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临床试验/NCT02970136
NCT02970136已完成不适用

Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention: South Florida Center for Reducing Health Disparities

University of Miami1 个研究点 分布在 1 个国家目标入组 754 人开始时间: 2017年4月11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
754
试验地点
1
主要终点
Percentage of Participants Who Are Screened for All Conditions

研究概览

简要总结

The purpose of this research study is to determine the best way to increase screening for cervical cancer, colorectal cancer, HIV, and Hepatitis C among under screened Hispanic, Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The investigator will compare home testing led by a community health worker (CHW) versus clinic testing guided by a CHW. Community Health Workers are people who have undergone several weeks of community outreach and health education training. During the study period the participant will continue to receive all of their regular medical care from their regular health care providers. If the participant does not have a health care provider, the Community Health Workers would be able to help in referring the participant for care at a local health care clinic located in their community.

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
50 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •live in one of the three target communities
  • •self-identify as Haitian, Hispanic and/or Black.
  • •be 50-64 years old
  • •need at least one of the four recommended screening services as per US Preventive Service Task Force 121 guidelines as follows: never having had a HIV test b) never having had a Hepatitis C Virus (HCV) test c) not having a Pap smear in the last three years d) not having had a colonoscopy in last 10 years and/or stool-based test in the last year.

排除标准

  • •plan to move out of the community during the next six months;
  • •current or prior enrollment (5 five years) in any research study that involved screening for these conditions.
  • •Are adults unable to consent
  • •Are individuals who are not yet adults (infants, children, teenagers)
  • •Pregnant women

研究组 & 干预措施

Home Based Screening

Experimental

The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker

干预措施: OraQuick Swab (Device)

Home Based Screening

Experimental

The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker

干预措施: Fecal Immunochemical Test (Device)

Home Based Screening

Experimental

The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker

干预措施: OraQuick Fingerstick (Device)

Home Based Screening

Experimental

The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker

干预措施: HPV Self-Sampling Test (Device)

Home Based Screening

Experimental

The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker

干预措施: Home Based Screening Tests (Other)

Clinic Based Screening

Active Comparator

The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests

干预措施: Standard Screening Tests (Other)

结局指标

主要结局

Percentage of Participants Who Are Screened for All Conditions

时间窗: Baseline

As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.

次要结局

  • Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months(Baseline, Up to 6 months)
  • Median Number of Screenings Completed(At baseline and at 6 months)

研究者

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

Olveen Carrasquillo

Professor of Medicine and Public Health Sciences

University of Miami

研究点 (1)

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