Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Detection of high-risk Human Papillomavirus (HPV) DNA
研究概览
简要总结
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%.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Virgo intacta
- •Pregnancy
- •History of cervical cancer, precancerous cervical lesions and total hysterectomy
结局指标
主要结局
Detection of high-risk Human Papillomavirus (HPV) DNA
时间窗: 3 months
Difference in detection of high-risk HPV DNA between 2 arms
次要结局
- Facilitators and barriers of uptake of cervical cancer screening(1 year)
- Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers(2 years)
- Cost-effectiveness of cervical cancer screening(2 years)
- Feasibility of self-sampling cervical cancer screening(1 year)
- Uptake of cervical cancer screening(3 months)
- Colposcopy referrals(2 years)
- Treatments for CIN 2, CIN 3 and cervical cancers(2 years)
- Risk factors for cervical cancer and CIN(2 years)
研究者
Ng Xin Rong
Family Physician
National Healthcare Group Polyclinics