[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653782":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":61,"studyPopulation":54,"armGroups":62,"interventions":72,"overallOfficials":78,"centralContacts":86,"locations":95,"responsibleParty":234,"collaborators":54,"id":236,"slug":237,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":238,"sex":244,"minAge":245,"maxAge":246,"enrollmentInfo":247,"targetDuration":54,"studyType":250,"phases":251,"briefSummary":253,"conditions":254,"keywords":257,"overallStatus":260,"whyStopped":54,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},{"fullName":5,"class":6},"Kirby Institute","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"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.","At Baseline.",[14,17,20,22,24,27,29],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":18,"description":21,"timeFrame":12},"To measure between self-collected and clinician-collected swabs, prevalence of any HRHPV.",{"measure":18,"description":23,"timeFrame":12},"To measure between self-collected and clinician-collected swabs, prevalence of HPV16.",{"measure":25,"description":26,"timeFrame":12},"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.",{"measure":25,"description":28,"timeFrame":12},"To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of any cytological abnormality.",{"measure":25,"description":30,"timeFrame":12},"To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of cytological HSIL.",[32,35,38,41,45],{"measure":33,"description":34,"timeFrame":12},"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.",{"measure":36,"description":37,"timeFrame":12},"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.",{"measure":39,"description":40,"timeFrame":12},"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.",{"measure":42,"description":43,"timeFrame":44},"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.","From Baseline through to Month 15.",{"measure":46,"description":47,"timeFrame":48},"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.","From Baseline until 5 years after the completion of the initial trial.",{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":54,"timePerspective":54,"maskingInfo":55},"RANDOMIZED","CROSSOVER","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.","SCREENING",null,{"masking":56,"maskingDescription":57,"whoMasked":58},"DOUBLE","Clinicians (care provider) 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.",[59,60],"INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nIn 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.\n\nClinicians 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.\n\nEnrolment will continue until 700 participants have been randomised at a mixture of metropolitan and regional clinical trial sites. The study duration is 5 years.\n\nParticipants will be recruited via their regular HIV medical care at participating clinical trial sites.\n\nParticipants 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.\n\nParticipants 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).\n\nDuring the HRA, the anoscopist will take small biopsies of any tissue suspected to have abnormal cells. The biopsy samples will undergo diagnostic histology.\n\nParticipants 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.",[63,69],{"label":64,"type":65,"description":66,"interventionNames":67},"Arm A: Self-collected anal swab followed by clinician-collected anal swab","EXPERIMENTAL","Cross over",[68],"Other: Self-collected anal swab",{"label":70,"type":65,"description":66,"interventionNames":71},"Arm B: Clinician-collected anal swab followed by self-collected anal swab",[68],[73],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":54},"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.",[64,70],[79,83],{"name":80,"affiliation":81,"role":82},"Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD","The Kirby Institute, University of New South Wales Sydney, Australia","STUDY_CHAIR",{"name":84,"affiliation":81,"role":85},"Scientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS","PRINCIPAL_INVESTIGATOR",[87,91],{"name":80,"role":88,"phone":89,"phoneExt":54,"email":90},"CONTACT","+61293850900","Mpoynten@kirby.unsw.edu.au",{"name":92,"role":88,"phone":93,"phoneExt":54,"email":94},"Ms Barbara Yeung, BHSc, MPH","+61293850879","byeung@kirby.unsw.edu.au",[96,115,130,145,156,167,178,190,202,218],{"facility":97,"status":54,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic","Cudgen","New South Wales","2487","Australia","AU",{"type":104,"coordinates":105},"Point",[106,107],153.55,-28.26667,{"lat":107,"lon":106},[110,114],{"name":111,"role":88,"phone":112,"phoneExt":54,"email":113},"A\u002FProfessor Vincent Cornellise, MBBS, PhD","+612 66772850","Vincent.Cornelisse@health.nsw.gov.au",{"name":111,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":116,"status":54,"city":117,"state":99,"zip":118,"country":101,"countryCode":102,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Taylor Square Private Clinic","Darlinghurst","2010",{"type":104,"coordinates":120},[121,122],151.21925,-33.87939,{"lat":122,"lon":121},[125,129],{"name":126,"role":88,"phone":127,"phoneExt":54,"email":128},"Dr