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Swabs in Screening for HPV (SWISH) (SWISH)

2026年8月25日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

700

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 澳大利亚
    • New South Wales
      • Cudgen、New South Wales、澳大利亚、2487
        • North Coast Sexual Health and HIV Services, Tweed Valley Sexual Health Clinic
        • 接触：
        • 首席研究员：
          • A/Professor Vincent Cornellise, MBBS, PhD
      • Darlinghurst、New South Wales、澳大利亚、2010
        • Taylor Square Private Clinic
        • 接触：
        • 首席研究员：
          • Dr Mark O'Reilly, MBBS
      • Sydney、New South Wales、澳大利亚、2010
        • Holdsworth House Medical Practice
        • 接触：
        • 首席研究员：
          • Dr Mark Bloch, MBBS
      • Sydney、New South Wales、澳大利亚、2010
        • St Vincent's Hospital, Sydney
        • 接触：
        • 首席研究员：
          • Prof Richard Hillman, MBChB, PhD, FRCP
      • Sydney、New South Wales、澳大利亚、2000
        • Sydney Sexual Health Centre
        • 接触：
        • 首席研究员：
          • Dr Rick Varma, MB ChB, MRCP
      • Sydney、New South Wales、澳大利亚、2050
        • RPA Sexual Health
        • 接触：
        • 首席研究员：
          • Dr Rachel Burdon, MBBS, MPH
      • Sydney、New South Wales、澳大利亚、2010
        • Easy Sydney Doctors
        • 接触：
        • 首席研究员：
          • Dr David Baker, MBBS
      • Sydney、New South Wales、澳大利亚、2150
        • Western Sydney Sexual Health Centre
        • 接触：
        • 首席研究员：
          • Prof David Lewis, MBBS, PhD
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Royal Adelaide Hospital
        • 接触：
        • 首席研究员：
          • Dr Michelle Thomas, MBBS, PhD
    • Victoria
      • Melbourne、Victoria、澳大利亚、3053
        • Melbourne Sexual Health Centre
        • 接触：
          • Professor Jason Ong, MBBS, PhD
          • 电话号码：+613 93416200
          • 邮箱：JOng@mshc.org.au
        • 首席研究员：
          • Professor Jason Ong, MBBS, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：放映
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm A: Self-collected anal swab followed by clinician-collected anal swab
Cross over
其他：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.
实验性的：Arm B: Clinician-collected anal swab followed by self-collected anal swab
Cross over
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Compare the sample validity of self-collected anal swabs with clinician-collected anal swabs, for HRHPV, in the eligible cohort.
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
To evaluate sample quality for cytology of self-collected ana swabs compared with clinician-collected anal swabs, in the eligible cohort.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：At Baseline.
To measure between self-collected and clinician-collected swabs according to modified Bethesda criteria, prevalence of cytological HSIL.
At Baseline.

其他结果措施

结果测量
措施说明
大体时间
To evaluate participant perception of self-collected anal swabs as an alternative to clinician-collected anal swabs.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kirby Institute

调查人员

  • 学习椅：Dr Isobel Mary Poynten, MBBS, MPH, DCH PhD、The Kirby Institute, University of New South Wales Sydney, Australia
  • 首席研究员：Scientia Prof Andrew Grulich, MBBS, PhD, FAFPHM, FAAHMS、The Kirby Institute, University of New South Wales Sydney, Australia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2030年8月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2026年8月20日

首先提交符合 QC 标准的

2026年8月25日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HEPP 202601
  • APP2047111 (其他赠款/资助编号：National Health and Medical Research Council, Australia)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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