An interventional study of Self-collected anal swab in Anal Cancer and Human Papilloma Virus (HPV), sponsored by Kirby Institute. Not yet recruiting at 10 sites in Australia. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Kirby Institute · Not applicable, Interventional, and Screening
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.
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.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 700 is above the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
i. English. ii. Alternatively, use of the accredited translation service usually utilised in the participant's healthcare appointments.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cross over
Other: Self-collected anal swab
Cross over
Other: 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.
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.
Time frame: At Baseline.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, the level of agreement between cytology testing results.
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.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of any cytological abnormality.
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.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of cytological HSIL.
Time frame: At Baseline.
To evaluate participant perception of self-collected anal swabs as an alternative to clinician-collected anal swabs.
To measure distribution of participant responses on the acceptability and feasibility of self-collected anal swabs in future screening, measured via the Participant Reported Experience Measures instrument.
Time frame: At Baseline.
To evaluate participant self-reported awareness of anal cancer, acceptability and willingness to complete self-collected swab for screening.
Interview data will be evaluated using standard qualitative analysis, including thematic analysis.
Time frame: At Baseline.
To evaluate use of methylation testing, compared with anal cytology as a triage test for anal HSIL.
To compare sensitivity and specificity of methylation testing compared with anal cytology, for predicting histologically confirmed HSIL.
Time frame: At Baseline.
To evaluate anal HSIL persistence at 12-month follow-up HRA, compared with Diagnostic HRA by Baseline anal swab methylation status.
To measure the proportion of participants diagnosed with HSIL at Diagnostic HRA who have persistent HSIL at 12-month follow-up HRA, stratified by Baseline anal swab methylation status.
Time frame: From Baseline through to Month 15.
To evaluate long-term anal cancer outcomes, for participants that consent to data linkage.
Evaluation of anal cancer diagnoses against HRHPV status, histological findings and methylation testing results.
Time frame: From Baseline until 5 years after the completion of the initial trial.
Start is estimated for Nov 2026; primary completion for Aug 2030, 45 months later.
Of 39 interventional studies with no phase under Anus Neoplasms, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 17. This study's planned 45 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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