NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Swabs in Screening for HPV (SWISH)

Not Yet RecruitingNA

Sponsor: Kirby Institute

Conditions: Anal Cancer, Human Papilloma Virus (HPV)

Interventions: Self-collected anal swab

Countries: Australia

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 overview

Sex: ALL

Age: 35 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (10)

Cudgen, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia