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Swabs in Screening for HPV (SWISH)

NCT07790601 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-08-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD · The Kirby Institute, University of New South Wales Sydney, Australia

  • Scientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS · The Kirby Institute, University of New South Wales Sydney, Australia

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2030-08-31
Completion
2030-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790601 on ClinicalTrials.gov