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临床试验/NCT03856684
NCT03856684已完成不适用

Randomized Trial Evaluating Women's Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 10,400 人开始时间: 2020年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10,400
试验地点
1
主要终点
Participation / no participation to complete cervical cancer screening

研究概览

简要总结

Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS (Short Message Service) reminder.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
30 Years 至 66 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •women from 30 to 66 years old
  • •women living in french territorial division 37 ("Indre-et-Loire")
  • •women with a mobile phone in database
  • •women who do not perform a pap smear in the last 4 years
  • •women who do not answer to a first "invitation" letter to perform a pap smear

排除标准

  • •HPV cervical pathology during treatment
  • •Hysterectomy including cervix

研究组 & 干预措施

Self-sampling kit sent at home

Active Comparator

Sending of a vaginal self-sampling kit at home

干预措施: Self-sampling kit sent at home (Behavioral)

Self-sampling kit sent at home + SMS reminder

Experimental

Sending of a vaginal self-sampling kit at home + a SMS reminder is sent if the woman do not (in 2 months) :

  • perform a pap smear
  • or send her vaginal self-sample to the laboratory
  • or contact the screening center to inform to an exclusion reason

干预措施: Self-sampling kit sent at home + SMS reminder (Behavioral)

Letter offering a self-sampling kit "on request"+ SMS reminder

Experimental

Sending of letter offering a vaginal self-sampling kit. Women can ask for this kit on line, on our website or by calling us.

If they do ask for the kit, one kit is sending to their home.

For these women, a SMS reminder is sent if the woman do not (in 2 months) :

  • perform a pap smear
  • or send her vaginal self-sample to the laboratory
  • or contact the screening center to inform to an exclusion reason

干预措施: Letter offering a self-sampling kit "on request"+ SMS reminder (Behavioral)

SMS offering a self-sampling kit "on request"+ SMS reminder

Experimental

Sending of SMS offering a vaginal self-sampling kit. Women can ask for this kit on line, on our website or by calling us.

If they do ask for the kit, one kit is sending to their home.

For these women, a SMS reminder is sent if the woman do not (in 2 months) :

  • perform a pap smear
  • or send her vaginal self-sample to the laboratory
  • or contact the screening center to inform to an exclusion reason

干预措施: SMS offering a self-sampling kit "on request"+ SMS reminder (Behavioral)

结局指标

主要结局

Participation / no participation to complete cervical cancer screening

时间窗: 9 months after postal mail (with or without the kit) or SMS

Complete cervical cancer screening is defined as one of the followings : * perform a pap smear * perform a vaginal self-sampling with negative HR-HPV test * perform a vaginal self-sampling with noninterpretable HR-HPV test result followed by a control pap smear (nine-month extension to do the pap smear after the sending of the HPV result) * perform a vaginal self-sampling with positive HR-HPV test result followed by a control pap smear (nine-month extension to do the pap smear after the sending of the HPV result)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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