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临床试验/NCT03551028
NCT03551028已完成不适用

Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by the Mobile

University of Virginia1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年7月1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
33
试验地点
1
主要终点
Acceptability of Self-Collection Paired With Mobile Mammography

研究概览

简要总结

Invasive cervical cancer incidence and mortality can be dramatically reduced through early detection and treatment, but many women do not complete screening at recommended intervals. Many low-income women in Virginia remain uninsured and are at significant risk of being medically underserved and failing to complete regular cervical cancer screening. Self-collection of specimens for HPV testing is an innovative approach that may increase access to cervical cancer screening in populations that do not participate in traditional clinic-based screening. Innovative delivery models are needed to reach at-risk populations. This study seeks to explore the acceptability and feasibility of pairing self-collection of HPV samples for DNA testing with mobile mammography in women living in rural Virginia.

详细描述

The proposed study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in rural Virginia. The procedures will be recruitment of under-screened women in rural Virginia to complete HPV testing using self-collection kits distributed through the mobile mammography unit. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •not pregnant

排除标准

  • •history of hysterectomy or pelvic RT non English speaking

研究组 & 干预措施

HPV self collection

Other

Pairing self-collection of HPV samples for DNA testing with women seeking mobile mammography.

干预措施: HPV self collection (Device)

结局指标

主要结局

Acceptability of Self-Collection Paired With Mobile Mammography

时间窗: 1 month (to allow for time to process samples and communicate results)

Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia specifically who were seeking a mammogram at an episodic clinic. The outcome measure of ACCEPTABILITY was measured through: participants who opted in, or uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.

Feasibility of Self-Collection for HPV Paired With Mobile Mammography

时间窗: 1 month (to allow for time to process samples and communicate results)

Assess the feasibility of self-collection for HPV testing among under-screened women in Southwest Virginia who were seeking a mammogram at an episodic clinic. FEASIBILITY was measured through: participant uptake of HPV self collection (yes/no); observations of clinic flow (i.e. how did this additional screening fit in with existing mammography services); and quality of samples collected (were any collected inaccurately or in a way that was impossible to detect).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma McKim Mitchell

Assistant Professor

University of Virginia

研究点 (1)

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