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Swabs in Screening for HPV (SWISH) (SWISH)

25 août 2026 mis à jour par: Kirby Institute

Randomised Controlled Trial of Self-collected vs Clinician-collected Anal Swabs for Anal Cancer Screening in People Living With HIV (PLHIV) in Australia

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

700

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Australie
    • New South Wales
      • Cudgen, New South Wales, Australie, 2487
        • North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic
        • Contact:
        • Chercheur principal:
          • A/Professor Vincent Cornellise, MBBS, PhD
      • Darlinghurst, New South Wales, Australie, 2010
        • Taylor Square Private Clinic
        • Contact:
        • Chercheur principal:
          • Dr Mark O'Reilly, MBBS
      • Sydney, New South Wales, Australie, 2010
        • Holdsworth House Medical Practice
        • Contact:
        • Chercheur principal:
          • Dr Mark Bloch, MBBS
      • Sydney, New South Wales, Australie, 2010
        • St Vincent's Hospital, Sydney
        • Contact:
        • Chercheur principal:
          • Prof Richard Hillman, MBChB, PhD, FRCP
      • Sydney, New South Wales, Australie, 2000
        • Sydney Sexual Health Centre
        • Contact:
        • Chercheur principal:
          • Dr Rick Varma, MB ChB, MRCP
      • Sydney, New South Wales, Australie, 2050
        • RPA Sexual Health
        • Contact:
        • Chercheur principal:
          • Dr Rachel Burdon, MBBS, MPH
      • Sydney, New South Wales, Australie, 2010
        • Easy Sydney Doctors
        • Contact:
        • Chercheur principal:
          • Dr David Baker, MBBS
      • Sydney, New South Wales, Australie, 2150
        • Western Sydney Sexual Health Centre
        • Contact:
        • Chercheur principal:
          • Prof David Lewis, MBBS, PhD
    • South Australia
      • Adelaide, South Australia, Australie, 5000
        • Royal Adelaide Hospital
        • Contact:
        • Chercheur principal:
          • Dr Michelle Thomas, MBBS, PhD
    • Victoria
      • Melbourne, Victoria, Australie, 3053
        • Melbourne Sexual Health Centre
        • Contact:
          • Professor Jason Ong, MBBS, PhD
          • Numéro de téléphone: +613 93416200
          • E-mail: JOng@mshc.org.au
        • Chercheur principal:
          • Professor Jason Ong, MBBS, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Dépistage
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm A: Self-collected anal swab followed by clinician-collected anal swab
Cross over
Autre: 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.
Expérimental: Arm B: Clinician-collected anal swab followed by self-collected anal swab
Cross over
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort.
Délai: At Baseline.
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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
To evaluate sample quality for cytology of self-collected ana swabs compared with clinician-collected anal swabs, in the eligible cohort.
Délai: At Baseline.
To measure the proportion of self-collected anal swabs that have satisfactory sample quality for cytology, compared with the proportion of clinician-collected anal swabs that have satisfactory sample quality.
At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
Délai: At Baseline.
To measure between self-collected and clinician-collected swabs, the level of agreement between HRHPV testing results.
At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
Délai: At Baseline.
To measure between self-collected and clinician-collected swabs, prevalence of any HRHPV.
At Baseline.
To compare the HRHPV findings of self-collected anal swabs compared with clinician-collected anal swabs, in the eligible cohort.
Délai: At Baseline.
To measure between self-collected and clinician-collected swabs, prevalence of HPV16.
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.
Délai: At Baseline.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, the level of agreement between cytology testing results.
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.
Délai: At Baseline.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of any cytological abnormality.
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.
Délai: At Baseline.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of cytological HSIL.
At Baseline.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
To evaluate participant perception of self-collected anal swabs as an alternative to clinician-collected anal swabs.
Délai: At Baseline.
To measure distribution of participant responses on the acceptability and feasibility of self-collected anal swabs in future screening, measured via the Participant Reported Experience Measures instrument.
At Baseline.
To evaluate participant self-reported awareness of anal cancer, acceptability and willingness to complete self-collected swab for screening.
Délai: At Baseline.
Interview data will be evaluated using standard qualitative analysis, including thematic analysis.
At Baseline.
To evaluate use of methylation testing, compared with anal cytology as a triage test for anal HSIL.
Délai: At Baseline.
To compare sensitivity and specificity of methylation testing compared with anal cytology, for predicting histologically confirmed HSIL.
At Baseline.
To evaluate anal HSIL persistence at 12-month follow-up HRA, compared with Diagnostic HRA by Baseline anal swab methylation status.
Délai: From Baseline through to Month 15.
To measure the proportion of participants diagnosed with HSIL at Diagnostic HRA who have persistent HSIL at 12-month follow-up HRA, stratified by Baseline anal swab methylation status.
From Baseline through to Month 15.
To evaluate long-term anal cancer outcomes, for participants that consent to data linkage.
Délai: From Baseline until 5 years after the completion of the initial trial.
Evaluation of anal cancer diagnoses against HRHPV status, histological findings and methylation testing results.
From Baseline until 5 years after the completion of the initial trial.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kirby Institute

Les enquêteurs

  • Chaise d'étude: Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD, The Kirby Institute, University of New South Wales Sydney, Australia
  • Chercheur principal: Scientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS, The Kirby Institute, University of New South Wales Sydney, Australia

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

31 août 2030

Achèvement de l'étude (Estimé)

31 décembre 2030

Dates d'inscription aux études

Première soumission

20 août 2026

Première soumission répondant aux critères de contrôle qualité

25 août 2026

Première publication (Réel)

27 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HEPP 202601
  • APP2047111 (Autre subvention/numéro de financement: National Health and Medical Research Council, Australia)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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