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Swabs in Screening for HPV (SWISH) (SWISH)

25 августа 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

700

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD
  • Номер телефона: +61293850900
  • Электронная почта: Mpoynten@kirby.unsw.edu.au

Учебное резервное копирование контактов

  • Имя: Ms Barbara Yeung, BHSc, MPH
  • Номер телефона: +61293850879
  • Электронная почта: byeung@kirby.unsw.edu.au

Места учебы

  • Австралия
    • New South Wales
      • Cudgen, New South Wales, Австралия, 2487
        • North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic
        • Контакт:
        • Главный следователь:
          • A/Professor Vincent Cornellise, MBBS, PhD
      • Darlinghurst, New South Wales, Австралия, 2010
        • Taylor Square Private Clinic
        • Контакт:
          • Dr Mark O'Reilly, MBBS
          • Номер телефона: +612 93316151
          • Электронная почта: moreilly@tspc.com.au
        • Главный следователь:
          • Dr Mark O'Reilly, MBBS
      • Sydney, New South Wales, Австралия, 2010
        • Holdsworth House Medical Practice
        • Контакт:
        • Главный следователь:
          • Dr Mark Bloch, MBBS
      • Sydney, New South Wales, Австралия, 2010
        • St Vincent's Hospital, Sydney
        • Контакт:
          • Prof Richard Hillman, MBChB, PhD, FRCP
          • Номер телефона: +61283823707
          • Электронная почта: Richard.Hillman@svha.org.au
        • Главный следователь:
          • Prof Richard Hillman, MBChB, PhD, FRCP
      • Sydney, New South Wales, Австралия, 2000
        • Sydney Sexual Health Centre
        • Контакт:
        • Главный следователь:
          • Dr Rick Varma, MB ChB, MRCP
      • Sydney, New South Wales, Австралия, 2050
        • RPA Sexual Health
        • Контакт:
        • Главный следователь:
          • Dr Rachel Burdon, MBBS, MPH
      • Sydney, New South Wales, Австралия, 2010
        • Easy Sydney Doctors
        • Контакт:
        • Главный следователь:
          • Dr David Baker, MBBS
      • Sydney, New South Wales, Австралия, 2150
        • Western Sydney Sexual Health Centre
        • Контакт:
        • Главный следователь:
          • Prof David Lewis, MBBS, PhD
    • South Australia
      • Adelaide, South Australia, Австралия, 5000
        • Royal Adelaide Hospital
        • Контакт:
        • Главный следователь:
          • Dr Michelle Thomas, MBBS, PhD
    • Victoria
      • Melbourne, Victoria, Австралия, 3053
        • Melbourne Sexual Health Centre
        • Контакт:
          • Professor Jason Ong, MBBS, PhD
          • Номер телефона: +613 93416200
          • Электронная почта: JOng@mshc.org.au
        • Главный следователь:
          • Professor Jason Ong, MBBS, PhD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Скрининг
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Arm A: Self-collected anal swab followed by clinician-collected anal swab
Cross over
Другой: 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.
Экспериментальный: Arm B: Clinician-collected anal swab followed by self-collected anal swab
Cross over
Другой: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort.
Временное ограничение: 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.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
To evaluate sample quality for cytology of self-collected ana swabs compared with clinician-collected anal swabs, in the eligible cohort.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: At Baseline.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of cytological HSIL.
At Baseline.

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
To evaluate participant perception of self-collected anal swabs as an alternative to clinician-collected anal swabs.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Kirby Institute

Следователи

  • Учебный стул: Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD, The Kirby Institute, University of New South Wales Sydney, Australia
  • Главный следователь: Scientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS, The Kirby Institute, University of New South Wales Sydney, Australia

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 ноября 2026 г.

Первичное завершение (Оцененный)

31 августа 2030 г.

Завершение исследования (Оцененный)

31 декабря 2030 г.

Даты регистрации исследования

Первый отправленный

20 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

25 августа 2026 г.

Первый опубликованный (Действительный)

27 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • HEPP 202601
  • APP2047111 (Другой номер гранта/финансирования: National Health and Medical Research Council, Australia)

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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