NCT07790601Not yet recruiting
Swabs in Screening for HPV (SWISH)
Randomised Controlled Trial of Self-collected vs Clinician-collected Anal Swabs for Anal Cancer Screening in People Living With HIV (PLHIV) in Australia
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- Kirby Institute
- Diseases
- HIV
- NCT number
- NCT07790601
What you commit to
- Study type: Interventional
- Planned participants: 700
- From 1 Nov 2026 to the primary completion date, 31 Aug 2030
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously undergone an HRA.
- Concurrent malignancy requiring systemic therapy, or medical conditions otherwise considered contraindicated to HRA by the delegated investigators.
Other illness
- History of anal cancer and/or anal HSIL.
Age
- Aged over 75 years of age at time of enrolment.
Other
- 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.
Who the study is looking for
- Living with HIV.
- 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.
- Able to commit to and undertake all study procedures.
- Willing and able to provide informed consent, in any of the following languages:
- English. ii. Alternatively, use of the accredited translation service usually utilised in the participant's healthcare appointments.
Age in the registry: 35 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic Coordinator of this site? Confirm its status | Cudgen | Australia | Unknown status |
| Taylor Square Private Clinic Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Melbourne Sexual Health Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Western Sydney Sexual Health Centre Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Holdsworth House Medical Practice Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Sydney Sexual Health Centre Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Easy Sydney Doctors Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| RPA Sexual Health Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.