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临床试验/NCT02121548
NCT02121548已完成不适用

Research Project of the South Florida Center for Reducing Cancer Disparities (SUCCESS): Testing CHWs and HPV Self-Sampling to Increase Cervical Cancer Screening Among Minority Immigrants in Miami-Dade County:

University of Miami2 个研究点 分布在 1 个国家目标入组 601 人开始时间: 2011年10月10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
601
试验地点
2
主要终点
Having had a pap smear in last 6 months

研究概览

简要总结

Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened for cervical cancer than the general population. One promising approach is outreach strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW programs, many women remain unscreened. In our NCI Community Networks sponsored project, we are testing an approach that combines CHWs with self sampling for the human papilloma virus (HPV) as a screening strategy among such hard to reach populations.

详细描述

Building on our existing community partnerships, we propose a randomized CBPR study among 600 women in three underserved communities in Miami-Dade County to determine optimal approaches to increase cervical cancer screening among Caribbean and other underserved women. The study is a three arm study with 200 women randomized at each site over 3 years. Women in the control group would be exposed to NCI approved culturally and linguistically appropriate outreach and educational materials on cervical cancer screening. Our two specific aims are 1) to determine if as compared to our control group, women randomized to the community health worker intervention group consisting one on one health education and facilitation of referrals to existing screening programs results in increase proportion of women who are screened 2) to determine if as compared to the CHW group, women randomized to a CHW intervention with the addition of a home based self-sampling strategy results in an additional increase in proportion of women who are screened versus the CHW group without HPV sampling. Secondary outcomes include comparisons of a) measures of access to care (health insurance, having a usual source of care, and visit to provider in six months) b) cost of providing the intervention in order to determine the cost of recruiting an individual woman into screening c) among women having abnormal screens, time to follow-up and further testing.

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
Single (Outcomes Assessor)

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

  • Haitian, Hispanic or African American women
  • ages 30-65 years
  • not having had a pap smear in the last three years
  • live in Miami-Dade County

排除标准

  • having had a hysterectomy
  • history of cervical cancer
  • plan to move out of the neighborhood during the next six months
  • are enrolled in any other cancer prevention/outreach related study

研究组 & 干预措施

Outreach

Placebo Comparator

Gets outreach materials and info on where to get screened by CHW.

干预措施: CHW Outreach (Behavioral)

CHW Outreach

Active Comparator

Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation

干预措施: CHW Outreach and HPV Self-sampling (Behavioral)

CHW Outreach and HPV Self-Sampling

Active Comparator

Same as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling

干预措施: CHW Outreach (Behavioral)

结局指标

主要结局

Having had a pap smear in last 6 months

时间窗: 6 months

Primary Outcome: The primary outcome is patient self-reporting on whether they had a Pap smear of HPV testing done since the initial evaluation. As an additional analysis, patients whom were contacted by phone but do no wish to return for follow-up evaluation will be asked by phone if they had the Pap Smear of HPV testing done.

次要结局

  • Cervical Cancer Knowledge and Access to Care(6 months)

研究者

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

Olveen Carrasquillo

Chief Division of General Internal Medicine

University of Miami

研究点 (2)

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