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临床试验/NCT03713710
NCT03713710已完成不适用

Self-Sampling for HPV Testing in African American Women - Mississippi Delta

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2016年11月28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
335
试验地点
2
主要终点
adherence to cervical cancer screening

研究概览

简要总结

The purpose of this study is to examine the efficacy and costs of this patient-centered approach ("Choice" between two cervical cancer screening modalities) in adherence to cervical cancer screening as compared to the current standard of care within the public health system in Mississippi (Pap test at the local department -"Pap") among un/under-screened African American women in the Mississippi Delta using a theory-based, culturally relevant intervention implemented by Peer Health Educators (PHEs).

详细描述

OBJECTIVE

Our objective is to examine the efficacy and costs of a patient-centered approach ("Choice" between self-sampling and Pap test) in adherence to cervical cancer screening as compared to Pap test at the local health department ("Pap") among un/under-screened African American women in the Mississippi Delta.

HYPOTHESES: Women in the "Choice" arm will have a higher cervical cancer screening adherence as well as higher satisfaction than women assigned to the "Pap" arm; (2) Within the "Choice" arm, more women will choose and complete self-sampling than Pap test; and (3) The "Choice" intervention will be on average less costly and more cost-effective than the "Pap" intervention.

SPECIFIC AIMS: (1) To compare the impact of these two intervention approaches, "Choice" versus "Pap", on cervical cancer screening adherence through a group randomized controlled trial; (2) To compare patient satisfaction between the two intervention approaches; and (3) To compare the costs and cost-effectiveness of these two intervention approaches, "Choice" versus "Pap".

STUDY DESIGN: 12 towns will be randomized to either "Choice" or "Pap" (180 women/arm). Peer Health Educators (PHEs) will identify African American women who report not having undergone cervical cancer screening in the past three years and deliver a brief theory-based, cultural relevant educational session on cervical cancer and screening using a door-to-door approach. Women randomized to the "Pap" arm will be provided with information on how to schedule an appointment at the local health department. Women randomized to the "Choice" arm will be given the choice of attending the health department for a Pap test or self-collecting their own sample at home to be sent for HPV testing. PHEs will follow-up with women in either arm who have a positive test in order to assure diagnostic evaluation and care.

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
25 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • no personal history of cervical cancer
  • not have engaged in cervical cancer screening in the past four years

排除标准

  • 未提供

结局指标

主要结局

adherence to cervical cancer screening

时间窗: baseline to 30 days

adherence to cerivcal cancer screening by attending the Pap testing or returning the self-collected sample for HPV testing

次要结局

  • Satisfaction with the intervention(baseline to 6 months)

研究者

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

Isabel Scarinci

Primary Investigator

University of Alabama at Birmingham

研究点 (2)

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