Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 920
- 试验地点
- 4
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.
详细描述
Primary Objectives:
The overall purpose of this protocol is to evaluate the feasibility and acceptability of CHW-delivered selfsample HPV testing (CHW-SS) to increase cervical cancer screening among women in RGV and other low- resource communities in Texas.
The specific aims of this protocol are to:
Specific Aim 1: Determine the feasibility of CHW-SS in the RGV and other low-resource communities in Texas (i.e., reach, screening uptake, notification of test results).
Specific Aim 2: Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV and other low-resource communities in Texas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Currently resident in RGV or other low-resource community in Texas
- •Stated willingness to comply with all study procedures
- •Females; Age ≥25 years
- •Have no history of hysterectomy with removal of the cervix
- •Have no history of cervical cancer or high-grade dysplasia
- •Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Unable to communicate in English or Spanish
- •Lack valid telephone contact information
- •Report being currently pregnant.
研究组 & 干预措施
PRECEDE-PROCEED
To identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up.
干预措施: PRECEDE-PROCEED (Behavioral)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: through study completion; an average 1 year.
次要结局
未报告次要终点