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临床试验/NCT06136702
NCT06136702招募中不适用

EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study

University Ghent5 个研究点 分布在 4 个国家目标入组 1,048 人开始时间: 2022年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,048
试验地点
5
主要终点
Uptake of cervical cancer screening

研究概览

简要总结

This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).

详细描述

ELEVATE, a five-year project conducted by an international research alliance led by Ghent University, aims to develop a new test and approach for cervical cancer screening in hard-to-reach populations. The test will combine self-sampling with a new low-cost, portable measurement device and will be validated in dedicated screening trials in Belgium, Brazil, Ecuador, and Portugal. The ELEVATE project targets women in Europe and Latin America who have never been screened or are not regularly screened. These women have a higher risk of developing cervical cancer. The project is supported by the European Union's Horizon 2020 Framework Programme for Research and Innovation Action, project number 825747.

To address the gaps in cervical cancer screening, the ELEVATE project is developing a screening strategy to make cervical screening more accessible to hard-to-reach women. This strategy will include the introduction of a new on-site HPV self-sampling screening tool and a portable testing device, able to detect the presence of HPV and cancer biomarker proteins. This portable, low-cost, on-site HPV testing tool will allow to streamline follow-up care for women at risk of developing cervical cancer.

This study is part of the ELEVATE project and takes place in hard-to-reach communities, focusing on socio-economically vulnerable women to assess the acceptability of educational sessions and self-sampling in these communities. This study includes a two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).

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
25 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • are between the ages of 25 to 65 years of age, in line with the European Guidelines for initiating and stopping cervical cancer screening
  • (ever been) sexually active;
  • not diagnosed or in treatment for cervical cancer;
  • not having had a hysterectomy
  • not being pregnant
  • Speaking the local language

排除标准

  • younger than 25 years old or older than 65 years old
  • diagnosed or in treatment for cervical cancer
  • having had a hysterectomy
  • being pregnant

结局指标

主要结局

Uptake of cervical cancer screening

时间窗: First encounter (day 0) and 3 months follow-up (day 90)

Compare the on-site uptake of self-sampling (arm2) with uptake of standard care (follow-up of arm1)

次要结局

  • Attitudes towards HPV self-sampling(First encounter (day 0))
  • User's experiences of HPV self-sampling(First encounter (day 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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