A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,327
- 试验地点
- 2
- 主要终点
- Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.
研究概览
简要总结
The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.
详细描述
The CHOice trial is a parallel randomised controlled, open label trial. Participants will be equally randomised into three arms: 1) Directly mailed a second reminder including a HPV self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be ordered by e-mail, by text message, by phone, or by website; and 3) Mailed a second reminder for a conventional practitioner-collected sample (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women resident in the Central Denmark Region who have not participate in cervical cancer screening after an invitation and one reminder
排除标准
- •Women younger than 30 years are not included due to the lower specificity of HPV DNA tests in younger women
研究组 & 干预措施
Intervention group 1
HPV self-sampling kit mailed directly
干预措施: HPV self-sampling kit mailed directly (Behavioral)
Intervention group 2
HPV self-sampling kit on demand
干预措施: HPV self-sampling kit on demand (Behavioral)
Intervention group 3
second reminder
干预措施: Second reminder (Behavioral)
结局指标
主要结局
Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.
时间窗: 90 days
Primary outcome will be the proportion of women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.
次要结局
- Women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out.(30,60 or 90 days)