Swabs in Screening for HPV (SWISH)

NCT07790601 | Not Yet Recruiting

• 2 other identifiers: HEPP 202601APP2047111
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 10

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.

Conditions

Anal Cancer; Human Papilloma Virus (HPV)

Keywords

Anal cancer screening; Screening for HPV

Outcome Measures

Primary Outcomes (1)

• Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort.

  To measure the percentage of self-collected anal swabs that are valid for HRHPV testing compared with clinician-collected anal swabs, as defined by internal control positivity.

  At Baseline.

Secondary Outcomes (7)

• To evaluate sample quality for cytology of self-collected ana swabs compared with clinician-collected anal swabs, in the eligible cohort.

  At Baseline.

• To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.

  At Baseline.

• To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.

  At Baseline.

• To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.

  At Baseline.

• To compare the cytology findings of self-collected anal swabs compared with clinician-collected anal swabs, according to the modified Bethesda criteria in the eligible cohort.

  At Baseline.

Other Outcomes (5)

• To evaluate participant perception of self-collected anal swabs as an alternative to clinician-collected anal swabs.

  At Baseline.

• To evaluate participant self-reported awareness of anal cancer, acceptability and willingness to complete self-collected swab for screening.

  At Baseline.

• To evaluate use of methylation testing, compared with anal cytology as a triage test for anal HSIL.

  At Baseline.

Study Arms (2)

Arm A: Self-collected anal swab followed by clinician-collected anal swab

EXPERIMENTAL

Cross over

Other: Self-collected anal swab

Arm B: Clinician-collected anal swab followed by self-collected anal swab

EXPERIMENTAL

Cross over

Other: Self-collected anal swab

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.

Arm A: Self-collected anal swab followed by clinician-collected anal swab; Arm B: Clinician-collected anal swab followed by self-collected anal swab

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living with HIV.
• 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.
• Able to commit to and undertake all study procedures.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (10)

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

Cudgen, New South Wales, 2487, Australia

Location

Taylor Square Private Clinic

Darlinghurst, New South Wales, 2010, Australia

Location

Sydney Sexual Health Centre

Sydney, New South Wales, 2000, Australia

Location

Easy Sydney Doctors

Sydney, New South Wales, 2010, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

St Vincent's Hospital, Sydney

Sydney, New South Wales, 2010, Australia

Location

RPA Sexual Health

Sydney, New South Wales, 2050, Australia

Location

Western Sydney Sexual Health Centre

Sydney, New South Wales, 2150, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Melbourne Sexual Health Centre

Melbourne, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD

  The Kirby Institute, University of New South Wales Sydney, Australia

  STUDY CHAIR

• Scientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS

  The Kirby Institute, University of New South Wales Sydney, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD

CONTACT

+61293850900; Mpoynten@kirby.unsw.edu.au

Ms Barbara Yeung, BHSc, MPH

CONTACT

+61293850879; byeung@kirby.unsw.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinicians (care provider) 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.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The current recommended method of anal swab collection for anal cancer screening is clinician-collected swabs. The intervention is use of self-collected anal swabs, to evaluate whether these are as effective and acceptable as clinician-collected for anal cancer screening. Participants will have both swabs and the order of anal swab collection on the same day at the Baseline Visit will be randomised: either the self-collected swab first or the clinician-collected swab first.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

AU (10)