• Concordance and Acceptability of Self-screening Versus Screening by a Healthcare Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIV

  NCT06507917

  RecruitingInterventionalNot ApplicableUpdated Dec 11, 2025
• Screening Strategies Among High-risk Populations for Anal Cancer

  NCT06628570

  RecruitingInterventionalNot ApplicableUpdated Aug 26, 2026
• The Prevent Anal Cancer Self-Swab Study

  NCT03489707

  CompletedInterventionalNot ApplicableUpdated Nov 12, 2024
• Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV

  NCT01946139

  CompletedInterventionalNot ApplicableUpdated Nov 7, 2023
• Anal Cancer Screening Study

  NCT00914537

  CompletedObservationalUpdated Nov 6, 2020
• Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico

  NCT05074264

  Active, not recruitingInterventionalNot ApplicableUpdated Aug 24, 2026

ClinicalTrials.gov ID

NCT07790601

Lead Sponsor

Kirby InstituteOTHER_GOV

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

700Estimated

Last Update Posted

Aug 27, 2026Actual

Start Date

Nov 1, 2026Estimated

Primary Completion Date

Aug 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

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

Brief 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. 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.

• Anal Cancer
• Human Papilloma Virus (HPV)

• Self-collected anal swab

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Living with HIV.
2. 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.
3. Able to commit to and undertake all study procedures.
4. Willing and able to provide informed consent, in any of the following languages:

i. English. ii. Alternatively, use of the accredited translation service usually utilised in the participant's healthcare appointments.

Exclusion Criteria:

1. Aged over 75 years of age at time of enrolment.
2. Previously undergone an HRA.
3. History of anal cancer and/or anal HSIL.
4. 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.
5. Concurrent malignancy requiring systemic therapy, or medical conditions otherwise considered contraindicated to HRA by the delegated investigators.

Primary Purpose

Screening

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

Double

Lead Sponsor

Kirby InstituteOTHER_GOV

dbaker@eastsydneydoctors.com.au+612 93322531

Rachel.Burdon@health.nsw.gov.au+612 95151200