Mark O'Reilly, MBBS","+612 93316151","moreilly@tspc.com.au",{"name":126,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":131,"status":54,"city":132,"state":99,"zip":133,"country":101,"countryCode":102,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Sydney Sexual Health Centre","Sydney","2000",{"type":104,"coordinates":135},[136,137],151.20732,-33.86785,{"lat":137,"lon":136},[140,144],{"name":141,"role":88,"phone":142,"phoneExt":54,"email":143},"Dr Rick Varma, MB ChB, MRCP","+612 93827440","rick.varma@health.nsw.gov.au",{"name":141,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":146,"status":54,"city":132,"state":99,"zip":118,"country":101,"countryCode":102,"cosmosGeoPoint":147,"geoPoint":149,"contacts":150},"Easy Sydney Doctors",{"type":104,"coordinates":148},[136,137],{"lat":137,"lon":136},[151,155],{"name":152,"role":88,"phone":153,"phoneExt":54,"email":154},"Dr David Baker, MBBS","+612 93322531","dbaker@eastsydneydoctors.com.au",{"name":152,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":157,"status":54,"city":132,"state":99,"zip":118,"country":101,"countryCode":102,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"Holdsworth House Medical Practice",{"type":104,"coordinates":159},[136,137],{"lat":137,"lon":136},[162,166],{"name":163,"role":88,"phone":164,"phoneExt":54,"email":165},"Dr Mark Bloch, MBBS","+612 93317228","Mark.Bloch@holdsworthhouse.com.au",{"name":163,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":168,"status":54,"city":132,"state":99,"zip":118,"country":101,"countryCode":102,"cosmosGeoPoint":169,"geoPoint":171,"contacts":172},"St Vincent's Hospital, Sydney",{"type":104,"coordinates":170},[136,137],{"lat":137,"lon":136},[173,177],{"name":174,"role":88,"phone":175,"phoneExt":54,"email":176},"Prof Richard Hillman, MBChB, PhD, FRCP","+61283823707","Richard.Hillman@svha.org.au",{"name":174,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":179,"status":54,"city":132,"state":99,"zip":180,"country":101,"countryCode":102,"cosmosGeoPoint":181,"geoPoint":183,"contacts":184},"RPA Sexual Health","2050",{"type":104,"coordinates":182},[136,137],{"lat":137,"lon":136},[185,189],{"name":186,"role":88,"phone":187,"phoneExt":54,"email":188},"Dr Rachel Burdon, MBBS, MPH","+612 95151200","Rachel.Burdon@health.nsw.gov.au",{"name":186,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":191,"status":54,"city":132,"state":99,"zip":192,"country":101,"countryCode":102,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"Western Sydney Sexual Health Centre","2150",{"type":104,"coordinates":194},[136,137],{"lat":137,"lon":136},[197,201],{"name":198,"role":88,"phone":199,"phoneExt":54,"email":200},"Prof David Lewis, MBBS, PhD","+612 97625388","david.lewis2@health.nsw.gov.au",{"name":198,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":203,"status":54,"city":204,"state":205,"zip":206,"country":101,"countryCode":102,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":104,"coordinates":208},[209,210],138.59863,-34.92866,{"lat":210,"lon":209},[213,217],{"name":214,"role":88,"phone":215,"phoneExt":54,"email":216},"Dr Michelle Thomas, MBBS, PhD","+618 70742790","michelle@adelaideprivate.com",{"name":214,"role":85,"phone":54,"phoneExt":54,"email":54},{"facility":219,"status":54,"city":220,"state":221,"zip":222,"country":101,"countryCode":102,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Melbourne Sexual Health Centre","Melbourne","Victoria","3053",{"type":104,"coordinates":224},[225,226],144.96332,-37.814,{"lat":226,"lon":225},[229,233],{"name":230,"role":88,"phone":231,"phoneExt":54,"email":232},"Professor Jason Ong, MBBS, PhD","+613 93416200","JOng@mshc.org.au",{"name":230,"role":85,"phone":54,"phoneExt":54,"email":54},{"type":235,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100653782","swabs-in-screening-for-hpv-swish-100653782",false,"NCT07790601","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","SWISH","Inclusion Criteria:\n\n1. Living with HIV.\n2. 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.\n3. Able to commit to and undertake all study procedures.\n4. Willing and able to provide informed consent, in any of the following languages:\n\ni. English. ii. Alternatively, use of the accredited translation service usually utilised in the participant's healthcare appointments.\n\nExclusion Criteria:\n\n1. Aged over 75 years of age at time of enrolment.\n2. Previously undergone an HRA.\n3. History of anal cancer and\u002For anal HSIL.\n4. 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.\n5. Concurrent malignancy requiring systemic therapy, or medical conditions otherwise considered contraindicated to HRA by the delegated investigators.","ALL","35 Years","75 Years",{"count":248,"type":249},700,"ESTIMATED","INTERVENTIONAL",[252],"NA","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.",[255,256],"Anal Cancer","Human Papilloma Virus (HPV)",[258,259],"Anal cancer screening","Screening for HPV","NOT_YET_RECRUITING","2026-08-25",{"date":263,"type":264},"2026-08-27","ACTUAL",{"date":266,"type":249},"2026-11-01",{"date":268,"type":249},"2030-12-31",{"name":5,"class":6},10]