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临床试验/NCT04557423
NCT04557423已完成不适用

Evidence-Based Approach to Empower Asian American Women in Cervical Cancer Screening

Fox Chase Cancer Center1 个研究点 分布在 1 个国家目标入组 797 人开始时间: 2021年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
797
试验地点
1
主要终点
Participation in screening

研究概览

简要总结

This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Asian American (Korean, Vietnamese, and Chinese) women. All women will receive an educational program and navigation assistance. Women in the intervention condition will also receive a self-sampling kit for self-collection of a cervical sample for HPV testing. The investigators will evaluate whether the inclusion of a self-sampling kit increases the proportion of Asian American women who participate in cervical cancer screening.

详细描述

Aim 1: Compare rates of providing a self-collected sample vs. obtaining clinic-based screening among 1100 Asian American women. It is hypothesized that the proportion of women in the HPV self-sampling program who provide a self-collected sample will be higher than the proportion of women in the clinic-based program who obtain clinic-based screening.

Aim 2: Examine mediators of participation. The investigators will examine both individual- and social/environmental-level factors associated with participation across both programs. It is hypothesized that higher levels of perceived self-efficacy, lower levels of embarrassment, and fewer barriers will be associated with higher rates of participation in both conditions. Further, it is hypothesized that women in the HPV self-sampling program will report greater self-efficacy, less embarrassment, and fewer barriers compared to women in the clinic-based program.

Aim 3: Assess the relative cost-effectiveness of HPV self-sampling vs. clinic-based screening. The investigators will conduct an incremental cost-effectiveness analysis from a societal perspective incorporating trial-based direct medical and participant-borne costs associated with HPV self-sampling vs. clinic-based screening. It is hypothesized that the self-sampling program will be less costly to implement and achieve a higher participation rate.

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

入选标准

  • Women who are of Asian race and self-identify as Korean, Vietnamese, or Chinese
  • are 30-65 years of age
  • are overdue for cervical cancer screening (e.g., no cytology-based screening within the past 3 years; no hrHPV testing either alone or in combination with cytology in the past 5 years)

排除标准

  • have a prior diagnosis of cervical cancer or cervical abnormality (e.g., dysplasia)
  • had a hysterectomy with removal of the cervix
  • have a compromised immune system (e.g., known HIV)
  • unable to provide informed consent

结局指标

主要结局

Participation in screening

时间窗: 6 months

The number of women who obtain clinic-based screening or return a self-collected sample

次要结局

  • Program delivery cost(6 months)

研究者

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

Carolyn Fang, PhD

Professor

Fox Chase Cancer Center

研究点 (1)

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