Swabs in Screening for HPV (SWISH)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorKirby Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Self-collected anal swab
Other interventionEach 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.
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Arm A: Self-collected anal swab followed by clinician-collected anal swabExperimental treatment 1 intervention
Group B: Arm B: Clinician-collected anal swab followed by self-collected anal swabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: