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临床试验/NCT07011836
NCT07011836招募中不适用

Enhancing the Effectiveness of Community Health Workers to Reduce Cervical Cancer Disparities in African American Women

ISA Associates, Inc.4 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
288
试验地点
4
主要终点
Completion of Cervical Cancer Screening

研究概览

简要总结

The goal of this clinical trial is to test whether an interactive, video-based patient navigation program can improve cervical cancer screening among African American women who are currently overdue for screening.

The main questions it aims to answer are:

Can an interactive video navigation tool (mNav), when paired with in-person navigation, improve screening adherence compared to a standard educational video alone?

Does the intervention improve knowledge, reduce barriers, and increase intentions to get screened?

Researchers will compare participants who receive both the interactive video (guided by an on-screen navigator) and in-person navigation to those who receive only a standard educational video to see if the tailored support increases screening rates.

Participants will:

Complete two phone surveys (one at the beginning and one six months later)

Be randomly assigned to one of two groups:

One group will receive an interactive video experience tailored to their concerns plus support from an in-person navigator

The other group will receive a standard educational video designed for African American women

Have their clinic records reviewed six months later to check for cervical cancer screening completion

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

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

入选标准

  • Black or African American woman
  • Nonadherent to USPSTF cervical cancer screening guidelines (no Pap test in the past 3 years or no HPV test in the past 5 years)
  • Age 21 to 65 years old
  • Not currently pregnant
  • No history of hysterectomy
  • Access to a mobile phone capable of receiving text messages and watching video content

排除标准

  • 未提供

研究组 & 干预措施

Intervention Group

Experimental

Participants use an interactive, personalized video-based navigation tool (mNav) and receive navigator support.

干预措施: mNav Interactive Video + Navigator (Behavioral)

Education Control Group

Active Comparator

Participants view a general cervical cancer education video made for Black women, without personalized content or navigator support.

干预措施: Educational Video (Behavioral)

结局指标

主要结局

Completion of Cervical Cancer Screening

时间窗: Within 6 months of enrollment

Whether participants completed cervical cancer screening, as verified through medical record review. Screening includes a Pap test, HPV test, or co-test, consistent with current guidelines.

次要结局

  • Cervical Cancer Screening Intention(Baseline and 6-month follow-up)
  • Cervical Cancer Knowledge Scale(Baseline and 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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