Swabs in Screening for HPV (SWISH)

This multi‐centred, order‐randomised, controlled, cross‐over clinical trial ofself‐versus clinician‐ collected swabs (SCS) and clinician‐collected swabs (CCS),enrolling 700 participants across participating clinical trial recruitment sites inAustralia. Participants will undertake SCS immediately followed by CCS, or vice versa, inan 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 aninferior sample for cytology compared with the first swab. For this reason, studiescomparing two swabs must control for the order of collection. In this trial, the order ofthe self‐collected and clinician‐collected anal swabs will be randomised. Randomisationwill be stratified by clinical trial site.Clinicians and participants will be unblinded to allow for swab collection; diagnosticand research laboratory staff, and research investigators who analyse the study outcomeswill 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 ofmetropolitan and regional clinical trial sites. The study duration is 5 years.Participants will be recruited via their regular HIV medical care at participatingclinical trial sites.Participants will be either gay or bisexual man (GBM) or trans women living with HIV aged35 years or older, or all other people living with HIV aged 45 years or older. It isexpected that most participants will be GBM, reflecting the Australian HIV epidemic butto ensure diversity, a minimum aggregate of 50 non‐ GBM living with HIV will be recruitedper the inclusion criteria.Participants who are HRHPV negative will exit the trial, unless they have been diagnosedwith possible HSIL (pHSIL) or HSIL on cytology. Participants who are tested positive forHRHPV will be referred for high‐resolution anoscopy (HRA). Participants who are testednegative for HRHPV but have pHSIL or HSIL diagnosed on cytology will be referred forhigh‐resolution anoscopy (HRA).During the HRA, the anoscopist will take small biopsies of any tissue suspected to haveabnormal 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 undergotreatment will exit the trial. Participants who are diagnosed with HSIL and do notreceive treatment will have a 12‐month Follow‐up HRA then exit the trial.