Swabs in Screening for HPV (SWISH)

Sponsor
Kirby Institute
Study ID
NCT07790601
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Self-collected anal swab — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING

Arms

  • Experimental: Arm A: Self-collected anal swab followed by clinician-collected anal swab
    Cross over
  • Experimental: Arm B: Clinician-collected anal swab followed by self-collected anal swab
    Cross over

Primary Outcome Measure

Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort. [ Time Frame: At Baseline. ]

Central Contacts

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