Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings

Обзор

Primary objective of the study is to determine the extent that offering of self-sampling in addition to clinician-sampling Human Papillomavirus (HPV) DNA testing will increase detection of HPV DNA through an increase in uptake rates of cervical cancer screening as compared to offering clinician-sampling HPV DNA testing alone. The hypothesis is that offering additional self-sampling will increase the detection of high-risk HPV DNA by at least 7.7%.

Подробное описание

This study is a pragmatic, multi-center, 1:1 randomized controlled trial designed to evaluate the impact of self-sampling HPV DNA testing on clinical outcomes and cost-effectiveness in cervical cancer screening. The trial will compare 2 approaches to HPV DNA testing within public primary care settings.

Participants in the intervention arm will first be offered a clinician-sampling HPV DNA test. If they decline, they will be offered the option of self-sampling HPV DNA test. The control arm will follow the standard protocol of offering only the conventional clinician-sampling HPV DNA test, reflecting the current standard of care in cervical cancer screening.

This study seeks to provide robust evidence on whether self-sampling can improve clinical outcomes, be cost-effective and be feasibility implemented in routine public primary healthcare settings. The findings are expected to inform future guidelines and policies for cervical cancer screening programs.

Вмешательства

• Диагностический тест Self-sampled HPV DNA testing
  Participants will be offered HPV DNA testing done through self-sampling (using self-sampling HPV DNA kits to obtain a mid-vaginal swab)
• Диагностический тест Clinician-sampled HPV DNA test
  Participants will be offered HPV DNA testing through clinician sampling (clinician-sampling (speculum examination by a nurse to obtain a cervical swab)

Первичные конечные точки

• Detection of high-risk Human Papillomavirus (HPV) DNA [Срок оценки: 3 months]

Вторичные конечные точки (8)

• Uptake of cervical cancer screening [Срок оценки: 3 months]
• Colposcopy referrals [Срок оценки: 2 years]
• Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers [Срок оценки: 2 years]
• Treatments for CIN 2, CIN 3 and cervical cancers [Срок оценки: 2 years]
• Cost-effectiveness of cervical cancer screening [Срок оценки: 2 years]
• Facilitators and barriers of uptake of cervical cancer screening [Срок оценки: 1 year]
• Feasibility of self-sampling cervical cancer screening [Срок оценки: 1 year]
• Risk factors for cervical cancer and CIN [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 30-69 years old female Singapore citizens
• Due for cervical cancer screening
• Engaged in sexual intercourse before
• Able to give informed consent
• Able to read and communicate in English, Chinese or Malay

Критерии исключения

• Virgo intacta
• Pregnancy
• History of cervical cancer, precancerous cervical lesions and total hysterectomy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Сингапур · 1 центр

• National Healthcare Group Polyclinics — Singapore

Публикации

• Ng XR, Quek IP, Pereira MJ, Molina JA, Ngeow J, Wong SKW. Randomised controlled trial evaluating the impact of different methods of HPV DNA testing for cervical cancer screening in Singapore's primary care settings: a study protocol. BMJ Open. 2025 Mar 24;15(3):e095091. doi: 10.1136/bmjopen-2024-095091. PMID 40132819

Идентификаторы

NCT: NCT06528184 · 2024/00194 · SCS-GRA-2023-00253

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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