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Could Self-Swabs make anal cancer screening easier for people with HIV?

NCT ID NCT07790601

Knowledge-focused Sponsor: Kirby Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether people living with HIV can collect their own anal swabs for anal cancer screening, compared with swabs taken by a clinician. About 700 participants in Australia will provide both types of swabs, which will be checked for high-risk HPV and precancerous cells. Researchers will also test new biomarkers that might predict whether precancerous lesions could develop into anal cancer. The goal is to see if self-collection is a reliable option that could make screening more accessible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Self-collected anal swab compared with clinician-collected anal swab
What this could lead to
If self-collected swabs work as well as clinician-collected ones, more people living with HIV might get screened for anal cancer, potentially catching precancerous changes earlier.
What could go wrong
The trial is early and focuses on whether the swabs are valid for testing, not yet on preventing cancer. Self-collected swabs might not match clinician-collected ones in sample quality, and the results may not apply to all groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anal carcinoma anus neoplasm HIV infectious disease human papilloma virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anal cancer Human papilloma virus (HPV)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Easy Sydney Doctors

    Sydney, New South Wales, 2010, Australia

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010, Australia

  • Melbourne Sexual Health Centre

    Melbourne, Victoria, 3053, Australia

  • North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic

    Cudgen, New South Wales, 2487, Australia

  • RPA Sexual Health

    Sydney, New South Wales, 2050, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • St Vincent's Hospital, Sydney

    Sydney, New South Wales, 2010, Australia

  • Sydney Sexual Health Centre

    Sydney, New South Wales, 2000, Australia

  • Taylor Square Private Clinic

    Darlinghurst, New South Wales, 2010, Australia

  • Western Sydney Sexual Health Centre

    Sydney, New South Wales, 2150, Australia

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