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Swabs in Screening for HPV (SWISH) (SWISH)

25 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

700

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD
  • Número de teléfono: +61293850900
  • Correo electrónico: Mpoynten@kirby.unsw.edu.au

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Cudgen, New South Wales, Australia, 2487
        • North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic
        • Contacto:
        • Investigador principal:
          • A/Professor Vincent Cornellise, MBBS, PhD
      • Darlinghurst, New South Wales, Australia, 2010
        • Taylor Square Private Clinic
        • Contacto:
          • Dr Mark O'Reilly, MBBS
          • Número de teléfono: +612 93316151
          • Correo electrónico: moreilly@tspc.com.au
        • Investigador principal:
          • Dr Mark O'Reilly, MBBS
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
        • Contacto:
        • Investigador principal:
          • Dr Mark Bloch, MBBS
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital, Sydney
        • Contacto:
        • Investigador principal:
          • Prof Richard Hillman, MBChB, PhD, FRCP
      • Sydney, New South Wales, Australia, 2000
        • Sydney Sexual Health Centre
        • Contacto:
        • Investigador principal:
          • Dr Rick Varma, MB ChB, MRCP
      • Sydney, New South Wales, Australia, 2050
        • RPA Sexual Health
        • Contacto:
        • Investigador principal:
          • Dr Rachel Burdon, MBBS, MPH
      • Sydney, New South Wales, Australia, 2010
        • Easy Sydney Doctors
        • Contacto:
        • Investigador principal:
          • Dr David Baker, MBBS
      • Sydney, New South Wales, Australia, 2150
        • Western Sydney Sexual Health Centre
        • Contacto:
        • Investigador principal:
          • Prof David Lewis, MBBS, PhD
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
        • Contacto:
        • Investigador principal:
          • Dr Michelle Thomas, MBBS, PhD
    • Victoria
      • Melbourne, Victoria, Australia, 3053
        • Melbourne Sexual Health Centre
        • Contacto:
          • Professor Jason Ong, MBBS, PhD
          • Número de teléfono: +613 93416200
          • Correo electrónico: JOng@mshc.org.au
        • Investigador principal:
          • Professor Jason Ong, MBBS, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm A: Self-collected anal swab followed by clinician-collected anal swab
Cross over
Otro: 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.
Experimental: Arm B: Clinician-collected anal swab followed by self-collected anal swab
Cross over
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort.
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To evaluate sample quality for cytology of self-collected ana swabs compared with clinician-collected anal swabs, in the eligible cohort.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: At Baseline.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of cytological HSIL.
At Baseline.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
To evaluate participant perception of self-collected anal swabs as an alternative to clinician-collected anal swabs.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Kirby Institute

Investigadores

  • Silla de estudio: Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD, The Kirby Institute, University of New South Wales Sydney, Australia
  • Investigador principal: Scientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS, The Kirby Institute, University of New South Wales Sydney, Australia

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

31 de agosto de 2030

Finalización del estudio (Estimado)

31 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

20 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de agosto de 2026

Publicado por primera vez (Actual)

27 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HEPP 202601
  • APP2047111 (Otro número de subvención/financiamiento: National Health and Medical Research Council, Australia)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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