HPV Self-sampling for Women Who do Not Attend the Organized Cervical Cancer Screening Programme (HERSELF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Adherence to HPV self-sampling in intervention 2 (opt-in) group
研究概览
简要总结
This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening.
An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post.
Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway.
详细描述
The goal of this randomized clinical trial is to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling to increase the adherence to cervical cancer screening in women who are overdue for cervical cancer screening, in comparison to the standard of care strategy.
The main questions this study aims to answer are:
- To test the effectiveness of an invitation strategy to improve the adherence to cervical cancer screening based on directly home-delivered HPV self-sampling tests + automated reminders, in comparison to the standard of care invitation.
- To test the effectiveness of an invitation strategy to improve the adherence to cervical cancer screening based on home-delivered HPV self-sampling tests using opt-in procedures for ordering the kit + automated reminders, in comparison to the standard of care invitation.
- To compare the cost-effectiveness between a) standard of care; b) directly home-delivered HPV self-sampling tests + automated reminders; and c) home-delivered HPV self-sampling tests using opt-in procedures for ordering the kit + automated reminders.
Eligible women will be randomized (1:1) into a control group and an intervention group:
- Control group: corresponds to the standard of care, which is an invitation to cervical cancer screening in a clinical setting, through a written letter, printed and sent by the primary healthcare unit where the women are registered.
- Intervention group: Women allocated to this group will be randomized (1:1) into two subgroups, described briefly as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 26 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 26 and 60 years old;
- •Women eligible for cervical cancer screening whose screening is at least 1 year overdue.
排除标准
- •No mobile phone number available at the National Health Service database;
- •Foreign mobile phone number;
- •No address available at the National Health Service database;
- •Foreign address.
结局指标
主要结局
Adherence to HPV self-sampling in intervention 2 (opt-in) group
时间窗: 45 and 90 days after the day the self-sampling kit is sent
Number of women who returned the self-sample in intervention 2 group divided by the number of women assigned to intervention 2 group
Adherence to conventional screening in control group
时间窗: 45 and 90 days after the conventional screening appointment date
Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group
Adherence to HPV self-sampling in intervention 1 (directly mailed) group
时间窗: 45 and 90 days after the day the self-sampling kit is sent
Number of women who returned the self-sample in intervention 1 group divided by the number of women assigned to intervention 1 group
Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group
时间窗: 45 and 90 days after the day the self-sampling kit is sent or 45 and 90 days after the conventional screening appointment date, as appropriate
The quotient of (Number of women in intervention 1 group who returned the self-sample divided by the women assigned to intervention 1 group) dividided by (Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group).
Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group
时间窗: 45 and 90 days after the day the self-sampling kit is sent or 45 and 90 days after the conventional screening appointment date, as appropriate
The quotient of (Number of women in intervention 2 group who returned the self-sample divided by the women assigned to intervention 2 group) dividided by (Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group).
次要结局
- Adherence to colposcopy in control group(45 and 90 days after the colposcopy appointment date)
- Adherence to colposcopy in intervention 1 (directly mailed) group(45 and 90 days after the colposcopy appointment date)
- Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 1 (directly mailed) group(Follow-up will end at 90 days)
- Adherence to colposcopy in intervention 2 (opt-in) group(45 and 90 days after the colposcopy appointment date)
- Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 2 (opt-in) group(Follow-up will end at 90 days)
- Adherence proportion to first follow-up step in intervention 1 (directly mailed) group VS Adherence proportion to first follow-up step in control group(45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate))
- Proportion of HR-HPV positivity in intervention 2 (opt-in) group among women who returned the self-sample(45 and 90 days after the day the self-sampling kit is sent)
- Adherence to first follow-up step in intervention 2 (opt-in) group(45 and 90 days after the clinician-sampling appointment date)
- Adherence to colposcopy in control group among women referred for colposcopy(45 and 90 days after the colposcopy appointment date)
- Adherence to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy(45 and 90 days after the colposcopy appointment date)
- Adherence to colposcopy in intervention 2 (opn-in) group among women referred for colposcopy(45 and 90 days after the colposcopy appointment date)
- Timelapse (in days) between the invitation to receive a self-sampling kit and the return of the opt-in answer, in intervention 2 (opt-in) group(Follow-up will end at 90 days)
- Adherence to first follow-up step in control group(45 and 90 days after the colposcopy appointment date)
- Adherence to first follow-up step in intervention 1 (directly mailed) group(45 and 90 days after the clinician-sampling appointment date)
- Adherence to first follow-up step in control group among women referred for follow-up(45 and 90 days after the colposcopy appointment date)
- Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up(45 and 90 days after the clinician-sampling appointment date)
- Adherence to first follow-up step in intervention 2 (opt-in) group among women referred for folow-up(45 and 90 days after the clinician-sampling appointment date)
- Adherence proportion to first follow-up step in intervention 2 (opt-in) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up(45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate))
- Adherence proportion to first follow-up step in intervention 2 (opt-in) group VS Adherence proportion to first follow-up step in control group(45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate))
- Adherence proportion to first follow-up step in intervention 1 (directly mailed) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up(45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate))
- Adherence proportion to colposcopy in intervention 1 (directly mailed) group VS Adherence proportion to colposcopy in control group(45 and 90 days after the colposcopy appointment date)
- Adherence proportion to colposcopy in intervention 2 (opt-in) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy(45 and 90 days after the colposcopy appointment date)
- Proportion of HR-HPV positivity in intervention 1 (directly mailed) group(45 and 90 days after the day the self-sampling kit is sent)
- Proportion of HR-HPV 16/18 positivity in control group among women who adhered to conventional screening(45 and 90 days after the conventional screening appointment date)
- Positive likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Specificity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Adherence proportion to colposcopy in intervention 2 (opt-in) group VS Adherence proportion to colposcopy in control group(45 and 90 days after the colposcopy appointment date)
- Proportion of HR-HPV positivity in control group(45 and 90 days after the conventional screening appointment date)
- Proportion of HR-HPV positivity in intervention 2 (opt-in) group(45 and 90 days after the day the self-sampling kit is sent)
- Proportion of HR-HPV positivity in control group among women who adhered to conventional screening(45 and 90 days after the conventional screening appointment date)
- Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group among women who returned the self-sample(45 and 90 days after the day the self-sampling kit is sent)
- Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group among women who returned the self-sample(45 and 90 days after the day the self-sampling kit is sent)
- Positive predictive value of self-sampling for the detection of HR-HPV, using clinician-sampling results as gold standard(90 days after clinicial-sampling appointment date)
- Accuracy of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Adherence proportion to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy(45 and 90 days after the colposcopy appointment date)
- Proportion of HR-HPV 16/18 positivity in control group(45 and 90 days after the conventional screening appointment date)
- Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group(45 and 90 days after the day the self-sampling kit is sent)
- Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group(45 and 90 days after the day the self-sampling kit is sent)
- Sensitivity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Negative likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Negative likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Proportion of HR-HPV positivity in intervention 1 (directly mailed) group among women who returned the self-sample(45 and 90 days after the day the self-sampling kit is sent)
- Negative likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Accuracy of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Sensitivity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Specificity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Positive likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Specificity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Positive likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Sensitivity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
- Accuracy of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard(90 days after the colposcopy appointment date)
研究者
Maria Margarida Martins Novais Teixeira
Medical Doctor
Instituto de Saude Publica da Universidade do Porto