospital, Sydney
Sydney, New South Wales, Australia
RPA Sexual Health
Sydney, New South Wales, Australia
Western Sydney Sexual Health Centre
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Melbourne Sexual Health Centre
Melbourne, Victoria, Australia