Swabs in Screening for HPV (SWISH)

NCT07790601 · tracked via the Priya Life Science Australia tracker

Sponsor

Kirby Institute

Phase

Not applicable

Started

2026-11-01

Last updated

2026-08-27

Condition(s) studied

Anal CancerHuman Papilloma Virus (HPV)

Investigational drug(s) / intervention(s)

Self-collected anal swab

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.

Study 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.

Eligibility

Sex

ALL

Min age

35 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Living with HIV. 2. Gay, bisexual or other man who has sex with men or trans woman aged at least 35 years, or all other people aged at least 45 years. 3. Able to commit to and undertake all study procedures. 4. Willing and able to provide informed consent, in any of the following languages: i. English. ii. Alternatively, use of the accredited translation service usually utilised in the participant's healthcare appointments. Exclusion Criteria: 1. Aged over 75 years of age at time of enrolment. 2. Previously undergone an HRA. 3. History of anal cancer and/or anal HSIL. 4. Medically directed treatment (including topical treatments) to the anal canal in the preceding two weeks, which in the opinion of the consenting investigator could impact swab viability. 5. Concurrent malignancy requiring systemic therapy, or medical conditions otherwise considered contraindicated to HRA by the delegated investigators.

Primary outcome measure(s)

Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort. — At Baseline.
To measure the percentage of self-collected anal swabs that are valid for HRHPV testing compared with clinician-collected anal swabs, as defined by internal control positivity.

Trial sites (10)

Facility	City	Region
North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic	Cudgen	New South Wales
Taylor Square Private Clinic	Darlinghurst	New South Wales
Sydney Sexual Health Centre	Sydney	New South Wales
Easy Sydney Doctors	Sydney	New South Wales
Holdsworth House Medical Practice	Sydney	New South Wales
St Vincent's Hospital, Sydney	Sydney	New South Wales
RPA Sexual Health	Sydney	New South Wales
Western Sydney Sexual Health Centre	Sydney	New South Wales
Royal Adelaide Hospital	Adelaide	South Australia
Melbourne Sexual Health Centre	Melbourne	Victoria

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07790601 on ClinicalTrials.gov ↗ ← All trials in Australia