Anal CancerSWISHNCT07790601
Swabs in Screening for HPV (SWISH)
A study testing Self-collected anal swab in people with Anal Cancer and Human Papilloma Virus (HPV), run by Kirby Institute at 10 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Anal Cancer, Human Papilloma Virus (HPV)
- What is being tested?
- Self-collected anal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 10 sitesAustralia
- Study dates
- 1 Nov 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Aged over 75 years of age at time of enrolment.
- Previously undergone an HRA.
- History of anal cancer and/or anal HSIL.
- 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.
- Concurrent malignancy requiring systemic therapy, or medical conditions otherwise considered contraindicated to HRA by the delegated investigators.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Australia10 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Dr Michelle Thomas, MBBS, PhD, +618 70742790, michelle@adelaideprivate.com
Dr Michelle Thomas, MBBS, PhD
North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic
Cudgen, New South Wales, 2487
A/Professor Vincent Cornellise, MBBS, PhD, +612 66772850, Vincent.Cornelisse@health.nsw.gov.au
A/Professor Vincent Cornellise, MBBS, PhD
Taylor Square Private Clinic
Darlinghurst, New South Wales, 2010
Dr Mark O'Reilly, MBBS, +612 93316151, moreilly@tspc.com.au
Dr Mark O'Reilly, MBBS
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053
Professor Jason Ong, MBBS, PhD, +613 93416200, JOng@mshc.org.au
Professor Jason Ong, MBBS, PhD
Sydney Sexual Health Centre
Sydney, New South Wales, 2000
Dr Rick Varma, MB ChB, MRCP, +612 93827440, rick.varma@health.nsw.gov.au
Dr Rick Varma, MB ChB, MRCP
Easy Sydney Doctors
Sydney, New South Wales, 2010
Dr David Baker, MBBS, +612 93322531, dbaker@eastsydneydoctors.com.au
Dr David Baker, MBBS
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Dr Mark Bloch, MBBS, +612 93317228, Mark.Bloch@holdsworthhouse.com.au
Dr Mark Bloch, MBBS
St Vincent's Hospital, Sydney
Sydney, New South Wales, 2010
Prof Richard Hillman, MBChB, PhD, FRCP, +61283823707, Richard.Hillman@svha.org.au
Prof Richard Hillman, MBChB, PhD, FRCP
RPA Sexual Health
Sydney, New South Wales, 2050
Dr Rachel Burdon, MBBS, MPH, +612 95151200, Rachel.Burdon@health.nsw.gov.au
Dr Rachel Burdon, MBBS, MPH
Western Sydney Sexual Health Centre
Sydney, New South Wales, 2150
Prof David Lewis, MBBS, PhD, +612 97625388, david.lewis2@health.nsw.gov.au
Prof David Lewis, MBBS, PhD
About this study
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
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.
Read the detailed description
This multi-centred, order-randomised, controlled, cross-over clinical trial of self-versus clinician- collected swabs (SCS) and clinician-collected swabs (CCS), enrolling 700 participants across participating clinical trial recruitment sites in Australia. Participants will undertake SCS immediately followed by CCS, or vice versa, in an order-randomised manner with all participants completing both methods of collection. Both anal swabs will be tested for HRHPV, cytology, and methylation.
In the cervix, evidence suggests that a second swab taken on the same day may produce an inferior sample for cytology compared with the first swab. For this reason, studies comparing two swabs must control for the order of collection. In this trial, the order of the self-collected and clinician-collected anal swabs will be randomised. Randomisation will be stratified by clinical trial site.
Clinicians and participants will be unblinded to allow for swab collection; diagnostic and research laboratory staff, and research investigators who analyse the study outcomes will be blinded to both the order and method of collection for each swab.
Enrolment will continue until 700 participants have been randomised at a mixture of metropolitan and regional clinical trial sites. The study duration is 5 years.
Participants will be recruited via their regular HIV medical care at participating clinical trial sites.
Participants will be either gay or bisexual man (GBM) or trans women living with HIV aged 35 years or older, or all other people living with HIV aged 45 years or older. It is expected that most participants will be GBM, reflecting the Australian HIV epidemic but to ensure diversity, a minimum aggregate of 50 non- GBM living with HIV will be recruited per the inclusion criteria.
Participants who are HRHPV negative will exit the trial, unless they have been diagnosed with possible HSIL (pHSIL) or HSIL on cytology. Participants who are tested positive for HRHPV will be referred for high-resolution anoscopy (HRA). Participants who are tested negative for HRHPV but have pHSIL or HSIL diagnosed on cytology will be referred for high-resolution anoscopy (HRA).
During the HRA, the anoscopist will take small biopsies of any tissue suspected to have abnormal cells. The biopsy samples will undergo diagnostic histology.
Participants who are not diagnosed with high-grade squamous intraepithelial lesion (HSIL), will exit the trial. Participants who are diagnosed with HSIL but undergo treatment will exit the trial. Participants who are diagnosed with HSIL and do not receive treatment will have a 12-month Follow-up HRA then exit the trial.
- Conditions
- Anal Cancer, Human Papilloma Virus (HPV)
- Being tested
- Self-collected anal swab
- Keywords
- Anal cancer screening, Screening for HPV
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-collected anal swabOther
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 group | Role | What they receive |
|---|---|---|
| Arm A: Self-collected anal swab followed by clinician-collected anal swab | Experimental | Cross over Receives: Other: Self-collected anal swab |
| Arm B: Clinician-collected anal swab followed by self-collected anal swab | Experimental | Cross over Receives: Other: Self-collected anal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort.
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.
Measured: At Baseline.
Secondary outcomes (7)
To evaluate sample quality for cytology of self-collected ana swabs compared with clinician-collected anal swabs, in the eligible cohort.
To measure the proportion of self-collected anal swabs that have satisfactory sample quality for cytology, compared with the proportion of clinician-collected anal swabs that have satisfactory sample quality.
Measured: At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
To measure between self-collected and clinician-collected swabs, the level of agreement between HRHPV testing results.
Measured: At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
To measure between self-collected and clinician-collected swabs, prevalence of any HRHPV.
Measured: At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
To measure between self-collected and clinician-collected swabs, prevalence of HPV16.
Measured: At Baseline.
To compare the cytology findings of self-collected anal swabs compared with clinician-collected anal swabs, according to the modified Bethesda criteria in the eligible cohort.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, the level of agreement between cytology testing results.
Measured: At Baseline.
To compare the cytology findings of self-collected anal swabs compared with clinician-collected anal swabs, according to the modified Bethesda criteria in the eligible cohort.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of any cytological abnormality.
Measured: At Baseline.
To compare the cytology findings of self-collected anal swabs compared with clinician-collected anal swabs, according to the modified Bethesda criteria in the eligible cohort.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of cytological HSIL.
Measured: At Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The current recommended method of anal swab collection for anal cancer screening is clinician-collected swabs. The intervention is use of self-collected anal swabs, to evaluate whether these are as effective and acceptable as clinician-collected for anal cancer screening. Participants will have both swabs and the order of anal swab collection on the same day at the Baseline Visit will be randomised: either the self-collected swab first or the clinician-collected swab first.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD, Study chair, The Kirby Institute, University of New South Wales Sydney, AustraliaScientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS, Principal investigator, The Kirby Institute, University of New South Wales Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790601
- Sponsor's protocol ID
- HEPP 202601
- Other IDs
- APP2047111
- Acronym
- SWISH
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07790601
- Acronym / sponsor ID
- SWISH / HEPP 202601
- Conditions
- Anal Cancer, Human Papilloma Virus (HPV)
- Keywords
- Anal cancer screening, Screening for HPV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multi-centred, order-randomised, controlled, cross-over clinical trial of self-versus clinician- collected swabs (SCS) and clinician-collected swabs (CCS), enrolling 700 participants across participating clinical trial recruitment sites in Australia. Participants will undertake SCS immediately followed by CCS, or vice versa, in an order-randomised manner with all participants completing both methods of collection. Both anal swabs will be tested for HRHPV, cytology, and methylation.
In the cervix, evidence suggests that a second swab taken on the same day may produce an inferior sample for cytology compared with the first swab. For this reason, studies comparing two swabs must control for the order of collection. In this trial, the order of the self-collected and clinician-collected anal swabs will be randomised. Randomisation will be stratified by clinical trial site.
Clinicians and participants will be unblinded to allow for swab collection; diagnostic and research laboratory staff, and research investigators who analyse the study outcomes will be blinded to both the order and method of collection for each swab.
Enrolment will continue until 700 participants have been randomised at a mixture of metropolitan and regional clinical trial sites. The study duration is 5 years.
Participants will be recruited via their regular HIV medical care at participating clinical trial sites.
Participants will be either gay or bisexual man (GBM) or trans women living with HIV aged 35 years or older, or all other people living with HIV aged 45 years or older. It is expected that most participants will be GBM, reflecting the Australian HIV epidemic but to ensure diversity, a minimum aggregate of 50 non- GBM living with HIV will be recruited per the inclusion criteria.
Participants who are HRHPV negative will exit the trial, unless they have been diagnosed with possible HSIL (pHSIL) or HSIL on cytology. Participants who are tested positive for HRHPV will be referred for high-resolution anoscopy (HRA). Participants who are tested negative for HRHPV but have pHSIL or HSIL diagnosed on cytology will be referred for high-resolution anoscopy (HRA).
During the HRA, the anoscopist will take small biopsies of any tissue suspected to have abnormal cells. The biopsy samples will undergo diagnostic histology.
Participants who are not diagnosed with high-grade squamous intraepithelial lesion (HSIL), will exit the trial. Participants who are diagnosed with HSIL but undergo treatment will exit the trial. Participants who are diagnosed with HSIL and do not receive treatment will have a 12-month Follow-up HRA then exit the trial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The current recommended method of anal swab collection for anal cancer screening is clinician-collected swabs. The intervention is use of self-collected anal swabs, to evaluate whether these are as effective and acceptable as clinician-collected for anal cancer screening. Participants will have both swabs and the order of anal swab collection on the same day at the Baseline Visit will be randomised: either the self-collected swab first or the clinician-collected swab first.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Self-collected anal swab followed by clinician-collected anal swab | Experimental | Other: Self-collected anal swabCross over |
| Arm B: Clinician-collected anal swab followed by self-collected anal swab | Experimental | Other: Self-collected anal swabCross over |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Aged over 75 years of age at time of enrolment.
- Previously undergone an HRA.
- History of anal cancer and/or anal HSIL.
- 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.
- Concurrent malignancy requiring systemic therapy, or medical conditions otherwise considered contraindicated to HRA by the delegated investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-collected anal swabEach 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. | Other | Arm A: Self-collected anal swab followed by clinician-collected anal swab, Arm B: Clinician-collected anal swab followed by self-collected anal swab |
Primary outcome
Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort.
Time frame: 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.
7 secondary outcomes
To evaluate sample quality for cytology of self-collected ana swabs compared with clinician-collected anal swabs, in the eligible cohort.
Time frame: At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
Time frame: At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
Time frame: At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
Time frame: At Baseline.
To compare the cytology findings of self-collected anal swabs compared with clinician-collected anal swabs, according to the modified Bethesda criteria in the eligible cohort.
Time frame: At Baseline.
To compare the cytology findings of self-collected anal swabs compared with clinician-collected anal swabs, according to the modified Bethesda criteria in the eligible cohort.
Time frame: At Baseline.
To compare the cytology findings of self-collected anal swabs compared with clinician-collected anal swabs, according to the modified Bethesda criteria in the eligible cohort.
Time frame: At Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD study chair
The Kirby Institute, University of New South Wales Sydney, Australia
Scientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS principal investigator
The Kirby Institute, University of New South Wales Sydney, Australia
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-collected anal swab in people with Anal Cancer and Human Papilloma Virus (HPV), run by Kirby Institute at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD (+61293850900, Mpoynten@kirby.unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort. (time frame: At Baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.